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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00974311
Other study ID # CRPC2
Secondary ID 2009-013174-41C3
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


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
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