Vaccine Immunotherapy for Prostate Cancer; Annual rept. 15 Apr 2007-14 Apr 2008

摘要

The purpose of the research supported by this award is to conduct a Phase II clinical trial (study) of an adenovirus/PSA (Ad/PSA) vaccine for the treatment of prostate cancer. Two protocols will be used in the trial: no. 1 - Phase II study of Adenovirus/PSA vaccine in men with recurrent prostate cancer after local therapy; and no. 2 - Phase II study of Adenovirus/PSA vaccine in men with hormone refractory prostate cancer. In the first protocol men with newly recurrent prostate cancer will be randomized to one of two arms of the study. Patients in Arm A will receive the Ad/PSA vaccine only; three injections spaced 30 days apart. Patients in Arm B will receive androgen deprivation therapy (ADT) followed at day 14 by the Ad/PSA vaccine, again with three injections. In the second protocol men with hormone refractory prostate cancer will be injected with the vaccine only, three injections 30 days apart. The patients will be followed for toxicity, the development of anti-PSA immune responses, and evidence of a clinical effect of the vaccination. The latter includes changes in serum PSA levels and in the PSA doubling times (PSADT). Patients in protocol no. 2 will also have CT and bone scans to monitor their prostate cancer.