Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
This is a randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.
Hormone-Refractory Prostate Cancer
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer|
- Overall Time to Disease Progression [ Time Frame: from randomization to 36 months ] [ Designated as safety issue: Yes ]Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.
- Overall Survival [ Time Frame: Time from randomization until 36 months ] [ Designated as safety issue: Yes ]Subjects were followed for 3 years from the time of randomization or until death.
|Study Start Date:||May 2000|
|Study Completion Date:||May 2005|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
|Active Comparator: sipuleucel-T (APC8015)||Biological: sipuleucel-T|
|Placebo Comparator: Placebo||Biological: APC-Placebo|