- The enrollment for phase 3 randomized, multisite ProVent trial reached full accrual in less than a year.
- The trial will evaluate sipuleucel-T for treatment of patients with early-stage prostate cancer undergoing active surveillance.
Why this matters
- The study will evaluate an immunotherapeutic in early prostate cancer and whether slowing biologic progression can reduce the number of patients who go on to receive prostatectomy.
- The low-risk, no-cost, and potentially high-benefit proposition led to quick enrollment; however, the high price of sipuleucel-T can shift the risk-benefit ratio in the real world.
- Intermediate-risk patients who have up to 40% risk for progression can benefit from sipuleucel-T treatment.
- In the randomized, open-label phase 3 ProVent trial, investigators are assessing whether a 4- to 6-week treatment with sipuleucel-T can reduce disease progression among men on active surveillance vs surveillance alone over 3 years.
- More than 500 patients with low-risk (Grade Group 1; Gleason score 3+3) and favorable intermediate-risk (Grade Group 2; Gleason score 3+4) prostate cancer are enrolled.
- The trial will monitor men's anxiety and QoL throughout the study period.
- The trial is funded by Dendreon.