Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer
PROSPER
PROSPER: A MULTINATIONAL, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF ENZALUTAMIDE IN PATIENTS WITH NONMETASTATIC CASTRATION-RESISTANT PROSTATE CANCER
3 other identifiers
interventional
1,401
30 countries
351
Brief Summary
The purpose of this study is to assess the safety and efficacy of enzalutamide in patients with non metastatic prostate cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2013
Longer than P75 for phase_3
351 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2013
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 6, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2017
CompletedResults Posted
Study results publicly available
July 12, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 28, 2025
CompletedJanuary 27, 2026
January 1, 2026
3.7 years
December 3, 2013
June 15, 2018
January 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Metastasis Free Survival (MFS)
MFS:time from randomization to first date of radiographic progression (RP) (by Blinded independent central radiology review \[BICR\]) at any time or death within 112 days of treatment discontinuation without evidence of RP.RP for bone disease:appearance of 1 or more metastatic lesions on bone scan.RP for soft tissue disease:per Response Evaluation Criteria in Solid Tumors,\[RECIST 1.1\])-at least a 20 percent (%) increase in the sum of diameters of target lesions,taking as reference the smallest sum on study (includes the baseline sum if smallest on study).Participants who did not have MFS event at the time of analysis data cut-off (28 June 2017) were censored at date of last assessment showing no objective evidence of RP prior to skeletal-related event or two or more consecutive missed tumor assessments. Participants who were randomized but later confirmed to have metastatic disease before randomization were censored on date of randomization. Analysis was based on Kaplan-Meier estimates.
From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Secondary Outcomes (46)
Time to Prostate-Specific Antigen (PSA) Progression
From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Time to First Use of New Antineoplastic Therapy
From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Overall Survival
From randomization until death (up to a maximum of 68.8 months)
Time to Pain Progression
From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
Time to First Use of Cytotoxic Chemotherapy
From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)
- +41 more secondary outcomes
Study Arms (2)
Placebo
SHAM COMPARATORSugar pill manufactured to mimic enzalutamide 40 mg capsule
Enzalutamide
EXPERIMENTAL160 mg by mouth once daily
Interventions
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
- Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or prior bilateral orchiectomy (medical or surgical castration);
- Testosterone ≤ 50 ng/dL (≤ 1.73 nmol/L) at screening;
- Progressive disease on androgen deprivation therapy at enrollment;
- PSA and the screening PSA assessed by the central laboratory (central PSA) should be ≥ 2 µg/L (2 ng/mL:
- PSA doubling time ≤ 10 months;
- No prior or present evidence of metastatic disease;
- Asymptomatic prostate cancer;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Estimated life expectancy ≥ 12 months.
You may not qualify if:
- Prior cytotoxic chemotherapy;
- Use of hormonal therapy or biologic therapy for prostate cancer (other than approved bone targeting agents and GnRH agonist/antagonist therapy) or use of an investigational agent within 4 weeks of randomization;
- Known or suspected brain metastasis or active leptomeningeal disease;
- History of another invasive cancer within 3 years of randomization;
- Absolute neutrophil count \< 1000/μL, platelet count \< 100,000/μL, or hemoglobin \< 10 g/dL (6.2 mmol/L) at screening;
- Total bilirubin ≥ 1.5 times the upper limit of normal;
- Creatinine \> 2 mg/dL (177 µmol/L) at screening;
- Albumin \< 3.0 g/dL (30 g/L) at screening;
- History of seizure or any condition that may predispose to seizure;
- Clinically significant cardiovascular disease;
- Gastrointestinal disorder affecting absorption;
- Major surgery within 4 weeks of randomization;
- Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
- Any concurrent disease, infection, or comorbid condition that interferes with the ability of the patient to participate in the trial, which places the patient at undue risk, or complicates the interpretation of data, in the opinion of the investigator or medical monitor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.collaborator
- Pfizerlead
- Astellas Pharma Inccollaborator
Study Sites (397)
Urological Associates of Southern Arizona, PC
Tucson, Arizona, 85741, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
UCLA Clark Urology Center
Los Angeles, California, 90095, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
Urology Associates of San Luis Obispo, a Medical Group, Inc
San Luis Obispo, California, 93405, United States
Urology Associates, P.C.
Englewood, Colorado, 80113, United States
c/o Lynn Buchwalder
New Haven, Connecticut, 06510, United States
C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut, 06510, United States
Smilow Cancer Center at Yale New Haven-Hospital
New Haven, Connecticut, 06510, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Urology of Indiana, LLC
Carmel, Indiana, 46032, United States
First Urology, PSC
Jeffersonville, Indiana, 47130, United States
IU Health Arnett Cancer Care
Lafayette, Indiana, 47904, United States
Kansas City Urology Care, PA
Overland Park, Kansas, 66211, United States
GU Research Network/ Wichita Urology Group
Wichita, Kansas, 67226, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, 21237, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Michigan Institute of Urology
Troy, Michigan, 48084, United States
GU Research Network
Omaha, Nebraska, 68130, United States
Brooklyn Urology Research Group
Brooklyn, New York, 11201, United States
Premier Medical Group of the Hudson Valley
Newburgh, New York, 12550, United States
Duke University Medical Center
Cary, North Carolina, 27518, United States
Carolina Urology Partners, PLLC
Charlotte, North Carolina, 28277, United States
Carolina Urology Partners, PLLC
Gastonia, North Carolina, 28054, United States
Gaston Medical Associates
Gastonia, North Carolina, 28054, United States
Carolina Urology Partners, PLLC
Huntersville, North Carolina, 28078, United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina, 27607, United States
Clinical Research Solutions
Middleburg Heights, Ohio, 44130, United States
Oregon Urology Institute
Springfield, Oregon, 97477, United States
Lancaster Urology
Lancaster, Pennsylvania, 17604, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Vanderbilt University Medical Center, Dept. of Urologic Surgery
Nashville, Tennessee, 37232, United States
Vanderbilt University Medical Center, The Urologic Clinic
Nashville, Tennessee, 37232, United States
Urology San Antonio
San Antonio, Texas, 78229, United States
Urology of Virginia, PLLC
Virginia Beach, Virginia, 23462, United States
COIBA(Centro de Oncologia e Investigacion Buenos Aires)
Berazategui, Buenos Aires, B1884BBF, Argentina
Centro Medico Austral(OMI)
CABA, Buenos Aires, C1019ABS, Argentina
Centro de Urologia
CABA, Buenos Aires, C1120AAT, Argentina
Hospital Italiano de Buenos Aires
CABA, Buenos Aires, C1199BB, Argentina
Sanatorio Parque
Rosario, Santa Fe Province, CP2000, Argentina
Instituto De Oncologia De Rosario
Rosario, Santa Fe Province, S200KZE, Argentina
Clinica Universidad Reina Fabiola
Córdoba, X5004HFP, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, X5016KEH, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja, F5300C0E, Argentina
The Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
Border Medical Oncology Research Unit
Albury, New South Wales, 2640, Australia
The Border Cancer Hospital Dispensary
Albury, New South Wales, 2640, Australia
The Border Cancer Hospital
Albury, New South Wales, 2640, Australia
Sydney cancer centre
Concord, New South Wales, 2139, Australia
Epic pharmacy
Lismore, New South Wales, 2480, Australia
North Coast Cancer Institute
Lismore, New South Wales, 2480, Australia
Macquarie University Hospital
North Ryde, New South Wales, 2109, Australia
Macquarie University
North Ryde, New South Wales, 2109, Australia
Epic Pharmacy Port Macquarie base hospital
Port Macquarie, New South Wales, 2444, Australia
Mid North Coast Cancer Institute
Port Macquarie, New South Wales, 2444, Australia
Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
The Tweed Hospital
Tweed Heads, New South Wales, 2485, Australia
Australian Clinical Trials
Wahroonga, New South Wales, 2076, Australia
Sydney Adventist Hospital
Wahroonga, New South Wales, 2076, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Icon Cancer Care Wesley
Auchenflower, Queensland, 4066, Australia
River City Pharmacy - APHS
Auchenflower, Queensland, 4066, Australia
Icon Cancer Care Chermside
Chermside, Queensland, 4032, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4101, Australia
Integrated Clinical Oncology Network (ICON)
South Brisbane, Queensland, 4101, Australia
Icon Cancer Care Southport
Southport, Queensland, 4215, Australia
Tasman Oncology Research Pty Ltd
Southport, Queensland, 4215, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, 5037, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
Cancer Care SA Pty Ltd
Kurralta Park, South Australia, 5037, Australia
Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson
Kurralta Park, South Australia, 5037, Australia
Box Hill Hospital (Eastern health)
Box Hill, Victoria, 3128, Australia
Eastern Clinical Research Unit (Eastern Health)
Box Hill, Victoria, 3128, Australia
Cabrini Hospital Brighton
Brighton, Victoria, 3186, Australia
Monash Medical Centre
Clayton, Victoria, 3168, Australia
Austin Health, Austin Hospital
Heidelberg, Victoria, 3084, Australia
Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
Cabrini Hospital- Education and Research Precinct
Malvern, Victoria, 3144, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Krankenhaus Barmherzige Schwestern Linz, Abteilung Radiologie
Linz, Upper Austria, 4010, Austria
Krankenhaus Barmherzige Schwestern Linz, Abteilung Urologie
Linz, Upper Austria, 4010, Austria
St. Vincent's Hospital, PET - CT Center
Linz, Upper Austria, 4010, Austria
Isotopix, Ambulatorium fuer Nuklearmedizin
Vienna, 1090, Austria
Medizinische Universitaet Wien, Universitaetsklinik fuer Innere Medizin I
Vienna, 1090, Austria
Diagnosezentrum Meidling GesmbH
Vienna, 1120, Austria
Algemeen Ziekenhuis Groeninge
Kortrijk, West-vlaanderen, 8500, Belgium
Clinique Universitaire de Bruxelles Hopital Erasme
Brussels, 1070, Belgium
Vzw Algemeen Ziekenhuis Maria Middelares
Ghent, 9000, Belgium
Universitaire Ziekenhuizen Leuven
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege, Site du Sart-Tilman
Liège, 4000, Belgium
Hospital Sao Rafael
Salvador, Estado de Bahia, 41253-190, Brazil
Liga Paranaense de Combate ao cancer / Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
Rio de Janeiro, Rio de Janeiro, 22.281-100, Brazil
Associacao Hospital de Caridade de Ijui
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital de Clínicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
Campinas, São Paulo, 13083-970, Brazil
Hospital Amaral Carvalho - Fundacao Dr. Amaral Carvalho
Jaú, São Paulo, 17210-080, Brazil
Fundacao Dr. Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Fundacao Dr.Amaral Carvalho
Jaú, São Paulo, 17210-120, Brazil
Centro de Estudos e Pesquisas em Hematologia e Oncologia (CEPHO)
Santo André, São Paulo, 09060-650, Brazil
Hospital Israelita Albert Einstein
Sao Paulp, São Paulo, 05652-900, Brazil
IAMSPE-Inst. de Assist. ao Servidor Publico Estadual
São Paulo, São Paulo, 04039-901, Brazil
Hospital Universitario Pedro Ernesto - UERJ
Rio de Janeiro, 20551-030, Brazil
Oncologia Rede D'Or
Rio de Janeiro, 22271-110, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9, Canada
Manitoba Prostate Centre CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
NS Health Authority, Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
The Male/Female Health and Research Centre
Barrie, Ontario, L4M 7G1, Canada
McMaster Institute of Urology @ St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6, Canada
Urology Associates / Urologic Medical Research
Kitchener, Ontario, N2N 2B9, Canada
London Regional Cancer Program - Victoria Hospital, London Health Sciences Centre(LHSC)
London, Ontario, N6A 4L6, Canada
Urology Reasearch - Victoria Hospital, London Health Sciences Centre(LHSC)
London, Ontario, N6A 5W9, Canada
SunnyBrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network- Princess Margaret Cancer Centre
Toronto, Ontario, M5G2M9, Canada
Urology South Shore Research
Greenfield Park, Quebec, J4V 2H3, Canada
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4, Canada
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
CHU de Quebec
Québec, Quebec, G1R 2J6, Canada
Fundacion Arturo Lopez Perez
Santiago, 7500836, Chile
Centro de Investigaciones Clinicas Vina del Mar
Santiago, 7630370, Chile
Instituto Clinico Oncologico del Sur (ICOS)
Temuco, 4810469, Chile
Instituto Oncologico Ltda.
Viña del Mar, 2540364, Chile
Centro de Investigaciones Clinicas
Viña del Mar, 2540488, Chile
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430030, China
Office of Hongqian Guo
Nanjing, Jiangsu, 210008, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Qingdao Municipal Hospital (East Hospital)
Qingdao, Shandong, 266071, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080, China
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, 200433, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The First Affiliated Hosptial of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
UNIMED Medical Institute Limited
Hong Kong, China
The Second Hospital of Tianjin Medical University
Tianjin, 300211, China
Rigshospitalet 7521
Copenhagen, Norrebro, 2200, Denmark
Copenhagen Prostate Cancer Center
Copenhagen, N, 2200, Denmark
Aarhus University Hospital
Arhus N, 8200, Denmark
Rigshospitalet
Copenhagen, 2100, Denmark
Frederiksberg Hospital
Frederiksberg, 2000, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Odense University Hospital
Odense C, 5000, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Docrates Syopasairaala
Helsinki, 00180, Finland
Helsingin yliopistollinen keskussairaala, Meilahden sairaala
Helsinki, 00290, Finland
Oulun yliopistollinen sairaala
Oulu, 90220, Finland
Satakunnan keskussairaala
Pori, 28500, Finland
Tampereen yliopistollinen Sairaala
Tampere, 33520, Finland
Hopitaux Universitaires de Strasbourg - Hopital Civil
Strasbourg, Alsace, FR-67091, France
Centre Paul Strauss
Strasbourg, Bas-rhin, 67000, France
Clinique Sainte Anne
Strasbourg, Bas-rhin, 67000, France
Societe MIM, Clinique Sainte Anne
Strasbourg, Bas-rhin, 67000, France
Institut Curie
Paris, Paris, 75005, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, Rhone, 69495, France
Institut Gustave Roussy
Villejuif, VAL DE Marne, 94805, France
Institut de Cancerologie de l'Ouest - Paul Papin
Angers, 49055, France
Institut Sainte Catherine
Avignon, 84918, France
Institut Bergonie
Bordeaux, 33076, France
Urologic Oncology Department- Institut Bergonie - Centre regional de Lutte contre le Cancer
Bordeaux, 33076, France
Cabinet de Radiologie
Brest, 29200, France
CHU Brest Hopital Morvan
Brest, 29200, France
Clinique pasteur Lancroze
Brest, 29200, France
Clinique Pasteur-Lanroze
Brest, 29200, France
CHRU de Brest
Brest, 29609, France
Hopital Pasteur
Colmar, 68024, France
Hopitaux Civils de Colmar
Colmar, 68024, France
Centre Regional de lutte Contre le Cancer Georges Francois Leclerc
Dijon, 21000, France
Clinique Victor Hugo
Le Mans, 72000, France
Hopital Calude Huriez - CHU Lille
Lille, 59037, France
Centre de Medecine Nucleaire LUMEN
Lyon, 69008, France
Centre Leon Berard
Lyon, 69008, France
Hopital Edouard Herriot - CHU Lyon
Lyon, 69437, France
Hopital Nord
Marseille, 13915 Cedex 20, France
ICM Val D'Aurelle
Montpellier, 34298, France
Hopital Europeen Georges Pompidou
Paris, 75908, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU Poitiers - Hopital la Miletrie
Poitiers, 86021, France
Institut de Cancerologie de I'Ouest - Rene Gauducheau
Saint-Herblain, 44805, France
Institut Claudius Regaud
Toulouse, 31059 Cedex 9, France
IUCT-Oncopole
Toulouse, 31059, France
Clinique Pasteur - CIMOF
Toulouse, 31076, France
Clinique Pasteur- Service Imagerie et Radiologie
Toulouse, 31076, France
Clinique Pasteur
Toulouse, 31076, France
Universitatsmedizin Mannheim, Medizinische Fakultat Mannheim der Universitat Heidelberg
Mannheim, Baden-Wurttemberg, 68167, Germany
Studienpraxis Urologie
Nürtingen, Baden-Wurttemberg, 72622, Germany
MVZ Zentrum fuer Diagnostische Radiologie und Nuklearmedizin Braunschweig GmbH
Braunschweig, Lower Saxony, 38102, Germany
Staedtisches Klinikum Braunschweig
Braunschweig, Lower Saxony, 38126, Germany
Hannover Medical School
Hanover, Lower Saxony, 30625, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
RWTH University Aachen
Aachen, North Rhine-Westphalia, 52057, Germany
Uniklinik der RWTH Aachen
Aachen, North Rhine-Westphalia, 52074, Germany
Clinic of Radiology
Aachen, North Rhine-Westphalia, D-52074, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, 01307, Germany
Charite, Campus Benjamin Franklin
Berlin, 12200, Germany
Charite, Universitaetsmedizin Berlin
Berlin, 12200, Germany
Martini-Klinik am UKE GmbH
Hamburg, 20246, Germany
Diagnostikzentrum Esslingen
Kirchheim, 73230, Germany
University General Hospital of Heraklion, Urology Clinic
Heraklion, Crete, 71110, Greece
General Hospital of Athens"Korgialeneio-Benakeio EES".Urology Clinic
Athens, 11526, Greece
General Hospital of Athens "Alexandra", Therapeutic Clinic
Athens, 11528, Greece
University General Hospital of Larissa, Urology Department
Larissa, 41110, Greece
University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
Pátrai, 26504, Greece
General Hospital" Papageorgiou",B' Univ.Urology Clinic
Thessaloniki, 56429, Greece
Queen Mary Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Laboratorio Medicina Nucleare-Ospedale G.B. Morgagni-Pierantoni
Forlì, FC, 47121, Italy
Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100, Italy
Medicina Nucleare, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100, Italy
Servizio di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100, Italy
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
Cremona, 26100, Italy
U.O. di Oncologia, Ospedale Civile Degli Infermi
Faenza (RA), 48018, Italy
U.O. di Radiologia, Ospedale Civile degli Infermi
Faenza (RA), 48018, Italy
U.O. di Oncologia, Ospedale Civile Umberto I
Lugo (RA), 48022, Italy
U.O. di Radiologia, Ospedale Civile Umberto I
Lugo (RA), 48022, Italy
Laboratorio Farmaci Antiblastici
Meldola (FC), 47014, Italy
U.O. Oncologia Medica
Meldola (FC), 47014, Italy
UO Radiologia
Meldola (FC), 47014, Italy
Dipartimento di Radiologia, Ospedale San Raffaele
Milan, 20132, Italy
Servizio di Farmacia, Ospedale San Raffaele
Milan, 20132, Italy
U.O. di Medicina Nucleare e Centro PET, Ospedale San Raffaele
Milan, 20132, Italy
U.O. di Urologia, Ospedale San Raffaele
Milan, 20132, Italy
Farmacia Studi Clinici e Sperimentali, Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
S.C. di Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
S.C. Diagnostica Radiologica 2, Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Divisione di Radiologia, Istituto Europeo di Oncologia
Milan, 20141, Italy
Reparto Oncologia Medica Urogenitale e Cervico Facciale, Istituto Europeo di Oncologia
Milan, 20141, Italy
Servizio Farmacia, Istituto Europeo di Oncologia
Milan, 20141, Italy
Farmacia Interna, Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41124, Italy
Medicina Nucleare, Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41124, Italy
Radiologia I, Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, 41124, Italy
U.O.S.C. di Oncologia Medica, A.O.R.N. "A. Cardarelli"
Naples, 80131, Italy
Farmacia Ospedaliera, AOU San Luigi Gonzaga
Orbassano (TO), 10043, Italy
SCDU Oncologia Medica II Pad, AOU San Luigi Gonzaga
Orbassano (TO), 10043, Italy
SCDU Radiodiagnostica, AOU San Luigi Gonzaga
Orbassano (TO), 10043, Italy
SS Medicina Nucleare, AOU San Luigi Gonzaga
Orbassano (TO), 10043, Italy
Farmacia, Istituto Oncologico Veneto (IOV)
Padua, 35128, Italy
IRCCS - Istituto Oncologico Veneto (IOV), UOC Oncologia Medica 1
Padua, 35128, Italy
Medicina Nucleare, Istituto Oncologico Veneto (IOV)
Padua, 35128, Italy
UOC Radiodiagnostica Oncologica, Istituto Oncologico Veneto (IOV)
Padua, 35128, Italy
Dipartimento di Onco-Ematologia Ospedale Santa Maria delle Croci
Ravenna, 48121, Italy
Servizio di Farmacia, AUSL di Ravenna
Ravenna, 48121, Italy
Servizio di Radiologia, AUSL di Ravenna
Ravenna, 48121, Italy
Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica
Roma, 00152, Italy
U.O. di Oncologia Medica, Ospedale Santa Chiara
Trento, 38122, Italy
U.O. Farmacia, Ospedale Santa Chiara
Trento, 38122, Italy
U.O. Radiologia, Ospedale Santa Chiara
Trento, 38122, Italy
Universiti Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, 56000, Malaysia
Sarawak General Hospital
Kuching, Sarawak, 93586, Malaysia
Subang Jaya Medical Centre Sdn. Bhd.
Subang Jaya, Selangor, 47500, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, 50586, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Maastricht University Medical Centre
Maastricht, AZ, 5202, Netherlands
Catharina Ziekenhuis
Eindhoven, North Brabant, 5623 EJ, Netherlands
Netherlands Cancer Institute
Amsterdam, 1066 CX, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
University Medical Center Groningen
Groningen, 9700 RB, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, 6525 GA, Netherlands
Canterbury District Health Board
Christchurch, Canterbury, 8140, New Zealand
Palmerston North Hospital
Palmerston North, Manawatu, 4414, New Zealand
Waikato Urology Research LTD
Hamilton, Waikato Region, 3204, New Zealand
Cancer and Blood Research
Auckland, 1023, New Zealand
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952, Poland
UROMEDYK, Poradnia Urologiczna
Kielce, 25-112, Poland
Malopolskie Centrum Medyczne s.c.
Krakow, 30-510, Poland
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
Lublin, 20-718, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza. Korczaka
Słupsk, 76-200, Poland
Profesorskie Centrum Medyczne Optimum
Wroclaw, 50-421, Poland
Centrum Medyczne Melita Medical
Wroclaw, 50-449, Poland
Wro Medica
Wroclaw, 51-685, Poland
Lexmedica
Wroclaw, 53-114, Poland
Federal State Budgetary Institution "N.N. Blokhin Russian Cancer Research Center"
Moscow, 115478, Russia
P. Hertsen Moscow Oncology Research Institute - branch of the National Medical Research
Moscow, 125284, Russia
State Budgetary Healthcare Institution City Multifield Hospital No.2
Saint Petersburg, 194354, Russia
SBEI HPE "First Pavlov State Medical University of St. Petersburg" of
Saint Petersburg, 197002, Russia
SBEI HPE "First Pavlov State Medical University of St. Petersburg" of
Saint Petersburg, 197022, Russia
Saint-Petersburg State Budgetary Healthcare Institution "Hospital for Veterans of War"
Saint Petersburg, 197183, Russia
SBHI "Saint-Petersburg clinical scientific
Saint Petersburg, 197758, Russia
SBEI of HPE "Bashkir State Medical University" of MoH of the RF
Ufa, 450073, Russia
Clinical Center Of Serbia, Clinic of Urology
Belgrade, 11000, Serbia
Clinical Center "Dr Dragisa Misovic -Dedinje", Clinic of Urology
Belgrade, 11040, Serbia
Clinical Center "Bezanijska Kosa", Department of Urology
Belgrade, 11080, Serbia
Clinical Center Zemun
Belgrade, 11080, Serbia
National University Hospital
Singapore, 119074, Singapore
National Cancer Centre Singapore
Singapore, 169610, Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Banská Bystrica, 975 17, Slovakia
Institut nuklearnej a molekularnej mediciny
Banská Bystrica, 975 17, Slovakia
Bratislavske radiodiagnosticke centrum, a.s.
Bratislava, 814 99, Slovakia
CUIMED, s.r.o., Urologicka ambulancia
Bratislava, 851 05, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Košice, 041 91, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Košice, 04191, Slovakia
Institut nuklearnej a molekularnej mediciny
Košice, 042 53, Slovakia
Univerzitna nemocnica Martin
Martin, 036 59, Slovakia
IZOTOPCENTRUM, s.r.o.
Nitra, 949 01, Slovakia
Jessenius-diagnosticke centrum, a.s.
Nitra, 949 01, Slovakia
UROEXAM spol. s r.o. urologicka ambulancia
Nitra, 949 01, Slovakia
Alfamedis, s.r.o.
Prešov, 080 01, Slovakia
MILAB s.r.o., UROCENTRUM
Prešov, 080 01, Slovakia
Vivamed, s.r.o
Prešov, 080 01, Slovakia
UVN SNP - FN Ruzomberok, Pracovisko Nuklearnej mediciny CCSR
Ružomberok, 034 26, Slovakia
Fakultna nemocnica s Poliklinikou Skalica a.s
Skalica, 909 82, Slovakia
GAMMALAB, spol. s.r.o., Oddelenie nuklearnej mediciny
Trnava, 917 01, Slovakia
GAMMALAB, spol.s.r.o., Oddelenie nuklearnej mediciny
Trnava, 917 01, Slovakia
KK MED s.r.o.
Žilina, 010 01, Slovakia
Fakultna nemocnica s poliklinikou Zilina, Urologicke oddelenie
Žilina, 012 07, Slovakia
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, 58128, South Korea
Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Universitari Son Espases,
Palma de Mallorca, Balearic Islands, 07010, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
ALTAHIA. Xarxa Assistencial Universitaria de Manresa
Manresa, Barcelona, 08243, Spain
Hospital Universitario Parc Tauli
Sabadell, Barcelona, 08208, Spain
ICO Girona-Hospital Universitari de Girona Dr. Josep Trueta
Girona, Catalonia, 17007, Spain
Hospital de Navarra
Pamplona, Navarre, 31008, Spain
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Cetir Centre Medic, S.L.
Barcelona, 08029, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Hospital Universitario de la Princesa
Madrid, 28006, Spain
MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Universitario 12 de octubre
Madrid, 28041, Spain
Urologmottagningen
Gothenburg, 41345, Sweden
Diagnostiskt centrum for bild- och funktionsmedicin
Malmo, 205 02, Sweden
Urologiska Kliniken
Malmo, 20502, Sweden
Apoteket AB Kliniska Provningar Molnlycke
Mölnlycke, 435 33, Sweden
Urologiska Kliniken
Örebro, 70185, Sweden
Karolinska Universitetssjukhuset
Solna, 17164, Sweden
Urologmottagningen
Stockholm, 11853, Sweden
Urologkliniken
Umeå, 90185, Sweden
Chang Gung Medical Fundation, Chiayi Branch(Chiayi Chang Gung Memorial Hospital)
Chiayi County, 613, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Chang Gung Medical Fundation,Kaohsiung (Kaohsiung Chang Gung Memorial Hospital)
Kaohsiung City, 830, Taiwan
Chang Gung Memorial Hospital, Keelung Branch (Keelung Chang Gung Memorial Hospital)
Keelung, 204, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Chi Mei Medical Centre
Tainan, 710, Taiwan
National Taiwan University Hospital
Taipei, 100, Taiwan
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Chang-Gung Memorial Hospital at Linkuo
Taoyuan, 333, Taiwan
Songklanagarind hospital
Hat Yai, Changwat Songkhla, 90110, Thailand
Maharaj Nakorn Chiang Mai Hospital
Muang, Chiang Mai, 50200, Thailand
King Chulalongkorn Memorial Hospital, Chulalongkorn University
Bangkok, 10330, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Cukurova Universitesi Tip Fakultesi
Adana, 01330, Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi
Ankara, 06100, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Izmir Bozyaka Egitim Arastirma Hastanesi
Izmir, 35170, Turkey (Türkiye)
Celal Bayar Universitesi Tip Fakultesi
Manisa, 45030, Turkey (Türkiye)
RCI Chernivtsi Regional Clinical Hospital
Chernivtsi, 58002, Ukraine
CI I.I. Mechnikov DRCH Dept of Urology #2
Dnipropetrovsk, 49005, Ukraine
CHI V.I.Shapoval RCC of Urology and Nephrology, Dep. Of Urology#4
Kharkiv, 61037, Ukraine
CNE Kyiv City Clinical Hospital #3 of Ex Body of KCC (Kyiv CSA), Department of Urology
Kyiv, 02125, Ukraine
Central City Clinical Hospital, City Oncological Center
Uzhhorod, 88000, Ukraine
CI Zaporizhzhia Regional Clinical Hospital, Dep. Of Urology,
Zaporizhzhia, 69600, Ukraine
East and North Hertfordshire NHS Trust
Northwood, Middlesex, HA6 2RN, United Kingdom
Belfast Health and Social Care Trust
Belfast, Northern Ireland, BT9 7AB, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, TYNE and WEAR, NE7 7DN, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2TH, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2WB, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8ED, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8HW, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
University College Hospitals NHS Trust
London, NW1 2BU, United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
University College London Hospitals NHS Foundation Trust
London, WC1E 6AG, United Kingdom
The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, OX3 7LE, United Kingdom
Related Publications (10)
Armstrong AJ, Azad AA, Iguchi T, Stenzl A, Mottet N, Russell D, Rosales M, Haas GP, Saad F, Hussain M, Sternberg CN. Radiographic Progression With and Without Prostate-Specific Antigen Rise in Patients With Advanced Prostate Cancer Treated With Enzalutamide. J Clin Oncol. 2026 Mar 27:JCO2402829. doi: 10.1200/JCO-24-02829. Online ahead of print.
PMID: 41894648DERIVEDHussain M, Sternberg CN, Efstathiou E, Fizazi K, Shen Q, Lin X, Sugg J, Steinberg J, Noerby B, De Giorgi U, Shore ND, Saad F. Nadir Prostate-specific Antigen as an Independent Predictor of Survival Outcomes: A Post Hoc Analysis of the PROSPER Randomized Clinical Trial. J Urol. 2023 Mar;209(3):532-539. doi: 10.1097/JU.0000000000003084. Epub 2023 Feb 9.
PMID: 36756959DERIVEDDe Giorgi U, Hussain M, Shore N, Fizazi K, Tombal B, Penson D, Saad F, Efstathiou E, Madziarska K, Steinberg J, Sugg J, Lin X, Shen Q, Sternberg CN. Which traits affect how long patients with advanced prostate cancer live when treated with enzalutamide? Future Oncol. 2022 Nov;18(35):3867-3874. doi: 10.2217/fon-2022-0661. Epub 2022 Oct 13.
PMID: 36226865DERIVEDCella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.
PMID: 35731340DERIVEDJoshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.
PMID: 35643841DERIVEDDe Giorgi U, Hussain M, Shore N, Fizazi K, Tombal B, Penson D, Saad F, Efstathiou E, Madziarska K, Steinberg J, Sugg J, Lin X, Shen Q, Sternberg CN. Consistent survival benefit of enzalutamide plus androgen deprivation therapy in men with nonmetastatic castration-resistant prostate cancer: PROSPER subgroup analysis by age and region. Eur J Cancer. 2021 Dec;159:237-246. doi: 10.1016/j.ejca.2021.10.015. Epub 2021 Nov 14.
PMID: 34784577DERIVEDSaad F, Sternberg CN, Efstathiou E, Fizazi K, Modelska K, Lin X, Sugg J, Steinberg J, Noerby B, Shore ND, Hussain M. Prostate-specific Antigen Progression in Enzalutamide-treated Men with Nonmetastatic Castration-resistant Prostate Cancer: Any Rise in Prostate-specific Antigen May Require Closer Monitoring. Eur Urol. 2020 Dec;78(6):847-853. doi: 10.1016/j.eururo.2020.08.025. Epub 2020 Oct 1.
PMID: 33010985DERIVEDSternberg CN, Fizazi K, Saad F, Shore ND, De Giorgi U, Penson DF, Ferreira U, Efstathiou E, Madziarska K, Kolinsky MP, Cubero DIG, Noerby B, Zohren F, Lin X, Modelska K, Sugg J, Steinberg J, Hussain M; PROSPER Investigators. Enzalutamide and Survival in Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Jun 4;382(23):2197-2206. doi: 10.1056/NEJMoa2003892. Epub 2020 May 29.
PMID: 32469184DERIVEDTombal B, Saad F, Penson D, Hussain M, Sternberg CN, Morlock R, Ramaswamy K, Ivanescu C, Attard G. Patient-reported outcomes following enzalutamide or placebo in men with non-metastatic, castration-resistant prostate cancer (PROSPER): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2019 Apr;20(4):556-569. doi: 10.1016/S1470-2045(18)30898-2. Epub 2019 Feb 12.
PMID: 30770294DERIVEDHussain M, Fizazi K, Saad F, Rathenborg P, Shore N, Ferreira U, Ivashchenko P, Demirhan E, Modelska K, Phung D, Krivoshik A, Sternberg CN. Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer. N Engl J Med. 2018 Jun 28;378(26):2465-2474. doi: 10.1056/NEJMoa1800536.
PMID: 29949494DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 6, 2013
Study Start
October 31, 2013
Primary Completion
June 28, 2017
Study Completion
November 28, 2025
Last Updated
January 27, 2026
Results First Posted
July 12, 2018
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
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.