Sipuleucel-T (Provenge) is FDA approved after a man becomes castrate resistant. In clinical trials it has shown that it extends life when compared to placebo.
The use of Provenge has raised many questions, the two most common ones are why PSA and disease progression continues while receiving this treatment (see post at for an explanation) and why men don’t get Provenge earlier in their disease, specifically while they are still hormone responsive and their disease is less aggressive. The answer to the second question is simple, the FDA has not approved it for earlier use and will not until the proper clinical trials have been completed showing the efficacy of the treatment in earlier stage disease.
Towards this end there have been a few published studies on the activity of Provenge in men who are hormone-responsive or hormone-naive. In one such study conducted by Beer et al, 176 men who were still hormone-dependent and who had a biochemical relapse (PSA only increase) after a radical prostatectomy were randomized in a 2:1 ratio to 3 to 4 months of androgen-deprivation therapy (ADT), with or without Provenge after the completion of the ADT.
The only currently usable result of the research is that between both groups the men’s quality of life was no different and the men who received Provenge treatment had a longer PSA doubling time (155 vs 105 days; P = .038). Since PSA doubling time probably reflects levels of aggressiveness can we assume that men who received earlier Provenge will live longer? No, we cannot assume this, we need to wait until data like this matures and we see if there is a difference in survival between the two groups.
Joel T. Nowak, M.A., M.S.W.