Some Findings From The Early Study of Provenge in Men with Early Stage Recurrent Prostate Cancer

There was just a release of some of the data from the on-going review sipuleucel-T, or Provenge, in men with early stage recurrent prostate cancer who have a rising serum prostate specific antigen (PSA) level, but who have not yet developed metastatic prostate cancer. The data wes presented by Oregon Health & Realm University Cancer Institute researchers at the 43rd Annual Meeting of the American Society of Clinical Oncologists (ASCO) in Chicago.
.
The study showed that Provenge did not significantly delay the time it took for a man’s PSA to reach a value of 3.0 ng/ml, the primary endpoint of the study. However, it did show a prolongation in prostate-specific antigen doubling time (PSADT). In addition, there was a trend observed in slowing the time to metastatic disease for patients who received sipuleucel-T compared with those who received placebo, but this early trend did not reach statistical significance. (We believe that the PSADT reflects the level of aggressness of prostate cancer).

“While there was no delay in the time to PSA recurrence, we did observe a slowing in the rate of rise of serum PSA in exploratory analyses. Additional follow-up is needed to determine if this effect on PSA will translate into patient