Early prostate cancer: phase 3 sipuleucel-T trial enrolled very quickly

  • 29 May 2020

  • Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Key points

  • 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.