A phase II study of imatinib with pioglitazone, etoricoxib, dexamethasone, and low-dose treosulfan: Combined anti-inflammatory, immunomodulatory, and angiostatic treatment in patients (pts) with castration-refractory prostate cancer (CRPC).

4599 Background: Therapeutic options for pts with CRPC are still limited. Continuous production and release of pro-inflammatory cytokines may account for its resistance towards cytotoxic drugs. Therefore, a phase II study was implemented in pts with CRPC to assess tumor response to combined biomodulatory agents. Primary objective was the PSA-response rate in pts with CRPC. Methods: 69 pts with histologically confirmed CRPC (according to EAU guidelines) were enrolled in 11 German centers. In the 6 months core phase and thereafter, pts were treated continuously with daily doses of imatinib mesylate, pioglitazone, etoricoxib, treosulfan and dexamethasone until PSA progression. During the study, PSA-values, ECOG performance status and QoL were continuously assessed. Pts responsive to study medication were allowed to enter the extension phase until disease progression or intolerable toxicity occurred. Results: The core phase of this study was finished in July 2009. Six pts are currently under treatment in the ...