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

Primary Purpose

Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the Prostate

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Enzalutamide

Placebo

About this trial

This is an interventional treatment trial for Nonmetastatic Castration-Resistant Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Urological Associates of Southern Arizona, PC
Ronald Reagan UCLA Medical Center
UCLA Clark Urology Center
University of California, Irvine Medical Center
Urology Associates of San Luis Obispo, a Medical Group, Inc
Urology Associates, P.C.
c/o Lynn Buchwalder
C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
Smilow Cancer Center at Yale New Haven-Hospital
Yale New Haven Hospital
Yale University School of Medicine
Lakeland Regional Cancer Center
Urology of Indiana, LLC
First Urology, PSC
IU Health Arnett Cancer Care
Kansas City Urology Care, PA
GU Research Network/ Wichita Urology Group
Chesapeake Urology Research Associates
University of Michigan Health System
Michigan Institute of Urology
GU Research Network
Brooklyn Urology Research Group
Premier Medical Group of the Hudson Valley
Duke University Medical Center
Carolina Urology Partners, PLLC
Carolina Urology Partners, PLLC
Gaston Medical Associates
Carolina Urology Partners, PLLC
Duke Women's Cancer Care Raleigh
Clinical Research Solutions
Oregon Urology Institute
Lancaster Urology
Carolina Urologic Research Center
Vanderbilt University Medical Center, Dept. of Urologic Surgery
Vanderbilt University Medical Center, The Urologic Clinic
Urology San Antonio
Urology of Virginia, PLLC
COIBA(Centro de Oncologia e Investigacion Buenos Aires)
Centro Medico Austral(OMI)
Centro de Urologia
Hospital Italiano de Buenos Aires
Sanatorio Parque
Instituto De Oncologia De Rosario
Clinica Universidad Reina Fabiola
Hospital Privado Centro Medico de Cordoba
Centro Oncologico Riojano Integral (CORI)
The Canberra Hospital
Border Medical Oncology Research Unit
The Border Cancer Hospital Dispensary
The Border Cancer Hospital
Sydney cancer centre
Epic pharmacy
North Coast Cancer Institute
Macquarie University Hospital
Macquarie University
Epic Pharmacy Port Macquarie base hospital
Mid North Coast Cancer Institute
Royal North Shore Hospital
The Tweed Hospital
Australian Clinical Trials
Sydney Adventist Hospital
Calvary Mater Newcastle
Westmead Hospital
Icon Cancer Care Wesley
River City Pharmacy - APHS
Icon Cancer Care Chermside
Icon Cancer Care South Brisbane
Integrated Clinical Oncology Network (ICON)
Icon Cancer Care Southport
Tasman Oncology Research Pty Ltd
Princess Alexandra Hospital
Adelaide Cancer Centre
Ashford Cancer Centre Research
Cancer Care SA Pty Ltd
Tenpharm Pty Ltd trading as EPIC Pharmacy Tennyson
Box Hill Hospital (Eastern health)
Eastern Clinical Research Unit (Eastern Health)
Cabrini Hospital Brighton
Monash Medical Centre
Austin Health, Austin Hospital
Cabrini Hospital Malvern
Cabrini Hospital- Education and Research Precinct
Peter MacCallum Cancer Centre
Sunshine Hospital
Krankenhaus Barmherzige Schwestern Linz, Abteilung Radiologie
Krankenhaus Barmherzige Schwestern Linz, Abteilung Urologie
St. Vincent's Hospital, PET - CT Center
Isotopix, Ambulatorium fuer Nuklearmedizin
Medizinische Universitaet Wien, Universitaetsklinik fuer Innere Medizin I
Diagnosezentrum Meidling GesmbH
Algemeen Ziekenhuis Groeninge
Clinique Universitaire de Bruxelles Hopital Erasme
Vzw Algemeen Ziekenhuis Maria Middelares
Universitaire Ziekenhuizen Leuven
Centre Hospitalier Universitaire de Liege, Site du Sart-Tilman
Hospital Sao Rafael
Liga Paranaense de Combate ao cancer / Hospital Erasto Gaertner
Associacao Hospital de Caridade de Ijui
Hospital da Cidade de Passo Fundo
Hospital de Clinicas de Porto Alegre
CLINIONCO - Clinica de Oncologia de Porto Alegre Ltda.
Hospital Sao Lucas da PUCRS
Instituto D'Or de Pesquisa e Ensino (IDOR)
Hospital Amaral Carvalho - Fundacao Dr. Amaral Carvalho
Fundacao Dr. Amaral Carvalho
Fundacao Dr.Amaral Carvalho
Hospital Israelita Albert Einstein
Hospital das Clinicas da Faculdade de Ciencias Medicas da UNICAMP
Centro de Estudos e Pesquisas em Hematologia e Oncologia (CEPHO)
IAMSPE-Inst. de Assist. ao Servidor Publico Estadual
Hospital Universitario Pedro Ernesto - UERJ
Oncologia Rede D'Or
Tom Baker Cancer Centre
Cross Cancer Institute
Vancouver Prostate Centre
Manitoba Prostate Centre CancerCare Manitoba
NS Health Authority, Queen Elizabeth II Health Sciences Centre
The Male/Female Health and Research Centre
McMaster Institute of Urology @ St. Joseph's Healthcare Hamilton
Urology Associates / Urologic Medical Research
London Regional Cancer Program - Victoria Hospital, London Health Sciences Centre(LHSC)
Urology Reasearch - Victoria Hospital, London Health Sciences Centre(LHSC)
SunnyBrook Health Sciences Centre
University Health Network- Princess Margaret Cancer Centre
Urology South Shore Research
Centre Hospitalier de l'Université de Montréal
McGill University Health Centre
CHU de Quebec
Fundacion Arturo Lopez Perez
Centro de Investigaciones Clinicas Vina del Mar
Instituto Clinico Oncologico del Sur (ICOS)
Instituto Oncologico Ltda.
Centro de Investigaciones Clinicas
Peking University First Hospital
Beijing Cancer Hospital
Peking University Third Hospital
Beijing Hospital
Peking Union Medical College Hospital
Chongqing Cancer Hospital
The First Affiliated Hospital of Guangzhou Medical University
Zhongnan Hospital of Wuhan University
Office of Hongqian Guo
Jiangsu Cancer Hospital
Jiangsu Province Hospital
The Second Affiliated Hospital of Soochow University
Wuxi People's Hospital
Qingdao Municipal Hospital (East Hospital)
Fudan University Shanghai Cancer Center
Huashan Hospital Fudan University
Shanghai First People's Hospital
Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai Changhai Hospital
The First Affiliated Hospital of Xi'an Jiaotong University
The Second Affiliated Hospital of Zhejiang University School of Medicine
The First Affiliated Hosptial of Wenzhou Medical University
UNIMED Medical Institute Limited
The Second Hospital of Tianjin Medical University
Rigshospitalet 7521
Copenhagen Prostate Cancer Center
Aarhus University Hospital
Rigshospitalet
Frederiksberg Hospital
Herlev Hospital
Odense University Hospital
Vejle Sygehus
Docrates Syopasairaala
Helsingin yliopistollinen keskussairaala, Meilahden sairaala
Oulun yliopistollinen sairaala
Satakunnan keskussairaala
Tampereen yliopistollinen Sairaala
Hopitaux Universitaires de Strasbourg - Hopital Civil
Centre Paul Strauss
Clinique Sainte Anne
Societe MIM, Clinique Sainte Anne
Institut Curie
Centre Hospitalier Lyon Sud
Institut Gustave Roussy
Institut de Cancerologie de l'Ouest - Paul Papin
Institut Sainte Catherine
Institut Bergonie
Urologic Oncology Department- Institut Bergonie - Centre regional de Lutte contre le Cancer
Cabinet de Radiologie
CHU Brest Hopital Morvan
Clinique pasteur Lancroze
Clinique Pasteur-Lanroze
CHRU de Brest
Hopital Pasteur
Hopitaux Civils de Colmar
Centre Regional de lutte Contre le Cancer Georges Francois Leclerc
Clinique Victor Hugo
Hopital Calude Huriez - CHU Lille
Hopital Edouard Herriot - CHU Lyon
Centre Leon Berard
Centre de Medecine Nucleaire LUMEN
Hopital Nord
ICM Val D'Aurelle
Hopital Europeen Georges Pompidou
Centre Hospitalier Lyon Sud
CHU Poitiers - Hopital la Miletrie
Institut de Cancerologie de I'Ouest - Rene Gauducheau
Clinique Pasteur - CIMOF
Clinique Pasteur- Service Imagerie et Radiologie
Clinique Pasteur
IUCT-Oncopole
Institut Claudius Regaud
Studienpraxis Urologie
Universitatsmedizin Mannheim, Medizinische Fakultat Mannheim der Universitat Heidelberg
MVZ Zentrum fuer Diagnostische Radiologie und Nuklearmedizin Braunschweig GmbH
Staedtisches Klinikum Braunschweig
Hannover Medical School
Medizinische Hochschule Hannover
RWTH University Aachen
Uniklinik der RWTH Aachen
Clinic of Radiology
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Charite, Campus Benjamin Franklin
Charite, Universitaetsmedizin Berlin
Martini-Klinik am UKE GmbH
Diagnostikzentrum Esslingen
University General Hospital of Heraklion, Urology Clinic
General Hospital of Athens"Korgialeneio-Benakeio EES".Urology Clinic
General Hospital of Athens "Alexandra", Therapeutic Clinic
University General Hospital of Larissa, Urology Department
University General Hospital of Patras, Oncology Department, Internal Medicine Clinic
General Hospital" Papageorgiou",B' Univ.Urology Clinic
Queen Mary Hospital
Tuen Mun Hospital
Prince of Wales Hospital
Laboratorio Medicina Nucleare-Ospedale G.B. Morgagni-Pierantoni
Farmacia, Azienda Socio Sanitaria Territoriale di Cremona
Medicina Nucleare, Azienda Socio Sanitaria Territoriale di Cremona
Servizio di Radiologia, Azienda Socio Sanitaria Territoriale di Cremona
Struttura Complessa di Oncologia, Azienda Socio Sanitaria Territoriale di Cremona
U.O. di Oncologia, Ospedale Civile Degli Infermi
U.O. di Radiologia, Ospedale Civile degli Infermi
U.O. di Oncologia, Ospedale Civile Umberto I
U.O. di Radiologia, Ospedale Civile Umberto I
Laboratorio Farmaci Antiblastici
U.O. Oncologia Medica
UO Radiologia
Dipartimento di Radiologia, Ospedale San Raffaele
Servizio di Farmacia, Ospedale San Raffaele
U.O. di Medicina Nucleare e Centro PET, Ospedale San Raffaele
U.O. di Urologia, Ospedale San Raffaele
Farmacia Studi Clinici e Sperimentali, Fondazione IRCCS Istituto Nazionale dei Tumori
S.C. di Oncologia Medica 1, Fondazione IRCCS Istituto Nazionale dei Tumori
S.C. Diagnostica Radiologica 2, Fondazione IRCCS Istituto Nazionale dei Tumori
Divisione di Radiologia, Istituto Europeo di Oncologia
Reparto Oncologia Medica Urogenitale e Cervico Facciale, Istituto Europeo di Oncologia
Servizio Farmacia, Istituto Europeo di Oncologia
Farmacia Interna, Azienda Ospedaliero-Universitaria Policlinico di Modena
Medicina Nucleare, Azienda Ospedaliero-Universitaria Policlinico di Modena
Radiologia I, Azienda Ospedaliero-Universitaria Policlinico di Modena
U.O.S.C. di Oncologia Medica, A.O.R.N. "A. Cardarelli"
Farmacia Ospedaliera, AOU San Luigi Gonzaga
SCDU Oncologia Medica II Pad, AOU San Luigi Gonzaga
SCDU Radiodiagnostica, AOU San Luigi Gonzaga
SS Medicina Nucleare, AOU San Luigi Gonzaga
Farmacia, Istituto Oncologico Veneto (IOV)
IRCCS - Istituto Oncologico Veneto (IOV), UOC Oncologia Medica 1
Medicina Nucleare, Istituto Oncologico Veneto (IOV)
UOC Radiodiagnostica Oncologica, Istituto Oncologico Veneto (IOV)
Ospedale Santa Maria delle Croci
Servizio di Farmacia, AUSL di Ravenna
Servizio di Radiologia, AUSL di Ravenna
Azienda Ospedaliera S. Camillo Forlanini, UOC per il governo clinico in Oncologia Medica
U.O. di Oncologia Medica, Ospedale Santa Chiara
U.O. Farmacia, Ospedale Santa Chiara
U.O. Radiologia, Ospedale Santa Chiara
National Cancer Center
Chonnam National University Hwasun Hospital
Gachon University Gil Medical Center
Seoul National University Hospital
Severance Hospital, Yonsei University Health System
Asan Medical Center
Gangnam Severance Hospital, Yonsei University Health System
Samsung Medical Center
Universiti Kebangsaan Malaysia Medical Centre
Sarawak General Hospital
Subang Jaya Medical Centre Sdn. Bhd.
Hospital Kuala Lumpur
University Malaya Medical Centre
Maastricht University Medical Centre
Catharina Ziekenhuis
Netherlands Cancer Institute
Albert Schweitzer Ziekenhuis
University Medical Center Groningen
Radboud University Nijmegen Medical Centre
Canterbury District Health Board
Palmerston North Hospital
Cancer and Blood Research
Waikato Urology Research LTD
Uniwersyteckie Centrum Kliniczne
UROMEDYK, Poradnia Urologiczna
Malopolskie Centrum Medyczne s.c.
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ
Wojewodzki Szpital Specjalistyczny im. Janusza. Korczaka
Profesorskie Centrum Medyczne Optimum
Centrum Medyczne Melita Medical
Wro Medica
Lexmedica
Federal State Budgetary Institution "N.N. Blokhin Russian Cancer Research Center"
P. Hertsen Moscow Oncology Research Institute - branch of the National Medical Research
State Budgetary Healthcare Institution City Multifield Hospital No.2
SBEI HPE "First Pavlov State Medical University of St. Petersburg" of
SBEI HPE "First Pavlov State Medical University of St. Petersburg" of
Saint-Petersburg State Budgetary Healthcare Institution "Hospital for Veterans of War"
SBHI "Saint-Petersburg clinical scientific
SBEI of HPE "Bashkir State Medical University" of MoH of the RF
Clinical Center Of Serbia, Clinic of Urology
Clinical Center "Dr Dragisa Misovic -Dedinje", Clinic of Urology
Clinical Center "Bezanijska Kosa", Department of Urology
Clinical Center Zemun
National University Hospital
National Cancer Centre Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta
Institut nuklearnej a molekularnej mediciny
Bratislavske radiodiagnosticke centrum, a.s.
CUIMED, s.r.o., Urologicka ambulancia
Vychodoslovensky onkologicky ustav, a.s.
Vychodoslovensky onkologicky ustav, a.s.
Institut nuklearnej a molekularnej mediciny
Univerzitna nemocnica Martin
IZOTOPCENTRUM, s.r.o.
Jessenius-diagnosticke centrum, a.s.
UROEXAM spol. s r.o. urologicka ambulancia
Alfamedis, s.r.o.
MILAB s.r.o., UROCENTRUM
Vivamed, s.r.o
UVN SNP - FN Ruzomberok, Pracovisko Nuklearnej mediciny CCSR
Fakultna nemocnica s Poliklinikou Skalica a.s
GAMMALAB, spol. s.r.o., Oddelenie nuklearnej mediciny
GAMMALAB, spol.s.r.o., Oddelenie nuklearnej mediciny
KK MED s.r.o.
Fakultna nemocnica s poliklinikou Zilina, Urologicke oddelenie
Hospital Clinico Universitario de Santiago de Compostela
Hospital Universitari Son Espases,
Hospital Germans Trias i Pujol
ALTAHIA. Xarxa Assistencial Universitaria de Manresa
Hospital Universitario Parc Tauli
ICO Girona-Hospital Universitari de Girona Dr. Josep Trueta
Hospital de Navarra
Complejo Hospitalario Universitario A Coruna
Hospital Del Mar
Cetir Centre Medic, S.L.
Hospital Clinic de Barcelona
Hospital Universitario de la Princesa
MD Anderson Cancer Center
Hospital Universitario 12 de octubre
Urologmottagningen
Diagnostiskt centrum for bild- och funktionsmedicin
Urologiska Kliniken
Apoteket AB Kliniska Provningar Molnlycke
Karolinska Universitetssjukhuset
Urologmottagningen
Urologkliniken
Urologiska Kliniken
Chang Gung Medical Fundation, Chiayi Branch(Chiayi Chang Gung Memorial Hospital)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung Veterans General Hospital
Chang Gung Medical Fundation,Kaohsiung (Kaohsiung Chang Gung Memorial Hospital)
Chang Gung Memorial Hospital, Keelung Branch (Keelung Chang Gung Memorial Hospital)
China Medical University Hospital
Taichung Veterans General Hospital
Chi Mei Medical Centre
National Taiwan University Hospital
Taipei Veterans General Hospital
Chang-Gung Memorial Hospital at Linkuo
Maharaj Nakorn Chiang Mai Hospital
Songklanagarind hospital
King Chulalongkorn Memorial Hospital, Chulalongkorn University
Rajavithi Hospital
Cukurova Universitesi Tip Fakultesi
Hacettepe Universitesi Tip Fakultesi
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Izmir Bozyaka Egitim Arastirma Hastanesi
Celal Bayar Universitesi Tip Fakultesi
RCI Chernivtsi Regional Clinical Hospital
CI Dnipropetrovsk I.I. Mechnykov RCH, Department of Urology #2
CHI V.I.Shapoval RCC of Urology and Nephrology, Dep. Of Urology#4
Kyiv City Clinical Hospital #3, Department of Urology
Central City Clinical Hospital, City Oncological Center
CI Zaporizhzhia Regional Clinical Hospital, Dep. Of Urology,
East and North Hertfordshire NHS Trust
Belfast Health and Social Care Trust
Royal Marsden NHS Foundation Trust
The Newcastle upon Tyne Hospitals NHS Foundation Trust
University Hospitals Birmingham NHS Foundation Trust
University Hospitals Birmingham NHS Foundation Trust
University Hospitals Bristol NHS Foundation Trust
University Hospitals Bristol NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
University College Hospitals NHS Trust
Imperial College Healthcare NHS Trust
University College London Hospitals NHS Foundation Trust
The Christie NHS Foundation Trust
Oxford University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Placebo

Enzalutamide

Arm Description

Sugar pill manufactured to mimic enzalutamide 40 mg capsule

160 mg by mouth once daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time to Prostate-Specific Antigen (PSA) Progression

Time to PSA progression was defined as the time from randomization to the date of first PSA value demonstrating progression, which was subsequently confirmed. For participants with PSA decline at Week 17, PSA progression was defined according to Prostate Cancer Working Group 2 (PCWG2) guidelines as the date that a 25% or greater increase and an absolute increase of 2 nanograms per milliliter (ng/mL) above the nadir (or baseline for participants with no PSA decline by Week 17) was documented, which was confirmed by a second consecutive value obtained at least 3 weeks or later. Participants without confirmed PSA progression at the time of analysis were right censored at the date of last PSA assessment before the analysis data cut-off date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

Time to First Use of New Antineoplastic Therapy

Time to first use of new antineoplastic therapy was defined as the time from randomization to first use of new antineoplastic for prostate cancer. Participants not starting treatment with a new antineoplastic therapy at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

Overall Survival

Overall survival (OS) was defined as the time (in months) from randomization to death from any cause. For participants who were alive at the time of the analysis data cutoff, OS time was censored at the last date the participant was known to be alive or analysis data cutoff date, whichever was earlier. Participants with no post baseline survival information were censored on the date of randomization. Analysis was based on Kaplan-Meier estimates.

Time to Pain Progression

Pain was assessed using the score from the Brief Pain Inventory-Short Form (BPI-SF) question 3: "Please rate your pain by marking the box beside the number that best describes your pain at its worst in the last 24 hours." Time to this event was defined as the time from randomization to onset of pain progression, where pain progression was defined as a 2-point or more increase from baseline in the question 3 score. Participants without observed pain progression at the time of analysis were right censored at the date of last pain assessment for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

Time to First Use of Cytotoxic Chemotherapy

Time to first use of cytotoxic chemotherapy was defined as the time from randomization to the first use of cytotoxic chemotherapy for prostate cancer. Participants not starting treatment with a cytotoxic chemotherapy for prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

Chemotherapy-Free Disease Specific Survival

Chemotherapy-free disease-specific survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer as assessed by the investigator. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died due to prostate cancer at the time of analysis were right censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

Chemotherapy-Free Survival

Chemotherapy-free survival was defined as the time from randomization to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause. Participants not starting treatment with a cytotoxic chemotherapy or not known to have died at the time of analysis were censored at the date of last assessment before the analysis data cutoff date for the purposes of analysis. Analysis was based on Kaplan-Meier estimates.

Percentage of Participants With Prostate Specific Antigen (PSA) Response

PSA response was calculated at each visit as a decline from baseline in PSA (ng/mL) to the maximal PSA response with thresholds at 50% and 90%. Additionally, PSA response was assessed as a decline to undetectable levels, where undetectable level was defined as below the limit of quantification of the centrally assessed PSA results (the lower limit of quantification was 0.02 ng/mL). PSA response was confirmed by a second consecutive value at least 3 weeks later.

Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score

The FACT-P questionnaire is a multidimensional, self-reported quality of life instrument consisting of 27 core items that assess participant function in 4 domains: physical, social/family, emotional, functional well-being, and supplemented by 12 site-specific items to assess prostate-related symptoms. Each item was rated on a 0 to 4 Likert-type scale, and then combined to produce subscale scores for each domain, as well as a global quality of life score which ranged from 0 to 156 where higher scores represented better quality of life.

Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Mobility Domain Score

EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the mobility questionnaire are reported.

Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Self-Care Domain Score

EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. Number of participants with various responses to the self-care questionnaire are reported.

Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Usual Activities Domain Score

Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Pain/Discomfort Domain Score

Number of Participants With European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Anxiety/ Depression Domain Score

European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Status Visual Analog Score (VAS)

EQ-5D-5L is a standardized instrument that measures health-related quality of life for men with prostate cancer. EQ-5D consists of EQ-5D descriptive system and EQ VAS. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable), higher scores indicating a better health state.

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 31

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 31 are reported. Question 31 was following: "Have you had to urinate frequently during the day?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 32

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 32 are reported. Question 32 was following: "Have you had to urinate frequently at night?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 33

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 33 are reported. Question 33 was following: "When you felt the urge to pass urine, did you have to hurry to get to the toilet?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 34

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 34 are reported. Question 34 was following: "Was it difficult for you to get enough sleep, because you needed to get up frequently at night to urinate?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 35

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 35 are reported. Question 35 was following: "Have you had difficulty going out of the house because you needed to be close to a toilet?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 36

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 36 are reported. Question 36 was following: "Have you had any unintentional release (leakage) of urine?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 37

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 37 are reported. Question 37 was following: "Did you have pain when you urinated?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 38

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 38 are reported. Question 38 was following: "Has wearing an incontinence aid been a problem for you?". This question was answered by only those participants who wore incontinence aid.

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 39

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 39 are reported. Question 39 was following: "Have your daily activities been limited by your urinary problems?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 40

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 40 are reported. Question 40 was following: "Have your daily activities been limited by your bowel problems?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 41

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 41 are reported. Question 41 was following: "Have you had any unintentional release (leakage) of stools?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 42

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 42 are reported. Question 42 was following: "Have you had blood in your stools?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 43

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 43 are reported. Question 43 was following: "Did you have a bloated feeling in your abdomen?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 44

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 44 are reported. Question 44 was following: "Did you have hot flushes?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 45

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 45 are reported. Question 45 was following: "Have you had sore or enlarged nipples or breasts?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 46

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 46 are reported. Question 46 was following: "Have you had swelling in your legs or ankles?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 47

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 47 are reported. Question 47 was following: "Has weight loss been a problem for you?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 48

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 48 are reported. Question 48 was following: "Has weight gain been a problem for you?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 49

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 49 are reported. Question 49 was following: "Have you felt less masculine as a result of your illness or treatment?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 50

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 50 are reported. Question 50 was following: "To what extent were you interested in sex?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 51

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 51 are reported. Question 51 was following: "To what extent were you sexually active (with or without intercourse)?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 52

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 52 are reported. Question 52 was following: "To what extent was sex enjoyable for you?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 53

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 53 are reported. Question 53 was following: "Did you have difficulty getting or maintaining an erection?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 54

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 54 are reported. Question 54 was following: "Did you have ejaculation problems (e.g, dry ejaculation)?"

Number of Participants With European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Prostate 25 (QLQ-PR25) Module Score for Question 55

The EORTC QLQ-PR25, a module of the EORTC QLQ-30 questionnaire was used to assess the quality of life. It consisted of 25 questions (Question 31 to 55) distributed on 6 domains: urinary symptoms (8 items), incontinence aid (1 item), bowel symptoms (4 items), hormonal treatment-related symptoms (HTRS) (6 items), sexual activity (2 items), and sexual functioning (4 items). Participants answered each of these questions using 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Number of participants with various responses to the question 55 are reported. Question 55 was following: "Have you felt uncomfortable about being sexually intimate?"

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A 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. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first). AEs included both non-serious adverse events (AEs) and SAEs.

Number of Participants With Treatment-Emergent Adverse Events Greater Than or Equal to Grade 3, Based on National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE), Version 4.0

An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug through the date of last dose +30 days (or the day before initiation of a new antineoplastic treatment, whichever occurred first).Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.

Number of Participants With Discontinuations From Study Treatment Due to Adverse Events (AEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (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. AEs included both non-serious adverse events (AEs) and SAEs.

Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Hematology

Hematology parameters: Haemoglobin (grams per liter [g/L]); leukocytes (log 10 raised to power 9 per liter [10*9/L]); lymphocytes (log 10 raised to power 6 per liter [10*6/L]); neutrophils (log 10 raised to power 6 per liter [10*6/L]); platelets (log 10 raised to power 9 per litre [10*9/L]).

Number of Participants With Increase of 2 or More National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE) (Version 4.0) Toxicity Grades Above Baseline - Chemistry

Chemistry parameters: Alanine aminotransferase (units per liter [U/L]); albumin (g/L); alkaline phosphatase (U/L); bilirubin (micromoles per liter [umol/L]); calcium (millimoles per liter [mmol/L]); creatine kinase (U/L); creatinine (umol/L); glucose, magnesium, phosphate, potassium, sodium (mmol/L).

Number of Participants With Clinically Significant Vital Signs

Vital signs included Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and heart rate.

Full Information

NCT ID

NCT02003924

First Posted

December 3, 2013

Last Updated

October 5, 2023

Sponsor

Pfizer

Collaborators

Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02003924

Brief Title

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

Acronym

PROSPER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 31, 2013 (Actual)

Primary Completion Date

June 28, 2017 (Actual)

Study Completion Date

December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

Collaborators

Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nonmetastatic Castration-Resistant Prostate Cancer, Prostate Cancer, Cancer of the Prostate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1401 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Sham Comparator

Arm Description

Sugar pill manufactured to mimic enzalutamide 40 mg capsule

Arm Title

Enzalutamide

Arm Type

Experimental

Arm Description

160 mg by mouth once daily

Intervention Type

Drug

Intervention Name(s)

Enzalutamide

Other Intervention Name(s)

MDV3100, Xtandi

Intervention Description

160 mg by mouth once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Sugar pill to mimic enzalutamide

Primary Outcome Measure Information:

Title

Metastasis Free Survival (MFS)

Description

Time Frame

From randomization until radiographic progression at any time, or death within 112 days of treatment discontinuation, whichever occurred first (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

Secondary Outcome Measure Information:

Title

Time to Prostate-Specific Antigen (PSA) Progression

Description

Time Frame

From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

Title

Time to First Use of New Antineoplastic Therapy

Description

Time Frame

From randomization until first use of new antineoplastic therapy(until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

Title

Overall Survival

Description

Time Frame

From randomization until death (up to a maximum of 68.8 months)

Title

Time to Pain Progression

Description

Time Frame

From randomization until onset of pain progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

Title

Time to First Use of Cytotoxic Chemotherapy

Description

Time Frame

From randomization up to the first use of cytotoxic chemotherapy (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

Title

Chemotherapy-Free Disease Specific Survival

Description

Time Frame

From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to prostate cancer (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

Title

Chemotherapy-Free Survival

Description

Time Frame

From randomization up to first use of cytotoxic chemotherapy for prostate cancer or death due to any cause (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

Title

Percentage of Participants With Prostate Specific Antigen (PSA) Response

Description

Time Frame

From randomization until first PSA progression (until the data cut-off date of 28 June 2017, maximum duration of treatment: 42.8 months)

Title

Change From Baseline in Quality of Life as Assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) Global Score

Description

Time Frame