Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER)

February 19, 2024 updated by: Pfizer

PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER

The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1401

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Cordoba, Argentina, X5016KEH
    - Hospital Privado Centro Medico de Cordoba
  - Cordoba, Argentina, X5004HFP
    - Clinica Universidad Reina Fabiola
  - La Rioja, Argentina, F5300C0E
    - Centro Oncologico Riojano Integral (CORI)
- Buenos Aires
  - Berazategui, Buenos Aires, Argentina, B1884BBF
    - COIBA(Centro de Oncologia e Investigacion Buenos Aires)
  - Caba, Buenos Aires, Argentina, C1019ABS
    - Centro Medico Austral(OMI)
  - Caba, Buenos Aires, Argentina, C1120AAT
    - Centro de Urología
  - Caba, Buenos Aires, Argentina, C1199BB
    - Hospital Italiano de Buenos Aires
- Santa FE
  - Rosario, Santa FE, Argentina, CP2000
    - Sanatorio Parque
  - Rosario, Santa FE, Argentina, S200KZE
    - Instituto de Oncologia de Rosario
Australia
- Australian Capital Territory
  - Garran, Australian Capital Territory, Australia, 2605
    - The Canberra Hospital
- New South Wales
  - Albury, New South Wales, Australia, 2640
    - Border Medical Oncology Research Unit
  - Albury, New South Wales, Australia, 2640
    - The Border Cancer Hospital Dispensary
  - Albury, New South Wales, Australia, 2640
    - The Border Cancer Hospital
  - Concord, New South Wales, Australia, 2139
    - Sydney cancer centre
  - Lismore, New South Wales, Australia, 2480
    - Epic Pharmacy
  - Lismore, New South Wales, Australia, 2480
    - North Coast Cancer Institute
  - North Ryde, New South Wales, Australia, 2109
    - Macquarie University Hospital
  - North Ryde, New South Wales, Australia, 2109
    - Macquarie University
  - Port Macquarie, New South Wales, Australia, 2444
    - Mid North Coast Cancer Institute
  - Port Macquarie, New South Wales, Australia, 2444
    - Epic Pharmacy Port Macquarie base hospital
  - St Leonards, New South Wales, Australia, 2065
    - Royal North Shore Hospital
  - Tweed Heads, New South Wales, Australia, 2485
    - The Tweed Hospital
  - Wahroonga, New South Wales, Australia, 2076
    - Sydney Adventist Hospital
  - Wahroonga, New South Wales, Australia, 2076
    - Australian Clinical Trials
  - Waratah, New South Wales, Australia, 2298
    - Calvary Mater Newcastle
  - Westmead, New South Wales, Australia, 2145
    - Westmead Hospital
- Queensland
  - Auchenflower, Queensland, Australia, 4066
    - Icon Cancer Care Wesley
  - Auchenflower, Queensland, Australia, 4066
    - River City Pharmacy - APHS
  - Chermside, Queensland, Australia, 4032
    - Icon Cancer Care Chermside
  - South Brisbane, Queensland, Australia, 4101
    - Icon Cancer Care South Brisbane
  - South Brisbane, Queensland, Australia, 4101
    - Integrated Clinical Oncology Network (ICON)
  - Southport, Queensland, Australia, 4215
    - Tasman Oncology Research Pty Ltd
  - Southport, Queensland, Australia, 4215
    - Icon Cancer Care Southport
  - Woolloongabba, Queensland, Australia, 4102
    - Princess Alexandra Hospital
- South Australia
  - Kurralta Park, South Australia, Australia, 5037
    - Adelaide Cancer Centre
  - Kurralta Park, South Australia, Australia, 5037
    - Cancer Care SA Pty Ltd
  - Kurralta Park, South Australia, Australia, 5037
    - Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson
  - Kurralta park, South Australia, Australia, 5037
    - Ashford Cancer Centre Research
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Box Hill Hospital (Eastern Health)
  - Box Hill, Victoria, Australia, 3128
    - Eastern Clinical Research Unit (Eastern Health)
  - Brighton, Victoria, Australia, 3186
    - Cabrini Hospital Brighton
  - Clayton, Victoria, Australia, 3168
    - Monash Medical Centre
  - Heidelberg, Victoria, Australia, 3084
    - Austin Health, Austin Hospital
  - Malvern, Victoria, Australia, 3144
    - Cabrini Hospital Malvern
  - Malvern, Victoria, Australia, 3144
    - Cabrini Hospital- Education and Research Precinct
  - Melbourne, Victoria, Australia, 3000
    - Peter MacCallum Cancer Centre
  - St Albans, Victoria, Australia, 3021
    - Sunshine Hospital
Austria
- - Vienna, Austria, 1090
    - Isotopix, Ambulatorium fuer Nuklearmedizin
  - Vienna, Austria, 1090
    - Medizinische Universitaet Wien, Universitaetsklinik fuer Innere Medizin I
  - Vienna, Austria, 1120
    - Diagnosezentrum Meidling GesmbH
- Upper Austria
  - Linz, Upper Austria, Austria, 4010
    - Krankenhaus Barmherzige Schwestern Linz, Abteilung Radiologie
  - Linz, Upper Austria, Austria, 4010
    - Krankenhaus Barmherzige Schwestern Linz, Abteilung Urologie
  - Linz, Upper Austria, Austria, 4010
    - St. Vincent's Hospital, PET - CT Center
Belgium
- - Bruxelles, Belgium, 1070
    - Clinique Universitaire de Bruxelles Hopital Erasme
  - Gent, Belgium, 9000
    - Vzw Algemeen Ziekenhuis Maria Middelares
  - Leuven, Belgium, 3000
    - Universitaire Ziekenhuizen Leuven
  - Liege, Belgium, 4000
    - Centre Hospitalier Universitaire de Liege, Site du Sart-Tilman
- West-vlaanderen
  - Kortrijk, West-vlaanderen, Belgium, 8500
    - Algemeen Ziekenhuis Groeninge
Brazil
- - Rio de Janeiro, Brazil, 20551-030
    - Hospital Universitario Pedro Ernesto - UERJ
  - Rio de Janeiro, Brazil, 22271-110
    - Oncologia Rede D'Or
- Bahia
  - Salvador, Bahia, Brazil, 41253-190
    - Hospital Sao Rafael
- Parana
  - Curitiba, Parana, Brazil, 81520-060
    - Liga Paranaense de Combate ao cancer / Hospital Erasto Gaertner
- RIO Grande DO SUL
  - Ijui, RIO Grande DO SUL, Brazil, 98700-000
    - Associacao Hospital de Caridade de Ijui
  - Passo Fundo, RIO Grande DO SUL, Brazil, 99010-260
    - Hospital da Cidade de Passo Fundo
  - Porto Alegre, RIO Grande DO SUL, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre
  - Porto Alegre, RIO Grande DO SUL, Brazil, 90430-090
    - CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
  - Porto Alegre, RIO Grande DO SUL, Brazil, 90610-000
    - Hospital São Lucas da PUCRS
- RJ
  - Rio de Janeiro, RJ, Brazil, 22.281-100
    - Instituto D'Or de Pesquisa e Ensino (IDOR)
- SAO Paulo
  - Jau, SAO Paulo, Brazil, 17210-080
    - Hospital Amaral Carvalho - Fundacao Dr. Amaral Carvalho
  - Jau, SAO Paulo, Brazil, 17210-120
    - Fundacao Dr. Amaral Carvalho
  - Jau, SAO Paulo, Brazil, 17210-120
    - Fundacao Dr.Amaral Carvalho
  - Sao Paulp, SAO Paulo, Brazil, 05652-900
    - Hospital Israelita Albert Einstein
- SP
  - Campinas, SP, Brazil, 13083-970
    - Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
  - Santo Andre, SP, Brazil, 09060-650
    - Centro de Estudos e Pesquisas em Hematologia e Oncologia (CEPHO)
  - Sao Paulo, SP, Brazil, 04039-901
    - IAMSPE-Inst. de Assist. ao Servidor Publico Estadual
Canada
- - Quebec, Canada, G1R 2J6
    - CHU de Québec
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - Vancouver Prostate Centre
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - Manitoba Prostate Centre CancerCare Manitoba
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - NS Health Authority, Queen Elizabeth II Health Sciences Centre
- Ontario
  - Barrie, Ontario, Canada, L4M 7G1
    - The Male/Female Health and Research Centre
  - Hamilton, Ontario, Canada, L8N 4A6
    - McMaster Institute of Urology @ St. Joseph's Healthcare Hamilton
  - Kitchener, Ontario, Canada, N2N 2B9
    - Urology Associates / Urologic Medical Research
  - London, Ontario, Canada, N6A 4L6
    - London Regional Cancer Program - Victoria Hospital, London Health Sciences Centre(LHSC)
  - London, Ontario, Canada, N6A 5W9
    - Urology Reasearch - Victoria Hospital, London Health Sciences Centre(LHSC)
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Health Sciences Centre
  - Toronto, Ontario, Canada, M5G2M9
    - University Health Network- Princess Margaret Cancer Centre
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H3
    - Urology South Shore Research
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Centre
  - Montreal, Quebec, Canada, H2X 3E4
    - Centre Hospitalier de l'Université de Montréal
Chile
- - Santiago, Chile, 7500836
    - Fundacion Arturo Lopez Perez
  - Santiago, Chile, 7630370
    - Centro de Investigaciones Clinicas Vina Del Mar
  - Temuco, Chile, 4810469
    - Instituto Clinico Oncologico del Sur (ICOS)
  - Vina del Mar, Chile, 2540364
    - Instituto Oncologico Ltda.
  - Vina del Mar, Chile, 2540488
    - Centro de Investigaciones Clinicas
China
- - Hong Kong, China
    - UNIMED Medical Institute Limited
  - Tianjin, China, 300211
    - The Second Hospital of Tianjin Medical University
- Beijing
  - Beijing, Beijing, China, 100034
    - Peking University First Hospital
  - Beijing, Beijing, China, 100191
    - Peking University Third Hospital
  - Beijing, Beijing, China, 100142
    - Beijing Cancer Hospital
  - Beijing, Beijing, China, 100730
    - Peking Union Medical College Hospital
  - Beijing, Beijing, China, 100730
    - Beijing Hospital
- Chongqing
  - Chongqing, Chongqing, China, 400030
    - Chongqing Cancer Hospital
- Guangdong
  - Guangzhou, Guangdong, China, 510120
    - The First Affiliated Hospital of Guangzhou Medical University
- Hubei
  - Wuhan, Hubei, China, 430030
    - Zhongnan Hospital of Wuhan University
- Jiangsu
  - Nanjing, Jiangsu, China, 210029
    - Jiangsu Province Hospital
  - Nanjing, Jiangsu, China, 210009
    - Jiangsu Cancer Hospital
  - Nanjing, Jiangsu, China, 210008
    - Office of Hongqian Guo
  - Suzhou, Jiangsu, China, 215004
    - The Second Affiliated Hospital of Soochow University
  - Wuxi, Jiangsu, China, 214023
    - WuXi People's Hospital
- Shandong
  - Qingdao, Shandong, China, 266071
    - Qingdao Municipal Hospital (East Hospital)
- Shanghai
  - Shanghai, Shanghai, China, 200032
    - Fudan University Shanghai Cancer Center
  - Shanghai, Shanghai, China, 200040
    - HuaShan Hospital Fudan University
  - Shanghai, Shanghai, China, 200080
    - Shanghai First People's Hospital
  - Shanghai, Shanghai, China, 200092
    - Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
  - Shanghai, Shanghai, China, 200433
    - Shanghai Changhai Hospital
- Shanxi
  - Xi'an, Shanxi, China, 710061
    - The First Affiliated Hospital of Xi'an Jiaotong University
- Zhejiang
  - Hangzhou, Zhejiang, China, 310009
    - The Second Affiliated Hospital of Zhejiang University School of Medicine
  - Wenzhou, Zhejiang, China, 325000
    - The First Affiliated Hosptial of Wenzhou Medical University
Denmark
- - Arhus N, Denmark, 8200
    - Aarhus University Hospital
  - Copenhagen, Denmark, 2100
    - Rigshospitalet
  - Frederiksberg, Denmark, 2000
    - Frederiksberg Hospital
  - Herlev, Denmark, 2730
    - Herlev Hospital
  - Odense C, Denmark, 5000
    - Odense University Hospital
  - Vejle, Denmark, 7100
    - Vejle Sygehus
- N
  - Copenhagen, N, Denmark, 2200
    - Copenhagen Prostate Cancer Center
- Norrebro
  - Copenhagen, Norrebro, Denmark, 2200
    - Rigshospitalet 7521
Finland
- - Helsinki, Finland, 00180
    - Docrates Syöpäsairaala
  - Helsinki, Finland, 00290
    - Helsingin yliopistollinen keskussairaala, Meilahden sairaala
  - Oulu, Finland, 90220
    - Oulun yliopistollinen sairaala
  - Pori, Finland, 28500
    - Satakunnan Keskussairaala
  - Tampere, Finland, 33520
    - Tampereen yliopistollinen sairaala
France
- - Angers Cedex 2, France, 49055
    - Institut de Cancérologie de l'Ouest - Paul Papin
  - Avignon, Cedex 9, France, 84918
    - Institut Sainte Catherine
  - Bordeaux Cedex, France, 33076
    - Institut Bergonié
  - Bordeaux Cedex, France, 33076
    - Urologic Oncology Department- Institut Bergonie - Centre regional de Lutte contre le Cancer
  - Brest, France, 29609
    - CHRU de Brest
  - Brest, France, 29200
    - CHU Brest Hopital Morvan
  - Brest, France, 29200
    - Cabinet de Radiologie
  - Brest, France, 29200
    - Clinique pasteur Lancroze
  - Brest, France, 29200
    - Clinique Pasteur-Lanroze
  - Colmar, France, 68024
    - Hôpitaux Civils de Colmar
  - Colmar Cedex, France, 68024
    - Hôpital Pasteur
  - Dijon, France, 21000
    - Centre Regional de lutte Contre le Cancer Georges Francois Leclerc
  - Le Mans,Cedex, France, 72000
    - Clinique Victor Hugo
  - Lille, France, 59037
    - Hopital Calude Huriez - CHU Lille
  - Lyon, France, 69008
    - Centre de Medecine Nucleaire LUMEN
  - Lyon Cedex, France, 69008
    - Centre Léon Bérard
  - Lyon Cedex 03, France, 69437
    - Hopital Edouard Herriot - CHU Lyon
  - Marseille, France, 13915 Cedex 20
    - Hôpital Nord
  - Montpellier Cedex, France, 34298
    - ICM Val d'Aurelle
  - Paris, Cedex 15, France, 75908
    - Hôpital Européen Georges Pompidou
  - Pierre Benite, France, 69495
    - Centre Hospitalier Lyon Sud
  - Poitiers, Cedex, France, 86021
    - CHU Poitiers - Hôpital la Milétrie
  - Saint-Herblain Cedex, France, 44805
    - Institut de Cancerologie de I'Ouest - Rene Gauducheau
  - Toulouse, France, 31059 Cedex 9
    - Institut Claudius Regaud
  - Toulouse Cedex 3, France, 31076
    - Clinique Pasteur
  - Toulouse Cedex 3, France, 31076
    - Clinique Pasteur - CIMOF
  - Toulouse Cedex 3, France, 31076
    - Clinique Pasteur- Service Imagerie et Radiologie
  - Toulouse Cedex 9, France, 31059
    - IUCT-Oncopole
- Alsace
  - STRASBOURG Cedex, Alsace, France, FR-67091
    - Hôpitaux Universitaires de Strasbourg - Hôpital Civil
- Bas-rhin
  - Strasbourg, Bas-rhin, France, 67000
    - Centre Paul Strauss
  - Strasbourg, Bas-rhin, France, 67000
    - Clinique Sainte Anne
  - Strasbourg, Bas-rhin, France, 67000
    - Societe MIM, Clinique Sainte Anne
- Paris
  - Paris Cedex, Paris, France, 75005
    - Institut Curie
- Rhone
  - Pierre Benite Cedex, Rhone, France, 69495
    - Centre Hospitalier Lyon Sud
- VAL DE Marne
  - Villejuif Cedex, VAL DE Marne, France, 94805
    - Institut Gustave Roussy
Germany
- - Berlin, Germany, 12200
    - Charite, Campus Benjamin Franklin
  - Berlin, Germany, 12200
    - Charite, Universitaetsmedizin Berlin
  - Hamburg, Germany, 20246
    - Martini-Klinik am UKE GmbH
  - Kirchheim, Germany, 73230
    - Diagnostikzentrum Esslingen
- Baden-wuerttemberg
  - Nuertingen, Baden-wuerttemberg, Germany, 72622
    - Studienpraxis Urologie
- Baden-wurttemberg
  - Mannheim, Baden-wurttemberg, Germany, 68167
    - Universitatsmedizin Mannheim, Medizinische Fakultat Mannheim der Universitat Heidelberg
- Niedersachsen
  - Braunschweig, Niedersachsen, Germany, 38102
    - MVZ Zentrum fuer Diagnostische Radiologie und Nuklearmedizin Braunschweig GmbH
  - Braunschweig, Niedersachsen, Germany, 38126
    - Staedtisches Klinikum Braunschweig
  - Hannover, Niedersachsen, Germany, 30625
    - Hannover Medical School
  - Hannover, Niedersachsen, Germany, 30625
    - Medizinische Hochschule Hannover
- Nordrhein-westfalen
  - Aachen, Nordrhein-westfalen, Germany, 52057
    - RWTH University Aachen
  - Aachen, Nordrhein-westfalen, Germany, 52074
    - Uniklinik der RWTH Aachen
  - Aachen, Nordrhein-westfalen, Germany, D-52074
    - Clinic of Radiology
- Saxony
  - Dresden, Saxony, Germany, 01307
    - Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Greece
- - Athens, Greece, 11526
    - General Hospital of Athens"Korgialeneio-Benakeio EES".Urology Clinic
  - Athens, Greece, 11528
    - General Hospital of Athens "Alexandra", Therapeutic Clinic
  - Larissa, Greece, 41110
    - University General Hospital of Larissa, Urology Department
  - Patra, Greece, 26504
    - University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
  - Thessaloniki, Greece, 56429
    - General Hospital" Papageorgiou",B' Univ.Urology Clinic
- Crete
  - Heraklion, Crete, Greece, 71110
    - University General Hospital of Heraklion, Urology Clinic
Hong Kong
- - Hong Kong, Hong Kong
    - Queen Mary Hospital
  - Hong Kong, Hong Kong
    - Tuen Mun Hospital
  - Shatin, Hong Kong
    - Prince of Wales Hospital
Italy
- - Cremona, Italy, 26100
    - Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
  - Cremona, Italy, 26100
    - Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
  - Cremona, Italy, 26100
    - Medicina Nucleare, Azienda Socio Sanitaria Territoriale di Cremona
  - Cremona, Italy, 26100
    - Servizio di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
  - Faenza (RA), Italy, 48018
    - U.O. di Oncologia, Ospedale Civile Degli Infermi
  - Faenza (RA), Italy, 48018
    - U.O. di Radiologia, Ospedale Civile degli Infermi
  - Lugo (RA), Italy, 48022
    - U.O. di Oncologia, Ospedale Civile Umberto I
  - Lugo (RA), Italy, 48022
    - U.O. di Radiologia, Ospedale Civile Umberto I
  - Meldola (FC), Italy, 47014
    - Laboratorio Farmaci Antiblastici
  - Meldola (FC), Italy, 47014
    - UO Radiologia
  - Meldola (FC), Italy, 47014
    - U.O. Oncologia Medica
  - Milano, Italy, 20132
    - Dipartimento di Radiologia, Ospedale San Raffaele
  - Milano, Italy, 20132
    - Servizio di Farmacia, Ospedale San Raffaele
  - Milano, Italy, 20132
    - U.O. di Medicina Nucleare e Centro PET, Ospedale San Raffaele
  - Milano, Italy, 20132
    - U.O. di Urologia, Ospedale San Raffaele
  - Milano, Italy, 20133
    - Farmacia Studi Clinici e Sperimentali, Fondazione IRCCS Istituto Nazionale dei Tumori
  - Milano, Italy, 20133
    - S.C. di Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale dei Tumori
  - Milano, Italy, 20133
    - S.C. Diagnostica Radiologica 2, Fondazione IRCCS Istituto Nazionale dei Tumori
  - Milano, Italy, 20141
    - Divisione di Radiologia, Istituto Europeo di Oncologia
  - Milano, Italy, 20141
    - Reparto Oncologia Medica Urogenitale e Cervico Facciale, Istituto Europeo di Oncologia
  - Milano, Italy, 20141
    - Servizio Farmacia, Istituto Europeo di Oncologia
  - Modena, Italy, 41124
    - Farmacia Interna, Azienda Ospedaliero-Universitaria Policlinico di Modena
  - Modena, Italy, 41124
    - Medicina Nucleare, Azienda Ospedaliero-Universitaria Policlinico di Modena
  - Modena, Italy, 41124
    - Radiologia I, Azienda Ospedaliero-Universitaria Policlinico di Modena
  - Napoli, Italy, 80131
    - U.O.S.C. di Oncologia Medica, A.O.R.N. "A. Cardarelli"
  - Orbassano (TO), Italy, 10043
    - Farmacia Ospedaliera, AOU San Luigi Gonzaga
  - Orbassano (TO), Italy, 10043
    - SCDU Oncologia Medica II Pad, AOU San Luigi Gonzaga
  - Orbassano (TO), Italy, 10043
    - SCDU Radiodiagnostica, AOU San Luigi Gonzaga
  - Orbassano (TO), Italy, 10043
    - SS Medicina Nucleare, AOU San Luigi Gonzaga
  - Padova, Italy, 35128
    - Farmacia, Istituto Oncologico Veneto (IOV)
  - Padova, Italy, 35128
    - IRCCS - Istituto Oncologico Veneto (IOV), UOC Oncologia Medica 1
  - Padova, Italy, 35128
    - Medicina Nucleare, Istituto Oncologico Veneto (IOV)
  - Padova, Italy, 35128
    - UOC Radiodiagnostica Oncologica, Istituto Oncologico Veneto (IOV)
  - Ravenna, Italy, 48121
    - Ospedale Santa Maria Delle Croci
  - Ravenna, Italy, 48121
    - Servizio di Farmacia, AUSL di Ravenna
  - Ravenna, Italy, 48121
    - Servizio di Radiologia, AUSL di Ravenna
  - Roma, Italy, 00152
    - Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica
  - Trento, Italy, 38122
    - U.O. di Oncologia Medica, Ospedale Santa Chiara
  - Trento, Italy, 38122
    - U.O. Radiologia, Ospedale Santa Chiara
  - Trento, Italy, 38122
    - U.O. Farmacia, Ospedale Santa Chiara
- FC
  - Forli, FC, Italy, 47121
    - Laboratorio Medicina Nucleare-Ospedale G.B. Morgagni-Pierantoni
Korea, Republic of
- - Incheon, Korea, Republic of, 21565
    - Gachon University Gil Medical Center
  - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital, Yonsei University Health System
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center
  - Seoul, Korea, Republic of, 06273
    - Gangnam Severance Hospital, Yonsei University Health System
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
    - National Cancer Center
- Jeonnam
  - Hwasun-gun, Jeonnam, Korea, Republic of, 58128
    - Chonnam National University Hwasun Hospital
Malaysia
- - Kuala Lumpur, Malaysia, 50586
    - Hospital Kuala Lumpur
  - Kuala Lumpur, Malaysia, 59100
    - University Malaya Medical Centre
- Kuala Lumpur
  - Cheras, Kuala Lumpur, Malaysia, 56000
    - Universiti Kebangsaan Malaysia Medical Centre
- Sarawak
  - Kuching, Sarawak, Malaysia, 93586
    - Sarawak General Hospital
- Selangor Darul Ehsan
  - Subang Jaya, Selangor Darul Ehsan, Malaysia, 47500
    - Subang Jaya Medical Centre Sdn. Bhd.
Netherlands
- - Amsterdam, Netherlands, 1066 CX
    - Netherlands Cancer Institute
  - Dordrecht, Netherlands, 3318 AT
    - Albert Schweitzer Ziekenhuis
  - Groningen, Netherlands, 9700 RB
    - University Medical Center Groningen
  - Nijmegen, Netherlands, 6525 GA
    - Radboud University Nijmegen Medical Centre
- AZ
  - Maastricht, AZ, Netherlands, 5202
    - Maastricht University Medical Centre
- Noord-brabant
  - Eindhoven, Noord-brabant, Netherlands, 5623 EJ
    - Catharina Ziekenhuis
New Zealand
- - Auckland, New Zealand, 1023
    - Cancer and Blood Research
  - Hamilton, New Zealand, 3214
    - Waikato Urology Research LTD
- Canterbury
  - Christchurch, Canterbury, New Zealand, 8140
    - Canterbury District Health Board
- Manawatu
  - Palmerston North, Manawatu, New Zealand, 4414
    - Palmerston North Hospital
Poland
- - Gdansk, Poland, 80-952
    - Uniwersyteckie Centrum Kliniczne
  - Kielce, Poland, 25-112
    - UROMEDYK, Poradnia Urologiczna
  - Krakow, Poland, 30-510
    - Malopolskie Centrum Medyczne s.c.
  - Lublin, Poland, 20-718
    - Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
  - Slupsk, Poland, 76-200
    - Wojewodzki Szpital Specjalistyczny im. Janusza. Korczaka
  - Wroclaw, Poland, 51-685
    - Wro Medica
  - Wroclaw, Poland, 53-114
    - LexMedica
  - Wroclaw, Poland, 50-449
    - Centrum Medyczne Melita Medical
  - Wroclaw, Poland, 50-421
    - Profesorskie Centrum Medyczne Optimum
Russian Federation
- - Moscow, Russian Federation, 115478
    - Federal State Budgetary Institution "N.N. Blokhin Russian Cancer Research Center"
  - Moscow, Russian Federation, 125284
    - P. Hertsen Moscow Oncology Research Institute - branch of the National Medical Research
  - Saint-Petersburg, Russian Federation, 194354
    - State Budgetary Healthcare Institution City Multifield Hospital No.2
  - Saint-Petersburg, Russian Federation, 197002
    - SBEI HPE "First Pavlov State Medical University of St. Petersburg" of
  - Saint-Petersburg, Russian Federation, 197022
    - SBEI HPE "First Pavlov State Medical University of St. Petersburg" of
  - Saint-Petersburg, Russian Federation, 197183
    - Saint-Petersburg State Budgetary Healthcare Institution "Hospital for Veterans of War"
  - Saint-Petersburg, Russian Federation, 197758
    - SBHI "Saint-Petersburg clinical scientific
  - Ufa, Russian Federation, 450073
    - SBEI of HPE "Bashkir State Medical University" of MoH of the RF
Serbia
- - Belgrade, Serbia, 11080
    - Clinical Center Zemun
  - Belgrade, Serbia, 11000
    - Clinical Center Of Serbia, Clinic of Urology
  - Belgrade, Serbia, 11040
    - Clinical Center "Dr Dragisa Misovic -Dedinje", Clinic of Urology
  - Belgrade, Serbia, 11080
    - Clinical Center "Bezanijska Kosa", Department of Urology
Singapore
- - Singapore, Singapore, 119074
    - National University Hospital
  - Singapore, Singapore, 169610
    - National Cancer Centre Singapore
Slovakia
- - Banska Bystrica, Slovakia, 975 17
    - Fakultna nemocnica s poliklinikou F.D. Roosevelta
  - Banska Bystrica, Slovakia, 975 17
    - Institut nuklearnej a molekularnej mediciny
  - Bratislava, Slovakia, 851 05
    - CUIMED, s.r.o., Urologicka ambulancia
  - Bratislava, Slovakia, 814 99
    - Bratislavske radiodiagnosticke centrum, a.s.
  - Kosice, Slovakia, 04191
    - Vychodoslovensky onkologicky ustav, a.s.
  - Kosice, Slovakia, 041 91
    - Vychodoslovensky onkologicky ustav, a.s.
  - Kosice, Slovakia, 042 53
    - Institut nuklearnej a molekularnej mediciny
  - Martin, Slovakia, 036 59
    - Univerzitna nemocnica Martin
  - Nitra, Slovakia, 949 01
    - Jessenius-diagnosticke centrum, a.s.
  - Nitra, Slovakia, 949 01
    - IZOTOPCENTRUM, s.r.o.
  - Nitra, Slovakia, 949 01
    - UROEXAM spol. s r.o. urologicka ambulancia
  - Presov, Slovakia, 080 01
    - Alfamedis, s.r.o.
  - Presov, Slovakia, 080 01
    - MILAB s.r.o., UROCENTRUM
  - Presov, Slovakia, 080 01
    - Vivamed, s.r.o
  - Ruzomberok, Slovakia, 034 26
    - UVN SNP - FN Ruzomberok, Pracovisko Nuklearnej mediciny CCSR
  - Skalica, Slovakia, 909 82
    - Fakultna nemocnica s Poliklinikou Skalica a.s
  - Trnava, Slovakia, 917 01
    - GAMMALAB, spol. s.r.o., Oddelenie nuklearnej mediciny
  - Trnava, Slovakia, 917 01
    - GAMMALAB, spol.s.r.o., Oddelenie nuklearnej mediciny
  - Zilina, Slovakia, 010 01
    - KK MED s.r.o.
  - Zilina, Slovakia, 012 07
    - Fakultna nemocnica s poliklinikou Zilina, Urologicke oddelenie
Spain
- - A Coruna, Spain, 15006
    - Complejo Hospitalario Universitario A Coruña
  - Barcelona, Spain, 08003
    - Hospital Del Mar
  - Barcelona, Spain, 08036
    - Hospital Clínic de Barcelona
  - Barcelona, Spain, 08029
    - Cetir Centre Medic, S.L.
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28006
    - Hospital Universitario de La Princesa
  - Madrid, Spain, 28033
    - MD Anderson Cancer Center
- A Coruna
  - Santiago de Compostela, A Coruna, Spain, 15706
    - Hospital Clínico Universitario de Santiago de Compostela
- Baleares
  - Palma de Mallorca, Baleares, Spain, 07010
    - Hospital Universitari Son Espases,
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Hospital Germans Trias i Pujol
  - Manresa, Barcelona, Spain, 08243
    - ALTAHIA. Xarxa Assistencial Universitaria de Manresa
  - Sabadell, Barcelona, Spain, 08208
    - Hospital Universitario Parc Taulí
- Cataluna
  - Gerona, Cataluna, Spain, 17007
    - ICO Girona-Hospital Universitari de Girona Dr. Josep Trueta
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Hospital de Navarra
Sweden
- - Goteborg, Sweden, 41345
    - Urologmottagningen
  - Malmo, Sweden, 20502
    - Urologiska Kliniken
  - Malmo, Sweden, 205 02
    - Diagnostiskt centrum for bild- och funktionsmedicin
  - Molnlycke, Sweden, 435 33
    - Apoteket AB Kliniska Provningar Molnlycke
  - Solna, Sweden, 17164
    - Karolinska Universitetssjukhuset
  - Stockholm, Sweden, 11853
    - Urologmottagningen
  - Umea, Sweden, 90185
    - Urologkliniken
  - Örebro, Sweden, 70185
    - Urologiska Kliniken
Taiwan
- - Chiayi County, Taiwan, 613
    - Chang Gung Medical Fundation, Chiayi Branch(Chiayi Chang Gung Memorial Hospital)
  - Kaohsiung, Taiwan, 81362
    - Kaohsiung Veterans General Hospital
  - Kaohsiung, Taiwan, 807
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Kaohsiung, Taiwan, 830
    - Chang Gung Medical Fundation,Kaohsiung (Kaohsiung Chang Gung Memorial Hospital)
  - Keelung City, Taiwan, 204
    - Chang Gung Memorial Hospital, Keelung Branch (Keelung Chang Gung Memorial Hospital)
  - Taichung, Taiwan, 40447
    - China Medical University Hospital
  - Taichung, Taiwan, 40705
    - Taichung Veterans General Hospital
  - Tainan City, Taiwan, 710
    - Chi Mei Medical Centre
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital
  - Taipei, Taiwan, 11217
    - Taipei Veterans General Hospital
  - Taoyuan County, Taiwan, 333
    - Chang-Gung Memorial Hospital at Linkuo
Thailand
- - Bangkok, Thailand, 10400
    - Rajavithi Hospital
  - Bangkok, Thailand, 10330
    - King Chulalongkorn Memorial Hospital, Chulalongkorn University
- Chiang MAI
  - Muang, Chiang MAI, Thailand, 50200
    - Maharaj Nakorn Chiang Mai Hospital
- Songkla
  - Hat Yai, Songkla, Thailand, 90110
    - Songklanagarind Hospital
Turkey
- - Adana, Turkey, 01330
    - Cukurova Universitesi Tip Fakultesi
  - Ankara, Turkey, 06100
    - Hacettepe Universitesi Tip Fakultesi
  - Istanbul, Turkey, 34098
    - Istanbul Universitesi Cerrahpasa Tip Fakultesi
  - Izmir, Turkey, 35170
    - Izmir Bozyaka Egitim Arastirma Hastanesi
  - Manisa, Turkey, 45030
    - Celal Bayar Universitesi Tip Fakultesi
Ukraine
- - Chernivtsi, Ukraine, 58002
    - RCI Chernivtsi Regional Clinical Hospital
  - Dnipropetrovsk, Ukraine, 49005
    - CI Dnipropetrovsk I.I. Mechnykov RCH, Department of Urology #2
  - Kharkiv, Ukraine, 61037
    - CHI V.I.Shapoval RCC of Urology and Nephrology, Dep. Of Urology#4
  - Kyiv, Ukraine, 02125
    - Kyiv City Clinical Hospital #3, Department of Urology
  - Uzhgorod, Ukraine, 88000
    - Central City Clinical Hospital, City Oncological Center
  - Zaporizhzhia, Ukraine, 69600
    - CI Zaporizhzhia Regional Clinical Hospital, Dep. Of Urology,
United Kingdom
- - Birmingham, United Kingdom, B15 2TH
    - University Hospitals Birmingham NHS Foundation Trust
  - Birmingham, United Kingdom, B15 2WB
    - University Hospitals Birmingham NHS Foundation Trust
  - Bristol, United Kingdom, BS2 8ED
    - University Hospitals Bristol NHS Foundation Trust
  - Bristol, United Kingdom, BS2 8HW
    - University Hospitals Bristol NHS Foundation Trust
  - Cambridge, United Kingdom, CB2 0QQ
    - Cambridge University Hospitals NHS Foundation Trust
  - London, United Kingdom, W12 0HS
    - Imperial College Healthcare NHS Trust
  - London, United Kingdom, NW1 2BU
    - University College Hospitals NHS Trust
  - London, United Kingdom, WC1E 6AG
    - University College London Hospitals NHS Foundation Trust
  - Manchester, United Kingdom, M20 4BX
    - The Christie NHS Foundation Trust
  - Oxford, United Kingdom, OX3 7LE
    - Oxford University Hospitals NHS Trust
- Middlesex
  - Northwood, Middlesex, United Kingdom, HA6 2RN
    - East and North Hertfordshire NHS Trust
- Northern Ireland
  - Belfast, Northern Ireland, United Kingdom, BT9 7AB
    - Belfast Health and Social Care Trust
- Surrey
  - Sutton, Surrey, United Kingdom, SM2 5PT
    - Royal Marsden NHS Foundation Trust
- Tyne and Wear
  - Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE7 7DN
    - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
United States
- Arizona
  - Tucson, Arizona, United States, 85741
    - Urological Associates of Southern Arizona, PC
- California
  - Los Angeles, California, United States, 90095
    - Ronald Reagan UCLA Medical Center
  - Los Angeles, California, United States, 90095
    - UCLA Clark Urology Center
  - Orange, California, United States, 92868
    - University of California, Irvine Medical Center
  - San Luis Obispo, California, United States, 93405
    - Urology Associates of San Luis Obispo, a Medical Group, Inc
- Colorado
  - Englewood, Colorado, United States, 80113
    - Urology Associates, P.C.
- Connecticut
  - New Haven, Connecticut, United States, 06520
    - Yale University School Of Medicine
  - New Haven, Connecticut, United States, 06510
    - Yale New Haven Hospital
  - New Haven, Connecticut, United States, 06510
    - C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
  - New Haven, Connecticut, United States, 06510
    - c/o Lynn Buchwalder
  - New Haven, Connecticut, United States, 06510
    - Smilow Cancer Center at Yale New Haven-Hospital
- Florida
  - Lakeland, Florida, United States, 33805
    - Lakeland Regional Cancer Center
- Indiana
  - Carmel, Indiana, United States, 46032
    - Urology of Indiana, LLC
  - Jeffersonville, Indiana, United States, 47130
    - First Urology, PSC
  - Lafayette, Indiana, United States, 47904
    - IU Health Arnett Cancer Care
- Kansas
  - Overland Park, Kansas, United States, 66211-1231
    - Kansas City Urology Care, PA
  - Wichita, Kansas, United States, 67226
    - GU Research Network/ Wichita Urology Group
- Maryland
  - Baltimore, Maryland, United States, 21237
    - Chesapeake Urology Research Associates
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - University of Michigan Health System
  - Troy, Michigan, United States, 48084
    - Michigan Institute of Urology
- Nebraska
  - Omaha, Nebraska, United States, 68130
    - GU Research Network
- New York
  - Brooklyn, New York, United States, 11201
    - Brooklyn Urology Research Group
  - Newburgh, New York, United States, 12550
    - Premier Medical Group of the Hudson Valley
- North Carolina
  - Cary, North Carolina, United States, 27518
    - Duke University Medical Center
  - Charlotte, North Carolina, United States, 28277
    - Carolina Urology Partners, PLLC
  - Gastonia, North Carolina, United States, 28054
    - Carolina Urology Partners, PLLC
  - Gastonia, North Carolina, United States, 28054
    - Gaston Medical Associates
  - Huntersville, North Carolina, United States, 28078
    - Carolina Urology Partners, PLLC
  - Raleigh, North Carolina, United States, 27607
    - Duke Women's Cancer Care Raleigh
- Ohio
  - Middleburg Heights, Ohio, United States, 44130
    - Clinical Research Solutions
- Oregon
  - Springfield, Oregon, United States, 97477
    - Oregon Urology Institute
- Pennsylvania
  - Lancaster, Pennsylvania, United States, 17604
    - Lancaster Urology
- South Carolina
  - Myrtle Beach, South Carolina, United States, 29572
    - Carolina Urologic Research Center
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center, Dept. of Urologic Surgery
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center, The Urologic Clinic
- Texas
  - San Antonio, Texas, United States, 78229
    - Urology San Antonio
- Virginia
  - Virginia Beach, Virginia, United States, 23462
    - Urology of Virginia, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
Progressive disease on androgen deprivation therapy at enrollment;
PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
PSA doubling time ≤ 10 months;
No prior or present evidence of metastatic disease;
Asymptomatic prostate cancer;
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
Estimated life expectancy ≥ 12 months.

Exclusion Criteria:

Prior cytotoxic chemotherapy;
Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
Known or suspected brain metastasis or active leptomeningeal disease;
History of another invasive cancer within 3 years of randomization;
Absolute neutrophil count < 1000/μL, platelet count < 100,000/μL, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
Total bilirubin ≥ 1.5 times the upper limit of normal;
Creatinine > 2 mg/dL (177 µmol/L) at screening;
Albumin < 3.0 g/dL (30 g/L) at screening;
History of seizure or any condition that may predispose to seizure;
Clinically significant cardiovascular disease;
Gastrointestinal disorder affecting absorption;
Major surgery within 4 weeks of randomization;
Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Placebo Sugar pill manufactured to mimic enzalutamide 40 mg capsule	Drug: Placebo Sugar pill to mimic enzalutamide
Experimental: Enzalutamide 160 mg by mouth once daily	Drug: Enzalutamide 160 mg by mouth once daily Other Names: Xtandi MDV3100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metastasis Free Survival (MFS) Time Frame: From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)	MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review [BICR]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,[RECIST 1.1])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.	From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Astellas Pharma Inc

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Investigators

Study Director: Pfizer Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2013

Primary Completion (Actual)

June 28, 2017

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimated)

December 6, 2013

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

MDV3100-14
C3431005 (Other Identifier: Alias Study Number)
2012-005665-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Roswell Park Cancer Institute

Recruiting

Nutrition and Exercise Interventions in Reducing Androgen Deprivation Therapy-Induced Obese Frailty in Prostate Cancer Survivors

Obesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditions

United States
Sidney Kimmel Cancer Center at Thomas Jefferson...
Regeneron Pharmaceuticals; Prostate Cancer Foundation

Withdrawn

Stereotactic Body Radiation Therapy With REGN2810 and/or Ipilimumab Before Surgery in Treating Participants With Progressive Advanced or Oligometastatic Prostate Cancer

Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
Jonsson Comprehensive Cancer Center
Progenics Pharmaceuticals, Inc.

Terminated

Randomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)

Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...

United States
University of Southern California
National Cancer Institute (NCI); Sanofi

Terminated

Cabazitaxel Plus Prednisone With Octreotide For Castration-Resistant Prostate Cancer (CRPC) Previously Treated With Docetaxel

Diarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer

United States
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

Completed

Effect of Quercetin on Green Tea Polyphenol Uptake in Prostate Tissue From Patients With Prostate Cancer Undergoing Surgery

Recurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer

United States
Ohio State University Comprehensive Cancer Center
Riverside Methodist Hospital

Completed

Tangerine or Red Tomato Juice in Treating Patients With Prostate Cancer Undergoing Surgery

Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer

United States
Ryan Kohlbrenner, MD
Radiological Society of North America

Completed

Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

Prostate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...

United States
Mayo Clinic
National Cancer Institute (NCI)

Withdrawn

Daily, Long-Term Intermittent Fasting for the Prevention of PSA-Recurrence in Patients With Localized Prostate Cancer After Radical Prostatectomy

Stage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...

United States
University of California, Irvine

Completed

Docetaxel Plus Lycopene in Castration Resistant, Chemotherapy-Naïve Prostate Cancer Patients

Recurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer

United States
Barbara Ann Karmanos Cancer Institute
Genentech, Inc.

Completed

Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy

Recurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer

United States

Clinical Trials on Placebo

Galderma R&D

Completed

Effect of CD07805/47 Gel in Rosacea Flushing

Rosacea

Germany
SamA Pharmaceutical Co., Ltd

Unknown

Clinical Trials to Assess the Efficacy and Safety of HLIM

Acute Bronchitis | Acute Upper Respiratory Tract Infection

Korea, Republic of
National Institute on Drug Abuse (NIDA)

Completed

Effects of Cannabis Administration Routes on Human Performance and Pharmacokinetics

Cannabis Use

United States
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Completed

Assessment of the Safety, Tolerability and Pharmacodynamics After Administration of One Dose of AZD8601 to Male Patients With Type II Diabetes Mellitus (T2DM)

Male Subjects With Type II Diabetes (T2DM)

Germany
Heptares Therapeutics Limited

Completed

Pharmacokinetics of Oral Capsule in Healthy Japanese vs. Caucasian Subjects (HTL0018318)

Pharmacokinetics | Safety Issues

United Kingdom
GlaxoSmithKline

Completed

A Clinical Study Assessing Critical Errors, Training/Teaching Time, and Preference Attributes of the ELLIPTA® Dry Powder Inhaler, in Comparison to Combinations of Dry Powder Inhalers Used to Provide Triple Therapy, in Patients With Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive

United Kingdom, Netherlands
Italfarmaco

Completed

Clinical Study to Evaluate the Efficacy and Safety of Givinostat in Ambulant Patients With Becker Muscular Dystrophy

Becker Muscular Dystrophy

Netherlands, Italy
Shijiazhuang Yiling Pharmaceutical Co. Ltd
Xuanwu Hospital, Beijing

Completed

Study on the Safety, Tolerance and Pharmacokinetics of Phenlarmide Tablets

Parkinson Disease

China
GlaxoSmithKline

Completed

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Oral and Intravenous GSK1322322 in Healthy Subjects

Infections, Bacterial

United States
West Penn Allegheny Health System

Completed

Sunovion Growth Study Pediatric Subjects With Mild Asthma & Allergic Rhinitis

Asthma | Allergic Rhinitis

United States

Outcome Measure	Measure Description	Time Frame
Time to Prostate-Specific Antigen (PSA) Progression Time Frame: From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)	Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.	From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Time to First Use of New Antineoplastic Therapy Time Frame: From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)	Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.	From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Overall Survival Time Frame: From randomization until death (up to a maximum of 68.8 months)	Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.	From randomization until death (up to a maximum of 68.8 months)
Time to Pain Progression Time Frame: From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)	Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.	From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Time to First Use of Cytotoxic Chemotherapy Time Frame: From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)	Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.	From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Chemotherapy-Free Disease Specific Survival Time Frame: From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)	Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.	From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Chemotherapy-Free Survival Time Frame: From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)	Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.	From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Percentage of Participants With Prostate Specific Antigen (PSA) Response Time Frame: From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)	PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.	From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the mobility questionnaire are reported.	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the usual activities questionnaire are reported.	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the pain/discomfort questionnaire are reported.	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the anxiety/depression questionnaire are reported.	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS) Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: "Have you had to urinate frequently during the day?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: "Have you had to urinate frequently at night?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: "When you felt the urge to pass urine, did you have to hurry to get to the toilet?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: "Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: "Have you had difficulty going out of the house because you needed to be close to a toilet?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: "Have you had any unintentional release (leakage) of urine?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: "Did you have pain when you urinated?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: "Has wearing an incontinence aid been a problem for you?". This question was answered by only those participants who wore incontinence aid.	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 39 are reported. Question 39 was following: "Have your daily activities been limited by your urinary problems?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 40 are reported. Question 40 was following: "Have your daily activities been limited by your bowel problems?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 41 are reported. Question 41 was following: "Have you had any unintentional release (leakage) of stools?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: "Have you had blood in your stools?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 43 are reported. Question 43 was following: "Did you have a bloated feeling in your abdomen?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 44 are reported. Question 44 was following: "Did you have hot flushes?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 45 are reported. Question 45 was following: "Have you had sore or enlarged nipples or breasts?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 46 are reported. Question 46 was following: "Have you had swelling in your legs or ankles?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 47 are reported. Question 47 was following: "Has weight loss been a problem for you?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 48 are reported. Question 48 was following: "Has weight gain been a problem for you?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 49 are reported. Question 49 was following: "Have you felt less masculine as a result of your illness or treatment?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 50 are reported. Question 50 was following: "To what extent were you interested in sex?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 51 are reported. Question 51 was following: "To what extent were you sexually active (with or without intercourse)?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 52 are reported. Question 52 was following: "To what extent was sex enjoyable for you?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 53 are reported. Question 53 was following: "Did you have difficulty getting or maintaining an erection?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 54 are reported. Question 54 was following: "Did you have ejaculation problems (e.g, dry ejaculation)?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177
Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55 Time Frame: Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177	The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 55 are reported. Question 55 was following: "Have you felt uncomfortable about being sexually intimate?"	Baseline, Weeks 17, 33, 49, 65, 81, 97, 113, 129, 145,161 and 177

Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER)

PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Clinical Trials on Prostate Cancer

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Latvia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations