search
Back to results

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

Primary Purpose

Castration-Resistant Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Enzalutamide
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Castration-Resistant Prostate Cancer focused on measuring Prostate Cancer, Castration-resistant

Eligibility Criteria

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

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

Sites / Locations

  • University of Alabama at Birmingham
  • University of Alabama at Birmingham
  • Mayo Clinic Hospital
  • Premiere Oncology of Arizona
  • Mayo Clinic Arizona
  • Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group
  • USC Westside Prostate Cancer Center
  • City of Hope
  • Cancer Center Oncology Medical Group
  • LAC & USC Medical Center
  • USC/Norris Comprehensive Cancer Center
  • Ronald Reagan UCLA Medical Center
  • UCLA
  • c/o Prostate Oncology Specialist, Inc.
  • North County Oncology Medical Clinic, Inc,
  • Medical Oncology Associates - SD
  • Sharp Memorial Hospital Investigational Pharmacy
  • Sharp Rees-Stealy
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • City of Hope Medical Group
  • Stanford Hospital and Clinics Research Pharmacy
  • Stanford University Medical Center
  • Research Pharmacist
  • University of Colorado Denver, Anschutz Cancer Pavilion
  • C/O: Thomas Ferencz R.Ph., BCOP
  • Yale University School of Med
  • George Washington University-Medical Faculty Associates
  • Palm Beach Cancer Institute
  • Palm Beach Cancer Institute
  • Palm Beach Cancer Institute
  • Palm Beach Cancer Institute
  • Peachtree Hematology-Oncology Consultants, P.C.
  • University of Chicago Medical Center
  • University of Chicago
  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
  • The Johns Hopkins Hospital
  • Massachusetts General Hospital (MGH)
  • Brigham & Women's Hospital (BWH)
  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Karmanos Cancer Institute
  • Weisberg Cancer Treatment Center
  • Mayo Clinic
  • Siteman Cancer Center-West County
  • Barnes-Jewish Hospital
  • Washington University School of Medicine
  • Siteman Cancer Center
  • Comprehensive Cancer Centers of Nevada
  • Nevada Cancer Institute, an affiliate of the UC San Diego Health System
  • Comprehensive Cancer Centers of Nevada
  • New Mexico Oncology Hematology Consultants, Ltd.
  • Roswell Park Cancer Institute
  • Weill Cornell Medical College-New York Presbyterian Hospital
  • Memorial Sloan-Kettering Cancer Center
  • Weill Cornell Medical College-New York Presbyterian Hospital
  • Duke University Medical Center
  • Pharmaceutical Research Services
  • Portland VA Medical Center
  • UPMC Cancer Centers
  • Hospital of the University of Pennsylvania
  • Fox Chase Cancer Center
  • University of Pittsburgh Cancer Institute
  • UPMC Cancer Centers
  • VA Pittsburgh Healthcare System
  • Hollings Cancer Center
  • Medical University of South Carolina (MUSC)
  • Carolina Urologic Research Center
  • Grand Strand Urology
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • The Sarah Cannon Research Institute
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Tennessee Oncology, PLLC
  • Vanderbilt University Medical Center
  • Tennessee Oncology, PLLC
  • Parkland Health and Hospital System
  • Texas Oncology, Sammons Cancer Center
  • UT Southwestern Medical Center at Dallas
  • Virginia Oncology Associates
  • Virginia Oncology Associates
  • Virginia Cancer Institute
  • Virginia Cancer Institute
  • Virginia Oncology Associates
  • Virginia Oncology Associates
  • Virginia Cancer Institute
  • Virginia Cancer Institute
  • Virginia Oncology Associates
  • Virginia Oncology Associates
  • Seattle Cancer Care Alliance
  • University of Washington Medical Center
  • University of Wisconsin Hospital and Clinics
  • Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)
  • Instituto Oulton
  • Clinica Universitaria Privada Reina Fabiola
  • Policlinico Neuquen
  • Policlinico Modelo de Cipolletti
  • Instituto de Investigaciones Clinicas Cipolletti
  • Sanatorio Mapaci
  • Instituto de Oncologia y Especialidades Medicas
  • Hospital Italiano Garibaldi
  • Centro de Diagnostico Dr. Enrique Rossi
  • Centro de Diagnostico Dr. Enrique Rossi
  • North Coast Cancer Institute
  • Sydney Cancer Centre
  • Mid North Coast Diagnostic Imaging
  • Port Macquarie Base Hospital Pharmacy
  • Port Macquarie Base Hospital
  • Prince of Wales Hospital, Department of Medical Oncology
  • The Tweed Hospital
  • PRP Diagnostic Imaging
  • Sydney West Cancer Trials Centre, Department of Medical Oncology
  • River City Pharmacy
  • Heart Care Partners
  • Icon Cancer Care Wesley
  • Icon Cancer Care Chermside
  • Southern X-Ray Chermside
  • Cancer Care Services
  • Icon Cancer Foundation
  • Icon Cancer Care South Brisbane
  • Mater Private Cardiology
  • Queensland X-Ray
  • XRadiology
  • Department of Medical Oncology
  • Royal Hobart Hospital
  • St. Vincent's Hospital Melbourne
  • Peninsula Oncology Centre
  • Austin Hospital
  • Sir Charles Gairdner Hospital, Department of Medical Oncology
  • 60 Eleanor St
  • Western Hospital
  • The Royal Melbourne Hospital
  • Krankenhaus der Barmherzigen Schwestern Linz
  • ISOTOPIX Ambulatorium fuer
  • Medical University of Vienna
  • Cliniques Universitaires Saint- Luc
  • AZ Sint- Lucas
  • VZW Jessa Ziekenhuis
  • AZ Groeninge - Campus Kennedylaan
  • AZ Groeninge - Campus Sint Maarten
  • University Hospital Gasthuisberg
  • H.-Hartziekenhuis Roeselare-Menen vzw
  • Tom Baker Cancer Centre
  • Tom Baker Cancer Centre - Holy Cross Site
  • Cross Cancer Institute
  • British Columbia Cancer Agency, Centre for the Southern Interior
  • B.C. Cancer Agency - Vancouver Centre
  • British Columbia Cancer Agency - Vancouver Island Centre
  • QEII Health Sciences Centre
  • QEII Health Sciences Centre
  • QEII Health Sciences Centre
  • Juravinski Cancer Centre
  • London Regional Cancer Program
  • Princess Margaret Hospital
  • Centre Hospitalier de l'Universite de Montreal
  • The Urology Specialists.
  • Imagerie medicale de la Capitale
  • CHU de Quebec
  • Centre de rechereche clinique et evaluative en oncologie
  • Hospital San Jose
  • Instituto Nacional del Cancer
  • Centro Investigacion Clinica del Sur
  • Instituto Oncologico
  • Centre Paul Papin
  • Institut Bergonie
  • Centre Regional Francois Baclesse de lutte contre le cancer
  • Centre hospitalier de Cannes
  • CHU Henri Mondor
  • Centre Hospitalier Intercommunal Frejus-Saint Raphael
  • Centre hospitalier departemental Vendee
  • Clinique Victor Hugo - Centre Jean Bernard
  • Centre Leon Berard
  • Groupement Hospitalier Edouard Herriot - Pavillon V
  • Institut Paoli Calmettes
  • Institut Curie
  • Hopital Europeen Georges Pompidou
  • Centre Hospitalier Lyon sud
  • CHU La Miletrie
  • Institut Jean Godinot
  • Centre Hospitalier
  • Institut de Cancerologie de la Loire
  • Centre d'Investigation Clinique, (CIE3)
  • Centre Rene Gauducheau
  • Hopital Foch
  • Institut Gustave Roussy
  • Universitaetsklinikum Aachen
  • Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin
  • Gemeinschaftspraxis Fuer Nuklearmedizin
  • Radiologische Gemeinschaftspraxis
  • FacharztzentrumInnere Medizin
  • Praxis Dr. Wolfgang Hoelzer
  • Staedtisches Klinikum Braunschweig gGmbH
  • Technical University Dresden
  • Martini-Klinik am UKE GmbH
  • Roentgenpraxis
  • Urologische Gemeinschaftspraxis Poppenbuettel
  • Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie
  • Medizinische Hochschule Hannover
  • Universitaetsklinikum Heidelberg
  • Universitaetsklinikum Mannheim
  • Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie
  • Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin
  • Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie
  • Abt.f.Diagnostische u. Interventionelle Radiologie
  • Klinik fuer Urologie
  • Nuklearmedizin
  • Azienda Ospedaliero-Universitaria di Modena Policlinico
  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
  • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
  • Azienda Ospedaliera San Camillo Forlanini
  • VU Medisch Centrum
  • UMC St. Radboud
  • Erasmus MC
  • Uniwersyteckie Centrum Kliniczne
  • Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny
  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika
  • Wojewodzki szpital specjalistyczny im. Janusza Korczaka
  • Hopelands Cancer Centre
  • GVI Oncology
  • Sandton Oncology Centre
  • Hospital Universitario Germans Trias i Pujol
  • Hospital del Mar
  • Radiodiagnostic Cetir Clinica Pilar
  • Hospital Santa Creu i Sant Pau
  • Hospital Vall d'Hebron
  • Hospital Madrid Norte Sanchinarro
  • Clinica Universidad de Navarra
  • Bishops Wood Hospital
  • Mount Vernon Hospital
  • The Royal Marsden Hospital
  • Belfast City Hospital
  • Cancer Centre
  • Bristol Haematology & Oncology Centre
  • Bristol Royal Infirmary
  • Cambridge University Hospitals NHS Foundation Trust
  • The Beatson West of Scotland Cancer Centre
  • University College Hospital
  • Hammersmith Hospital
  • The Christie NHS Foundation Trust
  • Northern Centre for Cancer Care
  • Churchill Hospital
  • The Manor Hospital Oxford

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Enzalutamide

Placebo

Arm Description

Formerly MDV3100

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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).
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.
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.
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.
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.
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.

Full Information

First Posted
September 9, 2009
Last Updated
November 15, 2018
Sponsor
Pfizer
Collaborators
Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00974311
Brief Title
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 30, 2009 (Actual)
Primary Completion Date
September 15, 2011 (Actual)
Study Completion Date
November 2, 2017 (Actual)

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
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Castration-Resistant Prostate Cancer
Keywords
Prostate Cancer, Castration-resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide
Arm Type
Experimental
Arm Description
Formerly MDV3100
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
MDV3100, Xtandi
Intervention Description
MDV3100, 160 mg orally per day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Primary Outcome Measure Information:
Title
Overall Survival
Description
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).
Time Frame
During study period (up to 101 months)
Secondary Outcome Measure Information:
Title
Radiographic Progression-free Survival
Description
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.
Time Frame
During DB phase (up to 24 months)
Title
Time to First Skeletal-related Event
Description
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.
Time Frame
During DB Phase (up to 24 months)
Title
Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Description
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.
Time Frame
Baseline up to 24 months
Title
Time to Prostate-specific Antigen (PSA) Progression
Description
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).
Time Frame
Baseline and at every study visit from Week 13 while on study drug (up to 24 months)
Title
Percentage of Participants With Pain Palliation
Description
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.
Time Frame
Baseline up to 24 months
Title
Percentage of Participants With Prostate Specific Antigen (PSA) Response
Description
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.
Time Frame
During DB phase (up to 24 months)
Title
Percentage of Participants With Soft-tissue Objective Response
Description
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.
Time Frame
During DB phase (up to 24 months)
Title
European Quality of Life Five-Domain (EQ-5D) Scale
Description
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.
Time Frame
Week 13
Title
Percentage of Participants With Circulating Tumor Cell (CTC) Conversion
Description
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.
Time Frame
Baseline up to 24 months
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
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)
Title
Number of Participants With Clinically Significant Changes in Vital Signs
Description
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.
Time Frame
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)
Title
Number of Participants With Any Newly Clinically Significant Abnormal Finding in Electrocardiogram (ECG)
Description
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.
Time Frame
Baseline, up to the end of DB phase or unscheduled visit (up to 24 months)
Title
Number of Participants With Grade 3/4 Post-Baseline Laboratory Toxicity (Hematology and Chemistry)
Description
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.
Time Frame
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)

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Premiere Oncology of Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211-1850
Country
United States
Facility Name
USC Westside Prostate Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Cancer Center Oncology Medical Group
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
LAC & USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-6984
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
c/o Prostate Oncology Specialist, Inc.
City
Marina Del Rey
State/Province
California
ZIP/Postal Code
90292
Country
United States
Facility Name
North County Oncology Medical Clinic, Inc,
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Medical Oncology Associates - SD
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Memorial Hospital Investigational Pharmacy
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Sharp Rees-Stealy
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
City of Hope Medical Group
City
South Pasadena
State/Province
California
ZIP/Postal Code
91030
Country
United States
Facility Name
Stanford Hospital and Clinics Research Pharmacy
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Research Pharmacist
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Denver, Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
C/O: Thomas Ferencz R.Ph., BCOP
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Yale University School of Med
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
George Washington University-Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Palm Beach Cancer Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Palm Beach Cancer Institute
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Palm Beach Cancer Institute
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Palm Beach Cancer Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Peachtree Hematology-Oncology Consultants, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital (MGH)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital (BWH)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Siteman Cancer Center-West County
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110-1094
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Siteman Cancer Center
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Nevada Cancer Institute, an affiliate of the UC San Diego Health System
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
New Mexico Oncology Hematology Consultants, Ltd.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Weill Cornell Medical College-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College-New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pharmaceutical Research Services
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Portland VA Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
UPMC Cancer Centers
City
McKeesport
State/Province
Pennsylvania
ZIP/Postal Code
15132
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
UPMC Cancer Centers
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Grand Strand Urology
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Dickson
State/Province
Tennessee
ZIP/Postal Code
37055
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Gallatin
State/Province
Tennessee
ZIP/Postal Code
37066
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Hermitage
State/Province
Tennessee
ZIP/Postal Code
37076
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Lebanon
State/Province
Tennessee
ZIP/Postal Code
37087
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37207
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-5536
Country
United States
Facility Name
Tennessee Oncology, PLLC
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Parkland Health and Hospital System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Oncology, Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Virginia Oncology Associates
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Virginia Oncology Associates
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Virginia Cancer Institute
City
Mechanicsville
State/Province
Virginia
ZIP/Postal Code
23116-1844
Country
United States
Facility Name
Virginia Cancer Institute
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23114
Country
United States
Facility Name
Virginia Oncology Associates
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235-4730
Country
United States
Facility Name
Virginia Oncology Associates
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
Country
United States
Facility Name
Virginia Oncology Associates
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23188
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University of Wisconsin Hospital and Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)
City
Buenos Aires
State/Province
AR
ZIP/Postal Code
C1425AWC
Country
Argentina
Facility Name
Instituto Oulton
City
Cordoba
State/Province
Provincia DE Cordoba
ZIP/Postal Code
X5000JJS
Country
Argentina
Facility Name
Clinica Universitaria Privada Reina Fabiola
City
Cordoba
State/Province
Provincia DE Cordoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Name
Policlinico Neuquen
City
Neuquen
State/Province
Provincia DE Neuquen
ZIP/Postal Code
8300
Country
Argentina
Facility Name
Policlinico Modelo de Cipolletti
City
Cipolletti
State/Province
Provincia DE RIO Negro
ZIP/Postal Code
8324
Country
Argentina
Facility Name
Instituto de Investigaciones Clinicas Cipolletti
City
Cipolletti
State/Province
Provincia DE RIO Negro
ZIP/Postal Code
R8324EMD
Country
Argentina
Facility Name
Sanatorio Mapaci
City
Rosario
State/Province
Provincia DE Santa FE
ZIP/Postal Code
S2000DTO
Country
Argentina
Facility Name
Instituto de Oncologia y Especialidades Medicas
City
Rosario
State/Province
Provincia DE Santa FE
ZIP/Postal Code
S2000KZE
Country
Argentina
Facility Name
Hospital Italiano Garibaldi
City
Rosario
State/Province
Provincia DE Santa FE
ZIP/Postal Code
S2001ODA
Country
Argentina
Facility Name
Centro de Diagnostico Dr. Enrique Rossi
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1043AAS
Country
Argentina
Facility Name
Centro de Diagnostico Dr. Enrique Rossi
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1425BEE
Country
Argentina
Facility Name
North Coast Cancer Institute
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Sydney Cancer Centre
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Mid North Coast Diagnostic Imaging
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Port Macquarie Base Hospital Pharmacy
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Port Macquarie Base Hospital
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Prince of Wales Hospital, Department of Medical Oncology
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
The Tweed Hospital
City
Tweed Heads
State/Province
New South Wales
ZIP/Postal Code
2485
Country
Australia
Facility Name
PRP Diagnostic Imaging
City
Wentworthville
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Sydney West Cancer Trials Centre, Department of Medical Oncology
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
River City Pharmacy
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Heart Care Partners
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Icon Cancer Care Wesley
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Icon Cancer Care Chermside
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Southern X-Ray Chermside
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Cancer Care Services
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Icon Cancer Foundation
City
Milton
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Facility Name
Icon Cancer Care South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Mater Private Cardiology
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Queensland X-Ray
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
XRadiology
City
Toowong
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Department of Medical Oncology
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Facility Name
Peninsula Oncology Centre
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Sir Charles Gairdner Hospital, Department of Medical Oncology
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
60 Eleanor St
City
Footscray
ZIP/Postal Code
3011
Country
Australia
Facility Name
Western Hospital
City
Footscray
ZIP/Postal Code
3011
Country
Australia
Facility Name
The Royal Melbourne Hospital
City
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Krankenhaus der Barmherzigen Schwestern Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
ISOTOPIX Ambulatorium fuer
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Cliniques Universitaires Saint- Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
AZ Sint- Lucas
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
VZW Jessa Ziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
AZ Groeninge - Campus Kennedylaan
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
AZ Groeninge - Campus Sint Maarten
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
H.-Hartziekenhuis Roeselare-Menen vzw
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Tom Baker Cancer Centre - Holy Cross Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2S 3C3
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency, Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
B.C. Cancer Agency - Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
British Columbia Cancer Agency - Vancouver Island Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
QEII Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L4M1
Country
Canada
Facility Name
The Urology Specialists.
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 1N8
Country
Canada
Facility Name
Imagerie medicale de la Capitale
City
Quebec
ZIP/Postal Code
G1H 6P3
Country
Canada
Facility Name
CHU de Quebec
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centre de rechereche clinique et evaluative en oncologie
City
Quebec
ZIP/Postal Code
G1R 3S3
Country
Canada
Facility Name
Hospital San Jose
City
Santiago
Country
Chile
Facility Name
Instituto Nacional del Cancer
City
Santiago
Country
Chile
Facility Name
Centro Investigacion Clinica del Sur
City
Temuco
Country
Chile
Facility Name
Instituto Oncologico
City
Vina del Mar
Country
Chile
Facility Name
Centre Paul Papin
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
Facility Name
Institut Bergonie
City
Bordeaux cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Regional Francois Baclesse de lutte contre le cancer
City
Caen Cedex
ZIP/Postal Code
14076
Country
France
Facility Name
Centre hospitalier de Cannes
City
Cannes Cedex
ZIP/Postal Code
B.P. 264 - 06401
Country
France
Facility Name
CHU Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Centre Hospitalier Intercommunal Frejus-Saint Raphael
City
Frejus Cedex
ZIP/Postal Code
BP110 - 83608
Country
France
Facility Name
Centre hospitalier departemental Vendee
City
LA Roche sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Clinique Victor Hugo - Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Leon Berard
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Groupement Hospitalier Edouard Herriot - Pavillon V
City
Lyon Cedex 3
ZIP/Postal Code
69003
Country
France
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
BP 156 - 13273
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Centre Hospitalier Lyon sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU La Miletrie
City
Poitiers Cedex
ZIP/Postal Code
86021
Country
France
Facility Name
Institut Jean Godinot
City
Reims Cedex
ZIP/Postal Code
51056
Country
France
Facility Name
Centre Hospitalier
City
Saint Etienne Cedex 2
ZIP/Postal Code
42030
Country
France
Facility Name
Institut de Cancerologie de la Loire
City
Saint Priest en Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
Centre d'Investigation Clinique, (CIE3)
City
Saint-Etienne CEDEX 2
ZIP/Postal Code
42055
Country
France
Facility Name
Centre Rene Gauducheau
City
SAINT-HERBLAIN Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
Hopital Foch
City
Suresnes Cedex
ZIP/Postal Code
92151
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitaetsklinikum Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Gemeinschaftspraxis Fuer Nuklearmedizin
City
Berlin
ZIP/Postal Code
D- 10439
Country
Germany
Facility Name
Radiologische Gemeinschaftspraxis
City
Berlin
ZIP/Postal Code
D- 13055
Country
Germany
Facility Name
FacharztzentrumInnere Medizin
City
Berlin
ZIP/Postal Code
D-13055
Country
Germany
Facility Name
Praxis Dr. Wolfgang Hoelzer
City
Berlin
ZIP/Postal Code
D-13055
Country
Germany
Facility Name
Staedtisches Klinikum Braunschweig gGmbH
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Technical University Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Martini-Klinik am UKE GmbH
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Roentgenpraxis
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Urologische Gemeinschaftspraxis Poppenbuettel
City
Hamburg
ZIP/Postal Code
22399
Country
Germany
Facility Name
Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
D-30625
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie
City
Muenster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Abt.f.Diagnostische u. Interventionelle Radiologie
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Klinik fuer Urologie
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Nuklearmedizin
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Azienda Ospedaliero-Universitaria di Modena Policlinico
City
Via Del Pozzo 71
State/Province
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
City
Orbassano
State/Province
TO
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
VU Medisch Centrum
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny
City
Lodz
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny im. M. Kopernika
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Wojewodzki szpital specjalistyczny im. Janusza Korczaka
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Hopelands Cancer Centre
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
GVI Oncology
City
Port Elizabeth
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Sandton Oncology Centre
City
Sandton
ZIP/Postal Code
2199
Country
South Africa
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Radiodiagnostic Cetir Clinica Pilar
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Madrid Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Clinica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Bishops Wood Hospital
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2JW
Country
United Kingdom
Facility Name
Mount Vernon Hospital
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
The Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Cancer Centre
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Bristol Haematology & Oncology Centre
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
University College Hospital
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Northern Centre for Cancer Care
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
The Manor Hospital Oxford
City
Oxford
ZIP/Postal Code
OX3 7RP
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35731340
Citation
Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.
Results Reference
derived
PubMed Identifier
35643841
Citation
Joshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.
Results Reference
derived
PubMed Identifier
34965947
Citation
Zhao JL, Fizazi K, Saad F, Chi KN, Taplin ME, Sternberg CN, Armstrong AJ, de Bono JS, Duggan WT, Scher HI. The Effect of Corticosteroids on Prostate Cancer Outcome Following Treatment with Enzalutamide: A Multivariate Analysis of the Phase III AFFIRM Trial. Clin Cancer Res. 2022 Mar 1;28(5):860-869. doi: 10.1158/1078-0432.CCR-21-1090.
Results Reference
derived
PubMed Identifier
34518652
Citation
Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):288-295. doi: 10.1038/s41391-021-00447-9. Epub 2021 Sep 13.
Results Reference
derived
PubMed Identifier
31830211
Citation
Armstrong AJ, Al-Adhami M, Lin P, Parli T, Sugg J, Steinberg J, Tombal B, Sternberg CN, de Bono J, Scher HI, Beer TM. Association Between New Unconfirmed Bone Lesions and Outcomes in Men With Metastatic Castration-Resistant Prostate Cancer Treated With Enzalutamide: Secondary Analysis of the PREVAIL and AFFIRM Randomized Clinical Trials. JAMA Oncol. 2020 Feb 1;6(2):217-225. doi: 10.1001/jamaoncol.2019.4636.
Results Reference
derived
PubMed Identifier
30126765
Citation
Poon DMC, Wong KCW, Chan TW, Law K, Chan K, Lee EKC, Lee C, Chan M; Hong Kong Society of Uro-Oncology (HKSUO). Survival Outcomes, Prostate-specific Antigen Response, and Tolerance in First and Later Lines of Enzalutamide Treatment for Metastatic Castration-resistant Prostate Cancer: A Real-World Experience in Hong Kong. Clin Genitourin Cancer. 2018 Oct;16(5):402-412.e1. doi: 10.1016/j.clgc.2018.07.008. Epub 2018 Jul 21. Erratum In: Clin Genitourin Cancer. 2019 Jun;17(3):240.
Results Reference
derived
PubMed Identifier
29272162
Citation
Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.
Results Reference
derived
PubMed Identifier
26278649
Citation
Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.
Results Reference
derived
PubMed Identifier
25917876
Citation
Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.
Results Reference
derived
PubMed Identifier
25361992
Citation
Cella D, Ivanescu C, Holmstrom S, Bui CN, Spalding J, Fizazi K. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial. Ann Oncol. 2015 Jan;26(1):179-185. doi: 10.1093/annonc/mdu510. Epub 2014 Oct 30.
Results Reference
derived
PubMed Identifier
25171902
Citation
Saad F, de Bono J, Shore N, Fizazi K, Loriot Y, Hirmand M, Franks B, Haas GP, Scher HI. Efficacy outcomes by baseline prostate-specific antigen quartile in the AFFIRM trial. Eur Urol. 2015 Feb;67(2):223-30. doi: 10.1016/j.eururo.2014.08.025. Epub 2014 Aug 27.
Results Reference
derived
PubMed Identifier
25123978
Citation
Merseburger AS, Scher HI, Bellmunt J, Miller K, Mulders PF, Stenzl A, Sternberg CN, Fizazi K, Hirmand M, Franks B, Haas GP, de Bono J, de Wit R. Enzalutamide in European and North American men participating in the AFFIRM trial. BJU Int. 2015 Jan;115(1):41-9. doi: 10.1111/bju.12898. Epub 2014 Oct 23.
Results Reference
derived
PubMed Identifier
25104109
Citation
Fizazi K, Scher HI, Miller K, Basch E, Sternberg CN, Cella D, Forer D, Hirmand M, de Bono JS. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol. 2014 Sep;15(10):1147-56. doi: 10.1016/S1470-2045(14)70303-1. Epub 2014 Aug 4. Erratum In: Lancet Oncol. 2014 Oct;15(11):e475.
Results Reference
derived
PubMed Identifier
22894553
Citation
Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs