A Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer
PREVAIL
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
3 other identifiers
interventional
1,717
21 countries
265
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Sep 2010
Typical duration for phase_3 prostate-cancer
265 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2010
CompletedFirst Submitted
Initial submission to the registry
September 29, 2010
CompletedFirst Posted
Study publicly available on registry
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2013
CompletedResults Posted
Study results publicly available
October 16, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2019
CompletedMarch 17, 2020
March 1, 2020
3 years
September 29, 2010
October 8, 2014
March 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival
Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization.
During study period (up to 3 years)
Radiographic Progression-free Survival (rPFS)
Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment.
During study period (up to 20 months)
Secondary Outcomes (5)
Time to First Skeletal-related Event
During study period (up to 3 years)
Time to Initiation of Cytotoxic Chemotherapy
During study period (up to 3 years)
Time to Prostate-specific Antigen (PSA) Progression
During study period (up to 3 years)
Percentage of Patients With Prostate Specific Antigen (PSA) Response ≥ 50%
During study period (up to 3 years)
Best Overall Soft Tissue Response
During study period (up to 3 years)
Other Outcomes (3)
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
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
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline to discontinuation from the study or death, whichever occurred first (maximum duration of 6.5 years)
Study Arms (2)
Enzalutamide
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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;
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Astellas Pharma Inccollaborator
- Medivation LLC, a wholly owned subsidiary of Pfizer Inc.collaborator
Study Sites (269)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
The University of Arizona Cancer Center-North Campus
Tucson, Arizona, 85719, United States
The University of Arizona Cancer Certer-North Campus
Tucson, Arizona, 85719, United States
Cancer Center Oncology Medical Group
La Mesa, California, 91942, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
LAC&USC Medical Center
Los Angeles, California, 90033, United States
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
Los Angeles, California, 90033, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Ronald Reagan UCLA Medical Center Drug Information Center Department of Pharmaceutical Services
Los Angeles, California, 90095, United States
UCLA Clark Urology Clinic
Los Angeles, California, 90095, United States
North County Oncology Medical Clinic, Inc
Oceanside, California, 92056, United States
UC Davis Medical Center
Sacramento, California, 95817, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Medical Oncology Associates-SD
San Diego, California, 92123, United States
Sharp Memorial Hospital Investigational Pharmacy
San Diego, California, 92123, United States
Sharp Rees-Stealy
San Diego, California, 92123, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Anschutz Cancer Center Pavilion Pharmacy
Aurora, Colorado, 80045, United States
University of Colorado Hospital, Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Lynn Cancer Institute Center for Hematology Oncology
Boca Raton, Florida, 33486, United States
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Jewish Hospital & St. Mary's Healthcare, Inc.
Louisville, Kentucky, 40245, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaoness Medical Center
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Barnes-Jewish St. Peters Hospital
City of Saint Peters, Missouri, 63376, United States
Barnes-Jewish West County Hospital
Creve Coeur, Missouri, 63141, United States
BJH Pharmacy
St Louis, Missouri, 63108, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
The Mount Sinai Medical Center
New York, New York, 10029, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Cancer Centers of North Carolina
Cary, North Carolina, 27518, United States
Levine Cancer Institute
Charlotte, North Carolina, 28203, United States
Levine Cancer Institute - Main
Charlotte, North Carolina, 28204, United States
Levine Cancer Institute - Southpark
Charlotte, North Carolina, 28211, United States
Levine Cancer Institute - University
Charlotte, North Carolina, 28262, United States
Levine Cancer Institute - Ballantyne
Charlotte, North Carolina, 28277, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Investigational Chemotherapy Services
Durham, North Carolina, 27710, United States
Cancer Centers of North Carolina
Raleigh, North Carolina, 27607, United States
Portland VA Medical Center Laboratory
Portland, Oregon, 97239, United States
Abramson Cancer Center of the University of Pennsylvania at Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Hematology / Oncology MUSC Hollings Cancer Center
Charleston, South Carolina, 29425, United States
Medical University of South Carolina - Urology Services
Charleston, South Carolina, 29425, United States
MUSC Department of Radiology
Charleston, South Carolina, 29425, United States
MUSC Urology Ambulatory Care
Charleston, South Carolina, 29425, United States
MUSC Hematology / Oncology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor
Mt. Pleasant, South Carolina, 29464, United States
MUSC Urology Medical Specialty Associates, East Cooper Medical Arts Center 3rd Floor
Mt. Pleasant, South Carolina, 29464, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
Virginia Oncology Associates
Hampton, Virginia, 23666, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Oncology Associates
Virginia Beach, Virginia, 23456, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
St George Private Hospital
Kogarah, New South Wales, 2217, Australia
Lismore Base Hospital, Lismore Cancer Care and Haematology Unit
Lismore, New South Wales, 2480, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
North Coast Cancer Institute
Port Macquarie, New South Wales, 2444, Australia
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Royal North Shore Hospital, Department of Medical Oncology
St Leonards, New South Wales, 2065, Australia
Sydney Adventist Hospital
Sydney, New South Wales, 2076, Australia
Australian Clinical Trials Pty Ltd
Wahroonga, New South Wales, 2076, Australia
SAN Pathology
Wahroonga, New South Wales, 2076, Australia
SAN Radiology
Wahroonga, New South Wales, 2076, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Heart Care Partners
Auchenflower, Queensland, 4066, Australia
Icon Cancer Care Wesley
Auchenflower, Queensland, 4066, Australia
River City Pharmacy
Auchenflower, Queensland, 4066, Australia
Icon Cancer Care Chermside
Chermside, Queensland, 4032, Australia
University of Queensland Centre for Clinical Research (UQCCR)
Herston, Queensland, 4006, Australia
Nuclear Medicine and Imaging Department
Herston, Queensland, 4029, Australia
Icon Cancer Care South Brisbane
South Brisbane, Queensland, 4101, Australia
Icon Cancer Foundation
South Brisbane, Queensland, 4101, Australia
Mater Private Cardiology
South Brisbane, Queensland, 4101, Australia
Adelaide Cancer Centre
Kurralta Park, South Australia, 5037, Australia
APHS Pharmacy
Kurralta Park, South Australia, 5037, Australia
Ashford Cancer Centre Research
Kurralta Park, South Australia, 5037, Australia
Cancer Care SA Pty Ltd
Kurralta Park, South Australia, 5037, Australia
Bendigo Health, Bendigo Hospital
Bendigo, Victoria, 3550, Australia
Bendigo Health Medical Imaging
Bendigo, Victoria, 3552, Australia
Eastern Health
Box Hill, Victoria, 3128, Australia
MIA Box Hill Radiology
Box Hill, Victoria, 3128, Australia
Oncology Eastern Clinical Research Unit (ECRU)
Box Hill, Victoria, 3128, Australia
Pharmacy Department
Box Hill, Victoria, 3128, Australia
Cabrini Hospital Brighton
Brighton, Victoria, 3186, Australia
Monash Health Translation Precinct
Clayton, Victoria, 3168, Australia
Peter MacCallum Cancer Centre
East Melbourne, Victoria, 3002, Australia
Barwon Health, Geelong Hospital
Geelong, Victoria, 3220, Australia
Austin Hospital
Heidelberg, Victoria, 3084, Australia
Cabrini Hospital Malvern
Malvern, Victoria, 3144, Australia
Cabrini Radiology
Malvern, Victoria, 3144, Australia
MDI Chemer
Malvern, Victoria, 3144, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Sunshine Hospital
St Albans, Victoria, 3021, Australia
Krankenhaus der Barmherzigen Schwestern Linz
Linz, 4010, Austria
Ordination Dr. Fink
Salzburg, 5020, Austria
Salzburger Universitatsklinikum
Salzburg, 5020, Austria
Medizinische Universitaet Wien
Vienna, 1090, Austria
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
AZ Sint-Lucas
Ghent, 9000, Belgium
Jessaziekenhuis
Hasselt, 3500, Belgium
AZ Groeninge, Campus KL
Kortrijk, 8500, Belgium
UZ Leuven - University Hospital Gasthuisberg
Leuven, 3000, Belgium
Centre Hospitalier Universitaire de Liege-Urologie
Liège, 4000, Belgium
Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
Tom Baker Cancer Centre - Holy Cross Site
Calgary, Alberta, T2S 3C3, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
British Columbia Cancer Agency, Sindi Ahluwalia Hawkins, Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3, Canada
Vancouver Prostate Centre
Vancouver, British Columbia, V5Z 1M9, Canada
Vancouver Island Health Authority-Royal Jubilee Hospital Medical Imaging
Victoria, British Columbia, V8R 1J8, Canada
British Columbia Cancer Agency - Vancouver Island Centre
Victoria, British Columbia, V8R 6V5, Canada
Manitoba Prostate Centre
Winnipeg, Manitoba, R3E 0V9, Canada
QEII Health Sciences Centre, Nova Scotia Cancer Centre.
Halifax, Nova Scotia, B3H 1V7, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V5C2, Canada
London RegCancer Program, London Health Sciences Centre
London, Ontario, N6A 4L6, Canada
The Ottawa Hospital Cancer Centre, General Campus
Ottawa, Ontario, K1H8L6, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K2H 8P4, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2L 4M1, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
Centre de recherche clinique el evaluative en oncologie (CRCEO)
Québec, Quebec, G1R 3S1, Canada
Aalborg Hospital Nord
Aalborg, 9100, Denmark
Aarhus Universitetshospital
Aarhus N, 8200, Denmark
Rigshospitalet
Copenhagen, 2200, Denmark
Frederiksberg Hospital
Frederiksberg, 2000, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Roskilde Sygehus
Roskilde, 4000, Denmark
Docrates Clinic
Helsinki, 00180, Finland
Helsinki University Central Hospital
Helsinki, 00290, Finland
Oulu University Hospital
Oulu, 90220, Finland
Tampere University Hospital
Tampere, 33520, Finland
Hopital Civil
Strasbourg, Alsace, FR-67901, France
Centre Eugene Marquis-Service d'Oncologie Medicale
Rennes, Brittany Region, 35042, France
Institut Bergonie
Bordeaux, Nouvelle-Aquitaine, FR-33076, France
ICO Paul Papin
Angers, 49055, France
Clinique Rhone Durance
Avignon, 84000, France
Institut Bergonie
Bordeaux, FR-33076, France
CHD Vendee
La Roche-sur-Yon, 85925, France
Centre Jean Bernard - Clinique Victor Hugo
Le Mans, 72000, France
Centre Leon Berard
Lyon, 69008 Cedex 08, France
Institut Curie
Paris, 75005, France
Groupe Hospitalier La Pitie Salpetriere
Paris, 75013, France
Hopital Europeen Georges Pompidou
Paris, 75908, France
Centre de Recherche Clinique
Saint-Herblain, 44805, France
HIA Begin, Service de Medecine Interne et Oncologie
Saint-Mandé, FR-94160, France
Institut de Cancerologie Lucien Neuwirth
Saint-Priest-en-Jarez, 42271, France
Clinique Pasteur
Toulouse, 31300, France
Institut Gustave Roussy
Villejuif, 94805, France
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Charite-Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12200, Germany
Staedtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126, Germany
Universitaetsklinikum Carl Gustav Carus Dresden an der
Dresden, 01307, Germany
Martini-Klinik am UKE Gmbh
Hamburg, 20246, Germany
Urologikum Hamburg
Hamburg, 22399, Germany
Universitaetsklinikum Heidelberg, Klinik Fuer Urologie
Heidelberg, 69120, Germany
Universitaetsklinikum des Saarlandes
Homburg/Saar, 66424, Germany
Universitaetsklinikum Mannheim, Klinik fuer Urologie
Mannheim, 68167, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Universitaetsklinikum Tuebingen, Universitaetsklinik fuer Urologie
Tübingen, 72076, Germany
Universitaetsklinikum Ulm
Ulm, 89075, Germany
Kliniken Nordoberpfalz AG, Klinikum Weiden
Weiden in Der Oberpfalz, 92637, Germany
Assaf Harofe Medical Center
Beer Yaakov, 70300, Israel
Soroka University Medical Center
Beersheba, 84101, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
The Chaim Sheba Medical Center
Ramat Gan, 52621, Israel
Azienda Socio Sanitaria Territoriale di Cremona
Cremona, CR, 26100, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, FC, 47014, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Orbassano, TO, 10043, Italy
Azienda USL8-Presidio Ospedaliero S.Donato
Arezzo, 52100, Italy
Ospedale G.B. Morgagni
Forlì, 47100, Italy
Azienda Ospedaliera San. Camillo Forlanini
Rome, 00152, Italy
Kyushu University Hospital
Fukuoka, Fukuoka, 8128582, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 2360004, Japan
Tohoku University Hospital
Sendai, Miyagi, 9800872, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 8528501, Japan
Osaka International Cancer Institute
Osaka, Osaka, 5418567, Japan
Kindai University Hospital
Ōsaka-sayama, Osaka, 5898511, Japan
Osaka University Hospital
Suita-shi, Osaka, 5650871, Japan
Tokushima University Hospital
Tokushima, Tokushima, 7708503, Japan
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 1138603, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, 1738610, Japan
Cancer Institute Hospital
Koutou-ku, Tokyo, 1358550, Japan
Kyorin University Hospital
Mitaka-shi, Tokyo, 181 8611, Japan
Showa University Hospital
Shinagawa-ku, Tokyo, 1428666, Japan
Keio University Hospital
Shinjyuku-ku, Tokyo, 1608582, Japan
Yamaguchi University Hospital
Ube-shi, Yamaguchi, 7558505, Japan
Chiba Cancer Center
Chiba, 2608717, Japan
Kyoto University Hospital
Kyoto, 6068507, Japan
Niigata University Medical and Dental Hospital
Niigata, 9518520, Japan
Osaka City University Hospital
Osaka, 5450051, Japan
Jikei University Hospital
Tokyo, 1058471, Japan
Yamagata Prefectural Central Hospital
Yamagata, 9902292, Japan
Klaipeda University Hospital
Klaipėda, 92288, Lithuania
Division of Oncourology, National Cancer Institute
Vilnius, 08660, Lithuania
Vrije Universiteit Medical Center, Department of Medical Oncology
Amsterdam, 1081 HV, Netherlands
Catharina Ziekenhuis
Eindhoven, 5623 EJ, Netherlands
University Medical Center Groningen, Department of Urology
Groningen, 9713 GZ, Netherlands
UMC St. Radboud
Nijmegen, 6525 GA, Netherlands
Wielkopolskie Centrum Onkologii
Poznan, Greater Poland Voivodeship, 61-866, Poland
EMC Instytut Medyczny S.A.
Wroclaw, Lower Silesian Voivodeship, 54-144, Poland
Apteka Szpitalna
Gdansk, Pomeranian Voivodeship, 80-214, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952, Poland
Niepubliczny Zaklad Opieki Zdrowotnej
Mysłowice, Silesian Voivodeship, 41-400, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Tramatologii im. M.Kopernika w Lodzi
Lodz, Łódź Voivodeship, 93-509, Poland
Russian Academy of Medical Sciences Institution
Moscow, 115478, Russia
North-Western State Medical University named after I.I.Mechnikov of the Ministry of Healthcare
Saint Petersburg, 191015, Russia
State Educational Institution of Higher Professional Education
Saint Petersburg, 197022, Russia
State healthcare institute
Saint Petersburg, 197758, Russia
Department of Urology, National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Fakultna nemocnica s poliklinikou F.D. Roosevelta B. bystrica
Banská Bystrica, 975 17, Slovakia
CUIMED s.r.o.
Bratislava, 851 05, Slovakia
Univerzitna Nemocnica Martin
Martin, 036 59, Slovakia
UROEXAM, spol. s r.o. urologicka ambulancia
Nitra, 949 01, Slovakia
Poliklinika Sekcov, wesper, s.r.o.
Prešov, 080 01, Slovakia
UROCENTRUM MILAB s.r.o.
Prešov, 080 01, Slovakia
National Cancer Center
Goyang-si, Gyeonggi-do, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Chonnam National University Hwasun Hospital
Hwasun-eup, Hwasun-gun, Jeollanam-do, 619763, South Korea
Samsung Medical Center
Gangnam-gu, Seoul, 06351, South Korea
Asan Medical Center
Songpa-gu, Seoul, 05505, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273, South Korea
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07010, Spain
Hospital Universitario German Trias i Pujol
Badalona, Barcelona, 08916, Spain
Althaia Xarxa Asistencial Manresa
Manresa, Barcelona, 08243, Spain
Clínica Universidad de Navarra
Pamplona, Navarre, 31008, Spain
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Clinic i Provincial
Barcelona, 08036, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Madrid Norte Sanchinarro
Madrid, 28050, Spain
Corporacio Sanitaria Parc Tauli
Sabadell(Barcelona), 08208, Spain
Sahlgrenska University Hospital
Gothenburg, SE-413 45, Sweden
Skane University Hospital
Malmo, SE-205 02, Sweden
Orebro University Hospital
Örebro, se-701 85, Sweden
Karolinska University Hospital Solna
Stockholm, SE-171 76, Sweden
Umea University Hospital
Umeå, SE-901 85, Sweden
Bishops Wood Hospital
Northwood, Middlesex, HA6 2JW, United Kingdom
Mount Vernon Hospital
Northwood, Middlesex, HA6 2RN, United Kingdom
Oxford University Hospitals NHS Trust
Oxford, Oxfordshire, OX3 7LJ, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
Northern Centre for Cancer Care
Newcastle upon Tyne, TYNE and WEAR, NE7 7DN, United Kingdom
Velindre Cancer Centre
Cardiff, Wales, CF14 2TL, United Kingdom
Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, Merseyside, CH63 4JY, United Kingdom
Clinical Investigations and Research Unit, Royal Sussex County Hospital
Brighton, East Sussex, BN2 5BE, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, BS2 8ED, United Kingdom
Edinburgh Cancer Centre
Edinburgh, EH4 2XU, United Kingdom
University College London Hospital NHS Trust
London, NW1 2PG, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
Related Publications (16)
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.
PMID: 35731340DERIVEDJoshua 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.
PMID: 35643841DERIVEDTombal 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.
PMID: 34518652DERIVEDArmstrong 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.
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PMID: 24881730DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2010
First Posted
October 1, 2010
Study Start
September 16, 2010
Primary Completion
September 30, 2013
Study Completion
February 14, 2019
Last Updated
March 17, 2020
Results First Posted
October 16, 2014
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share
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.