A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

— PREVAIL  

Official title:

PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212991
• Other study ID #: MDV3100-03
• Secondary ID: 2010-020821-41C3
• Status: Completed
• Phase: Phase 3
• Start date: September 16, 2010
• Est. completion date: February 14, 2019

Study information

• Verified date: March 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1717
• Est. completion date: February 14, 2019
• Est. primary completion date: September 30, 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Randomized, Double Blind Treatment Period:

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features

• Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy

• Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease

• No prior treatment with cytotoxic chemotherapy

• Asymptomatic or mildly symptomatic from prostate cancer

Exclusion Criteria:

• Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment

• Known or suspected brain metastasis or active leptomeningeal disease

• History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer

Open-Label Treatment Period:

The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment.

Eligible patients must meet all inclusion criteria.

• Received randomized double-blind treatment in PREVAIL;

• Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;

• Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;

The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each patient must not meet any of the following criteria:

• Has taken commercially available enzalutamide (Xtandi);

• Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment

• Known or suspected brain metastasis or active leptomeningeal disease

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Enzalutamide
Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.
• Placebo
Participants received placebo, administered as four capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.

Locations

Country	Name	City	State
Australia	Heart Care Partners	Auchenflower	Queensland
Australia	Icon Cancer Care Wesley	Auchenflower	Queensland
Australia	River City Pharmacy	Auchenflower	Queensland
Australia	Bendigo Health Medical Imaging	Bendigo	Victoria
Australia	Bendigo Health, Bendigo Hospital	Bendigo	Victoria
Australia	Eastern Health	Box Hill	Victoria
Australia	MIA Box Hill Radiology	Box Hill	Victoria
Australia	Oncology Eastern Clinical Research Unit (ECRU)	Box Hill	Victoria
Australia	Pharmacy Department	Box Hill	Victoria
Australia	Cabrini Hospital Brighton	Brighton	Victoria
Australia	Icon Cancer Care Chermside	Chermside	Queensland
Australia	Monash Health Translation Precinct	Clayton	Victoria
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Peter MacCallum Cancer Centre	East Melbourne	Victoria
Australia	Barwon Health, Geelong Hospital	Geelong	Victoria
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Nuclear Medicine and Imaging Department	Herston	Queensland
Australia	University of Queensland Centre for Clinical Research (UQCCR)	Herston	Queensland
Australia	St George Private Hospital	Kogarah	New South Wales
Australia	Adelaide Cancer Centre	Kurralta Park	South Australia
Australia	APHS Pharmacy	Kurralta Park	South Australia
Australia	Ashford Cancer Centre Research	Kurralta park	South Australia
Australia	Cancer Care SA Pty Ltd	Kurralta Park	South Australia
Australia	Lismore Base Hospital, Lismore Cancer Care and Haematology Unit	Lismore	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Cabrini Radiology	Malvern	Victoria
Australia	MDI Chemer	Malvern	Victoria
Australia	Cabrini Hospital Malvern	Malvern,	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	North Coast Cancer Institute	Port Macquarie	New South Wales
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Icon Cancer Care South Brisbane	South Brisbane	Queensland
Australia	Icon Cancer Foundation	South Brisbane	Queensland
Australia	Mater Private Cardiology	South Brisbane	Queensland
Australia	Sunshine Hospital	St Albans	Victoria
Australia	Royal North Shore Hospital, Department of Medical Oncology	St Leonards	New South Wales
Australia	Sydney Adventist Hospital	Sydney	New South Wales
Australia	Australian Clinical Trials Pty Ltd	Wahroonga	New South Wales
Australia	SAN Pathology	Wahroonga	New South Wales
Australia	SAN Radiology	Wahroonga	New South Wales
Australia	Calvary Mater Newcastle	Waratah	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Austria	Krankenhaus der Barmherzigen Schwestern Linz	Linz
Austria	Ordination Dr. Fink	Salzburg
Austria	Salzburger Universitatsklinikum	Salzburg
Austria	Medizinische Universitaet Wien	Wien
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	AZ Sint-Lucas	Ghent
Belgium	Jessaziekenhuis	Hasselt
Belgium	AZ Groeninge, Campus KL	Kortrijk
Belgium	UZ Leuven - University Hospital Gasthuisberg	Leuven
Belgium	Centre Hospitalier Universitaire de Liege-Urologie	Liege
Canada	Alberta Health Services - Cancer Care, Tom Baker Cancer Centre	Calgary	Alberta
Canada	Tom Baker Cancer Centre - Holy Cross Site	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	QEII Health Sciences Centre	Halifax	Nova Scotia
Canada	QEII Health Sciences Centre, Nova Scotia Cancer Centre.	Halifax	Nova Scotia
Canada	Juravinski Cancer Centre at Hamilton Health Sciences	Hamilton	Ontario
Canada	British Columbia Cancer Agency, Sindi Ahluwalia Hawkins, Centre for the Southern Interior	Kelowna	British Columbia
Canada	London RegCancer Program, London Health Sciences Centre	London	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	The Ottawa Hospital Cancer Centre, General Campus	Ottawa	Ontario
Canada	Centre de recherche clinique el evaluative en oncologie (CRCEO)	Quebec
Canada	CHU de Quebec - L'Hotel-Dieu de Quebec	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Vancouver Prostate Centre	Vancouver	British Columbia
Canada	British Columbia Cancer Agency - Vancouver Island Centre	Victoria	British Columbia
Canada	Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging	Victoria	British Columbia
Canada	Manitoba Prostate Centre	Winnipeg	Manitoba
Denmark	Aalborg Hospital Nord	Aalborg
Denmark	Aarhus Universitetshospital	Aarhus N
Denmark	Rigshospitalet	Copenhagen
Denmark	Frederiksberg Hospital	Frederiksberg
Denmark	Herlev Hospital	Herlev
Denmark	Roskilde Sygehus	Roskilde
Finland	Docrates Clinic	Helsinki
Finland	Helsinki University Central Hospital	Helsinki
Finland	Oulu University Hospital	Oulu
Finland	Tampere University Hospital	Tampere
France	ICO Paul Papin	Angers
France	Clinique Rhone Durance	Avignon
France	Institut Bergonie	Bordeaux
France	Institut Bergonie	Bordeaux	Nouvelle Aquitaine
France	CHD Vendee	La Roche sur Yon Cedex
France	Centre Jean Bernard - Clinique Victor Hugo	Le Mans
France	Centre Leon Berard	Lyon
France	Groupe Hospitalier La Pitie Salpetriere	Paris
France	Institut Curie	Paris
France	Hopital Europeen Georges Pompidou	Paris Cedex 15
France	Centre Eugene Marquis-Service d'Oncologie Medicale	Rennes cedex	Bretagne
France	Centre de Recherche Clinique	Saint Herblain Cedex
France	HIA Begin, Service de Medecine Interne et Oncologie	Saint-Mande
France	Institut de Cancerologie Lucien Neuwirth	Saint-Priest en Jarez
France	Hopital Civil	Strasbourg	Alsace
France	Clinique Pasteur	Toulouse
France	Institut Gustave Roussy	Villejuif
Germany	Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin	Berlin
Germany	Staedtisches Klinikum Braunschweig gGmbH	Braunschweig
Germany	Universitaetsklinikum Carl Gustav Carus Dresden an der	Dresden
Germany	Martini-Klinik am UKE Gmbh	Hamburg
Germany	Urologikum Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitaetsklinikum Heidelberg, Klinik Fuer Urologie	Heidelberg
Germany	Universitaetsklinikum des Saarlandes	Homburg/Saar
Germany	Universitaetsklinikum Mannheim, Klinik fuer Urologie	Mannheim
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie	Tuebingen
Germany	Universitaetsklinikum Ulm	Ulm
Germany	Kliniken Nordoberpfalz AG, Klinikum Weiden	Weiden In Der Oberpfalz
Israel	Soroka University Medical Center	Beer Sheva
Israel	Assaf Harofe Medical Center	Beer Yaakov
Israel	Bnai Zion Medical Center	Haifa
Israel	Rabin Medical Center	Petach Tikva
Israel	The Chaim Sheba Medical Center	Ramat Gan
Italy	Azienda USL8-Presidio Ospedaliero S.Donato	Arezzo
Italy	Azienda Socio Sanitaria Territoriale di Cremona	Cremona	CR
Italy	Ospedale G.B. Morgagni	Forli
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)	Meldola	FC
Italy	Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	TO
Italy	Azienda Ospedaliera San. Camillo Forlanini	Rome
Japan	Nippon Medical School Hospital	Bunkyo-ku	Tokyo
Japan	Chiba Cancer Center	Chiba
Japan	Kyushu University Hospital	Fukuoka-shi	Fukuoka
Japan	Nihon University Itabashi Hospital	Itabashi-ku	Tokyo
Japan	Cancer Institute Hospital	Koutou-ku	Tokyo
Japan	Kyoto University Hospital	Kyoto
Japan	Kyorin University Hospital	Mitaka-shi	Tokyo
Japan	Nagasaki University Hospital	Nagasaki-shi	Nagasaki
Japan	Niigata University Medical and Dental Hospital	Niigata
Japan	Osaka City University Hospital	Osaka
Japan	Kindai University Hospital	Osaka-sayama	Osaka
Japan	Osaka International Cancer Institute	Osaka-shi	Osaka
Japan	Tohoku University Hospital	Sendai-Shi	Miyagi
Japan	Showa University Hospital	Shinagawa-ku	Tokyo
Japan	Keio University Hospital	Shinjyuku-ku	Tokyo
Japan	Osaka University Hospital	Suita-shi	Osaka
Japan	Tokushima University Hospital	Tokushima-shi	Tokushima
Japan	Jikei University Hospital	Tokyo
Japan	Yamaguchi University Hospital	Ube-shi	Yamaguchi
Japan	Yamagata Prefectural Central Hospital	Yamagata
Japan	Yokohama City University Hospital	Yokohama-shi	Kanagawa-ken
Korea, Republic of	Samsung Medical Center	Gangnam-gu	Seoul
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-eup, Hwasun-gun	Jeonnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Asan Medical Center	Songpa-gu	Seoul
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	Division of Oncourology, National Cancer Institute	Vilnius
Netherlands	Vrije Universiteit Medical Center, Department of Medical Oncology	Amsterdam
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	University Medical Center Groningen, Department of Urology	Groningen
Netherlands	UMC St. Radboud	Nijmegen
Poland	Apteka Szpitalna	Gdansk	Pomorskie
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk	Pomorskie
Poland	Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi	Lodz	Lodzkie
Poland	Niepubliczny Zaklad Opieki Zdrowotnej	Myslowice	Slaskie
Poland	Wielkopolskie Centrum Onkologii	Poznan	Wielkopolskie
Poland	EMC Instytut Medyczny S.A.	Wroclaw	Dolnoslaskie
Russian Federation	Russian Academy of Medical Sciences Institution	Moscow
Russian Federation	State Educational Institution of Higher Professional Education	St-Petersburg
Russian Federation	State healthcare institute	St-Petersburg
Russian Federation	North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare	St.-Petersburg
Singapore	Department of Urology, National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Slovakia	Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica	Banska Bystrica
Slovakia	CUIMED s.r.o.	Bratislava
Slovakia	Univerzitna Nemocnica Martin	Martin
Slovakia	UROEXAM, spol. s r.o. urologicka ambulancia	Nitra
Slovakia	Poliklinika Sekcov, wesper, s.r.o.	Presov
Slovakia	UROCENTRUM MILAB s.r.o.	Presov
Spain	Complejo Hospitalario Universitario A Coruna	A Coruna
Spain	Hospital Universitario German Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Madrid Norte Sanchinarro	Madrid
Spain	Hospital Universitario Ramon y Cajal	Madrid
Spain	Althaia Xarxa Asistencial Manresa	Manresa	Barcelona
Spain	Hospital Son Espases	Palma de Mallorca	Islas Baleares
Spain	Clínica Universidad de Navarra	Pamplona	Navarra
Spain	Corporacio Sanitaria Parc Tauli	Sabadell(Barcelona)
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Skane University Hospital	Malmo
Sweden	Orebro University Hospital	Orebro
Sweden	Karolinska University Hospital Solna	Stockholm
Sweden	Umea University Hospital	Umea
United Kingdom	Clatterbridge Cancer Centre NHS Foundation Trust	Bebington	Wirral, Merseyside
United Kingdom	Clinical Investigations and Research Unit, Royal Sussex County Hospital	Brighton, East Sussex
United Kingdom	University Hospitals Bristol NHS Foundation Trust	Bristol
United Kingdom	Velindre Cancer Centre	Cardiff	Wales
United Kingdom	Edinburgh Cancer Centre	Edinburgh
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	University College London Hospital NHS Trust	London
United Kingdom	Northern Centre for Cancer Care	Newcastle Upon Tyne	Tyne and Wear
United Kingdom	Bishops Wood Hospital	Northwood	Middlesex
United Kingdom	Mount Vernon Hospital	Northwood	Middlesex
United Kingdom	Oxford University Hospitals NHS Trust	Oxford	Oxfordshire
United Kingdom	Royal Marsden Hospital	Sutton	Surrey
United States	Anschutz Cancer Center Pavilion Pharmacy	Aurora	Colorado
United States	University of Colorado Hospital, Anschutz Cancer Pavilion	Aurora	Colorado
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Lynn Cancer Institute Center for Hematology Oncology	Boca Raton	Florida
United States	Beth Israel Deaoness Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Cancer Centers of North Carolina	Cary	North Carolina
United States	Hematology / Oncology MUSC Hollings Cancer Center	Charleston	South Carolina
United States	Medical University of South Carolina - Urology Services	Charleston	South Carolina
United States	MUSC Department of Radiology	Charleston	South Carolina
United States	MUSC Urology Ambulatory Care	Charleston	South Carolina
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Levine Cancer Institute - Ballantyne	Charlotte	North Carolina
United States	Levine Cancer Institute - Main	Charlotte	North Carolina
United States	Levine Cancer Institute - Southpark	Charlotte	North Carolina
United States	Levine Cancer Institute - University	Charlotte	North Carolina
United States	Northwestern Medical Faculty Foundation	Chicago	Illinois
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Barnes-Jewish West County Hospital	Creve Coeur	Missouri
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Investigational Chemotherapy Services	Durham	North Carolina
United States	Karmanos Cancer Institute Weisberg Cancer Treatment Center	Farmington Hills	Michigan
United States	Virginia Oncology Associates	Hampton	Virginia
United States	Cancer Center Oncology Medical Group	La Mesa	California
United States	Keck Hospital of USC	Los Angeles	California
United States	LAC&USC Medical Center	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services	Los Angeles	California
United States	UCLA Clark Urology Clinic	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center / Investigational Drug Services	Los Angeles	California
United States	Jewish Hospital & St. Mary's Healthcare, Inc.	Louisville	Kentucky
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor	Mount Pleasant	South Carolina
United States	MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor	Mount Pleasant	South Carolina
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	The Mount Sinai Medical Center	New York	New York
United States	Virginia Oncology Associates	Newport News	Virginia
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	North County Oncology Medical Clinic, Inc	Oceanside	California
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	Portland VA Medical Center Laboratory	Portland	Oregon
United States	Cancer Centers of North Carolina	Raleigh	North Carolina
United States	Mayo Clinic	Rochester	Minnesota
United States	UC Davis Medical Center	Sacramento	California
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	BJH Pharmacy	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Barnes-Jewish St. Peters Hospital	Saint Peters	Missouri
United States	Medical Oncology Associates-SD	San Diego	California
United States	Sharp Memorial Hospital Investigational Pharmacy	San Diego	California
United States	Sharp Rees-Stealy	San Diego	California
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California
United States	The University of Arizona Cancer Center-North Campus	Tucson	Arizona
United States	The University of Arizona Cancer Certer-North Campus	Tucson	Arizona
United States	Virginia Oncology Associates	Virginia Beach	Virginia

Sponsors (3)

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

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Finland,  France,  Germany,  Israel,  Italy,  Japan,  Korea, Republic of,  Lithuania,  Netherlands,  Poland,  Russian Federation,  Singapore,  Slovakia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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. 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. Treatment-emergent were events between first dose of study drug and up to a maximum of 6.5 years that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.	Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Other	Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria 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 up to a maximum duration of 6.5 years. Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.	Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Other	Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)	Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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. Treatment-emergent were events between first dose of study drug and up to a maximum duration of 6.5 years that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.	Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Primary	Overall Survival	Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.	During study period (up to 3 years)
Primary	Radiographic Progression-free Survival (rPFS)	Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.	During study period (up to 20 months)
Secondary	Time to First Skeletal-related Event	Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.	During study period (up to 3 years)
Secondary	Time to Initiation of Cytotoxic Chemotherapy	The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.	During study period (up to 3 years)
Secondary	Time to Prostate-specific Antigen (PSA) Progression	Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a = 25% increase and an absolute increase of = 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a = 25% increase and an absolute increase of = 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.	During study period (up to 3 years)
Secondary	Percentage of Patients With Prostate Specific Antigen (PSA) Response = 50%	PSA response was defined as a = 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.	During study period (up to 3 years)
Secondary	Best Overall Soft Tissue Response	The best overall soft tissue objective response is defined as partial response [PR] or complete response [CR] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.	During study period (up to 3 years)