IND 209 is an open-label, randomized, non-blinded Phase II clinical study of REOLYSIN® in combination with docetaxel versus docetaxel alone in patients with recurrent or metastatic castration resistant prostate cancer. Patients will receive docetaxel weekly, with either REOLYSIN® (test arm) or placebo (control arm) administered on days 1 through 5 of each twenty-one day treatment cycle. Approximately forty response evaluable patients will be enrolled in each arm. The primary objective is the efficacy of the treatment combination, based upon disease progression as measured at 12 weeks. Secondary objectives include the effect of the treatment combination on circulating tumour cell status, objective response rate, and overall survival. Other objectives will include the measurement of molecular factors which may be prognostic or predictive of response.
The study is being sponsored and conducted by the National Cancer Institute of Canada (NCIC) Clinical Trials Group (CTG) at Queen’s University in Kingston, Ontario.