Clinical Trials Update
Holly Kelly, RN, Clinical Research Manager
The Department of Urology continues to be active in identifying research protocols that may benefit patients. Two of many protocols that are actively accruing participants are described here. Please contact the Department of Urology if you have patients who may be eligible.
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F ± GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic, Castrate-Resistant Prostate Cancer
BNIT-PRV-301 is a randomized, placebo-controlled, multi- center, Phase 3 efficacy trial of PROSTVAC-V/F in men with asymptomatic or minimally symptomatic, metastatic, castrate-resistant prostate cancer. It is a three-arm study and will evaluate overall survival in two separate comparisons: PROSTVAC plus adjuvant dose GMCSF versus control and PROSTVAC without GM-CSF versus control.
Patients will be randomized with equal probability into one of three double-blind arms. The intended interventions for randomized patients are:
• (Arm V+G) PROSTVAC-V/F plus adjuvant dose GM-CSF
• (Arm V) PROSTVAC-V/F plus GM-CSF placebo
• (Arm P) Double placebo (empty fowlpox vector/plus GM-CSF placebo)
This study is sponsored by BN Immuno Therapeutics, Inc. BB-IND 13946.
A Randomized, Double-Blind, Phase II, Efficacy and Safety Study of MDV3100 (ASP9785) vs. Bicalutamide in Castrate Men with Metastatic Prostate Cancer
This is a multinational phase II, randomized, double-blind, parallel study to determine the efficacy and safety of oral MDV3100 (160 mg/day) compared to bicalutamide (50 mg/day) in castrate men with metastatic prostate cancer who have progressed while on LHRH agonist/ antagonist or after receiving a bilateral orchiectomy.
Subjects will be randomized 1:1 to one of two treatment arms: MDV3100, 160 mg orally once daily, or bicalutamide 50 mg orally once daily.
The study is sponsored by Astellas Pharma Global Development, Inc. (APGD). IND 74,563