Sipuleucel-T in management of favorable-risk prostate cancer: the ProVent trial

At the end of last year, Dendreon announced that the Phase III ProVent trial of sipuelucel-T (Provenge) in the treatment of men with relatively lower-risk forms of prostate cancer (as compared to active surveillance) had been fully enrolled ahead of schedule.

The ProVent trial is designed to see whether, at 3 years of follow-up, up-front treatment with sipuleucel-T can delay progression and/or treatment of prostate cancer in men initially diagnosed with very low-, low-, or favorable intermediate-risk prostate cancer who would otherwise have agreed to initial management on active surveillance. There are all sorts of questions about the significance of this trial — especially in the men with very low- and low-risk disease. However, there is no doubt whatsoever that it is an interesting trial from a scientific point of view.

A recent article on the Medscape Oncology web site has addressed some of the philosophical and more practical aspects of this trial. One commentator in thaT article notes that:

  • Provenge is “extremely” well tolerated, has a relatively short treatment time, and may prevent some men from having to undergo surgery or radiation.
  • The product will be available to the trial participants at no cost (as opposed to ts commercial cost of nearly $100,000), and so, from a patient perspective, “Why not enroll?”
  • But, “You’re overtreating the majority of these Gleason score 3 + 3 patients … [who will] do fine without it.”

On the other hand, it should be noted that for the men with favorable intermediate-risk prostate cancer (Gleason 3 + 4 = 7), there may be a very real benefit.

The “New” Prostate Cancer InfoLink has previously noted our concern that a follow-up period of 3 years may not be long enough for us to see if these is a real benefit overall or in the subset of patients with favorable intermediate risk disease.

The trial is an open-label trial with 2:1 randomization. In other words, according to the original trial design:

  • 300 patients were going to be randomized to treatment with sipuleucel-T.
  • 150 patients were going to be randomized to standard  forms of active surveillance.

We understand that close to 500 patients have actually been enrolled in the trial, and that trial results are current,y expected in 2023.

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