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

Primary Purpose

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 Prostate Cancer focused on measuring Progressive Metastatic Prostate Cancer

Eligibility Criteria

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

Randomized, Double Blind Treatment Period:

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy
  • Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease
  • No prior treatment with cytotoxic chemotherapy
  • Asymptomatic or mildly symptomatic from prostate cancer

Exclusion Criteria:

  • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
  • Known or suspected brain metastasis or active leptomeningeal disease
  • History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer

Open-Label Treatment Period:

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

Eligible patients must meet all inclusion criteria.

  • Received randomized double-blind treatment in PREVAIL;
  • Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site;
  • Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy;

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

  • Has taken commercially available enzalutamide (Xtandi);
  • Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment
  • Known or suspected brain metastasis or active leptomeningeal disease

Sites / Locations

  • University of Alabama at Birmingham
  • University of Alabama at Birmingham
  • The University of Arizona Cancer Center-North Campus
  • The University of Arizona Cancer Certer-North Campus
  • Cancer Center Oncology Medical Group
  • Keck Hospital of USC
  • LAC&USC Medical Center
  • USC/Norris Comprehensive Cancer Center / Investigational Drug Services
  • USC/Norris Comprehensive Cancer Center
  • Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services
  • UCLA Clark Urology Clinic
  • North County Oncology Medical Clinic, Inc
  • UC Davis Medical Center
  • University of California Davis Comprehensive Cancer Center
  • Medical Oncology Associates-SD
  • Sharp Memorial Hospital Investigational Pharmacy
  • Sharp Rees-Stealy
  • Stanford University Medical Center
  • Anschutz Cancer Center Pavilion Pharmacy
  • University of Colorado Hospital, Anschutz Cancer Pavilion
  • Lynn Cancer Institute Center for Hematology Oncology
  • Northwestern Medical Faculty Foundation
  • Northwestern Memorial Hospital
  • Jewish Hospital & St. Mary's Healthcare, Inc.
  • Brigham & Women's Hospital
  • Beth Israel Deaoness Medical Center
  • Dana Farber Cancer Institute
  • Karmanos Cancer Institute
  • Karmanos Cancer Institute Weisberg Cancer Treatment Center
  • Mayo Clinic
  • Barnes-Jewish West County Hospital
  • BJH Pharmacy
  • Barnes-Jewish Hospital
  • Washington University School of Medicine
  • Barnes-Jewish St. Peters Hospital
  • Nebraska Methodist Hospital
  • The Mount Sinai Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • Cancer Centers of North Carolina
  • Levine Cancer Institute
  • Levine Cancer Institute - Main
  • Levine Cancer Institute - Southpark
  • Levine Cancer Institute - University
  • Levine Cancer Institute - Ballantyne
  • Duke University Medical Center
  • Investigational Chemotherapy Services
  • Cancer Centers of North Carolina
  • Portland VA Medical Center Laboratory
  • Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine
  • UPMC Presbyterian
  • UPMC Hillman Cancer Center
  • Hematology / Oncology MUSC Hollings Cancer Center
  • Medical University of South Carolina - Urology Services
  • MUSC Department of Radiology
  • MUSC Urology Ambulatory Care
  • MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor
  • MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor
  • UT Southwestern Medical Center at Dallas
  • Virginia Oncology Associates
  • Virginia Oncology Associates
  • Virginia Oncology Associates
  • Virginia Oncology Associates
  • Seattle Cancer Care Alliance
  • University of Washington Medical Center
  • University of Wisconsin Hospital and Clinics
  • Concord Repatriation General Hospital
  • St George Private Hospital
  • Lismore Base Hospital, Lismore Cancer Care and Haematology Unit
  • Liverpool Hospital
  • North Coast Cancer Institute
  • Prince of Wales Hospital
  • Royal North Shore Hospital, Department of Medical Oncology
  • Sydney Adventist Hospital
  • Australian Clinical Trials Pty Ltd
  • SAN Pathology
  • SAN Radiology
  • Calvary Mater Newcastle
  • Westmead Hospital
  • Heart Care Partners
  • Icon Cancer Care Wesley
  • River City Pharmacy
  • Icon Cancer Care Chermside
  • University of Queensland Centre for Clinical Research (UQCCR)
  • Nuclear Medicine and Imaging Department
  • Icon Cancer Care South Brisbane
  • Icon Cancer Foundation
  • Mater Private Cardiology
  • Adelaide Cancer Centre
  • APHS Pharmacy
  • Ashford Cancer Centre Research
  • Cancer Care SA Pty Ltd
  • Bendigo Health, Bendigo Hospital
  • Bendigo Health Medical Imaging
  • Eastern Health
  • MIA Box Hill Radiology
  • Oncology Eastern Clinical Research Unit (ECRU)
  • Pharmacy Department
  • Cabrini Hospital Brighton
  • Monash Health Translation Precinct
  • Peter MacCallum Cancer Centre
  • Barwon Health, Geelong Hospital
  • Austin Hospital
  • Cabrini Hospital Malvern
  • Cabrini Radiology
  • MDI Chemer
  • Peter MacCallum Cancer Centre
  • Sunshine Hospital
  • Krankenhaus der Barmherzigen Schwestern Linz
  • Ordination Dr. Fink
  • Salzburger Universitatsklinikum
  • Medizinische Universitaet Wien
  • Cliniques Universitaires Saint-Luc
  • AZ Sint-Lucas
  • Jessaziekenhuis
  • AZ Groeninge, Campus KL
  • UZ Leuven - University Hospital Gasthuisberg
  • Centre Hospitalier Universitaire de Liege-Urologie
  • Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
  • Tom Baker Cancer Centre - Holy Cross Site
  • Cross Cancer Institute
  • British Columbia Cancer Agency, Sindi Ahluwalia Hawkins, Centre for the Southern Interior
  • Vancouver Prostate Centre
  • Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging
  • British Columbia Cancer Agency - Vancouver Island Centre
  • Manitoba Prostate Centre
  • QEII Health Sciences Centre, Nova Scotia Cancer Centre.
  • QEII Health Sciences Centre
  • QEII Health Sciences Centre
  • Juravinski Cancer Centre at Hamilton Health Sciences
  • London RegCancer Program, London Health Sciences Centre
  • The Ottawa Hospital Cancer Centre, General Campus
  • The Ottawa Hospital Cancer Centre
  • Sunnybrook Health Sciences Centre
  • Princess Margaret Cancer Centre
  • Centre Hospitalier de l'Universite de Montreal
  • CHU de Quebec - L'Hotel-Dieu de Quebec
  • Centre de recherche clinique el evaluative en oncologie (CRCEO)
  • Aalborg Hospital Nord
  • Aarhus Universitetshospital
  • Rigshospitalet
  • Frederiksberg Hospital
  • Herlev Hospital
  • Roskilde Sygehus
  • Docrates Clinic
  • Helsinki University Central Hospital
  • Oulu University Hospital
  • Tampere University Hospital
  • Hopital Civil
  • Centre Eugene Marquis-Service d'Oncologie Medicale
  • Institut Bergonie
  • ICO Paul Papin
  • Clinique Rhone Durance
  • Institut Bergonie
  • CHD Vendee
  • Centre Jean Bernard - Clinique Victor Hugo
  • Centre Leon Berard
  • Hopital Europeen Georges Pompidou
  • Institut Curie
  • Groupe Hospitalier La Pitie Salpetriere
  • Centre de Recherche Clinique
  • HIA Begin, Service de Medecine Interne et Oncologie
  • Institut de Cancerologie Lucien Neuwirth
  • Clinique Pasteur
  • Institut Gustave Roussy
  • Medizinische Hochschule Hannover
  • Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
  • Staedtisches Klinikum Braunschweig gGmbH
  • Universitaetsklinikum Carl Gustav Carus Dresden an der
  • Martini-Klinik am UKE Gmbh
  • Urologikum Hamburg
  • Universitaetsklinikum Heidelberg, Klinik Fuer Urologie
  • Universitaetsklinikum des Saarlandes
  • Universitaetsklinikum Mannheim, Klinik fuer Urologie
  • Universitaetsklinikum Muenster
  • Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie
  • Universitaetsklinikum Ulm
  • Kliniken Nordoberpfalz AG, Klinikum Weiden
  • Soroka University Medical Center
  • Assaf Harofe Medical Center
  • Bnai Zion Medical Center
  • Rabin Medical Center
  • The Chaim Sheba Medical Center
  • Azienda Socio Sanitaria Territoriale di Cremona
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga
  • Azienda USL8-Presidio Ospedaliero S.Donato
  • Ospedale G.B. Morgagni
  • Azienda Ospedaliera San. Camillo Forlanini
  • Kyushu University Hospital
  • Yokohama City University Hospital
  • Tohoku University Hospital
  • Nagasaki University Hospital
  • Kindai University Hospital
  • Osaka International Cancer Institute
  • Osaka University Hospital
  • Tokushima University Hospital
  • Nippon Medical School Hospital
  • Nihon University Itabashi Hospital
  • Cancer Institute Hospital
  • Kyorin University Hospital
  • Showa University Hospital
  • Keio University Hospital
  • Yamaguchi University Hospital
  • Chiba Cancer Center
  • Kyoto University Hospital
  • Niigata University Medical and Dental Hospital
  • Osaka City University Hospital
  • Jikei University Hospital
  • Yamagata Prefectural Central Hospital
  • National Cancer Center
  • Seoul National University Bundang Hospital
  • Chonnam National University Hwasun Hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Severance Hospital, Yonsei University Health System
  • Gangnam Severance Hospital, Yonsei University Health System
  • Klaipeda University Hospital
  • Division of Oncourology, National Cancer Institute
  • Vrije Universiteit Medical Center, Department of Medical Oncology
  • Catharina Ziekenhuis
  • University Medical Center Groningen, Department of Urology
  • UMC St. Radboud
  • EMC Instytut Medyczny S.A.
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi
  • Apteka Szpitalna
  • Uniwersyteckie Centrum Kliniczne
  • Niepubliczny Zaklad Opieki Zdrowotnej
  • Wielkopolskie Centrum Onkologii
  • Russian Academy of Medical Sciences Institution
  • State Educational Institution of Higher Professional Education
  • State healthcare institute
  • North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare
  • Department of Urology, National University Hospital
  • Singapore General Hospital
  • Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica
  • CUIMED s.r.o.
  • Univerzitna Nemocnica Martin
  • UROEXAM, spol. s r.o. urologicka ambulancia
  • Poliklinika Sekcov, wesper, s.r.o.
  • UROCENTRUM MILAB s.r.o.
  • Hospital Universitario German Trias i Pujol
  • Althaia Xarxa Asistencial Manresa
  • Hospital Son Espases
  • Clínica Universidad de Navarra
  • Complejo Hospitalario Universitario A Coruna
  • Hospital del Mar
  • Hospital Vall d'Hebron
  • Hospital Clinic i Provincial
  • Hospital Universitario Ramon y Cajal
  • Hospital Madrid Norte Sanchinarro
  • Corporacio Sanitaria Parc Tauli
  • Sahlgrenska University Hospital
  • Skane University Hospital
  • Orebro University Hospital
  • Karolinska University Hospital Solna
  • Umea University Hospital
  • Bishops Wood Hospital
  • Mount Vernon Hospital
  • Oxford University Hospitals NHS Trust
  • Royal Marsden Hospital
  • Northern Centre for Cancer Care
  • Velindre Cancer Centre
  • Clatterbridge Cancer Centre NHS Foundation Trust
  • Clinical Investigations and Research Unit, Royal Sussex County Hospital
  • University Hospitals Bristol NHS Foundation Trust
  • Edinburgh Cancer Centre
  • University College London Hospital NHS Trust
  • Guy's and St Thomas' NHS Foundation Trust
  • Imperial College Healthcare NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Enzalutamide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Overall Survival
Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.
Radiographic Progression-free Survival (rPFS)
Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.

Secondary Outcome Measures

Time to First Skeletal-related Event
Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.
Time to Initiation of Cytotoxic Chemotherapy
The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.
Time to Prostate-specific Antigen (PSA) Progression
Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.
Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%
PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.
Best Overall Soft Tissue Response
The best overall soft tissue objective response is defined as partial response [PR] or complete response [CR] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.

Full Information

First Posted
September 29, 2010
Last Updated
March 12, 2020
Sponsor
Pfizer
Collaborators
Astellas Pharma Inc, Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01212991
Brief Title
A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
Acronym
PREVAIL
Official Title
PREVAIL: A MULTINATIONAL PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED EFFICACY AND SAFETY STUDY OF ORAL MDV3100 IN CHEMOTHERAPY-NAÏVE PATIENTS WITH PROGRESSIVE METASTATIC PROSTATE CANCER WHO HAVE FAILED ANDROGEN DEPRIVATION THERAPY
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 16, 2010 (Actual)
Primary Completion Date
September 30, 2013 (Actual)
Study Completion Date
February 14, 2019 (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
The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Progressive Metastatic Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1717 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enzalutamide
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Intervention Description
Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants received placebo, administered as four capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.
Primary Outcome Measure Information:
Title
Overall Survival
Description
Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.
Time Frame
During study period (up to 3 years)
Title
Radiographic Progression-free Survival (rPFS)
Description
Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.
Time Frame
During study period (up to 20 months)
Secondary Outcome Measure Information:
Title
Time to First Skeletal-related Event
Description
Time to first skeletal-related event was defined as the time from randomization to the date of the first occurrence of a skeletal-related event for each patient. A skeletal-related event was defined as radiation therapy or surgery to bone for prostate cancer, pathological bone fracture, spinal cord compression, or initiation/change in antineoplastic therapy to treat bone pain from prostate cancer. Skeletal-related events were recorded at each scheduled and unscheduled study visit and during long-term follow-up if a skeletal-related event was not documented previously. Patients who did not have a skeletal-related event at the time of the analysis data cutoff were censored at the date of last assessment indicating no evidence of skeletal-related event. Patients with no postbaseline assessments were censored on the date of randomization.
Time Frame
During study period (up to 3 years)
Title
Time to Initiation of Cytotoxic Chemotherapy
Description
The time to initiation of cytotoxic chemotherapy is defined as the time from randomization to the date of initiation of cytotoxic chemotherapy for the treatment of prostate cancer for each patient. For patients who did not start cytotoxic chemotherapy at the time of the analysis data cutoff, time to initiation of cytotoxic chemotherapy was censored at the date of last assessment where no cytotoxic chemotherapy was indicated or at the analysis data cutoff date, whichever was first. Time to initiation of cytotoxic chemotherapy for patients with no postbaseline assessments was censored on the date of randomization.
Time Frame
During study period (up to 3 years)
Title
Time to Prostate-specific Antigen (PSA) Progression
Description
Time to PSA progression was defined as the time from randomization to date of first confirmed observation of PSA progression for each patient. For patients with PSA declines at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, and confirmed 3 or more weeks later. For patients with no PSA decline at week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above baseline was documented, and confirmed 3 or more weeks later. For patients who did not have confirmed PSA progression at the time of the analysis data cutoff, time to PSA progression was censored at the date of the last PSA assessment showing no evidence of confirmed PSA progression or the analysis data cutoff date, whichever was first. Time to PSA progression for patients with no postbaseline assessments was censored on the date of randomization.
Time Frame
During study period (up to 3 years)
Title
Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%
Description
PSA response was defined as a ≥ 50% reduction in PSA from baseline to the lowest postbaseline PSA value and required confirmation by a consecutive assessment at least 3 weeks later. Patients were evaluable for PSA response rate if a patient had a PSA level measured at baseline and at least one postbaseline assessment.
Time Frame
During study period (up to 3 years)
Title
Best Overall Soft Tissue Response
Description
The best overall soft tissue objective response is defined as partial response [PR] or complete response [CR] while on study treatment based on investigator assessments of target, nontarget, and new lesions using RECIST 1.1. Soft tissue was assessed by CT or MRI at regularly scheduled visits. Only patients with measurable soft tissue disease (ie, at least 1 target lesion identified per RECIST 1.1) at screening are included in this analysis. All percentages are based on number of participants with measurable soft tissue disease at screening in each treatment group.
Time Frame
During study period (up to 3 years)
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum of 6.5 years that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.
Time Frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) Greater Than or Equal to (>=) Grade 3, Based on National Cancer Institute Common Terminology Criteria for AEs (CTCAE), Version 4.0
Description
An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. As per NCI CTCAE, Grade 3 events =medically significant but not immediately life-threatening, unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment, Grade 4 events =participant to be in imminent danger of death. Grade 5 events =death. A treatment-emergent AE (TEAE) was defined as an AE that occurred from the date and time of the first dose of study drug up to a maximum duration of 6.5 years. Number of participants with AEs of any of the Grade 3 or above (Grade 4, 5) were reported.
Time Frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Title
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to a maximum duration of 6.5 years that were absent before treatment or that worsened relative to pre-treatment state. Relatedness to study drug was assessed by the investigator.
Time Frame
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Randomized, Double Blind Treatment Period: Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy Progressive disease despite androgen deprivation therapy as defined by rising PSA levels or progressive soft tissue or bony disease No prior treatment with cytotoxic chemotherapy Asymptomatic or mildly symptomatic from prostate cancer Exclusion Criteria: Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment Known or suspected brain metastasis or active leptomeningeal disease History of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer Open-Label Treatment Period: The following inclusion criteria apply to patients receiving enzalutamide or placebo during double-blind treatment. Eligible patients must meet all inclusion criteria. Received randomized double-blind treatment in PREVAIL; Open-label day 1 visit is within 6 months after this amendment is approved and becomes effective at the study site; Is willing to maintain androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) agonist/antagonist or has had a bilateral orchiectomy; The exclusion criteria apply only to patients starting new treatment with enzalutamide after receiving placebo as randomized treatment. Each patient must not meet any of the following criteria: Has taken commercially available enzalutamide (Xtandi); Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment Known or suspected brain metastasis or active leptomeningeal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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
35249
Country
United States
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
The University of Arizona Cancer Center-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
The University of Arizona Cancer Certer-North Campus
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
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
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
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 / Investigational Drug Services
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 Drug Information Center Department of Pharmaceutical Services
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCLA Clark Urology Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
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
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
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
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Anschutz Cancer Center Pavilion Pharmacy
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital, Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Lynn Cancer Institute Center for Hematology Oncology
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Jewish Hospital & St. Mary's Healthcare, Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40245
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaoness 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
Karmanos Cancer Institute 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
Barnes-Jewish West County Hospital
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
BJH Pharmacy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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
Barnes-Jewish St. Peters Hospital
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Facility Name
Nebraska Methodist Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
The Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
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
Cancer Centers of North Carolina
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Levine Cancer Institute - Main
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Levine Cancer Institute - Southpark
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Levine Cancer Institute - University
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28262
Country
United States
Facility Name
Levine Cancer Institute - Ballantyne
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Investigational Chemotherapy Services
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cancer Centers of North Carolina
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Portland VA Medical Center Laboratory
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Hematology / Oncology MUSC Hollings Cancer Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina - Urology Services
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC Department of Radiology
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC Urology Ambulatory Care
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
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
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
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 Oncology Associates
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23456
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
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
St George Private Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Lismore Base Hospital, Lismore Cancer Care and Haematology Unit
City
Lismore
State/Province
New South Wales
ZIP/Postal Code
2480
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
North Coast Cancer Institute
City
Port Macquarie
State/Province
New South Wales
ZIP/Postal Code
2444
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Royal North Shore Hospital, Department of Medical Oncology
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Sydney Adventist Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Australian Clinical Trials Pty Ltd
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
SAN Pathology
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
SAN Radiology
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
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
River City Pharmacy
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
University of Queensland Centre for Clinical Research (UQCCR)
City
Herston
State/Province
Queensland
ZIP/Postal Code
4006
Country
Australia
Facility Name
Nuclear Medicine and Imaging Department
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Icon Cancer Care South Brisbane
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Icon Cancer Foundation
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
Adelaide Cancer Centre
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
APHS Pharmacy
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Ashford Cancer Centre Research
City
Kurralta park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Cancer Care SA Pty Ltd
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Bendigo Health, Bendigo Hospital
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3550
Country
Australia
Facility Name
Bendigo Health Medical Imaging
City
Bendigo
State/Province
Victoria
ZIP/Postal Code
3552
Country
Australia
Facility Name
Eastern Health
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
MIA Box Hill Radiology
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Oncology Eastern Clinical Research Unit (ECRU)
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Pharmacy Department
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Cabrini Hospital Brighton
City
Brighton
State/Province
Victoria
ZIP/Postal Code
3186
Country
Australia
Facility Name
Monash Health Translation Precinct
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Barwon Health, Geelong Hospital
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Cabrini Hospital Malvern
City
Malvern,
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Cabrini Radiology
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
MDI Chemer
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Sunshine Hospital
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Krankenhaus der Barmherzigen Schwestern Linz
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Ordination Dr. Fink
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Salzburger Universitatsklinikum
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universitaet Wien
City
Wien
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
Jessaziekenhuis
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
AZ Groeninge, Campus KL
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
UZ Leuven - University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Universitaire de Liege-Urologie
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Alberta Health Services - Cancer Care, 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, Sindi Ahluwalia Hawkins, Centre for the Southern Interior
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
Vancouver Prostate Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 1J8
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
Manitoba Prostate Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
QEII Health Sciences Centre, Nova Scotia Cancer 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 at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
London RegCancer Program, London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre, General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
The Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2H 8P4
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Princess Margaret Cancer Centre
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
H2L 4M1
Country
Canada
Facility Name
CHU de Quebec - L'Hotel-Dieu de Quebec
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Facility Name
Centre de recherche clinique el evaluative en oncologie (CRCEO)
City
Quebec
ZIP/Postal Code
G1R 3S1
Country
Canada
Facility Name
Aalborg Hospital Nord
City
Aalborg
ZIP/Postal Code
9100
Country
Denmark
Facility Name
Aarhus Universitetshospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Facility Name
Frederiksberg Hospital
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Roskilde Sygehus
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Docrates Clinic
City
Helsinki
ZIP/Postal Code
00180
Country
Finland
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Hopital Civil
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
FR-67901
Country
France
Facility Name
Centre Eugene Marquis-Service d'Oncologie Medicale
City
Rennes cedex
State/Province
Bretagne
ZIP/Postal Code
35042
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
State/Province
Nouvelle Aquitaine
ZIP/Postal Code
FR-33076
Country
France
Facility Name
ICO Paul Papin
City
Angers
ZIP/Postal Code
49055
Country
France
Facility Name
Clinique Rhone Durance
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
FR-33076
Country
France
Facility Name
CHD Vendee
City
La Roche sur Yon Cedex
ZIP/Postal Code
85925
Country
France
Facility Name
Centre Jean Bernard - Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008 Cedex 08
Country
France
Facility Name
Hopital Europeen Georges Pompidou
City
Paris Cedex 15
ZIP/Postal Code
75908
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Groupe Hospitalier La Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Centre de Recherche Clinique
City
Saint Herblain Cedex
ZIP/Postal Code
44805
Country
France
Facility Name
HIA Begin, Service de Medecine Interne et Oncologie
City
Saint-Mande
ZIP/Postal Code
FR-94160
Country
France
Facility Name
Institut de Cancerologie Lucien Neuwirth
City
Saint-Priest en Jarez
ZIP/Postal Code
42271
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Medizinische Hochschule Hannover
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Staedtisches Klinikum Braunschweig gGmbH
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Universitaetsklinikum Carl Gustav Carus Dresden an der
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
Urologikum Hamburg
City
Hamburg
ZIP/Postal Code
22399
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg, Klinik Fuer Urologie
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg/Saar
ZIP/Postal Code
66424
Country
Germany
Facility Name
Universitaetsklinikum Mannheim, Klinik fuer Urologie
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Kliniken Nordoberpfalz AG, Klinikum Weiden
City
Weiden In Der Oberpfalz
ZIP/Postal Code
92637
Country
Germany
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Assaf Harofe Medical Center
City
Beer Yaakov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
The Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Azienda Socio Sanitaria Territoriale di Cremona
City
Cremona
State/Province
CR
ZIP/Postal Code
26100
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
City
Orbassano
State/Province
TO
ZIP/Postal Code
10043
Country
Italy
Facility Name
Azienda USL8-Presidio Ospedaliero S.Donato
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Ospedale G.B. Morgagni
City
Forli
ZIP/Postal Code
47100
Country
Italy
Facility Name
Azienda Ospedaliera San. Camillo Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Kyushu University Hospital
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8128582
Country
Japan
Facility Name
Yokohama City University Hospital
City
Yokohama-shi
State/Province
Kanagawa-ken
ZIP/Postal Code
2360004
Country
Japan
Facility Name
Tohoku University Hospital
City
Sendai-Shi
State/Province
Miyagi
ZIP/Postal Code
9800872
Country
Japan
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
8528501
Country
Japan
Facility Name
Kindai University Hospital
City
Osaka-sayama
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Osaka International Cancer Institute
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
5418567
Country
Japan
Facility Name
Osaka University Hospital
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
5650871
Country
Japan
Facility Name
Tokushima University Hospital
City
Tokushima-shi
State/Province
Tokushima
ZIP/Postal Code
7708503
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138603
Country
Japan
Facility Name
Nihon University Itabashi Hospital
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
1738610
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koutou-ku
State/Province
Tokyo
ZIP/Postal Code
1358550
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181 8611
Country
Japan
Facility Name
Showa University Hospital
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
1428666
Country
Japan
Facility Name
Keio University Hospital
City
Shinjyuku-ku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Facility Name
Yamaguchi University Hospital
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
7558505
Country
Japan
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
2608717
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
6068507
Country
Japan
Facility Name
Niigata University Medical and Dental Hospital
City
Niigata
ZIP/Postal Code
9518520
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
5450051
Country
Japan
Facility Name
Jikei University Hospital
City
Tokyo
ZIP/Postal Code
1058471
Country
Japan
Facility Name
Yamagata Prefectural Central Hospital
City
Yamagata
ZIP/Postal Code
9902292
Country
Japan
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi-do
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun-eup, Hwasun-gun
State/Province
Jeonnam
ZIP/Postal Code
619763
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Gangnam-gu
State/Province
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Songpa-gu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of
Facility Name
Klaipeda University Hospital
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Division of Oncourology, National Cancer Institute
City
Vilnius
ZIP/Postal Code
08660
Country
Lithuania
Facility Name
Vrije Universiteit Medical Center, Department of Medical Oncology
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Catharina Ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
University Medical Center Groningen, Department of Urology
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
UMC St. Radboud
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
EMC Instytut Medyczny S.A.
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
54-144
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
93-509
Country
Poland
Facility Name
Apteka Szpitalna
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-214
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej
City
Myslowice
State/Province
Slaskie
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Wielkopolskie Centrum Onkologii
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Russian Academy of Medical Sciences Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education
City
St-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
State healthcare institute
City
St-Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare
City
St.-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Department of Urology, National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Facility Name
CUIMED s.r.o.
City
Bratislava
ZIP/Postal Code
851 05
Country
Slovakia
Facility Name
Univerzitna Nemocnica Martin
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
UROEXAM, spol. s r.o. urologicka ambulancia
City
Nitra
ZIP/Postal Code
949 01
Country
Slovakia
Facility Name
Poliklinika Sekcov, wesper, s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
UROCENTRUM MILAB s.r.o.
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Hospital Universitario German Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Althaia Xarxa Asistencial Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Facility Name
Hospital Son Espases
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07010
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruna
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Madrid Norte Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell(Barcelona)
ZIP/Postal Code
08208
Country
Spain
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
Skane University Hospital
City
Malmo
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Orebro University Hospital
City
Orebro
ZIP/Postal Code
se-701 85
Country
Sweden
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
SE-171 76
Country
Sweden
Facility Name
Umea University Hospital
City
Umea
ZIP/Postal Code
SE-901 85
Country
Sweden
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
Oxford University Hospitals NHS Trust
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Northern Centre for Cancer Care
City
Newcastle Upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Velindre Cancer Centre
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Clatterbridge Cancer Centre NHS Foundation Trust
City
Bebington
State/Province
Wirral, Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Clinical Investigations and Research Unit, Royal Sussex County Hospital
City
Brighton, East Sussex
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8ED
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
University College London Hospital NHS Trust
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
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PubMed Identifier
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PubMed Identifier
35643841
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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.
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PubMed Identifier
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PubMed Identifier
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Citation
Armstrong AJ, Lin P, Tombal B, Saad F, Higano CS, Joshua AM, Parli T, Rosbrook B, van Os S, Beer TM. Five-year Survival Prediction and Safety Outcomes with Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer from the PREVAIL Trial. Eur Urol. 2020 Sep;78(3):347-357. doi: 10.1016/j.eururo.2020.04.061. Epub 2020 Jun 9.
Results Reference
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PubMed Identifier
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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
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PubMed Identifier
31274110
Citation
Armstrong AJ, Lin P, Higano CS, Iversen P, Sternberg CN, Tombal B, Phung D, Parli T, Krivoshik A, Beer TM. Prognostic Association of Prostate-specific Antigen Decline with Clinical Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Treated with Enzalutamide in a Randomized Clinical Trial. Eur Urol Oncol. 2019 Nov;2(6):677-684. doi: 10.1016/j.euo.2018.11.005. Epub 2018 Dec 3.
Results Reference
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PubMed Identifier
30202945
Citation
Armstrong AJ, Lin P, Higano CS, Sternberg CN, Sonpavde G, Tombal B, Templeton AJ, Fizazi K, Phung D, Wong EK, Krivoshik A, Beer TM. Development and validation of a prognostic model for overall survival in chemotherapy-naive men with metastatic castration-resistant prostate cancer. Ann Oncol. 2018 Nov 1;29(11):2200-2207. doi: 10.1093/annonc/mdy406.
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PubMed Identifier
29522174
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Rathkopf DE, Beer TM, Loriot Y, Higano CS, Armstrong AJ, Sternberg CN, de Bono JS, Tombal B, Parli T, Bhattacharya S, Phung D, Krivoshik A, Scher HI, Morris MJ. Radiographic Progression-Free Survival as a Clinically Meaningful End Point in Metastatic Castration-Resistant Prostate Cancer: The PREVAIL Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):694-701. doi: 10.1001/jamaoncol.2017.5808.
Results Reference
derived
PubMed Identifier
28682871
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Results Reference
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PubMed Identifier
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PubMed Identifier
28117385
Citation
Bryce AH, Alumkal JJ, Armstrong A, Higano CS, Iversen P, Sternberg CN, Rathkopf D, Loriot Y, de Bono J, Tombal B, Abhyankar S, Lin P, Krivoshik A, Phung D, Beer TM. Radiographic progression with nonrising PSA in metastatic castration-resistant prostate cancer: post hoc analysis of PREVAIL. Prostate Cancer Prostatic Dis. 2017 Jun;20(2):221-227. doi: 10.1038/pcan.2016.71. Epub 2017 Jan 24.
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PubMed Identifier
27477525
Citation
Beer TM, Armstrong AJ, Rathkopf D, Loriot Y, Sternberg CN, Higano CS, Iversen P, Evans CP, Kim CS, Kimura G, Miller K, Saad F, Bjartell AS, Borre M, Mulders P, Tammela TL, Parli T, Sari S, van Os S, Theeuwes A, Tombal B. Enzalutamide in Men with Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer: Extended Analysis of the Phase 3 PREVAIL Study. Eur Urol. 2017 Feb;71(2):151-154. doi: 10.1016/j.eururo.2016.07.032. Epub 2016 Jul 28.
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PubMed Identifier
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PubMed Identifier
26578735
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Learn more about this trial

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

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