Primary and secondary endpoints
toxicity
SECONDARY
ROADSTER is a phase I/II, randomized controlled trial with safety and feasibility as primary outcomes. The planned accrual for the phase I portion of the study will be 12 patients: six patients in cohort 1 and six patients in cohort 2. Safety of each cohort will be declared if no more than one patient in each cohort experiences a grade 3 or higher CTCAE V4.0 toxicity at 6 weeks or 6 months post-treatment. Feasibility will be declared if 10 or more of the planned 12 patients are successfully accrued and complete the study as per protocol within 24 months of activation. If the initial accrual of 12 men across both cohorts demonstrates both safety and feasibility, the study will expand to the phase II portion, in which 30 men in total will be enrolled and randomized between these two cohorts. Sample sizes were chosen to support measuring the safety and feasibility of this study in the phase 1 and 2 portions. No formal statistical sample size calculation was performed.Secondary endpoints will include biochemical response, defined as a decrease of PSA by 50% from the baseline level; acute toxicity, defined by changes in CTCAE v4.0 scores; and changes in EPIC QoL scores. These secondary endpoints will be assessed at baseline, 6 weeks after treatment and 6 months after treatment.