Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)

November 15, 2018 updated by: Pfizer

Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy

This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1199

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
      • Ciudad Autonoma de Buenos Aires, Argentina, C1043AAS
        • Centro de Diagnóstico Dr. Enrique Rossi
      • Ciudad Autonoma de Buenos Aires, Argentina, C1425BEE
        • Centro de Diagnóstico Dr. Enrique Rossi
    • AR
      • Buenos Aires, AR, Argentina, C1425AWC
        • Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)
    • Provincia DE Cordoba
      • Cordoba, Provincia DE Cordoba, Argentina, X5000JJS
        • Instituto Oulton
      • Cordoba, Provincia DE Cordoba, Argentina, X5004FHP
        • Clinica Universitaria Privada Reina Fabiola
    • Provincia DE Neuquen
      • Neuquen, Provincia DE Neuquen, Argentina, 8300
        • Policlinico Neuquen
    • Provincia DE RIO Negro
      • Cipolletti, Provincia DE RIO Negro, Argentina, 8324
        • Policlinico Modelo de Cipolletti
      • Cipolletti, Provincia DE RIO Negro, Argentina, R8324EMD
        • Instituto de Investigaciones Clinicas Cipolletti
    • Provincia DE Santa FE
      • Rosario, Provincia DE Santa FE, Argentina, S2000DTO
        • Sanatorio Mapaci
      • Rosario, Provincia DE Santa FE, Argentina, S2000KZE
        • Instituto de Oncologia y Especialidades Medicas
      • Rosario, Provincia DE Santa FE, Argentina, S2001ODA
        • Hospital Italiano Garibaldi
  • Australia
      • Footscray, Australia, 3011
        • Western Hospital
      • Footscray, Australia, 3011
        • 60 Eleanor St
      • Victoria, Australia, 3050
        • The Royal Melbourne Hospital
    • New South Wales
      • Coffs Harbour, New South Wales, Australia, 2450
        • North Coast Cancer Institute
      • Concord, New South Wales, Australia, 2139
        • Sydney cancer centre
      • Port Macquarie, New South Wales, Australia, 2444
        • Mid North Coast Diagnostic Imaging
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Macquarie Base Hospital
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Macquarie Base Hospital Pharmacy
      • Randwick, New South Wales, Australia, 2031
        • Prince of Wales Hospital, Department of Medical Oncology
      • Tweed Heads, New South Wales, Australia, 2485
        • The Tweed Hospital
      • Wentworthville, New South Wales, Australia, 2145
        • PRP Diagnostic Imaging
      • Westmead, New South Wales, Australia, 2145
        • Sydney West Cancer Trials Centre, Department of Medical Oncology
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Heart Care Partners
      • Auchenflower, Queensland, Australia, 4066
        • Icon Cancer Care Wesley
      • Auchenflower, Queensland, Australia, 4064
        • River City Pharmacy
      • Chermside, Queensland, Australia, 4032
        • Icon Cancer Care Chermside
      • Chermside, Queensland, Australia, 4032
        • Southern X-Ray Chermside
      • Herston, Queensland, Australia, 4029
        • Cancer Care Services
      • Milton, Queensland, Australia, 4064
        • Icon Cancer Foundation
      • South Brisbane, Queensland, Australia, 4101
        • Icon Cancer Care South Brisbane
      • South Brisbane, Queensland, Australia, 4101
        • Mater Private Cardiology
      • South Brisbane, Queensland, Australia, 4101
        • Queensland X-Ray
      • Toowong, Queensland, Australia, 4066
        • XRadiology
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Department of Medical Oncology
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Royal Hobart Hospital
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St. Vincent's Hospital Melbourne
      • Frankston, Victoria, Australia, 3199
        • Peninsula Oncology Centre
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital, Department of Medical Oncology
  • Austria
      • Linz, Austria, 4010
        • Krankenhaus Der Barmherzigen Schwestern Linz
      • Vienna, Austria, 1090
        • Medical University of Vienna
      • Vienna, Austria, 1090
        • ISOTOPIX Ambulatorium fuer
  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint- Luc
      • Ghent, Belgium, 9000
        • AZ Sint- Lucas
      • Hasselt, Belgium, 3500
        • VZW Jessa Ziekenhuis
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Campus Kennedylaan
      • Kortrijk, Belgium, 8500
        • AZ Groeninge - Campus Sint Maarten
      • Leuven, Belgium, 3000
        • University Hospital Gasthuisberg
      • Roeselare, Belgium, 8800
        • H.-Hartziekenhuis Roeselare-Menen VZW
  • Canada
      • Quebec, Canada, G1R 2J6
        • CHU de Québec
      • Quebec, Canada, G1H 6P3
        • Imagerie medicale de la Capitale
      • Quebec, Canada, G1R 3S3
        • Centre de rechereche clinique et evaluative en oncologie
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre
      • Calgary, Alberta, Canada, T2S 3C3
        • Tom Baker Cancer Centre - Holy Cross Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • British Columbia Cancer Agency, Centre for the Southern Interior
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • B.C. Cancer Agency - Vancouver Centre
      • Victoria, British Columbia, Canada, V8R 6V5
        • British Columbia Cancer Agency - Vancouver Island Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Sciences Centre
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • QEII Health Sciences Centre
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • QEII Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • London Regional Cancer Program
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2L4M1
        • Centre Hospitalier de l'Université de Montréal
      • Montreal, Quebec, Canada, H2X 1N8
        • The Urology Specialists.
  • Chile
      • Santiago, Chile
        • Instituto Nacional del Cancer
      • Santiago, Chile
        • Hospital San Jose
      • Temuco, Chile
        • Centro Investigacion Clinica Del Sur
      • Vina del Mar, Chile
        • Instituto Oncologico
  • France
      • Angers Cedex 9, France, 49933
        • Centre Paul Papin
      • Bordeaux cedex, France, 33076
        • Institut Bergonie
      • Caen Cedex, France, 14076
        • Centre Regional Francois Baclesse de lutte contre le cancer
      • Cannes Cedex, France, B.P. 264 - 06401
        • Centre Hospitalier de Cannes
      • Creteil, France, 94010
        • CHU Henri Mondor
      • Frejus Cedex, France, BP110 - 83608
        • Centre Hospitalier Intercommunal Frejus-Saint Raphael
      • LA Roche sur Yon, France, 85925
        • Centre Hospitalier Departemental Vendee
      • Le Mans, France, 72000
        • Clinique Victor Hugo - Centre Jean Bernard
      • Lyon Cedex 08, France, 69373
        • Centre Léon Bérard
      • Lyon Cedex 3, France, 69003
        • Groupement Hospitalier Edouard Herriot - Pavillon V
      • Marseille, France, BP 156 - 13273
        • Institut Paoli Calmettes
      • Paris, France, 75015
        • Hôpital Europeén Georges Pompidou
      • Paris, France, 75005
        • Institut Curie
      • Pierre Benite, France, 69495
        • Centre Hospitalier LYON SUD
      • Poitiers Cedex, France, 86021
        • CHU La Miletrie
      • Reims Cedex, France, 51056
        • Institut Jean Godinot
      • SAINT-HERBLAIN Cedex, France, 44805
        • Centre Rene Gauducheau
      • Saint Etienne Cedex 2, France, 42030
        • Centre Hospitalier
      • Saint Priest en Jarez, France, 42271
        • Institut de Cancérologie de la Loire
      • Saint-Etienne CEDEX 2, France, 42055
        • Centre d'Investigation Clinique, (CIE3)
      • Suresnes Cedex, France, 92151
        • Hôpital Foch
      • Villejuif, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Aachen, Germany, 52074
        • Universitaetsklinikum Aachen
      • Berlin, Germany, 12200
        • Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin
      • Berlin, Germany, D- 10439
        • Gemeinschaftspraxis Fuer Nuklearmedizin
      • Berlin, Germany, D- 13055
        • Radiologische Gemeinschaftspraxis
      • Berlin, Germany, D-13055
        • FacharztzentrumInnere Medizin
      • Berlin, Germany, D-13055
        • Praxis Dr. Wolfgang Hoelzer
      • Braunschweig, Germany, 38126
        • Staedtisches Klinikum Braunschweig gGmbH
      • Dresden, Germany, 01307
        • Technical University Dresden
      • Hamburg, Germany, 20246
        • Martini-Klinik am UKE GmbH
      • Hamburg, Germany, 22391
        • Roentgenpraxis
      • Hamburg, Germany, 22399
        • Urologische Gemeinschaftspraxis Poppenbuettel
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover
      • Hannover, Germany, D-30625
        • Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie
      • Heidelberg, Germany, 69120
        • Universitaetsklinikum Heidelberg
      • Mannheim, Germany, 68167
        • Universitaetsklinikum Mannheim
      • Muenster, Germany, D-48149
        • Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie
      • Muenster, Germany, D-48149
        • Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin
      • Muenster, Germany, D-48149
        • Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie
      • Tuebingen, Germany, D-72076
        • Abt.f.Diagnostische u. Interventionelle Radiologie
      • Tuebingen, Germany, D-72076
        • Klinik fuer Urologie
      • Tuebingen, Germany, D-72076
        • Nuklearmedizin
  • Italy
      • Cremona, Italy, 26100
        • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
      • Rome, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini
    • Modena
      • Via Del Pozzo 71, Modena, Italy, 41100
        • Azienda Ospedaliero-Universitaria di Modena Policlinico
    • TO
      • Orbassano, TO, Italy, 10043
        • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU Medisch Centrum
      • Nijmegen, Netherlands, 6525 GA
        • UMC St. Radboud
      • Rotterdam, Netherlands, 3075 EA
        • Erasmus MC
  • Poland
      • Gdansk, Poland, 80-952
        • Uniwersyteckie Centrum Kliniczne
      • Grudziadz, Poland, 86-300
        • Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
      • Lodz, Poland, 93-513
        • Wojewodzki Szpital Specjalistyczny im. M. Kopernika
      • Lodz, Poland, 93-509
        • Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny
      • Slupsk, Poland, 76-200
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka
  • South Africa
      • Durban, South Africa, 4001
        • Hopelands Cancer Centre
      • Port Elizabeth, South Africa, 6045
        • GVI Oncology
      • Sandton, South Africa, 2199
        • Sandton Oncology Centre
  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08035
        • Hospital Vall d'hebrón
      • Barcelona, Spain, 08025
        • Hospital Santa Creu i Sant Pau
      • Barcelona, Spain, 08006
        • Radiodiagnostic Cetir Clinica Pilar
      • Madrid, Spain, 28050
        • Hospital Madrid Norte Sanchinarro
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Birmingham, United Kingdom, B15 2TH
        • Cancer Centre
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology & Oncology Centre
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Glasgow, United Kingdom, G12 0YN
        • The Beatson West of Scotland Cancer Centre
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
      • London, United Kingdom, NW1 2BU
        • University College Hospital
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Northern Centre for Cancer Care
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital
      • Oxford, United Kingdom, OX3 7RP
        • The Manor Hospital Oxford
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2JW
        • Bishops Wood Hospital
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Hospital
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Hospital
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
      • Scottsdale, Arizona, United States, 85258
        • Premiere Oncology of Arizona
    • California
      • Beverly Hills, California, United States, 90211-1850
        • Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group
      • Beverly Hills, California, United States, 90211
        • USC Westside Prostate Cancer Center
      • Duarte, California, United States, 91010
        • City of Hope
      • La Mesa, California, United States, 91942
        • Cancer Center Oncology Medical Group
      • Los Angeles, California, United States, 90095
        • UCLA
      • Los Angeles, California, United States, 90033
        • USC/Norris Comprehensive Cancer Center
      • Los Angeles, California, United States, 90095-6984
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90033
        • LAC & USC Medical Center
      • Marina Del Rey, California, United States, 90292
        • c/o Prostate Oncology Specialist, Inc.
      • Oceanside, California, United States, 92056
        • North County Oncology Medical Clinic, Inc,
      • San Diego, California, United States, 92123
        • Medical Oncology Associates - Sd
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital Investigational Pharmacy
      • San Diego, California, United States, 92123
        • Sharp Rees-Stealy
      • San Francisco, California, United States, 94115
        • UCSF Helen Diller Family Comprehensive Cancer Center
      • South Pasadena, California, United States, 91030
        • City of Hope Medical Group
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics Research Pharmacy
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver, Anschutz Cancer Pavilion
      • Aurora, Colorado, United States, 80045
        • Research Pharmacist
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • C/O: Thomas Ferencz R.Ph., BCOP
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Med
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University-Medical Faculty Associates
    • Florida
      • Atlantis, Florida, United States, 33462
        • Palm Beach Cancer Institute
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Cancer Institute
      • Wellington, Florida, United States, 33414
        • Palm Beach Cancer Institute
      • West Palm Beach, Florida, United States, 33401
        • Palm Beach Cancer Institute
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Peachtree Hematology-Oncology Consultants, P.C.
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Of Chicago Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Johns Hopkins Hospital
      • Baltimore, Maryland, United States, 21231
        • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital (MGH)
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital (BWH)
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Weisberg Cancer Treatment Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Creve Coeur, Missouri, United States, 63141
        • Siteman Cancer Center-West County
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Saint Louis, Missouri, United States, 63110-1094
        • Barnes-Jewish Hospital
      • Saint Peters, Missouri, United States, 63376
        • Siteman Cancer Center
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute, an affiliate of the UC San Diego Health System
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Oncology Hematology Consultants, Ltd.
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10021
        • Weill Cornell Medical College-New York Presbyterian Hospital
      • New York, New York, United States, 10065
        • Weill Cornell Medical College-New York Presbyterian Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
      • Durham, North Carolina, United States, 27710
        • Pharmaceutical Research Services
    • Oregon
      • Portland, Oregon, United States, 97239
        • Portland VA Medical Center
    • Pennsylvania
      • McKeesport, Pennsylvania, United States, 15132
        • UPMC Cancer Centers
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh Cancer Institute
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC Cancer Centers
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina (MUSC)
      • Charleston, South Carolina, United States, 29425
        • Hollings Cancer Center
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
      • Myrtle Beach, South Carolina, United States, 29572
        • Grand Strand Urology
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology, PLLC
      • Dickson, Tennessee, United States, 37055
        • Tennessee Oncology, PLLC
      • Franklin, Tennessee, United States, 37067
        • Tennessee Oncology, PLLC
      • Gallatin, Tennessee, United States, 37066
        • Tennessee Oncology, PLLC
      • Hermitage, Tennessee, United States, 37076
        • Tennessee Oncology, PLLC
      • Lebanon, Tennessee, United States, 37087
        • Tennessee Oncology, PLLC
      • Murfreesboro, Tennessee, United States, 37129
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Research Institute
      • Nashville, Tennessee, United States, 37205
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37207
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37211
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, United States, 37232-5536
        • Vanderbilt University Medical Center
      • Smyrna, Tennessee, United States, 37167
        • Tennessee Oncology, PLLC
    • Texas
      • Dallas, Texas, United States, 75235
        • Parkland Health and Hospital System
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas
      • Dallas, Texas, United States, 75246
        • Texas Oncology, Sammons Cancer Center
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Virginia Oncology Associates
      • Hampton, Virginia, United States, 23666
        • Virginia Oncology Associates
      • Mechanicsville, Virginia, United States, 23116-1844
        • Virginia Cancer Institute
      • Midlothian, Virginia, United States, 23114
        • Virginia Cancer Institute
      • Newport News, Virginia, United States, 23606
        • Virginia Oncology Associates
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates
      • Richmond, Virginia, United States, 23230
        • Virginia Cancer Institute
      • Richmond, Virginia, United States, 23235-4730
        • Virginia Cancer Institute
      • Virginia Beach, Virginia, United States, 23456
        • Virginia Oncology Associates
      • Williamsburg, Virginia, United States, 23188
        • Virginia Oncology Associates
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, United States, 98195
        • University of Washington Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

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

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Progressive prostate cancer
  • Medical or surgical castration with testosterone less than 50 ng/dl
  • One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate bone marrow, hepatic, and renal function
  • Able to swallow the study drug and comply with study requirements
  • Informed consent

Exclusion Criteria:

  • Metastases in the brain or active epidural disease
  • Another malignancy within the previous 5 years
  • Clinically significant cardiovascular disease
  • Gastrointestinal disorder affecting absorption

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo comparator
Experimental: Enzalutamide
Formerly MDV3100
Drug: Enzalutamide
MDV3100, 160 mg orally per day
Other Names:
  • Xtandi
  • MDV3100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: During study period (up to 101 months)
Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).
During study period (up to 101 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Progression-free Survival
Time Frame: During DB phase (up to 24 months)
Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Participants were assessed for objective disease progression at regularly scheduled visits. The consensus guidelines of the Prostate Cancer Clinical Trials Working Group 2 were taken into consideration for the determination of disease progression. Radiographic disease progression was defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for soft tissue disease, or the appearance of two or more new bone lesions on bone scan. Progression at the first scheduled reassessment at Week 13 required a confirmatory scan 6 or more weeks later. Participants who did not reach the endpoint were right censored at their last assessment.
During DB phase (up to 24 months)
Time to First Skeletal-related Event
Time Frame: During DB Phase (up to 24 months)
The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Participants were assessed for skeletal-related events at regularly scheduled visits. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. Participants who did not reach the endpoint were right censored at their last assessment.
During DB Phase (up to 24 months)
Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Time Frame: Baseline up to 24 months
The FACT-P was a 39-item participant questionnaire which assessed physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The sum of scores on all 5 domains constitutes the global FACT-P. The global/total FACT-P score ranged from 0 (worst) to 156 (best), higher scores indicate better health status. Responders were those participants who had a 10-point improvement in their total FACT-P score, as compared with baseline, on two consecutive measurements obtained at least 3 weeks apart.
Baseline up to 24 months
Time to Prostate-specific Antigen (PSA) Progression
Time Frame: Baseline and at every study visit from Week 13 while on study drug (up to 24 months)
Time to PSA progression was defined as time from randomization to PSA progression. Participants who did not reach the endpoint were right censored at their last assessment or for participants with no post-baseline PSA assessment, date of randomization. For participants with PSA declines at Week 13, the PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 nanogram per milliliter (ng/mL) above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For participants with no PSA declines at Week 13, PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment).
Baseline and at every study visit from Week 13 while on study drug (up to 24 months)
Percentage of Participants With Pain Palliation
Time Frame: Baseline up to 24 months
The proportion of participants with pain palliation was assessed for participants with a stable and sufficient pain burden at study entry. Pain burden was measured by question #3 of the Brief Pain Inventory (Short Form). This scale measures pain on a 0 to 10 scale with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Pain palliation at Week 13 was determined for the proportion of men with baseline bone metastasis(es) who had baseline pain attributable to the metastasis(es). Palliation was defined as >=30% reduction in average pain score at Week 13 compared to baseline without a >=30% increase in analgesic use.
Baseline up to 24 months
Percentage of Participants With Prostate Specific Antigen (PSA) Response
Time Frame: During DB phase (up to 24 months)
Participants were evaluable for PSA response rate if they had a PSA level measured at baseline and at least 1 post-baseline assessment. Both PSA responses of > 50% and > 90% were determined. PSA responses required confirmation with a subsequent assessment that was conducted at least 3 weeks later.
During DB phase (up to 24 months)
Percentage of Participants With Soft-tissue Objective Response
Time Frame: During DB phase (up to 24 months)
The best overall soft tissue response as assessed using RECIST v1.1 during the study was summarized using the investigators' response assessments and also the derived response assessments by treatment group. Only participants with measurable soft tissue disease at screening were included in this analysis. Participants with measurable disease at screening are participants who had at least 1 target lesion identified per RECIST v1.1 at screening. Percentage of participants summarizes the number of participants with complete or partial objective response (%). Soft Tissue assessment based on Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-247.
During DB phase (up to 24 months)
European Quality of Life Five-Domain (EQ-5D) Scale
Time Frame: Week 13
EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Five parameters (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were assessed on 3-point categorical scale (1= no problems, 2= some/moderate problems and 3= severe problem). Score were transformed and resulted in a total EQ-5D score range of 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better health and quality of life.
Week 13
Percentage of Participants With Circulating Tumor Cell (CTC) Conversion
Time Frame: Baseline up to 24 months
CTC conversion was assessed for participants with baseline CTC counts of greater than or equal to (>=) 5 cells per 7.5 milliliter (mL) of blood. A CTC conversion was defined as a decline in the CTC count to less than (<) 5 cells per 7.5 mL of blood. In this outcome measure percentage of participants with CTC conversion was reported.
Baseline up to 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant and jeopardized participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events which occurred between first dose of study drug and up to the safety follow-up visit or the initiation of another anti-neoplastic therapy, whichever occurred first (up to 101 months). AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.
Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Number of Participants With Clinically Significant Changes in Vital Signs
Time Frame: Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: absolute result greater than (>) 180 millimeter of mercury (mmHg) and >40 mmHg increase from baseline (BL) and less than (<) 90 mmHg and >30 mmHg decrease from BL; diastolic blood pressure (DBP) values: absolute result >105 mmHg and >30 mmHg increase from BL and absolute result < 50 mmHg and >20 mmHg decrease from BL; any abnormalities in SBP or DBP; heart rate values: absolute result > 120 beats per minute (bpm) and >30 bpm increase from BL and absolute result < 50 bpm and >20 bpm decrease from BL or any abnormalities in heart rate. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.
Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Number of Participants With Any Newly Clinically Significant Abnormal Finding in Electrocardiogram (ECG)
Time Frame: Baseline, up to the end of DB phase or unscheduled visit (up to 24 months)
Any new post baseline abnormality was defined as any abnormal ECG finding that appeared after baseline assessment which was not seen at the screening or baseline ECG assessment. Where, criteria of abnormality was QTcF interval > 470 millisecond (msec). Participants were counted once only for a specific abnormality. This outcome measure was planned to be analysed in double blind phase only. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.
Baseline, up to the end of DB phase or unscheduled visit (up to 24 months)
Number of Participants With Grade 3/4 Post-Baseline Laboratory Toxicity (Hematology and Chemistry)
Time Frame: Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Laboratory parameters included hematological and chemistry parameters. Chemistry parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, creatine kinase, creatinine, glucose, magnesium, phosphate, potassium and sodium. Hematology parameters included haemoglobin, leukocytes, lymphocytes, neutrophils and platelet. Test abnormalities were graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 as Grade 3= severe and Grade 4= life-threatening or disabling. Only categories with at least 1 participant with abnormality are reported in this outcome measure. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.
Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)

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.

Publications and helpful links

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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)

September 30, 2009

Primary Completion (Actual)

September 15, 2011

Study Completion (Actual)

November 2, 2017

Study Registration Dates

First Submitted

September 9, 2009

First Submitted That Met QC Criteria

September 9, 2009

First Posted (Estimate)

September 10, 2009

Study Record Updates

Last Update Posted (Actual)

December 11, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRPC2
  • 2009-013174-41 (EudraCT Number)
  • C3431010 (Other Identifier: Alias Study Number)

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.

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