CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
Status:
Terminated
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
The current protocol will evaluate the safety of combining treatment with
bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with
PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with
safety the primary endpoint. Secondary endpoints will be to determine whether prostate
associated immune responses are seen, and whether treatment is associated with an increase in
PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of
six patients will be treated in each dose level. The investigators hypothesize that
short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell
mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4,
and that this will have therapeutic benefit in patients with recurrent prostate cancer.