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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00974311
Recruitment Status : Completed
First Posted : September 10, 2009
Results First Posted : October 30, 2012
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
Astellas Pharma Inc
Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Castration-Resistant Prostate Cancer Drug: Enzalutamide Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 30, 2009
Actual Primary Completion Date : September 15, 2011
Actual Study Completion Date : November 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Enzalutamide
Formerly MDV3100
Drug: Enzalutamide
MDV3100, 160 mg orally per day
Other Names:
  • MDV3100
  • Xtandi

Placebo Comparator: Placebo Drug: Placebo
Placebo comparator




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: During study period (up to 101 months) ]
    Survival was defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for participants who were lost to follow-up since randomization or not known to have died at the data analysis cut-off date (this included participants who were known to have died after the data analysis cut-off date).


Secondary Outcome Measures :
  1. Radiographic Progression-free Survival [ Time Frame: During DB phase (up to 24 months) ]
    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.

  2. Time to First Skeletal-related Event [ Time Frame: During DB Phase (up to 24 months) ]
    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.

  3. Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: Baseline up to 24 months ]
    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.

  4. Time to Prostate-specific Antigen (PSA) Progression [ Time Frame: Baseline and at every study visit from Week 13 while on study drug (up to 24 months) ]
    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).

  5. Percentage of Participants With Pain Palliation [ Time Frame: Baseline up to 24 months ]
    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.

  6. Percentage of Participants With Prostate Specific Antigen (PSA) Response [ Time Frame: During DB phase (up to 24 months) ]
    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.

  7. Percentage of Participants With Soft-tissue Objective Response [ Time Frame: During DB phase (up to 24 months) ]
    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.

  8. European Quality of Life Five-Domain (EQ-5D) Scale [ Time Frame: Week 13 ]
    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.

  9. Percentage of Participants With Circulating Tumor Cell (CTC) Conversion [ Time Frame: Baseline up to 24 months ]
    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.


Other Outcome Measures:
  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months) ]
    AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of following outcomes or deemed significant and jeopardized participants or required treatment to prevent other AE outcomes for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were events which occurred between first dose of study drug and up to the safety follow-up visit or the initiation of another anti-neoplastic therapy, whichever occurred first (up to 101 months). AEs included both serious and non-serious AEs. Clinically significant physical examination abnormalities were reported as AEs. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.

  2. Number of Participants With Clinically Significant Changes in Vital Signs [ Time Frame: Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months) ]
    Criteria for abnormalities in vital signs included: sitting/supine systolic blood pressure (SBP) values: absolute result greater than (>) 180 millimeter of mercury (mmHg) and >40 mmHg increase from baseline (BL) and less than (<) 90 mmHg and >30 mmHg decrease from BL; diastolic blood pressure (DBP) values: absolute result >105 mmHg and >30 mmHg increase from BL and absolute result < 50 mmHg and >20 mmHg decrease from BL; any abnormalities in SBP or DBP; heart rate values: absolute result > 120 beats per minute (bpm) and >30 bpm increase from BL and absolute result < 50 bpm and >20 bpm decrease from BL or any abnormalities in heart rate. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.

  3. Number of Participants With Any Newly Clinically Significant Abnormal Finding in Electrocardiogram (ECG) [ Time Frame: Baseline, up to the end of DB phase or unscheduled visit (up to 24 months) ]
    Any new post baseline abnormality was defined as any abnormal ECG finding that appeared after baseline assessment which was not seen at the screening or baseline ECG assessment. Where, criteria of abnormality was QTcF interval > 470 millisecond (msec). Participants were counted once only for a specific abnormality. This outcome measure was planned to be analysed in double blind phase only. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.

  4. Number of Participants With Grade 3/4 Post-Baseline Laboratory Toxicity (Hematology and Chemistry) [ Time Frame: Baseline, up to the safety follow-up visit or unscheduled visit or the initiation of another anti-neoplastic therapy whichever occurred first (up to 101 months) ]
    Laboratory parameters included hematological and chemistry parameters. Chemistry parameters included alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, calcium, creatine kinase, creatinine, glucose, magnesium, phosphate, potassium and sodium. Hematology parameters included haemoglobin, leukocytes, lymphocytes, neutrophils and platelet. Test abnormalities were graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 as Grade 3= severe and Grade 4= life-threatening or disabling. Only categories with at least 1 participant with abnormality are reported in this outcome measure. Unscheduled visit was performed at any time during the study whenever necessary to assess for or follow-up on AEs, at the participant's request or if deemed necessary by the investigator.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974311


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00974311     History of Changes
Other Study ID Numbers: CRPC2
2009-013174-41 ( EudraCT Number )
C3431010 ( Other Identifier: Alias Study Number )
First Posted: September 10, 2009    Key Record Dates
Results First Posted: October 30, 2012
Last Update Posted: December 11, 2018
Last Verified: November 2018

Keywords provided by Pfizer:
Prostate Cancer
Castration-resistant

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action