Clinical trial NCT00974311: Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
Official title: Affirm: A Multinational Phase 3, Randomized, Double-blind, Placebo-controlled Efficacy And Safety Study Of Oral Mdv3100 In Patients With Progressive Castration-resistant Prostate Cancer Previously Treated With Docetaxel Based Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Castration-Resistant Prostate Cancer
Keywords: Prostate Cancer
Castration-resistant
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Inc
name: Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
First posted: 2009-09-10
Enrollment: 1199
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Overall Survival
timeFrame: During study period (up to 101 months)
Secondary outcomes:
measure: Radiographic Progression-free Survival
timeFrame: During DB phase (up to 24 months)
measure: Time to First Skeletal-related Event
timeFrame: During DB Phase (up to 24 months)
measure: Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: Baseline up to 24 months
measure: Time to Prostate-specific Antigen (PSA) Progression
timeFrame: Baseline and at every study visit from Week 13 while on study drug (up to 24 months)
measure: Percentage of Participants With Pain Palliation
timeFrame: Baseline up to 24 months
measure: Percentage of Participants With Prostate Specific Antigen (PSA) Response
timeFrame: During DB phase (up to 24 months)
measure: Percentage of Participants With Soft-tissue Objective Response
timeFrame: During DB phase (up to 24 months)
measure: European Quality of Life Five-Domain (EQ-5D) Scale
timeFrame: Week 13
measure: Percentage of Participants With Circulating Tumor Cell (CTC) Conversion
timeFrame: Baseline up to 24 months
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
measure: Number of Participants With Clinically Significant Changes in Vital Signs
timeFrame: Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
measure: Number of Participants With Any Newly Clinically Significant Abnormal Finding in Electrocardiogram (ECG)
timeFrame: Baseline, up to the end of DB phase or unscheduled visit (up to 24 months)
measure: Number of Participants With Grade 3/4 Post-Baseline Laboratory Toxicity (Hematology and Chemistry)
timeFrame: Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months)
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital
state: Arizona
city: Scottsdale
country: United States
facility: Premiere Oncology of Arizona
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Beverly Hills
country: United States
facility: Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group
state: California
city: Beverly Hills
country: United States
facility: USC Westside Prostate Cancer Center
state: California
city: Duarte
country: United States
facility: City of Hope
state: California
city: La Mesa
country: United States
facility: Cancer Center Oncology Medical Group
state: California
city: Los Angeles
country: United States
facility: LAC & USC Medical Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Marina Del Rey
country: United States
facility: c/o Prostate Oncology Specialist, Inc.
state: California
city: Oceanside
country: United States
facility: North County Oncology Medical Clinic, Inc,
state: California
city: San Diego
country: United States
facility: Medical Oncology Associates - SD
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital Investigational Pharmacy
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: South Pasadena
country: United States
facility: City of Hope Medical Group
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics Research Pharmacy
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: Research Pharmacist
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver, Anschutz Cancer Pavilion
state: Colorado
city: New Haven
country: United States
facility: C/O: Thomas Ferencz R.Ph., BCOP
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Med
state: Connecticut
city: Washington
country: United States
facility: George Washington University-Medical Faculty Associates
state: District of Columbia
city: Atlantis
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Wellington
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Peachtree Hematology-Oncology Consultants, P.C.
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
state: Maryland
city: Baltimore
country: United States
facility: The Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital (MGH)
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital (BWH)
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Weisberg Cancer Treatment Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Creve Coeur
country: United States
facility: Siteman Cancer Center-West County
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Peters
country: United States
facility: Siteman Cancer Center
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Institute, an affiliate of the UC San Diego Health System
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants, Ltd.
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College-New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College-New York Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Durham
country: United States
facility: Pharmaceutical Research Services
state: North Carolina
city: Portland
country: United States
facility: Portland VA Medical Center
state: Oregon
city: McKeesport
country: United States
facility: UPMC Cancer Centers
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Cancer Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Cancer Centers
state: Pennsylvania
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Charleston
country: United States
facility: Hollings Cancer Center
state: South Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Grand Strand Urology
state: South Carolina
city: Chattanooga
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Dickson
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Franklin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Gallatin
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Hermitage
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Lebanon
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Murfreesboro
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Smyrna
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Dallas
country: United States
facility: Parkland Health and Hospital System
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Chesapeake
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Hampton
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Mechanicsville
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Midlothian
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Virginia Beach
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Williamsburg
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Instituto Medico de Asistencia e Investigaciones S.A (IMAI Research)
state: AR
city: Cordoba
country: Argentina
facility: Instituto Oulton
state: Provincia DE Cordoba
city: Cordoba
country: Argentina
facility: Clinica Universitaria Privada Reina Fabiola
state: Provincia DE Cordoba
city: Neuquen
country: Argentina
facility: Policlinico Neuquen
state: Provincia DE Neuquen
city: Cipolletti
country: Argentina
facility: Policlinico Modelo de Cipolletti
state: Provincia DE RIO Negro
city: Cipolletti
country: Argentina
facility: Instituto de Investigaciones Clinicas Cipolletti
state: Provincia DE RIO Negro
city: Rosario
country: Argentina
facility: Sanatorio Mapaci
state: Provincia DE Santa FE
city: Rosario
country: Argentina
facility: Instituto de Oncologia y Especialidades Medicas
state: Provincia DE Santa FE
city: Rosario
country: Argentina
facility: Hospital Italiano Garibaldi
state: Provincia DE Santa FE
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro de Diagnostico Dr. Enrique Rossi
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro de Diagnostico Dr. Enrique Rossi
city: Coffs Harbour
country: Australia
facility: North Coast Cancer Institute
state: New South Wales
city: Concord
country: Australia
facility: Sydney Cancer Centre
state: New South Wales
city: Port Macquarie
country: Australia
facility: Mid North Coast Diagnostic Imaging
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital Pharmacy
state: New South Wales
city: Port Macquarie
country: Australia
facility: Port Macquarie Base Hospital
state: New South Wales
city: Randwick
country: Australia
facility: Prince of Wales Hospital, Department of Medical Oncology
state: New South Wales
city: Tweed Heads
country: Australia
facility: The Tweed Hospital
state: New South Wales
city: Wentworthville
country: Australia
facility: PRP Diagnostic Imaging
state: New South Wales
city: Westmead
country: Australia
facility: Sydney West Cancer Trials Centre, Department of Medical Oncology
state: New South Wales
city: Auchenflower
country: Australia
facility: River City Pharmacy
state: Queensland
city: Auchenflower
country: Australia
facility: Heart Care Partners
state: Queensland
city: Auchenflower
country: Australia
facility: Icon Cancer Care Wesley
state: Queensland
city: Chermside
country: Australia
facility: Icon Cancer Care Chermside
state: Queensland
city: Chermside
country: Australia
facility: Southern X-Ray Chermside
state: Queensland
city: Herston
country: Australia
facility: Cancer Care Services
state: Queensland
city: Milton
country: Australia
facility: Icon Cancer Foundation
state: Queensland
city: South Brisbane
country: Australia
facility: Icon Cancer Care South Brisbane
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Private Cardiology
state: Queensland
city: South Brisbane
country: Australia
facility: Queensland X-Ray
state: Queensland
city: Toowong
country: Australia
facility: XRadiology
state: Queensland
city: Adelaide
country: Australia
facility: Department of Medical Oncology
state: South Australia
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
city: Frankston
country: Australia
facility: Peninsula Oncology Centre
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital, Department of Medical Oncology
state: Western Australia
city: Footscray
country: Australia
facility: 60 Eleanor St
city: Footscray
country: Australia
facility: Western Hospital
city: Victoria
country: Australia
facility: The Royal Melbourne Hospital
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Linz
city: Vienna
country: Austria
facility: ISOTOPIX Ambulatorium fuer
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Brussels
country: Belgium
facility: Cliniques Universitaires Saint- Luc
city: Ghent
country: Belgium
facility: AZ Sint- Lucas
city: Hasselt
country: Belgium
facility: VZW Jessa Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Kennedylaan
city: Kortrijk
country: Belgium
facility: AZ Groeninge - Campus Sint Maarten
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Roeselare
country: Belgium
facility: H.-Hartziekenhuis Roeselare-Menen vzw
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre
state: Alberta
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre - Holy Cross Site
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Kelowna
country: Canada
facility: British Columbia Cancer Agency, Centre for the Southern Interior
state: British Columbia
city: Vancouver
country: Canada
facility: B.C. Cancer Agency - Vancouver Centre
state: British Columbia
city: Victoria
country: Canada
facility: British Columbia Cancer Agency - Vancouver Island Centre
state: British Columbia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: The Urology Specialists.
state: Quebec
city: Quebec
country: Canada
facility: Imagerie medicale de la Capitale
city: Quebec
country: Canada
facility: CHU de Quebec
city: Quebec
country: Canada
facility: Centre de rechereche clinique et evaluative en oncologie
city: Santiago
country: Chile
facility: Hospital San Jose
city: Santiago
country: Chile
facility: Instituto Nacional del Cancer
city: Temuco
country: Chile
facility: Centro Investigacion Clinica del Sur
city: Vina del Mar
country: Chile
facility: Instituto Oncologico
city: Angers Cedex 9
country: France
facility: Centre Paul Papin
city: Bordeaux cedex
country: France
facility: Institut Bergonie
city: Caen Cedex
country: France
facility: Centre Regional Francois Baclesse de lutte contre le cancer
city: Cannes Cedex
country: France
facility: Centre hospitalier de Cannes
city: Creteil
country: France
facility: CHU Henri Mondor
city: Frejus Cedex
country: France
facility: Centre Hospitalier Intercommunal Frejus-Saint Raphael
city: LA Roche sur Yon
country: France
facility: Centre hospitalier departemental Vendee
city: Le Mans
country: France
facility: Clinique Victor Hugo - Centre Jean Bernard
city: Lyon Cedex 08
country: France
facility: Centre Leon Berard
city: Lyon Cedex 3
country: France
facility: Groupement Hospitalier Edouard Herriot - Pavillon V
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Paris
country: France
facility: Institut Curie
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon sud
city: Poitiers Cedex
country: France
facility: CHU La Miletrie
city: Reims Cedex
country: France
facility: Institut Jean Godinot
city: Saint Etienne Cedex 2
country: France
facility: Centre Hospitalier
city: Saint Priest en Jarez
country: France
facility: Institut de Cancerologie de la Loire
city: Saint-Etienne CEDEX 2
country: France
facility: Centre d'Investigation Clinique, (CIE3)
city: SAINT-HERBLAIN Cedex
country: France
facility: Centre Rene Gauducheau
city: Suresnes Cedex
country: France
facility: Hopital Foch
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Aachen
country: Germany
facility: Universitaetsklinikum Aachen
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin-Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Gemeinschaftspraxis Fuer Nuklearmedizin
city: Berlin
country: Germany
facility: Radiologische Gemeinschaftspraxis
city: Berlin
country: Germany
facility: FacharztzentrumInnere Medizin
city: Berlin
country: Germany
facility: Praxis Dr. Wolfgang Hoelzer
city: Braunschweig
country: Germany
facility: Staedtisches Klinikum Braunschweig gGmbH
city: Dresden
country: Germany
facility: Technical University Dresden
city: Hamburg
country: Germany
facility: Martini-Klinik am UKE GmbH
city: Hamburg
country: Germany
facility: Roentgenpraxis
city: Hamburg
country: Germany
facility: Urologische Gemeinschaftspraxis Poppenbuettel
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover - Klinik fuer Urologie und Urologische Onkologie
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Mannheim
country: Germany
facility: Universitaetsklinikum Mannheim
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster, Klinik fuer Klinische Radiologie
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Nuklearmedizin
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster, Klinik und Poliklinik fuer Urologie
city: Tuebingen
country: Germany
facility: Abt.f.Diagnostische u. Interventionelle Radiologie
city: Tuebingen
country: Germany
facility: Klinik fuer Urologie
city: Tuebingen
country: Germany
facility: Nuklearmedizin
city: Via Del Pozzo 71
country: Italy
facility: Azienda Ospedaliero-Universitaria di Modena Policlinico
state: Modena
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga
state: TO
city: Cremona
country: Italy
facility: Azienda Ospedaliera "Istituti Ospitalieri" di Cremona
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Grudziadz
country: Poland
facility: Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Regionalny Osrodek Onkologiczny
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika
city: Slupsk
country: Poland
facility: Wojewodzki szpital specjalistyczny im. Janusza Korczaka
city: Durban
country: South Africa
facility: Hopelands Cancer Centre
city: Port Elizabeth
country: South Africa
facility: GVI Oncology
city: Sandton
country: South Africa
facility: Sandton Oncology Centre
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Radiodiagnostic Cetir Clinica Pilar
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Madrid Norte Sanchinarro
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Northwood
country: United Kingdom
facility: Bishops Wood Hospital
state: Middlesex
city: Northwood
country: United Kingdom
facility: Mount Vernon Hospital
state: Middlesex
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
state: Surrey
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Birmingham
country: United Kingdom
facility: Cancer Centre
city: Bristol
country: United Kingdom
facility: Bristol Haematology & Oncology Centre
city: Bristol
country: United Kingdom
facility: Bristol Royal Infirmary
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: University College Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
city: Newcastle upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Oxford
country: United Kingdom
facility: The Manor Hospital Oxford
Study officials:
affiliation: Pfizer
name: Pfizer Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Cella D, Ganguli A, Turnbull J, Rohay J, Morlock R. US Population Reference Values for Health-Related Quality of Life Questionnaires Based on Demographics of Patients with Prostate Cancer. Adv Ther. 2022 Aug;39(8):3696-3710. doi: 10.1007/s12325-022-02204-3. Epub 2022 Jun 22.
citation: Joshua AM, Armstrong A, Crumbaker M, Scher HI, de Bono J, Tombal B, Hussain M, Sternberg CN, Gillessen S, Carles J, Fizazi K, Lin P, Duggan W, Sugg J, Russell D, Beer TM. Statin and metformin use and outcomes in patients with castration-resistant prostate cancer treated with enzalutamide: A meta-analysis of AFFIRM, PREVAIL and PROSPER. Eur J Cancer. 2022 Jul;170:285-295. doi: 10.1016/j.ejca.2022.04.005. Epub 2022 May 26.
citation: Zhao JL, Fizazi K, Saad F, Chi KN, Taplin ME, Sternberg CN, Armstrong AJ, de Bono JS, Duggan WT, Scher HI. The Effect of Corticosteroids on Prostate Cancer Outcome Following Treatment with Enzalutamide: A Multivariate Analysis of the Phase III AFFIRM Trial. Clin Cancer Res. 2022 Mar 1;28(5):860-869. doi: 10.1158/1078-0432.CCR-21-1090.
citation: Tombal BF, Freedland SJ, Armstrong AJ, Beer TM, Stenzl A, Sternberg CN, Hussain M, Ganguli A, Ramaswamy K, Bhadauria H, Ivanescu C, Turnbull J, Holmstrom S, Saad F. Impact of enzalutamide on patient-reported fatigue in patients with prostate cancer: data from the pivotal clinical trials. Prostate Cancer Prostatic Dis. 2022 Feb;25(2):288-295. doi: 10.1038/s41391-021-00447-9. Epub 2021 Sep 13.
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.
citation: Poon DMC, Wong KCW, Chan TW, Law K, Chan K, Lee EKC, Lee C, Chan M; Hong Kong Society of Uro-Oncology (HKSUO). Survival Outcomes, Prostate-specific Antigen Response, and Tolerance in First and Later Lines of Enzalutamide Treatment for Metastatic Castration-resistant Prostate Cancer: A Real-World Experience in Hong Kong. Clin Genitourin Cancer. 2018 Oct;16(5):402-412.e1. doi: 10.1016/j.clgc.2018.07.008. Epub 2018 Jul 21.
citation: Heller G, McCormack R, Kheoh T, Molina A, Smith MR, Dreicer R, Saad F, de Wit R, Aftab DT, Hirmand M, Limon A, Fizazi K, Fleisher M, de Bono JS, Scher HI. Circulating Tumor Cell Number as a Response Measure of Prolonged Survival for Metastatic Castration-Resistant Prostate Cancer: A Comparison With Prostate-Specific Antigen Across Five Randomized Phase III Clinical Trials. J Clin Oncol. 2018 Feb 20;36(6):572-580. doi: 10.1200/JCO.2017.75.2998. Epub 2017 Dec 22.
citation: Antoun S, Bayar A, Ileana E, Laplanche A, Fizazi K, di Palma M, Escudier B, Albiges L, Massard C, Loriot Y. High subcutaneous adipose tissue predicts the prognosis in metastatic castration-resistant prostate cancer patients in post chemotherapy setting. Eur J Cancer. 2015 Nov;51(17):2570-7. doi: 10.1016/j.ejca.2015.07.042. Epub 2015 Aug 13.
citation: Gibbons JA, Ouatas T, Krauwinkel W, Ohtsu Y, van der Walt JS, Beddo V, de Vries M, Mordenti J. Clinical Pharmacokinetic Studies of Enzalutamide. Clin Pharmacokinet. 2015 Oct;54(10):1043-55. doi: 10.1007/s40262-015-0271-5.
citation: Cella D, Ivanescu C, Holmstrom S, Bui CN, Spalding J, Fizazi K. Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial. Ann Oncol. 2015 Jan;26(1):179-185. doi: 10.1093/annonc/mdu510. Epub 2014 Oct 30.
citation: Saad F, de Bono J, Shore N, Fizazi K, Loriot Y, Hirmand M, Franks B, Haas GP, Scher HI. Efficacy outcomes by baseline prostate-specific antigen quartile in the AFFIRM trial. Eur Urol. 2015 Feb;67(2):223-30. doi: 10.1016/j.eururo.2014.08.025. Epub 2014 Aug 27.
citation: Merseburger AS, Scher HI, Bellmunt J, Miller K, Mulders PF, Stenzl A, Sternberg CN, Fizazi K, Hirmand M, Franks B, Haas GP, de Bono J, de Wit R. Enzalutamide in European and North American men participating in the AFFIRM trial. BJU Int. 2015 Jan;115(1):41-9. doi: 10.1111/bju.12898. Epub 2014 Oct 23.
citation: Fizazi K, Scher HI, Miller K, Basch E, Sternberg CN, Cella D, Forer D, Hirmand M, de Bono JS. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol. 2014 Sep;15(10):1147-56. doi: 10.1016/S1470-2045(14)70303-1. Epub 2014 Aug 4.
citation: Scher HI, Fizazi K, Saad F, Taplin ME, Sternberg CN, Miller K, de Wit R, Mulders P, Chi KN, Shore ND, Armstrong AJ, Flaig TW, Flechon A, Mainwaring P, Fleming M, Hainsworth JD, Hirmand M, Selby B, Seely L, de Bono JS; AFFIRM Investigators. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012 Sep 27;367(13):1187-97. doi: 10.1056/NEJMoa1207506. Epub 2012 Aug 15.