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

Castration-Resistant Prostate Cancer Clinical Trial

— AFFIRM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974311
• Other study ID #: CRPC2
• Secondary ID: 2009-013174-41C3
• Status: Completed
• Phase: Phase 3
• Start date: September 30, 2009
• Est. completion date: November 2, 2017

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1199
• Est. completion date: November 2, 2017
• Est. primary completion date: September 15, 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Progressive prostate cancer

• Medical or surgical castration with testosterone less than 50 ng/dl

• One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Adequate bone marrow, hepatic, and renal function

• Able to swallow the study drug and comply with study requirements

• Informed consent

Exclusion Criteria:

• Metastases in the brain or active epidural disease

• Another malignancy within the previous 5 years

• Clinically significant cardiovascular disease

• Gastrointestinal disorder affecting absorption

Related Conditions & MeSH terms

• Castration-Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Enzalutamide
MDV3100, 160 mg orally per day
• Placebo
Placebo comparator

Locations

Country	Name	City	State
Argentina	Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)	Buenos Aires	AR
Argentina	Instituto de Investigaciones Clinicas Cipolletti	Cipolletti	Provincia DE RIO Negro
Argentina	Policlinico Modelo de Cipolletti	Cipolletti	Provincia DE RIO Negro
Argentina	Centro de Diagnostico Dr. Enrique Rossi	Ciudad Autonoma de Buenos Aires
Argentina	Centro de Diagnostico Dr. Enrique Rossi	Ciudad Autonoma de Buenos Aires
Argentina	Clinica Universitaria Privada Reina Fabiola	Cordoba	Provincia DE Cordoba
Argentina	Instituto Oulton	Cordoba	Provincia DE Cordoba
Argentina	Policlinico Neuquen	Neuquen	Provincia DE Neuquen
Argentina	Hospital Italiano Garibaldi	Rosario	Provincia DE Santa FE
Argentina	Instituto de Oncologia y Especialidades Medicas	Rosario	Provincia DE Santa FE
Argentina	Sanatorio Mapaci	Rosario	Provincia DE Santa FE
Australia	Department of Medical Oncology	Adelaide	South Australia
Australia	Heart Care Partners	Auchenflower	Queensland
Australia	Icon Cancer Care Wesley	Auchenflower	Queensland
Australia	River City Pharmacy	Auchenflower	Queensland
Australia	Icon Cancer Care Chermside	Chermside	Queensland
Australia	Southern X-Ray Chermside	Chermside	Queensland
Australia	North Coast Cancer Institute	Coffs Harbour	New South Wales
Australia	Sydney Cancer Centre	Concord	New South Wales
Australia	St. Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	60 Eleanor St	Footscray
Australia	Western Hospital	Footscray
Australia	Peninsula Oncology Centre	Frankston	Victoria
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Cancer Care Services	Herston	Queensland
Australia	Royal Hobart Hospital	Hobart	Tasmania
Australia	Icon Cancer Foundation	Milton	Queensland
Australia	Sir Charles Gairdner Hospital, Department of Medical Oncology	Nedlands	Western Australia
Australia	Mid North Coast Diagnostic Imaging	Port Macquarie	New South Wales
Australia	Port Macquarie Base Hospital	Port Macquarie	New South Wales
Australia	Port Macquarie Base Hospital Pharmacy	Port Macquarie	New South Wales
Australia	Prince of Wales Hospital, Department of Medical Oncology	Randwick	New South Wales
Australia	Icon Cancer Care South Brisbane	South Brisbane	Queensland
Australia	Mater Private Cardiology	South Brisbane	Queensland
Australia	Queensland X-Ray	South Brisbane	Queensland
Australia	XRadiology	Toowong	Queensland
Australia	The Tweed Hospital	Tweed Heads	New South Wales
Australia	The Royal Melbourne Hospital	Victoria
Australia	PRP Diagnostic Imaging	Wentworthville	New South Wales
Australia	Sydney West Cancer Trials Centre, Department of Medical Oncology	Westmead	New South Wales
Austria	Krankenhaus der Barmherzigen Schwestern Linz	Linz
Austria	ISOTOPIX Ambulatorium fuer	Vienna
Austria	Medical University of Vienna	Vienna
Belgium	Cliniques Universitaires Saint- Luc	Brussels
Belgium	AZ Sint- Lucas	Ghent
Belgium	VZW Jessa Ziekenhuis	Hasselt
Belgium	AZ Groeninge - Campus Kennedylaan	Kortrijk
Belgium	AZ Groeninge - Campus Sint Maarten	Kortrijk
Belgium	University Hospital Gasthuisberg	Leuven
Belgium	H.-Hartziekenhuis Roeselare-Menen vzw	Roeselare
Canada	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	Halifax	Nova Scotia
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	British Columbia Cancer Agency, Centre for the Southern Interior	Kelowna	British Columbia
Canada	London Regional Cancer Program	London	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	The Urology Specialists.	Montreal	Quebec
Canada	Centre de rechereche clinique et evaluative en oncologie	Quebec
Canada	CHU de Quebec	Quebec
Canada	Imagerie medicale de la Capitale	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	B.C. Cancer Agency - Vancouver Centre	Vancouver	British Columbia
Canada	British Columbia Cancer Agency - Vancouver Island Centre	Victoria	British Columbia
Chile	Hospital San Jose	Santiago
Chile	Instituto Nacional del Cancer	Santiago
Chile	Centro Investigacion Clinica del Sur	Temuco
Chile	Instituto Oncologico	Vina del Mar
France	Centre Paul Papin	Angers Cedex 9
France	Institut Bergonie	Bordeaux cedex
France	Centre Regional Francois Baclesse de lutte contre le cancer	Caen Cedex
France	Centre hospitalier de Cannes	Cannes Cedex
France	CHU Henri Mondor	Creteil
France	Centre Hospitalier Intercommunal Frejus-Saint Raphael	Frejus Cedex
France	Centre hospitalier departemental Vendee	LA Roche sur Yon
France	Clinique Victor Hugo - Centre Jean Bernard	Le Mans
France	Centre Leon Berard	Lyon Cedex 08
France	Groupement Hospitalier Edouard Herriot - Pavillon V	Lyon Cedex 3
France	Institut Paoli Calmettes	Marseille
France	Hopital Europeen Georges Pompidou	Paris
France	Institut Curie	Paris
France	Centre Hospitalier Lyon sud	Pierre Benite
France	CHU La Miletrie	Poitiers Cedex
France	Institut Jean Godinot	Reims Cedex
France	Centre Hospitalier	Saint Etienne Cedex 2
France	Institut de Cancerologie de la Loire	Saint Priest en Jarez
France	Centre d'Investigation Clinique, (CIE3)	Saint-Etienne CEDEX 2
France	Centre Rene Gauducheau	SAINT-HERBLAIN Cedex
France	Hopital Foch	Suresnes Cedex
France	Institut Gustave Roussy	Villejuif
Germany	Universitaetsklinikum Aachen	Aachen
Germany	Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin	Berlin
Germany	FacharztzentrumInnere Medizin	Berlin
Germany	Gemeinschaftspraxis Fuer Nuklearmedizin	Berlin
Germany	Praxis Dr. Wolfgang Hoelzer	Berlin
Germany	Radiologische Gemeinschaftspraxis	Berlin
Germany	Staedtisches Klinikum Braunschweig gGmbH	Braunschweig
Germany	Technical University Dresden	Dresden
Germany	Martini-Klinik am UKE GmbH	Hamburg
Germany	Roentgenpraxis	Hamburg
Germany	Urologische Gemeinschaftspraxis Poppenbuettel	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie	Hannover
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Universitaetsklinikum Mannheim	Mannheim
Germany	Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie	Muenster
Germany	Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin	Muenster
Germany	Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie	Muenster
Germany	Abt.f.Diagnostische u. Interventionelle Radiologie	Tuebingen
Germany	Klinik fuer Urologie	Tuebingen
Germany	Nuklearmedizin	Tuebingen
Italy	Azienda Ospedaliera "Istituti Ospitalieri" di Cremona	Cremona
Italy	Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano	TO
Italy	Azienda Ospedaliera San Camillo Forlanini	Rome
Italy	Azienda Ospedaliero-Universitaria di Modena Policlinico	Via Del Pozzo 71	Modena
Netherlands	VU Medisch Centrum	Amsterdam
Netherlands	UMC St. Radboud	Nijmegen
Netherlands	Erasmus MC	Rotterdam
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego	Grudziadz
Poland	Wojewodzki Szpital Specjalistyczny im. M. Kopernika	Lodz
Poland	Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny	Lodz
Poland	Wojewodzki szpital specjalistyczny im. Janusza Korczaka	Slupsk
South Africa	Hopelands Cancer Centre	Durban
South Africa	GVI Oncology	Port Elizabeth
South Africa	Sandton Oncology Centre	Sandton
Spain	Hospital Universitario Germans Trias i Pujol	Badalona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Radiodiagnostic Cetir Clinica Pilar	Barcelona
Spain	Hospital Madrid Norte Sanchinarro	Madrid
Spain	Clinica Universidad de Navarra	Pamplona
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Cancer Centre	Birmingham
United Kingdom	Bristol Haematology & Oncology Centre	Bristol
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	The Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Hammersmith Hospital	London
United Kingdom	University College Hospital	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Northern Centre for Cancer Care	Newcastle upon Tyne
United Kingdom	Bishops Wood Hospital	Northwood	Middlesex
United Kingdom	Mount Vernon Hospital	Northwood	Middlesex
United Kingdom	Churchill Hospital	Oxford
United Kingdom	The Manor Hospital Oxford	Oxford
United Kingdom	The Royal Marsden Hospital	Sutton	Surrey
United States	New Mexico Oncology Hematology Consultants, Ltd.	Albuquerque	New Mexico
United States	Peachtree Hematology-Oncology Consultants, P.C.	Atlanta	Georgia
United States	Palm Beach Cancer Institute	Atlantis	Florida
United States	Research Pharmacist	Aurora	Colorado
United States	University of Colorado Denver, Anschutz Cancer Pavilion	Aurora	Colorado
United States	The Johns Hopkins Hospital	Baltimore	Maryland
United States	The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group	Beverly Hills	California
United States	USC Westside Prostate Cancer Center	Beverly Hills	California
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital (BWH)	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital (MGH)	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Hollings Cancer Center	Charleston	South Carolina
United States	Medical University of South Carolina (MUSC)	Charleston	South Carolina
United States	Tennessee Oncology, PLLC	Chattanooga	Tennessee
United States	Virginia Oncology Associates	Chesapeake	Virginia
United States	University of Chicago	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Siteman Cancer Center-West County	Creve Coeur	Missouri
United States	Parkland Health and Hospital System	Dallas	Texas
United States	Texas Oncology, Sammons Cancer Center	Dallas	Texas
United States	UT Southwestern Medical Center at Dallas	Dallas	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Tennessee Oncology, PLLC	Dickson	Tennessee
United States	City of Hope	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Pharmaceutical Research Services	Durham	North Carolina
United States	Weisberg Cancer Treatment Center	Farmington Hills	Michigan
United States	Tennessee Oncology, PLLC	Franklin	Tennessee
United States	Tennessee Oncology, PLLC	Gallatin	Tennessee
United States	Virginia Oncology Associates	Hampton	Virginia
United States	Tennessee Oncology, PLLC	Hermitage	Tennessee
United States	Cancer Center Oncology Medical Group	La Mesa	California
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Nevada Cancer Institute, an affiliate of the UC San Diego Health System	Las Vegas	Nevada
United States	Tennessee Oncology, PLLC	Lebanon	Tennessee
United States	LAC & USC Medical Center	Los Angeles	California
United States	Ronald Reagan UCLA Medical Center	Los Angeles	California
United States	UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	c/o Prostate Oncology Specialist, Inc.	Marina Del Rey	California
United States	UPMC Cancer Centers	McKeesport	Pennsylvania
United States	Virginia Cancer Institute	Mechanicsville	Virginia
United States	Virginia Cancer Institute	Midlothian	Virginia
United States	Tennessee Oncology, PLLC	Murfreesboro	Tennessee
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Grand Strand Urology	Myrtle Beach	South Carolina
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	The Sarah Cannon Research Institute	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	C/O: Thomas Ferencz R.Ph., BCOP	New Haven	Connecticut
United States	Yale University School of Med	New Haven	Connecticut
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Weill Cornell Medical College-New York Presbyterian Hospital	New York	New York
United States	Weill Cornell Medical College-New York Presbyterian Hospital	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	Palm Beach Cancer Institute	Palm Beach Gardens	Florida
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	Portland VA Medical Center	Portland	Oregon
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	Siteman Cancer Center	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	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	Premiere Oncology of Arizona	Scottsdale	Arizona
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington
United States	Tennessee Oncology, PLLC	Smyrna	Tennessee
United States	City of Hope Medical Group	South Pasadena	California
United States	Stanford Hospital and Clinics Research Pharmacy	Stanford	California
United States	Stanford University Medical Center	Stanford	California
United States	Virginia Oncology Associates	Virginia Beach	Virginia
United States	George Washington University-Medical Faculty Associates	Washington	District of Columbia
United States	Palm Beach Cancer Institute	Wellington	Florida
United States	Palm Beach Cancer Institute	West Palm Beach	Florida
United States	Virginia Oncology Associates	Williamsburg	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,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Chile,  France,  Germany,  Italy,  Netherlands,  Poland,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant and jeopardized participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events which occurred between first dose of study drug and up to the safety follow-up visit or the initiation of another anti-neoplastic therapy, whichever occurred first (up to 101 months). AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.	Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Other	Number of Participants With Clinically Significant Changes in Vital Signs	Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: absolute result greater than (>) 180 millimeter of mercury (mmHg) and >40 mmHg increase from baseline (BL) and less than (<) 90 mmHg and >30 mmHg decrease from BL; diastolic blood pressure (DBP) values: absolute result >105 mmHg and >30 mmHg increase from BL and absolute result < 50 mmHg and >20 mmHg decrease from BL; any abnormalities in SBP or DBP; heart rate values: absolute result > 120 beats per minute (bpm) and >30 bpm increase from BL and absolute result < 50 bpm and >20 bpm decrease from BL or any abnormalities in heart rate. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.	Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Other	Number of Participants With Any Newly Clinically Significant Abnormal Finding in Electrocardiogram (ECG)	Any new post baseline abnormality was defined as any abnormal ECG finding that appeared after baseline assessment which was not seen at the screening or baseline ECG assessment. Where, criteria of abnormality was QTcF interval > 470 millisecond (msec). Participants were counted once only for a specific abnormality. This outcome measure was planned to be analysed in double blind phase only. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.	Baseline, up to the end of DB phase or unscheduled visit (up to 24 months)
Other	Number of Participants With Grade 3/4 Post-Baseline Laboratory Toxicity (Hematology and Chemistry)	Laboratory parameters included hematological and chemistry parameters. Chemistry parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, creatine kinase, creatinine, glucose, magnesium, phosphate, potassium and sodium. Hematology parameters included haemoglobin, leukocytes, lymphocytes, neutrophils and platelet. Test abnormalities were graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 as Grade 3= severe and Grade 4= life-threatening or disabling. Only categories with at least 1 participant with abnormality are reported in this outcome measure. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.	Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Primary	Overall Survival	Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).	During study period (up to 101 months)
Secondary	Radiographic Progression-free Survival	Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Participants were assessed for objective disease progression at regularly scheduled visits. The consensus guidelines of the Prostate Cancer Clinical Trials Working Group 2 were taken into consideration for the determination of disease progression. Radiographic disease progression was defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for soft tissue disease, or the appearance of two or more new bone lesions on bone scan. Progression at the first scheduled reassessment at Week 13 required a confirmatory scan 6 or more weeks later. Participants who did not reach the endpoint were right censored at their last assessment.	During DB phase (up to 24 months)
Secondary	Time to First Skeletal-related Event	The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Participants were assessed for skeletal-related events at regularly scheduled visits. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. Participants who did not reach the endpoint were right censored at their last assessment.	During DB Phase (up to 24 months)
Secondary	Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)	The FACT-P was a 39-item participant questionnaire which assessed physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The sum of scores on all 5 domains constitutes the global FACT-P. The global/total FACT-P score ranged from 0 (worst) to 156 (best), higher scores indicate better health status. Responders were those participants who had a 10-point improvement in their total FACT-P score, as compared with baseline, on two consecutive measurements obtained at least 3 weeks apart.	Baseline up to 24 months
Secondary	Time to Prostate-specific Antigen (PSA) Progression	Time to PSA progression was defined as time from randomization to PSA progression. Participants who did not reach the endpoint were right censored at their last assessment or for participants with no post-baseline PSA assessment, date of randomization. For participants with PSA declines at Week 13, the PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 nanogram per milliliter (ng/mL) above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For participants with no PSA declines at Week 13, PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment).	Baseline and at every study visit from Week 13 while on study drug (up to 24 months)
Secondary	Percentage of Participants With Pain Palliation	The proportion of participants with pain palliation was assessed for participants with a stable and sufficient pain burden at study entry. Pain burden was measured by question #3 of the Brief Pain Inventory (Short Form). This scale measures pain on a 0 to 10 scale with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Pain palliation at Week 13 was determined for the proportion of men with baseline bone metastasis(es) who had baseline pain attributable to the metastasis(es). Palliation was defined as >=30% reduction in average pain score at Week 13 compared to baseline without a >=30% increase in analgesic use.	Baseline up to 24 months
Secondary	Percentage of Participants With Prostate Specific Antigen (PSA) Response	Participants were evaluable for PSA response rate if they had a PSA level measured at baseline and at least 1 post-baseline assessment. Both PSA responses of > 50% and > 90% were determined. PSA responses required confirmation with a subsequent assessment that was conducted at least 3 weeks later.	During DB phase (up to 24 months)
Secondary	Percentage of Participants With Soft-tissue Objective Response	The best overall soft tissue response as assessed using RECIST v1.1 during the study was summarized using the investigators' response assessments and also the derived response assessments by treatment group. Only participants with measurable soft tissue disease at screening were included in this analysis. Participants with measurable disease at screening are participants who had at least 1 target lesion identified per RECIST v1.1 at screening. Percentage of participants summarizes the number of participants with complete or partial objective response (%). Soft Tissue assessment based on Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-247.	During DB phase (up to 24 months)
Secondary	European Quality of Life Five-Domain (EQ-5D) Scale	EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Five parameters (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were assessed on 3-point categorical scale (1= no problems, 2= some/moderate problems and 3= severe problem). Score were transformed and resulted in a total EQ-5D score range of 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better health and quality of life.	Week 13
Secondary	Percentage of Participants With Circulating Tumor Cell (CTC) Conversion	CTC conversion was assessed for participants with baseline CTC counts of greater than or equal to (>=) 5 cells per 7.5 milliliter (mL) of blood. A CTC conversion was defined as a decline in the CTC count to less than (<) 5 cells per 7.5 mL of blood. In this outcome measure percentage of participants with CTC conversion was reported.	Baseline up to 24 months