Last April there was some preliminary data from the long-term Phase II STAND study presented at 29th Annual European Association of Urology (EAU) Congress that showed that sipuleucel-T (Provenge) when given after the start of androgen deprivation therapy (ADT) seemed to enhance and sustain the immune response in men with a biochemical failure (PSA only) of prostate cancer.
ADT remains the standard treatment option for men with biochemical failure after failure of local therapy. The STAND study is a Phase II randomized trial that consisted of two patient study groups, one completing Provenge two weeks before starting ADT and the second receiving Provenge three months after the start of ADT.
Preliminary results suggest enhanced cellular immune responses when Provenge was given after ADT. These responses were persistent for at least 12 months and robust in both patient groups.
According to Neal Shore, M.D., medical director at the Carolina Urologic Research Center and an occasional guest on the Malecare Teleconference page, “The STAND study results are encouraging as they provide additional evidence on how sipuleucel-T can be sequenced with other treatments which will assist clinician decision-making upon whether immune responses correlate with certain clinical parameters, such as prostate specific antigen (PSA) recurrence.”
I do not believe that the findings of this study are ready for translational clinical impact for us men with advanced prostate cancer given that Provenge, with a $124,000 price tag, is not approved for use prior to the prostate cancer becoming castrate resistant. It also adds a new complication to the decision making mix as a study released at the last annual ASCO meeting (see: http://advancedprostatecancer.net/?p=2238 and
http://advancedprostatecancer.net/?p=2221) showed that starting ADT immediately upon having a biochemical failure did not provide any survival advantage over waiting for some disease progression.
So, even if we forget the insurance issue are we better off with earlier ADT and then Provenge or are we better off delaying ADT and Provenge? We are going to need some additional studies to get at this answer.
(Also see: http://advancedprostatecancer.net/?p=3835)
Joel T. Nowak, M.A., M.S.W.