We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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 : Active, not recruiting
First Posted : September 10, 2009
Results First Posted : October 30, 2012
Last Update Posted : March 19, 2014
Information provided by (Responsible Party):

Study Description
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 Design

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
Study Start Date : September 2009
Primary Completion Date : November 2011
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Enzalutamide
Formerly MDV3100
Drug: Enzalutamide
MDV3100, 160 mg orally per day
Other Name: Formerly MDV3100
Placebo Comparator: Placebo Drug: Placebo
Placebo comparator

Outcome Measures

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: During study period (up to 3 years) ]
    Survival is defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for patients who were lost to follow-up since randomization or not known to have died at the data analysis cutoff date (this included patients who were known to have died after the data analysis cutoff date).

Secondary Outcome Measures :
  1. Radiographic Progression-free Survival [ Time Frame: During study period (up to 3 years) ]
    Radiographic progression-free survival was defined as time from randomization to the earliest objective evidence of radiographic progression or death due to any cause. Patients 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 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. Patients who did not reach the endpoint were right censored at their last assessment.

  2. Time to First Skeletal-related Event [ Time Frame: During study period (up to 3 years) ]
    The time to first skeletal-related event was defined as time from randomization to the occurrence of the first skeletal-related event. Patients 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. Patients who did not reach the endpoint were right censored at their last assessment.

  3. Functional Assessment of Cancer Therapy - Prostate (FACT-P) [ Time Frame: During study period (up to 3 years) ]

    The FACT-P questionnaire is a 39-item questionnaire consisting of 5 domains; "physical well-being," "social/family well-being," "emotional well-being," "functional well-being," and "additional concerns" (consisting of items relating to prostate cancer and its treatment). Each item can be answered on a scale of 0-4. The sum of scores on all 5 domains constitutes the FACT-P.

    Patients were defined as having a quality of life response if they had a 10-point improvement in their global 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 3 years) ]

    Time to PSA progression was defined as time from randomization to PSA progression. Patients who did not reach the endpoint were right censored at their last assessment or for patients with no post-baseline PSA assessment, date of randomization.

    For patients with PSA declines at Week 13, the PSA progression date was defined as the date that a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir was documented, 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 patients 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 Patients With Pain Palliation [ Time Frame: During study period (up to 3 years) ]
    The proportion of patients with pain palliation was assessed for patients 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 Patients With Prostate Specific Antigen (PSA) Response [ Time Frame: During study period (up to 3 years) ]
    Patients 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 Patients With Soft-tissue Objective Response [ Time Frame: During study period (up to 3 years) ]

    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 patients with measurable soft tissue disease at screening were included in this analysis. Patients with measurable disease at screening are patients who had at least 1 target lesion identified per RECIST v1.1 at screening.

    Percentage of Participants summarizes the number of patients 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 Scale (EQ-5D) [ Time Frame: At Week 13 visit ]


    The EQ-5D is a standardized instrument for use as a measure of quality of life. Five parameters (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) were assessed on 3-point categorical scales ranging from "no problem" to "severe problem." Higher scores reflect worse quality of life.

  9. Circulating Tumor Cell (CTC) Conversion Rate [ Time Frame: During study period (up to 3 years) ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  • 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
  • GI disorder affecting absorption
Contacts and Locations

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

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Scottsdale, Arizona, United States, 85258
Scottsdale, Arizona, United States, 85259
United States, California
Beverly Hills, California, United States, 90211
Duarte, California, United States, 91010
Los Angeles, California, United States, 90024
Los Angeles, California, United States, 90033
Marina Del Rey, California, United States, 90292
Palo Alto, California, United States, 94304
San Diego, California, United States, 92123
San Francisco, California, United States, 94115
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Washington, District of Columbia, United States, 20037
United States, Florida
Jacksonville, Florida, United States, 32224
Tampa, Florida, United States, 33612
West Palm Beach, Florida, United States, 33401
United States, Georgia
Atlanta, Georgia, United States, 30309
Atlanta, Georgia, United States, 30318
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Kansas
Kansas City, Kansas, United States, 66160
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Maryland
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deconess Medical Center
Boston, Massachusetts, United States, 02115
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Montana
St. Louis, Montana, United States, 63110
United States, Nevada
Las Vegas, Nevada, United States, 89135
Las Vegas, Nevada, United States, 89169
United States, New Mexico
Albuquerque, New Mexico, United States, 87109
United States, New York
Buffalo, New York, United States, 14623
New York, New York, United States, 10016
New York, New York, United States, 10021
New York, New York, United States, 10029
New York, New York, United States, 10065
United States, North Carolina
Durham, North Carolina, United States, 27705
Raleigh, North Carolina, United States, 27607
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Oregon
Portland, Oregon, United States, 97239
Portland, Oregon, United States, 97240
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19111
Pittsburgh, Pennsylvania, United States, 15232
Pittsburgh, Pennsylvania, United States, 15240
United States, South Carolina
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
Chattanooga, Tennessee, United States, 37404
Nashville, Tennessee, United States, 37203
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75246
Dallas, Texas, United States, 75390
Houston, Texas, United States, 77030
United States, Virginia
Norfolk, Virginia, United States, 23502
Richmond, Virginia, United States, 23230
United States, Washington
Seattle, Washington, United States, 98109
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Cipolletti, Provincia de Rio Negro, Argentina
Rosario, Provincia de Santa Fe, Argentina
Buenos Aires, Argentina
Cordoba, Argentina
La Rioja, Argentina
Australia, New South Wales
Banks Town, New South Wales, Australia
Coffs Harbour, New South Wales, Australia
Concord, New South Wales, Australia
Port Macquarie, New South Wales, Australia
Randwick, New South Wales, Australia
Tweed Heads, New South Wales, Australia
Westmead, New South Wales, Australia
Australia, Queensland
Herston, Queensland, Australia
South Brisbane, Queensland, Australia, 4101
Australia, Tasmania
Hobart, Tasmania, Australia
Australia, Victoria
Fitzroy, Victoria, Australia
Footscray, Victoria, Australia, 3011
Franston, Victoria, Australia
Heidelberg, Victoria, Australia, 3084
Parkville, Victoria, Australia, 3050
Adelaide, Australia
Nedlands, Australia
Linz, Austria
Wien, Austria
Bruxelles, Flemish Brabant, Belgium
Brussels, Belgium, B-1070
Gent, Belgium
Hasselt, Belgium
Kortijk, Belgium, B-8500
Leuven, Belgium, B-3000
Roeselare, Belgium
Canada, Alberta
Calgary, Alberta, Canada, T2S 3C3
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada, V5Z4E6
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Hamilton, Ontario, Canada, L8V 5C2
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada, H2L 4M1
Montreal, Quebec, Canada
Quebec City, Quebec, Canada, G1R 3S1
Quebec City, Quebec, Canada
Vina del Mar, Valparasio, Chile
Santiago, Chile
Temuco, Chile
Vina del Mar, Chile
Angers, France
Bordeaux, France
Caen, France
Cannes, France
Creteil, France
La Roche Sur Yon, France
LeMans, France
Lyon, France, 69373
Marseille Cedex, France
Nantes, France
Paris, France
Pierre Benite, France
Poitiers, France
Reims, France
Saint Priest en Jarez, France
Suresnes, France
Villejuif, France, 94805
Aachen, Germany
Berlin, Germany
Braunschweig, Germany
Dresden, Germany
Hamburg, Germany
Hannover, Germany
Heidelberg, Germany
Manheim, Germany
Munster, Germany
Cremona, Italy
Milano, Italy
Modena, Italy
Orbassano, Italy
Perugia, Italy
Rome, Italy
Amsterdam, Netherlands
Nijmegen, Netherlands
Rotterdam, Netherlands
Gdansk, Poland
Lodz, Poland
Slupsk, Poland
Szczecin, Poland
South Africa
Durban, South Africa
Johannesburg, South Africa
Port Elizabeth, South Africa
Barcelona, Cataluna, Spain
Barcelona, Spain
Madrid, Spain
Palma de Mallorca, Spain
Pamplona, Spain
United Kingdom
Northwood, Middlesex, United Kingdom
Belfast, Northern Ireland, United Kingdom
Glasgow, Scotland, United Kingdom
Birmingham, United Kingdom
Bristol, United Kingdom
Cambridge, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Newcastle Upon Tyne, United Kingdom
Oxford, United Kingdom
Surrey, United Kingdom, SM2-5PT
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
More Information

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

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00974311     History of Changes
Other Study ID Numbers: CRPC2
First Posted: September 10, 2009    Key Record Dates
Results First Posted: October 30, 2012
Last Update Posted: March 19, 2014
Last Verified: February 2014

Keywords provided by Medivation, Inc.:
Prostate Cancer

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