Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC (TALAPRO-2)

April 22, 2024 updated by: Pfizer

A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF TALAZOPARIB WITH ENZALUTAMIDE IN METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Part 1 is an open-label, non-randomized, safety and PK run-in study designed to confirm the starting dose of talazoparib in combination with enzalutamide through assessment of target safety events and PK at select sites. Part 2 is a randomized, double-blind, placebo-controlled, multinational study comparing talazoparib plus enzalutamide vs. placebo plus enzalutamide in patients with mCRPC.

Study Type

Interventional

Enrollment (Actual)

1054

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
      • Caba, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Caba, Argentina, C1431FWO
        • Centro de Educacion Medica e Investigaciones Clinicas "Norberto Quirno" Cemic
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado Centro Médico de Córdoba
      • Cordoba, Argentina, X5004FHP
        • Clínica Universitaria Reina Fabiola
    • Buenos Aires
      • Pergamino, Buenos Aires, Argentina, B2700CPM
        • Centro de Investigacion Pergamino SA - Clinica Pergamino SA
    • Santa FE
      • Rosario, Santa FE, Argentina, S2000KZE
        • Instituto de Oncología de Rosario
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris O'Brien Lifehouse
      • Darlinghurst, New South Wales, Australia, 2010
        • St Vincent'S Hospital Sydney
      • Port Macquarie, New South Wales, Australia, 2444
        • Port Macquarie Base Hospital
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • River City Pharmacy
      • Auchenflower, Queensland, Australia, 4066
        • Icon Cancer Centre Wesley
      • Brisbane, Queensland, Australia, 4102
        • Princess Alexandra Hospital
      • Chermside, Queensland, Australia, 4032
        • ICON Cancer Centre Chermside
      • South Brisbane, Queensland, Australia, 4101
        • ICON Cancer Centre South Brisbane
      • South Brisbane, Queensland, Australia, 4101
        • Integrated Clinical Oncology Network Pty Ltd (ICON)
      • Southport, Queensland, Australia, 4215
        • ICON Cancer Centre Southport
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Peter MacCallum Cancer Centre
      • North Melbourne, Victoria, Australia, 3051
        • Peter MacCallum Cancer Centre
  • Belgium
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Gent, Belgium, 9000
        • UZ Gent
      • Gent, Belgium, 9000
        • A.Z. Sint-Lucas
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Ottignies, Belgium, 1340
        • Clinique Saint-Pierre Ottignies
      • Yvoir, Belgium, 5530
        • CHU UCL Namur site Godinne
  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 20230-130
        • Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA
      • Rio de Janeiro, RJ, Brazil, 20231-050
        • Instituto Nacional de Câncer José de Alencar Gomes da Silva - INCA
      • Rio de Janeiro, RJ, Brazil, 20551-030
        • Hospital Universitario Pedro Ernesto-Centro de Pesquisas (CEPUSA)
      • Rio de Janeiro, RJ, Brazil, 22031-011
        • Hospital CopaDor
      • Rio de Janeiro, RJ, Brazil, 22211-230
        • Hospital Gloria D'Or
      • Rio de Janeiro, RJ, Brazil, 22251-040
        • Oncologia D'Or
      • Rio de Janeiro, RJ, Brazil, 22281-100
        • Instituto D'or de Pesquisa e Ensino
      • Rio de Janeiro, RJ, Brazil, 22291-110
        • Oncologia D'Or
    • RS
      • Ijui, RS, Brazil, 98700-000
        • Associacao Hospital de Caridade de Ijui
      • Lajeado, RS, Brazil, 95900-022
        • Sociedade Beneficencia e Caridade de Lajeado - Hospital Bruno Born
      • Porto Alegre, RS, Brazil, 90610-000
        • Centro de Pesquisa Clinica em Oncologia - Hospital Sao Lucas da Pontificia Universidade Catolica
      • Porto Alegre, RS, Brazil, 90850-170
        • Centro Gaucho Integrado - Hospital Mae de Deus
      • Porto Alegre, RS, Brazil, 91010-004
        • MedPlex Eixo Norte
      • Porto Alegre, RS, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Fundação Pio XII - Hospital de Câncer de Barretos
      • Santo Andre, SP, Brazil, 09060-870
        • Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Oncologia (CEPHO)
      • Santo Andre, SP, Brazil, 09060-650
        • Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa de Hematologia e Oncologia (CEPHO)
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
      • Sao Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo-ICESP-Nucleo de Pesquisa
      • Sao Paulo, SP, Brazil, 01327-001
        • Hospital Alemao Oswaldo Cruz
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre - Alberta Health Services
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Cancer Center
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Centre integre universitaire de sante et de services sociaux du Saguenay-Lac-Saint-Jean
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H2X 3E4
        • CHUM - Centre hospitalier de l'Université de Montréal
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre integre universitaire de sante et de services sociaux de l'Estrie
  • Chile
      • Araucania, Chile, 4800827
        • James Lind Centro de lnvestigacion del Cancer
    • Metropolitana
      • Santiago, Metropolitana, Chile, 7500713
        • Sociedad Prosalud Montes y Orlandi Ltda. Fantasy name (Orlandi Oncologia)
    • Region DE LA Araucania
      • Temuco, Region DE LA Araucania, Chile, 4781156
        • Centro de Investigacion Clinica del Sur
      • Temuco, Region DE LA Araucania, Chile, 4810469
        • Sociedad de Investigaciones Medicas Ltda (SIM)
      • Temuco, Region DE LA Araucania, Chile, 4810561
        • Sociedad de Investigaciones Medicas Ltda (SIM)
    • Valparaiso
      • Vina del Mar, Valparaiso, Chile, 2540488
        • Centro de Investigaciones Clinicas Vina del Mar
      • Vina del Mar, Valparaiso, Chile, 2540634
        • Centro de Investigaciones Clinicas Vina del Mar
  • China
      • Beijing, China, 100021
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
      • Chongqing, China, 400030
        • Chongqing University Cancer Hospital
      • Shanghai, China, 200025
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Shanghai, China, 200072
        • Shanghai Tenth People's Hospital
      • Shanghai, China, 200032
        • Fudan University Cancer Hospital, Deptartment of Urology
      • Shanghai, China, 201100
        • The Fifth People's Hospital of Shanghai, Fudan University
      • Tianjin, China, 300211
        • The Second Hospital of Tianjin Medical University
      • Wenzhou, China, 325035
        • The First Affiliated Hospital of Wenzhou Medical University
    • Anhui
      • Hefei, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 100191
        • Peking University Third Hospital
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100730
        • Beijing Hospital
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital / Urology Department
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
      • Xiamen, Fujian, China, 361003
        • First Affiliated Hospital of Xiamen University
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430022
        • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
    • Jiangsu
      • Lianyungang, Jiangsu, China, 222061
        • The First People's Hospital of Lianyungang
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School
      • Nantong, Jiangsu, China, 226000
        • Nantong Tumor Hospital
      • Suzhou, Jiangsu, China, 215004
        • Second Affiliated Hospital of Suzhou University
      • Suzhou, Jiangsu, China
        • Second Affiliated Hospital of Suzhou University
      • Wuxi, Jiangsu, China, 214023
        • Wuxi People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China, 130000
        • Jilin Cancer Hospital
      • Changchun, Jilin, China, 130000
        • Jilin Province Tumor Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200080
        • Shanghai General Hospital
      • Shanghai, Shanghai, China, 200032
        • Zhongshan Hospital Fudan University
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Yunnan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital
      • Ningbo, Zhejiang, China, 315010
        • The First Affiliated Hospital of Ningbo University
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hosptial of Wenzhou Medical University
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
      • Ostrava-Poruba, Czechia, 708 52
        • Fakultni nemocnice Ostrava
      • Pardubice, Czechia, 532 03
        • Multiscan s.r.o.
      • Praha 10, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
  • Finland
      • Helsinki, Finland, 00180
        • Docrates Cancer Center
      • Helsinki, Finland, 00029
        • HUS Helsinki University Hospital
      • Kempele, Finland, 90440
        • OYS apteekki
      • Kuopio, Finland, 70029
        • Kuopio University Hospital
      • Kuopio, Finland, 70210
        • Kuopio University Hospital
      • Oulu, Finland, 90220
        • Oulun yliopistollinen sairaala
      • Tampere, Finland, 33520
        • Tampere University Hospital
      • Turku, Finland, 20520
        • Turku University Hospital
  • France
      • Bayonne, France, 64100
        • Centre d'Oncologie du Pays-Basque
      • Bayonne, France, 64100
        • Clinique Ramsay Belharra
      • Bordeaux, France, 33075
        • Hopital Saint Andre - CHU de Bordeaux
      • LA ROCHE SUR YON cedex 9, France, 85925
        • CHD Vendée
      • Le Mans, France, 72000
        • Clinique Victor Hugo-Centre Jean Bernard
      • Le Mans, France, 72015 Cedex 02
        • Clinique Victor Hugo
      • Le Mans, France, 72000
        • Centre de cancerologie de la Sarthe
      • Lyon CEDEX 08, France, 69373
        • Centre Leon Berard
      • Lyon Cedex 08, France, 69373
        • Centre Leon Berard
      • Montpellier cedex 5, France, 34295
        • CHU Montpellier-Hopital Saint Eloi
      • Paris, France, 75010
        • Hopital Saint-Louis
      • Paris Cedex 15, France, 75908
        • Hôpital Européen Georges Pompidou
      • Strasbourg, France, 67000
        • Clinique Sainte Anne
      • Strasbourg, France, 67200
        • Hopitaux Universitaires de Strasbourg - ICANS
      • Suresnes, France, 92150
        • Hôpital Foch
      • Suresnes Cedex, France, 92151
        • Hôpital Foch
      • VILLEJUIF cedex, France, 94805
        • Institut Gustave Roussy
  • Germany
      • Duesseldorf, Germany, 40225
        • Universitaetsklinikum Duesseldorf
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany, 69120
        • Universitaetsklinik Heidelberg
      • Kirchheim, Germany, 73230
        • Diagnostikzentrum
      • Muenster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Nuertingen, Germany, 72622
        • Studienpraxis Urologie
  • Hungary
      • Budapest, Hungary, 1122
        • Országos Onkológiai Intézet
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Budapest, Hungary, 1082
        • Semmelweis Egyetem Urologiai Klinika
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Pecs, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai Kozpont Onkoterapias Intezet
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale - Napoli
    • BO
      • Bologna, BO, Italy, 40138
        • Azienda Ospedaliero-Universitaria Policlinico Sant' Orsola Malpighi
    • CR
      • Cremona, CR, Italy, 26100
        • ASST di Cremona
    • FC
      • Meldola, FC, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
    • TN
      • Terni, TN, Italy, 05100
        • Azienda Ospedaliera S. Maria
      • Trento, TN, Italy, 38122
        • Ospedale Santa Chiara
    • TO
      • Orbassano, TO, Italy, 10043
        • AOU San Luigi Gonzaga
  • Japan
      • Chiba, Japan, 260-8717
        • Chiba Cancer Center
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital
      • Kumamoto, Japan, 860-0008
        • National Hospital Organization Kumamoto Medical Center
      • Tokushima, Japan, 770-8503
        • Tokushima University Hospital
      • Yamagata, Japan, 990-2292
        • Yamagata Prefectural Central Hospital
      • Yamagata, Japan, 990-9585
        • Yamagata University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 466-8560
        • Nagoya University Hospital
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Hirosaki University School of Medicine & Hospital
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama, Ehime, Japan, 791-0280
        • National Hospital Organization Shikoku Cancer Center
    • Hiroshima
      • Kure, Hiroshima, Japan, 737-0023
        • National Hospital Organization Kure Medical Center and Chugoku Cancer Center
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Kanazawa University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Yokosuka, Kanagawa, Japan, 238-8558
        • Yokosuka Kyosai Hospital
    • Osaka
      • Osaka-shi, Osaka, Japan, 5418567
        • Osaka International Cancer Institute
      • Osakasayama, Osaka, Japan, 589-8511
        • Kindai University Hospital
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University School of Medicine, University Hospital
    • Tokyo
      • Meguro-ku, Tokyo, Japan, 152-8902
        • National Hospital Organization Tokyo Medical Center
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Chilgok Hospital
      • 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, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 05505
        • Cancer Center Clinical Trial, Asan Medical Center
      • Seoul, Korea, Republic of, 06351
        • Clinical Trials Center Pharmacy
      • Seoul, Korea, Republic of, 06591
        • Clinical Trial Pharmacy, The Catholic University of Korea
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • Clinical Trial Pharmacy, National Cancer Center
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
    • BAY OF Plenty
      • Tauranga, BAY OF Plenty, New Zealand, 3112
        • Tauranga Urology Research Limited
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8011
        • Canterbury District Health Board
    • Waikato
      • Hamilton, Waikato, New Zealand, 3204
        • Waikato Hospital
  • Norway
      • Gralum, Norway, 1712
        • Sykehusapoteket Ostfold, Kalnes
      • Gralum, Norway, 1714
        • Ostfold County Hospital, Kalnes
      • Lorenskog, Norway, 1478
        • Akershus University Hospital
      • Oslo, Norway, 0379
        • Oslo University Hospital -Ullevål & Radiumhospitalet
      • Trondheim, Norway, 7030
        • St. Olavs Hospital, Trondheim University Hospital
  • Peru
      • Arequipa, Peru
        • Clinica Monte Carmelo S.C.R.LTDA.
      • Lima, Peru, Lima 11
        • Hospital Militar Central "Coronel Luis Arias Schreiber"
      • Lima, Peru, Lima 41
        • Clinica Internacional Sede San Borja
      • Lima, Peru, Lima 41
        • Clinica Oncosalud
  • Poland
      • Brzozow, Poland, 36-200
        • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza
      • Gdynia, Poland, 81-519
        • Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii i Radioterapii
      • Konin, Poland, 62-500
        • Przychodnia Lekarska "Komed" Roman Karaszewski
      • Otwock, Poland, 05-400
        • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina
      • Warszawa, Poland, 02-473
        • City Clinic Sp. z o.o.
      • Warszawa, Poland, 02-797
        • NZOZ Szpital Mazovia; Oddzial urologiczny
  • Portugal
      • Braga, Portugal, 4710-243
        • Centro Clínico Académico - Braga, Associação (2CABraga)
      • Coimbra, Portugal, 3000-075
        • Instituto Português Oncologia de Coimbra Francisco Gentil - E.P.E
      • Lisboa, Portugal, 1400-038
        • Fundacao Champalimaud
      • Lisboa, Portugal, 1500-650
        • Hospital da Luz Lisboa
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto - Hospital de Santo António
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia do Porto Francisco Gentil
  • South Africa
      • Johannesburg, South Africa, 2193
        • Wits Clinical Research
    • Eastern CAPE
      • Port Elizabeth, Eastern CAPE, South Africa, 6045
        • Cancercare Langenhoven Drive Oncology Centre
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research
      • Johannesburg, Gauteng, South Africa, 2196
        • The Medical Oncology Centre of Rosebank
      • Johannesburg, Gauteng, South Africa, 2193
        • Wits Clinical Research Charlotte Maxeke Johannesburg Academic Hospital (CMJAH), Clinical Trial Site
      • Parktown, Gauteng, South Africa, 2193
        • Wits Clinical Research
    • Western CAPE
      • Cape Town, Western CAPE, South Africa, 7700
        • Cancercare Rondebosch Oncology
      • George, Western CAPE, South Africa, 6530
        • Outeniqua Cancercare Oncology Unit
      • Kraaifontein, Cape Town, Western CAPE, South Africa, 7570
        • Cape Town Oncology Trials
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Madrid, Spain, 28006
        • Hospital Universitario La Princesa
      • Madrid, Spain, 28041
        • Hospital Universitario 12 De Octubre
      • Madrid, Spain, 28033
        • MD Anderson Cancer Center
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Marañón
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Institut Catala d'Oncologia - ICO L'Hospitalet
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria i Universitaria Parc Tauli
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Hospital Universitario Virgen de la Arrixaca
  • Sweden
      • Goteborg, Sweden, 413 45
        • Klinisk Provningsenhet (KPE) Onkologi
      • Stockholm, Sweden, 171 76
        • Patientomrade Backencancer, Tema Cancer
      • Umeå, Sweden, 901 85
        • Cancercentrum
  • United Kingdom
      • Cornwall, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospitals NHS trust
      • Glasgow, United Kingdom, G12 0YN
        • NHS Greater Glasgow and Clyde
      • Liverpool, United Kingdom, L7 8YA
        • The Clatterbridge Cancer Centre - Liverpool
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare Nhs Trust
      • London, United Kingdom, W2 1NY
        • Imperial College Healthcare Nhs Trust
      • London, United Kingdom, W6 8RF
        • Imperial College Healthcare NHS Trust, Charing Cross Hospital
      • Oxford, United Kingdom, OX3 7LE
        • Oxford University Hospitals NHS Trust
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • University Hospitals Plymouth NHS Trust
    • Wirral
      • Bebington, Wirral, United Kingdom, CH63 4JY
        • The Clatterbridge Cancer Centre NHS Foundation Trust
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Alaska Urological Institute dba Alaska Clinical Research Center
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
      • Gilbert, Arizona, United States, 85297
        • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
      • Mesa, Arizona, United States, 85202
        • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
      • Mesa, Arizona, United States, 85206
        • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
      • Scottsdale, Arizona, United States, 85260
        • Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers
      • Tucson, Arizona, United States, 85715
        • Arizona Urology Specialists
      • Tucson, Arizona, United States, 85741
        • Arizona Urology Specialists
    • California
      • Beverly Hills, California, United States, 90211
        • Beverly Hills Cancer Center
      • Chula Vista, California, United States, 91911
        • South County Hematology/Oncology
      • Chula Vista, California, United States, 91913
        • Sharp Rees-Stealy
      • Glendale, California, United States, 91206
        • Glendale Adventist Medical Center
      • Greenbrae, California, United States, 94904
        • Marin Cancer Care, Inc.
      • La Mesa, California, United States, 91942
        • Cancer Center Oncology Medical Group
      • Loma Linda, California, United States, 92354
        • Loma Linda University Medical Center
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Center - Hematology/Oncology Clinic
      • Long Beach, California, United States, 90822
        • VA Long Beach Healthcare System
      • Los Angeles, California, United States, 90095
        • UCLA Clark Urology Center
      • Orange, California, United States, 92868
        • University of California, Irvine Medical Center
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute
      • Rancho Mirage, California, United States, 92270
        • Eisenhower Medical Center
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group, Incorporation
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital Investigational Pharmacy
      • San Diego, California, United States, 92123
        • Sharp Rees-Stealy
      • San Diego, California, United States, 92123
        • Medical Oncology Associates-SD
      • Stanford, California, United States, 94305
        • Stanford Health Care
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital - Anschutz Cancer Pavilion
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver CTO/CTRC
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital- Anschutz Inpatient Pavilion
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital- Anschutz Outpatient Pavilion
      • Denver, Colorado, United States, 80211
        • The Urology Center Of Colorado
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Florida Cancer Specialists
      • Brandon, Florida, United States, 33511
        • Florida Cancer Specialists
      • Celebration, Florida, United States, 34747
        • AdventHealth Medical Group Hematology & Oncology at Celebration
      • Clearwater, Florida, United States, 33761
        • Florida Cancer Specialists
      • Daytona Beach, Florida, United States, 32117
        • Florida Cancer Specialists
      • Fort Myers, Florida, United States, 33905
        • Florida Cancer Specialists
      • Gainesville, Florida, United States, 32605
        • Florida Cancer Specialists
      • Kissimmee, Florida, United States, 34741
        • AdventHealth Medical Group Hematology & Oncology at Kissimmee
      • Lakeland, Florida, United States, 33805
        • Lakeland Regional Health Hollis Cancer Center
      • Largo, Florida, United States, 33770
        • Florida Cancer Specialists
      • Lecanto, Florida, United States, 34461
        • Florida Cancer Specialists
      • New Port Richey, Florida, United States, 34655
        • Florida Cancer Specialists
      • Ocala, Florida, United States, 34471
        • Florida Cancer Specialists
      • Orange City, Florida, United States, 32763
        • Florida Cancer Specialists
      • Orlando, Florida, United States, 32806
        • Florida Cancer Specialists
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando
      • Orlando, Florida, United States, 32804
        • Investigational Drug Services, Advent Health Orlando
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
      • Spring Hill, Florida, United States, 34608
        • Florida Cancer Specialists
      • Stuart, Florida, United States, 34994
        • Florida Cancer Specialists
      • Tampa, Florida, United States, 33607
        • Florida Cancer Specialists
      • Tavares, Florida, United States, 32778
        • Florida Cancer Specialists
      • The Villages, Florida, United States, 32159
        • Florida Cancer Specialists
      • Vero Beach, Florida, United States, 32960
        • Florida Cancer Specialists
      • Wellington, Florida, United States, 33414
        • Florida Cancer Specialists
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists
      • Winter Park, Florida, United States, 32792
        • Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Piedmont Cancer Institute
      • Fayetteville, Georgia, United States, 30214
        • Piedmont Cancer Institute
      • Newnan, Georgia, United States, 30265
        • Southeastern Regional Medical Center
      • Newnan, Georgia, United States, 30265
        • Piedmont Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • John H. Stroger, Jr. Hospital of Cook County/IND Pharmacy
      • Chicago, Illinois, United States, 60612
        • Cook County Health (CCH)
      • Hinsdale, Illinois, United States, 60521
        • AMITA Health Adventist Medical Center Hinsdale
      • Hinsdale, Illinois, United States, 60521
        • AMITA Health Cancer Institute
      • Zion, Illinois, United States, 60099
        • Midwestern Regional Medical Center
    • Indiana
      • Jeffersonville, Indiana, United States, 47130
        • First Urology, PSC
      • Jeffersonville, Indiana, United States, 47130
        • Clark Memorial Hospital Radiology
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital and Clinics
    • Kansas
      • Fairway, Kansas, United States, 66205
        • The University of Kansas Clinical Research Center
      • Westwood, Kansas, United States, 66205
        • The University of Kansas Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Missouri
      • Saint Louis, Missouri, United States, 63106
        • VA Saint Louis Healthcare System
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • GU Research Network/Urology Cancer Center
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Clara Maass Medical Center
      • Belleville, New Jersey, United States, 07109
        • New Jersey Cancer Care and Blood Disorders
      • Nutley, New Jersey, United States, 07110
        • University Radiology
      • Voorhees, New Jersey, United States, 08043
        • New Jersey Urology, LLC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Urology Group of New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center - Montefiore Medical Park
      • Poughkeepsie, New York, United States, 12603
        • Premier Medical Group of the Hudson Valley PC
      • Syracuse, New York, United States, 13210
        • Associated Medical Professionals of New York, PLLC
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • TriState urologic Services PSC Inc., dba The Urology Group
      • Middleburg Heights, Ohio, United States, 44130
        • Clinical Research Solutions
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Providence Cancer Institute Clackamas Clinic
      • Clackamas, Oregon, United States, 97015-9303
        • Kaiser Sunnyside Medical Center
      • Hillsboro, Oregon, United States, 97124
        • Kaiser Westside Medical Center
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Newberg, Oregon, United States, 97132
        • Providence Cancer Institute Newberg Clinic
      • Oregon City, Oregon, United States, 97045
        • Providence Cancer Institute Willamette Falls
      • Portland, Oregon, United States, 97213
        • Providence Cancer Institute Franz Clinic
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97227
        • Kaiser Permanente Northwest
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Oncology and Hematology Care Clinic - Westside
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • UPMC Hillman Cancer Center - Altoona
      • Bethel Park, Pennsylvania, United States, 15102
        • UPMC Hillman Cancer Center - Upper St. Clair
      • Greensburg, Pennsylvania, United States, 15601
        • UPMC Hillman Cancer Center - Arnold Palmer - Mt View
      • Lancaster, Pennsylvania, United States, 17604
        • Keystone Urology Specialists
      • Monroeville, Pennsylvania, United States, 15146
        • UPMC Hillman Cancer Center - Monroeville
      • Pittsburgh, Pennsylvania, United States, 15232
        • UPMC Hillman Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC Hillman Cancer Center - Passavant (HOA)
      • Pittsburgh, Pennsylvania, United States, 15237
        • UPMC Hillman Cancer Center - Passavant (OHA)
      • Seneca, Pennsylvania, United States, 16346
        • UPMC Hillman Cancer Center - Northwest
      • Uniontown, Pennsylvania, United States, 15401
        • UPMC Hillman Cancer Center - Uniontown
      • Washington, Pennsylvania, United States, 15301
        • UPMC Hillman Cancer Center - Washington
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Carolina Urologic Research Center
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Tennessee Oncology, PLLC
      • Chattanooga, Tennessee, United States, 37404
        • Sarah Cannon Research Institute
      • Cleveland, Tennessee, United States, 37311
        • Tennesse Oncology, PLLC
      • Nashville, Tennessee, United States, 37232
        • The Vanderbilt Clinic
      • Nashville, Tennessee, United States, 37209
        • Urology Associates P.C.
      • Nashville, Tennessee, United States, 37232
        • Vanderbuilt University Medical Center, Department of Urology
    • Texas
      • Austin, Texas, United States, 78745
        • Urology Austin PLLC
      • El Paso, Texas, United States, 79912
        • Rio Grande Urology, P.A.
      • Houston, Texas, United States, 77027
        • Houston Metro Urology
      • Round Rock, Texas, United States, 78681
        • Urology Austin, PLLC
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Medical Center - Temple
    • Utah
      • Farmington, Utah, United States, 84025
        • Farmington Health Center -University of Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah, Huntsman Cancer Institute
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Hospital
      • Salt Lake City, Utah, United States, 84119
        • Redwood Health Center-University of Utah
      • South Jordan, Utah, United States, 84095
        • South Jordan Health Center -University of Utah
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute Infusion Pharmacy
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital & Clinics
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Clinical Science Center

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

Description

Inclusion Criteria:

Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell features

Asymptomatic or mildly symptomatic metastatic castration resistant prostate cancer (mCRPC) (score on BPI-SF Question #3 must be < 4).

For enrollment into Part 2 only (optional in Part 1): assessment of DDR mutation status

Consent to a saliva sample collection for a germline comparator unless prohibited by local regulations or ethics committee decision (optional for patients in Part 1).

Surgically or medically castrated, with serum testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening.

Metastatic disease in bone documented on bone scan or in soft tissue documented on CT/MRI scan.

Progressive disease at study entry in the setting of medical or surgical castration as defined by 1 or more of the following 3 criteria:

  • Prostate specific antigen (PSA) progression defined by a minimum of 2 rising PSA values from 3 consecutive assessments with an interval of at least 7 days between assessments..
  • Soft tissue disease progression as defined by RECIST 1.1.
  • Bone disease progression defined by Prostate Cancer Working Group 3 (PCWG3) with 2 or more new metastatic bone lesions on a whole body radionuclide bone scan.

Ongoing bisphosphonate or denosumab use prior to Day 1 (Part 1) or randomization (Part 2) is allowed but not mandatory.

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.

Life expectancy ≥ 12 months as assessed by the investigator.

Able to swallow the study drug and have no known intolerance to study drugs or excipients.

Must agree to use a condom when having sex with a partner from the time of the first dose of study drug through 4 months after last dose of study treatment. Must also agree for female partner of childbearing potential to use an additional highly effective form of contraception from the time of the first dose of study treatment through 4 months after last dose of study treatment when having sex with a non pregnant female partner of childbearing potential.

Must agree not to donate sperm from the first dose of study drug to 4 months after the last dose of study drug.

Evidence of a personally signed and dated informed consent document (and molecular prescreening consent if appropriate) indicating that the patient [or a legally acceptable representative/legal guardian] has been informed of all pertinent aspects of the study.

Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

Any prior systemic cancer treatment initiated in in the non metastatic CRPC and mCRPC disease state.

Patients whose only evidence of metastasis is adenopathy below the aortic bifurcation.

Prior treatment with second-generation androgen receptor inhibitors (enzalutamide, apalutamide, and darolutamide), a PARP inhibitor, cyclophosphamide, or mitoxantrone for prostate cancer.

Prior treatment with platinum-based chemotherapy within 6 months (from the last dose) prior to Day 1 (Part 1) or randomization (Part 2), or any history of disease progression on platinum-based therapy within 6 months (from the last dose).

Treatment with cytotoxic chemotherapy, biologic therapy including sipuleucel T, or radionuclide therapy received in the castration-sensitive prostate cancer is NOT exclusionary if discontinued in the 28 days prior to Day 1 (Part 1) or randomization (Part 2).

Treatment with any investigational agent within 4 weeks before Day 1 (Part 1) or randomization (Part 2).

Prior treatment with opioids for pain related to either primary prostate cancer or metastasis within 28 days prior to Day 1 (Part 1) or randomization (Part 2).

Current use of potent P-gp inhibitors within 7 days prior to Day 1 (Part 1) or randomization (Part 2).

Major surgery (as defined by the investigator) within 2 weeks before Day 1 (Part 1) or randomization (Part 2), or palliative localized radiation therapy within 3 weeks before randomization (Part 2).

Clinically significant cardiovascular disease

Significant renal dysfunction as defined by any of the following laboratory abnormalities:

• Renal: eGFR < 30 mL/min/1.73 m2 by the MDRD equation (available via www.mdrd.com).

Patients enrolled in Part 1 only: Moderate renal impairment (eGFR 30-59 mL/min/1.73 m2) at screening.

Significant hepatic dysfunction as defined by any of the following laboratory abnormalities on screening labs:

  • Total serum bilirubin >1.5 times the upper limit of normal (ULN) (>3 × ULN for patients with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation).
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 times ULN (>5 × ULN if liver function abnormalities are due to hepatic metastasis).
  • Albumin <2.8 g/dL

Absolute neutrophil count < 1500/µL, platelets < 100,000/µL, or hemoglobin < 9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology values at screening).

Known or suspected brain metastasis or active leptomeningeal disease.

Symptomatic or impending spinal cord compression or cauda equina syndrome.

Any history of myelodysplastic syndrome, acute myeloid leukemia, or prior malignancy except any of the following:

  • Carcinoma in situ or non melanoma skin cancer
  • Any prior malignancies ≥3 years before randomization with no subsequent evidence of recurrence or progression regardless of the stage.
  • Stage 0 or Stage 1 cancer <3 years before randomization that has a remote probability of recurrence or progression in the opinion of the investigator

Gastrointestinal disorder affecting absorption.

Fertile male subjects who are unwilling or unable to use highly effective methods of contraception for the duration of the study and for 4 months after the last dose of investigational product.

Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or patients who are Pfizer employees, including their family members, directly involved in the conduct of the study.

Other acute or chronic medical (concurrent disease, infection, or comorbidity) or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that interferes with ability to participate in the study, may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.

History of seizure or any condition that may predispose to seizure (eg, prior cortical stroke, significant brain trauma). Also, history of loss of consciousness or transient ischemic attack within 12 months of randomization (Part 2).

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination arm
Talazoparib plus enzalutamide
Drug: Talazoparib with enzalutamide
Talazoparib 0.5 mg/day plus enzalutamide 160mg/day
Active Comparator: Monotherapy arm
Ezalutamide plus placebo
Drug: Placebo with enzalutamide
Placebo plus enzalutamide 160 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Occuring Within the First 66 Days of Dosing - Part 1
Time Frame: Post dose on Day 1 up to Day 66 in Part 1
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per Common Terminology Criteria for Adverse Events (CTCAE) version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
Post dose on Day 1 up to Day 66 in Part 1
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by Preferred Term (PT) and Max CTCAE Grade Occuring Within the First 66 Days of Dosing - Part 1
Time Frame: Post dose on Day 1 up to Day 66 in Part 1
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1=mild AE; Grade 2=moderate AE; Grade 3=severe AE; Grade 4=life-threatening or disabling AE; Grade 5=death related to an AE. Medical Dictionary for Regulatory Activities (MedDRA) v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with at least 1 occurrence in participants are reported for this outcome measure. Results as of 16 Aug 2022 are reported.
Post dose on Day 1 up to Day 66 in Part 1
Number of Participants With All-Causality TEAEs During the Overall Period of Part 1
Time Frame: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
An adverse event (AE) was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. Serious TEAE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Number of Participants With Treatment-Related TEAEs During the Overall Period of Part 1
Time Frame: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. Treatment-related AE was any untoward medical occurrence attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1= mild AE; Grade 2= moderate AE; Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. SAEs were determined according to the investigator's assessment. Results as of 16 Aug 2022 are reported.
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Number of Participants With All-Causality Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade Occuring Anytime After Dosing - Part 1
Time Frame: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are defined as newly occurring AEs or those worsening after first dose. As per CTCAE version 4, Grade 1=mild AE; Grade 2=moderate AE; Grade 3=severe AE; Grade 4=life-threatening or disabling AE; Grade 5=death related to an AE. MedDRA v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with at least 1 occurrence in participants are reported for this outcome measure. Results as of 16 Aug 2022 are reported.
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Number of Participants With Treatment-Related Clustered Treatment-Emergent Cytopenias by PT and Max CTCAE Grade in >=10% of Participants Occuring Anytime After Dosing - Part 1
Time Frame: Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
An AE was any untoward medical occurrence in a participant who received study intervention without regard to possibility of causal relationship. TEAEs are newly occurring AEs or those worsening after first dose. Treatment-related AE was any AE attributed to study intervention in a participant who received study intervention. As per CTCAE version 4, Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening or disabling; Grade 5=death related to an AE. MedDRA v25.0 coding dictionary applied. PTs for the cluster terms are: ANEMIA, including Anemia, Hematocrit decreased, Hemoglobin decreased, and Red blood cell count decreased; THROMBOCYTOPENIA, including, Thrombocytopenia and Platelet count decreased; NEUTROPENIA, including Febrile neutropenia, Neutropenia and Neutrophil count decreased; LEUKOPENIA, including Leukopenia, White blood cell count decreased. Events in any grade with incidence in >=10% of participants are reported. Results as of 16 Aug 2022 are reported.
Post dose on Day 1 up to 28 days after the last dose of study intervention, or before new systemic antineoplastic therapy, whichever occurred first (maximum of 235.14 weeks)
Blinded Independent Central Review (BICR) Assessed Radiographic Progression-Free Survival (rPFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for All-Comers - Part 2 Cohort 1
Time Frame: From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by computed tomography (CT) of chest and CT or magnetic resonance imaging (MRI) of abdomen and pelvis. Progression is defined using RECIST 1.1 as a >=20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Results as of 16 Aug 2022 are reported for this outcome measure.
From the start of treatment to the time of first documented progression, or death (maximum up to 42 months)
BICR Assessed rPFS Per RECIST 1.1 in Patients With DDR Deficiencies - Part 2
Time Frame: From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)
rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per RECIST 1.1, or death, whichever occurs first. Soft tissue disease status was assessed at regular intervals during the course of the study by CT of chest and CT or MRI of abdomen and pelvis. Results as of 03 Oct 2022 are reported for this outcome measure.
From the start of treatment to the time of first documented progression, or death (maximum up to 38 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: randomization up to 47 months
time from randomization to death from any cause
randomization up to 47 months
Objective response in measurable soft tissue disease (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: baseline up to 6 months
proportion of patients with measurable soft tissue disease at baseline with objective response per RECIST 1.1
baseline up to 6 months
Duration of soft tissue response (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: baseline up to 25 months
duration of responses in patients with measurable soft tissue disease at baseline per RECIST 1.1
baseline up to 25 months
PSA response (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: baseline up to 25 months
proportion of patients with PSA response grater than or equal to 50%
baseline up to 25 months
Time to PSA progression (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: baseline up to 25 months
time from baseline to PSA progression
baseline up to 25 months
Time to initiation of cytotoxic chemotherapy (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: randomization up to 47 months
time from randomization to initiation of cytotoxic chemotherapy
randomization up to 47 months
Time to initiation of antineoplastic therapy (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: randomization up to 47 months
time from randomization to initiation of antineoplastic treatment
randomization up to 47 months
Time to first symptomatic skeletal event (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: randomization up to 47 months
time from randomization to first symptomatic skeletal event (symptomatic fractures, spinal cord compression, surgery or radiation to the bone whichever is first)
randomization up to 47 months
PFS on next line of therapy (PFS2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: randomization up to 47 months
PFS2 based on investigator assessment
randomization up to 47 months
Opiate use for cancer pain (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: randomization up to 47 months
time from randomization to opiate use for prostate cancer pain
randomization up to 47 months
Incidence of adverse events (part 1 and 2)
Time Frame: Day 1 up to 26 months
AEs and SAEs incidence by type and severity (graded by NCI CTCAE version 4.03)
Day 1 up to 26 months
Pharmacokinetic assessment of talazoparib (part 1)
Time Frame: Week 1, 5, 9, and 13
plasma concentration of talazoparib
Week 1, 5, 9, and 13
Pharmacokinetic assessment of talazoparib (part 2)
Time Frame: week 3, 5, 9 13, and 17
plasma concentration of talazoparib
week 3, 5, 9 13, and 17
Pharmacokinetic assessment of enzalutamide (part 1)
Time Frame: week 1, 5, 9, and 13
plasma concentration of enzalutamide
week 1, 5, 9, and 13
Pharmacokinetic assessment of enzalutamide (part 2)
Time Frame: week 3, 5, 9 13, and 17
plasma concentration of enzalutamide
week 3, 5, 9 13, and 17
Patient-reported outcome:pain symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: baseline up to 47 months
change from baseline in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)
baseline up to 47 months
Patient-reported outcome: pain symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: baseline up to 47 months
time to deterioration in patient-reported pain symptoms per Brief Pain Inventory Short Form (BPI-SF)
baseline up to 47 months
Patient-reported outcome: cancer specific global health status/QoL, functioning, and symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: baseline up to 47 months
change from baseline in patient-reported Global health status/QoL per EORTC QLQ-C30
baseline up to 47 months
Patient-reported outcome: cancer specific global health status/QoL, functioning, and symptoms (part 2) in unselected patients and in patients harboring DDR deficiencies
Time Frame: baseline up to 47 months
time to definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30
baseline up to 47 months
Patient-reported outcome: general health status (part2) in unselected patients and patients harboring DDR deficiencies
Time Frame: baseline up to 47 months
change from baseline in patient-reported general health status per EQ-5D-5L
baseline up to 47 months
Patient-reported outcome: general health status (part 2) in unselected patients and patients harboring DDR deficiencies
Time Frame: baseline up to 47 months
time to definitive deterioration in patient-reported disease-specific urinary symptoms per EORTC QLQ-PR25
baseline up to 47 months

Collaborators and Investigators

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

Sponsor

Pfizer

Collaborators

Astellas Pharma Inc

Investigators

  • Study Director: 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

Helpful Links

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)

December 18, 2017

Primary Completion (Actual)

October 3, 2022

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 10, 2018

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C3441021
  • 2017-003295-31 (EudraCT Number)
  • TALAPRO-2 (Other Identifier: Alias Study 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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