Tolerability Of Ongoing Phase Ii Study Of Concomitant Radiation And Docetaxel Followed By Docetaxel In Prostate Cancer Patients With A Persistent Or Rising Psa After Radical Prostatectomy

e16054 Background: Patients with a detectable PSA after radical prostatectomy (RRP) have persistent disease and inevitably succumb to disease as progression ensues. Radiation has been used in the salvage setting, but has only been found to cure less than half of these patients. SWOG 8794 has recently reported a significant increase in metastasis free survival in 15 years with adjuvant radiation for patients with high risk findings after RRP. It is of particular interest if adjuvant chemoradiation (CRT) can improve the rate of reaching a PSA nadir of zero after RRP in men with persistent or rising PSA. This ongoing IRB approved trial has thus far evaluated the tolerability of CRT utilizing the radiosensitizing agent Docetaxel (DX) for 7 weeks after RRP followed by adjuvant full dose DX (75mg/m2). Methods: Patients: Chemotherapy/hormone naïve, status post RRP, post-op PSA > 0.2 ng/mL on two separate occasions, ECOG ≤ 2; treated with taxane-based chemotherapy (DX 20mg/m2 weekly) concurrent with standard dose radiation for 7 weeks, and post-radiation chemotherapy DX (75mg/ m2) given every 21 days for 4 cycles with premedication intravenous dexamethasone. Primary endpoint: Rate of PSA decline; Number of subjects reaching PSA nadir of zero. Secondary endpoints: Progression Free Survival (PFS) based on PSA progression, toxicity graded via Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE), and overall survival (OS). Results: From 5/07 to 12/08, 16 pts with detectable PSA after RRP were treated; Median age 65 [48–74]; 16/16 completed CRT; 11/16 completed CRT and adjuvant DX; 3/16 dropped out due to adverse events after CRT; Toxicity: 19% (3/16) patients experienced Grade 3 toxicity during CRT and adjuvant DX; 29% (4/14) patients had Grade 3 toxicity during adjuvant DX; no Grade 4 toxicities. See Table . Conclusions: DX in combination with standard radiation appears to be well tolerated in patients with persistent PSA after RRP. [Table: see text] No significant financial relationships to disclose.