AzTrials
AzTrials

Castration-Resistant Prostate CancerPhase 3AFFIRMNCT00974311

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

A Phase 3 study testing Enzalutamide in people with Castration-Resistant Prostate Cancer, run by Pfizer at 249 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration-Resistant Prostate Cancer
What is being tested?
Enzalutamide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,199 participants
Where
249 sitesin 15 countries
Study dates
30 Sep 2009to 2 Nov 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Progressive prostate cancer
  • Medical or surgical castration with testosterone less than 50 ng/dl
  • One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate bone marrow, hepatic, and renal function
  • Able to swallow the study drug and comply with study requirements
  • Informed consent

Who cannot join

  • Metastases in the brain or active epidural disease
  • Another malignancy within the previous 5 years
  • Clinically significant cardiovascular disease
  • Gastrointestinal disorder affecting absorption

Trial locations and contacts

249 sites in 15 countries.

249 sites in 15 countries

United States98 sites

  • New Mexico Oncology Hematology Consultants, Ltd.

    Albuquerque, New Mexico, 87109

  • Peachtree Hematology-Oncology Consultants, P.C.

    Atlanta, Georgia, 30318

  • Palm Beach Cancer Institute

    Atlantis, Florida, 33462

  • Research Pharmacist

    Aurora, Colorado, 80045

  • University of Colorado Denver, Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group

    Beverly Hills, California, 90211-1850

  • USC Westside Prostate Cancer Center

    Beverly Hills, California, 90211

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital (MGH)

    Boston, Massachusetts, 02114

  • Brigham & Women's Hospital (BWH)

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

  • Tennessee Oncology, PLLC

    Chattanooga, Tennessee, 37404

  • Virginia Oncology Associates

    Chesapeake, Virginia, 23320

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Chicago

    Chicago, Illinois, 60637

  • Siteman Cancer Center

    City of Saint Peters, Missouri, 63376

  • Siteman Cancer Center-West County

    Creve Coeur, Missouri, 63141

  • Parkland Health and Hospital System

    Dallas, Texas, 75235

  • Texas Oncology, Sammons Cancer Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • City of Hope

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Pharmaceutical Research Services

    Durham, North Carolina, 27710

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • Tennessee Oncology, PLLC

    Franklin, Tennessee, 37067

  • Tennessee Oncology, PLLC

    Gallatin, Tennessee, 37066

  • Virginia Oncology Associates

    Hampton, Virginia, 23666

  • Tennessee Oncology, PLLC

    Hermitage, Tennessee, 37076

  • Cancer Center Oncology Medical Group

    La Mesa, California, 91942

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89128

  • Nevada Cancer Institute, an affiliate of the UC San Diego Health System

    Las Vegas, Nevada, 89135

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Tennessee Oncology, PLLC

    Lebanon, Tennessee, 37087

  • LAC & USC Medical Center

    Los Angeles, California, 90033

  • USC/Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095-6984

  • UCLA

    Los Angeles, California, 90095

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • c/o Prostate Oncology Specialist, Inc.

    Marina del Rey, California, 90292

  • UPMC Cancer Centers

    McKeesport, Pennsylvania, 15132

  • Virginia Cancer Institute

    Mechanicsville, Virginia, 23116-1844

  • Virginia Cancer Institute

    Midlothian, Virginia, 23114

  • Tennessee Oncology, PLLC

    Murfreesboro, Tennessee, 37129

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • Grand Strand Urology

    Myrtle Beach, South Carolina, 29572

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • The Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-5536

  • C/O: Thomas Ferencz R.Ph., BCOP

    New Haven, Connecticut, 06510

  • Yale University School of Med

    New Haven, Connecticut, 06520

  • Weill Cornell Medical College-New York Presbyterian Hospital

    New York, New York, 10021

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Weill Cornell Medical College-New York Presbyterian Hospital

    New York, New York, 10065

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • North County Oncology Medical Clinic, Inc,

    Oceanside, California, 92056

  • Palm Beach Cancer Institute

    Palm Beach Gardens, Florida, 33410

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • UPMC Cancer Centers

    Pittsburgh, Pennsylvania, 15237

  • VA Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Portland VA Medical Center

    Portland, Oregon, 97239

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Virginia Cancer Institute

    Richmond, Virginia, 23235-4730

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Medical Oncology Associates - SD

    San Diego, California, 92123

  • Sharp Memorial Hospital Investigational Pharmacy

    San Diego, California, 92123

  • Sharp Rees-Stealy

    San Diego, California, 92123

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94115

  • Premiere Oncology of Arizona

    Scottsdale, Arizona, 85258

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Tennessee Oncology, PLLC

    Smyrna, Tennessee, 37167

  • City of Hope Medical Group

    South Pasadena, California, 91030

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110-1094

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford Hospital and Clinics Research Pharmacy

    Stanford, California, 94305

  • Stanford University Medical Center

    Stanford, California, 94305

  • Virginia Oncology Associates

    Virginia Beach, Virginia, 23456

  • George Washington University-Medical Faculty Associates

    Washington D.C., District of Columbia, 20037

  • Palm Beach Cancer Institute

    Wellington, Florida, 33414

  • Palm Beach Cancer Institute

    West Palm Beach, Florida, 33401

  • Virginia Oncology Associates

    Williamsburg, Virginia, 23188

Other trials in United States

Australia29 sites

  • Department of Medical Oncology

    Adelaide, South Australia, 5000

  • River City Pharmacy

    Auchenflower, Queensland, 4064

  • Heart Care Partners

    Auchenflower, Queensland, 4066

  • Icon Cancer Care Wesley

    Auchenflower, Queensland, 4066

  • Icon Cancer Care Chermside

    Chermside, Queensland, 4032

  • Southern X-Ray Chermside

    Chermside, Queensland, 4032

  • North Coast Cancer Institute

    Coffs Harbour, New South Wales, 2450

  • Sydney Cancer Centre

    Concord, New South Wales, 2139

  • St. Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • 60 Eleanor St

    Footscray, 3011

  • Western Hospital

    Footscray, 3011

  • Peninsula Oncology Centre

    Frankston, Victoria, 3199

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Cancer Care Services

    Herston, Queensland, 4029

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Icon Cancer Foundation

    Milton, Queensland, 4064

  • Sir Charles Gairdner Hospital, Department of Medical Oncology

    Nedlands, Western Australia, 6009

  • Mid North Coast Diagnostic Imaging

    Port Macquarie, New South Wales, 2444

  • Port Macquarie Base Hospital Pharmacy

    Port Macquarie, New South Wales, 2444

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444

  • Prince of Wales Hospital, Department of Medical Oncology

    Randwick, New South Wales, 2031

  • Icon Cancer Care South Brisbane

    South Brisbane, Queensland, 4101

  • Mater Private Cardiology

    South Brisbane, Queensland, 4101

  • Queensland X-Ray

    South Brisbane, Queensland, 4101

  • XRadiology

    Toowong, Queensland, 4066

  • The Tweed Hospital

    Tweed Heads, New South Wales, 2485

  • The Royal Melbourne Hospital

    Victoria, 3050

  • PRP Diagnostic Imaging

    Wentworthville, New South Wales, 2145

  • Sydney West Cancer Trials Centre, Department of Medical Oncology

    Westmead, New South Wales, 2145

Other trials in Australia

France22 sites

  • Centre Paul Papin

    Angers, 49933

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Regional Francois Baclesse de lutte contre le cancer

    Caen, 14076

  • Centre hospitalier de Cannes

    Cannes, B.P. 264 - 06401

  • CHU Henri Mondor

    Créteil, 94010

  • Centre Hospitalier Intercommunal Frejus-Saint Raphael

    Fréjus, BP110 - 83608

  • Centre hospitalier departemental Vendee

    La Roche-sur-Yon, 85925

  • Clinique Victor Hugo - Centre Jean Bernard

    Le Mans, 72000

  • Groupement Hospitalier Edouard Herriot - Pavillon V

    Lyon, 69003

  • Centre Leon Berard

    Lyon, 69373

  • Institut Paoli Calmettes

    Marseille, BP 156 - 13273

  • Institut Curie

    Paris, 75005

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Centre Hospitalier Lyon sud

    Pierre-Bénite, 69495

  • CHU La Miletrie

    Poitiers, 86021

  • Institut Jean Godinot

    Reims, 51056

  • Centre Hospitalier

    Saint-Etienne, 42030

  • Centre d'Investigation Clinique, (CIE3)

    Saint-Etienne, 42055

  • Centre Rene Gauducheau

    Saint-Herblain, 44805

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42271

  • Hopital Foch

    Suresnes, 92151

  • Institut Gustave Roussy

    Villejuif, 94805

Other trials in France

Germany21 sites

  • Universitaetsklinikum Aachen

    Aachen, 52074

  • Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin

    Berlin, 12200

  • Gemeinschaftspraxis Fuer Nuklearmedizin

    Berlin, D- 10439

  • Radiologische Gemeinschaftspraxis

    Berlin, D- 13055

  • FacharztzentrumInnere Medizin

    Berlin, D-13055

  • Praxis Dr. Wolfgang Hoelzer

    Berlin, D-13055

  • Staedtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38126

  • Technical University Dresden

    Dresden, 01307

  • Martini-Klinik am UKE GmbH

    Hamburg, 20246

  • Roentgenpraxis

    Hamburg, 22391

  • Urologische Gemeinschaftspraxis Poppenbuettel

    Hamburg, 22399

  • Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie

    Hanover, D-30625

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Mannheim

    Mannheim, 68167

  • Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie

    Münster, D-48149

  • Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin

    Münster, D-48149

  • Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie

    Münster, D-48149

  • Abt.f.Diagnostische u. Interventionelle Radiologie

    Tübingen, D-72076

  • Klinik fuer Urologie

    Tübingen, D-72076

  • Nuklearmedizin

    Tübingen, D-72076

Other trials in Germany

Canada17 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Tom Baker Cancer Centre - Holy Cross Site

    Calgary, Alberta, T2S 3C3

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 3A7

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • British Columbia Cancer Agency, Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L4M1

  • The Urology Specialists.

    Montreal, Quebec, H2X 1N8

  • Imagerie medicale de la Capitale

    Québec, Quebec, G1H 6P3

  • CHU de Quebec

    Québec, Quebec, G1R 2J6

  • Centre de rechereche clinique et evaluative en oncologie

    Québec, Quebec, G1R 3S3

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

  • B.C. Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

  • British Columbia Cancer Agency - Vancouver Island Centre

    Victoria, British Columbia, V8R 6V5

Other trials in Canada

United Kingdom15 sites

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Cancer Centre

    Birmingham, B15 2TH

  • Bristol Haematology & Oncology Centre

    Bristol, BS2 8ED

  • Bristol Royal Infirmary

    Bristol, BS2 8HW

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • University College Hospital

    London, NW1 2BU

  • Hammersmith Hospital

    London, W12 0HS

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Northern Centre for Cancer Care

    Newcastle upon Tyne, NE7 7DN

  • Bishops Wood Hospital

    Northwood, Middlesex, HA6 2JW

  • Mount Vernon Hospital

    Northwood, Middlesex, HA6 2RN

  • Churchill Hospital

    Oxford, OX3 7LJ

  • The Manor Hospital Oxford

    Oxford, OX3 7RP

  • The Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Argentina11 sites

  • Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)

    Buenos Aires, AR, C1425AWC

  • Centro de Diagnostico Dr. Enrique Rossi

    Buenos Aires, C1043AAS

  • Centro de Diagnostico Dr. Enrique Rossi

    Buenos Aires, C1425BEE

  • Policlinico Modelo de Cipolletti

    Cipolletti, Río Negro Province, 8324

  • Instituto de Investigaciones Clinicas Cipolletti

    Cipolletti, Río Negro Province, R8324EMD

  • Instituto Oulton

    Córdoba, Córdoba Province, X5000JJS

  • Clinica Universitaria Privada Reina Fabiola

    Córdoba, Córdoba Province, X5004FHP

  • Policlinico Neuquen

    Neuquén, Neuquén Province, 8300

  • Sanatorio Mapaci

    Rosario, Santa Fe Province, S2000DTO

  • Instituto de Oncologia y Especialidades Medicas

    Rosario, Santa Fe Province, S2000KZE

  • Hospital Italiano Garibaldi

    Rosario, Santa Fe Province, S2001ODA

Other trials in Argentina

Belgium7 sites

  • Cliniques Universitaires Saint- Luc

    Brussels, 1200

  • AZ Sint- Lucas

    Ghent, 9000

  • VZW Jessa Ziekenhuis

    Hasselt, 3500

  • AZ Groeninge - Campus Kennedylaan

    Kortrijk, 8500

  • AZ Groeninge - Campus Sint Maarten

    Kortrijk, 8500

  • University Hospital Gasthuisberg

    Leuven, 3000

  • H.-Hartziekenhuis Roeselare-Menen vzw

    Roeselare, 8800

Other trials in Belgium

Spain7 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Radiodiagnostic Cetir Clinica Pilar

    Barcelona, 08006

  • Hospital Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Madrid Norte Sanchinarro

    Madrid, 28050

  • Clinica Universidad de Navarra

    Pamplona, 31008

Other trials in Spain

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego

    Grudziądz, 86-300

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny

    Lodz, 93-509

  • Wojewodzki Szpital Specjalistyczny im. M. Kopernika

    Lodz, 93-513

  • Wojewodzki szpital specjalistyczny im. Janusza Korczaka

    Słupsk, 76-200

Other trials in Poland

Chile4 sites

  • Hospital San Jose

    Santiago

  • Instituto Nacional del Cancer

    Santiago

  • Centro Investigacion Clinica del Sur

    Temuco

  • Instituto Oncologico

    Viña del Mar

Other trials in Chile

Italy4 sites

  • Azienda Ospedaliera "Istituti Ospitalieri" di Cremona

    Cremona, 26100

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga

    Orbassano, TO, 10043

  • Azienda Ospedaliera San Camillo Forlanini

    Rome, 00152

  • Azienda Ospedaliero-Universitaria di Modena Policlinico

    Via Del Pozzo 71, Modena, 41100

Other trials in Italy

Austria3 sites

  • Krankenhaus der Barmherzigen Schwestern Linz

    Linz, 4010

  • ISOTOPIX Ambulatorium fuer

    Vienna, 1090

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

Netherlands3 sites

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • UMC St. Radboud

    Nijmegen, 6525 GA

  • Erasmus MC

    Rotterdam, 3075 EA

Other trials in Netherlands

South Africa3 sites

  • Hopelands Cancer Centre

    Durban, 4001

  • GVI Oncology

    Port Elizabeth, 6045

  • Sandton Oncology Centre

    Sandton, 2199

Other trials in South Africa

About this study

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

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

Being tested
Enzalutamide, Placebo
Keywords
Prostate Cancer, Castration-resistant
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EnzalutamideDrug

    Also called MDV3100, Xtandi

    MDV3100, 160 mg orally per day

  • PlaceboDrug

    Placebo comparator

Study groups in NCT00974311
Study groupRoleWhat they receive
EnzalutamideExperimentalFormerly MDV3100
Receives: Drug: Enzalutamide
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).

    Measured: During study period (up to 101 months)

Secondary outcomes (9)

  1. Radiographic Progression-free Survival

    Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Participants were assessed for objective disease progression at regularly scheduled visits. The consensus guidelines of the Prostate Cancer Clinical Trials Working Group 2 were taken into consideration for the determination of disease progression. Radiographic disease progression was defined by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 for soft tissue disease, or the appearance of two or more new bone lesions on bone scan. Progression at the first scheduled reassessment at Week 13 required a confirmatory scan 6 or more weeks later. Participants who did not reach the endpoint were right censored at their last assessment.

    Measured: During DB phase (up to 24 months)

  2. Time to First Skeletal-related Event

    The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Participants were assessed for skeletal-related events at regularly scheduled visits. A skeletal-related event was defined as radiation therapy or surgery to bone, pathologic bone fracture, spinal cord compression, or change of antineoplastic therapy to treat bone pain. Participants who did not reach the endpoint were right censored at their last assessment.

    Measured: During DB Phase (up to 24 months)

  3. Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)

    The FACT-P was a 39-item participant questionnaire which assessed physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and additional prostate cancer specific concerns (12 items). All items were scored from 0 (not at all) to 4 (very much). The sum of scores on all 5 domains constitutes the global FACT-P. The global/total FACT-P score ranged from 0 (worst) to 156 (best), higher scores indicate better health status. Responders were those participants who had a 10-point improvement in their total FACT-P score, as compared with baseline, on two consecutive measurements obtained at least 3 weeks apart.

    Measured: Baseline up to 24 months

  4. Time to Prostate-specific Antigen (PSA) Progression

    Time to PSA progression was defined as time from randomization to PSA progression. Participants who did not reach the endpoint were right censored at their last assessment or for participants with no post-baseline PSA assessment, date of randomization. For participants with PSA declines at Week 13, the PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 nanogram per milliliter (ng/mL) above the nadir was documented, which was confirmed by a second consecutive value obtained 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment). For participants with no PSA declines at Week 13, PSA progression date was defined as the date that a >=25% increase and an absolute increase of >=2 ng/mL above the baseline was documented, which was confirmed by a second consecutive value 3 or more weeks later (required only if PSA progression did not occur at last PSA assessment).

    Measured: Baseline and at every study visit from Week 13 while on study drug (up to 24 months)

  5. Percentage of Participants With Pain Palliation

    The proportion of participants with pain palliation was assessed for participants with a stable and sufficient pain burden at study entry. Pain burden was measured by question #3 of the Brief Pain Inventory (Short Form). This scale measures pain on a 0 to 10 scale with 0 indicating no pain and 10 indicating pain as bad as you can imagine. Pain palliation at Week 13 was determined for the proportion of men with baseline bone metastasis(es) who had baseline pain attributable to the metastasis(es). Palliation was defined as >=30% reduction in average pain score at Week 13 compared to baseline without a >=30% increase in analgesic use.

    Measured: Baseline up to 24 months

  6. Percentage of Participants With Prostate Specific Antigen (PSA) Response

    Participants were evaluable for PSA response rate if they had a PSA level measured at baseline and at least 1 post-baseline assessment. Both PSA responses of > 50% and > 90% were determined. PSA responses required confirmation with a subsequent assessment that was conducted at least 3 weeks later.

    Measured: During DB phase (up to 24 months)

  7. Percentage of Participants With Soft-tissue Objective Response

    The best overall soft tissue response as assessed using RECIST v1.1 during the study was summarized using the investigators' response assessments and also the derived response assessments by treatment group. Only participants with measurable soft tissue disease at screening were included in this analysis. Participants with measurable disease at screening are participants who had at least 1 target lesion identified per RECIST v1.1 at screening. Percentage of participants summarizes the number of participants with complete or partial objective response (%). Soft Tissue assessment based on Eisenhauer EA, Therasse P, Bogaerts J et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009; 45:228-247.

    Measured: During DB phase (up to 24 months)

  8. European Quality of Life Five-Domain (EQ-5D) Scale

    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility or index score. Five parameters (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were assessed on 3-point categorical scale (1= no problems, 2= some/moderate problems and 3= severe problem). Score were transformed and resulted in a total EQ-5D score range of 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better health and quality of life.

    Measured: Week 13

  9. Percentage of Participants With Circulating Tumor Cell (CTC) Conversion

    CTC conversion was assessed for participants with baseline CTC counts of greater than or equal to (>=) 5 cells per 7.5 milliliter (mL) of blood. A CTC conversion was defined as a decline in the CTC count to less than (<) 5 cells per 7.5 mL of blood. In this outcome measure percentage of participants with CTC conversion was reported.

    Measured: Baseline up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2009 (estimated)
  2. Study start30 Sep 2009
  3. Primary completion15 Sep 2011
  4. Study completion2 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00974311
Sponsor's protocol ID
CRPC2
Other IDs
2009-013174-41, C3431010, 2009
Acronym
AFFIRM
Status last verified
Nov 2018
First submitted
9 Sep 2009
Last updated
11 Dec 2018
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 35731340

  • 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.

    PubMed 35643841

  • Zhao JL, Fizazi K, Saad F, Chi KN, Taplin ME, Sternberg CN, Armstrong AJ, de Bono JS, Duggan WT, Scher HI. The Effect of Corticosteroids on Prostate Cancer Outcome Following Treatment with Enzalutamide: A Multivariate Analysis of the Phase III AFFIRM Trial. Clin Cancer Res. 2022 Mar 1;28(5):860-869. doi: 10.1158/1078-0432.CCR-21-1090.

    PubMed 34965947

  • Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):288-295. doi: 10.1038/s41391-021-00447-9. Epub 2021 Sep 13.

    PubMed 34518652

  • 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.

    PubMed 31830211

  • Poon DMC, Wong KCW, Chan TW, Law K, Chan K, Lee EKC, Lee C, Chan M; Hong Kong Society of Uro-Oncology (HKSUO). Survival Outcomes, Prostate-specific Antigen Response, and Tolerance in First and Later Lines of Enzalutamide Treatment for Metastatic Castration-resistant Prostate Cancer: A Real-World Experience in Hong Kong. Clin Genitourin Cancer. 2018 Oct;16(5):402-412.e1. doi: 10.1016/j.clgc.2018.07.008. Epub 2018 Jul 21.

    PubMed 30126765

  • Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.

    PubMed 29272162

  • Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.

    PubMed 26278649

  • Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.

    PubMed 25917876

  • Cella D, Ivanescu C, Holmstrom S, Bui CN, Spalding J, Fizazi K. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial. Ann Oncol. 2015 Jan;26(1):179-185. doi: 10.1093/annonc/mdu510. Epub 2014 Oct 30.

    PubMed 25361992

  • Saad F, de Bono J, Shore N, Fizazi K, Loriot Y, Hirmand M, Franks B, Haas GP, Scher HI. Efficacy outcomes by baseline prostate-specific antigen quartile in the AFFIRM trial. Eur Urol. 2015 Feb;67(2):223-30. doi: 10.1016/j.eururo.2014.08.025. Epub 2014 Aug 27.

    PubMed 25171902

  • Merseburger AS, Scher HI, Bellmunt J, Miller K, Mulders PF, Stenzl A, Sternberg CN, Fizazi K, Hirmand M, Franks B, Haas GP, de Bono J, de Wit R. Enzalutamide in European and North American men participating in the AFFIRM trial. BJU Int. 2015 Jan;115(1):41-9. doi: 10.1111/bju.12898. Epub 2014 Oct 23.

    PubMed 25123978

  • Fizazi K, Scher HI, Miller K, Basch E, Sternberg CN, Cella D, Forer D, Hirmand M, de Bono JS. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol. 2014 Sep;15(10):1147-56. doi: 10.1016/S1470-2045(14)70303-1. Epub 2014 Aug 4.

    PubMed 25104109

  • Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15.

    PubMed 22894553

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Enzalutamide in people with Castration-Resistant Prostate Cancer, run by Pfizer at 249 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 249 sites in United States, Australia, France, Germany, Canada and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: During study period (up to 101 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00974311, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.

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