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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Description:

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).

Outcome Time Frame:

During study period (up to 3 years)

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CRPC2

NCT ID:

NCT00974311

Start Date:

September 2009

Completion Date:

November 2012

Related Keywords:

• Castration-Resistant Prostate Cancer
• MDV3100
• Prostate Cancer
• Castration-resistant
• Prostatic Neoplasms