Phase I Study of Preoperative Radiation and Docetaxel for High-risk Prostate Cancer

Abstract

0 mg/m 2 , 10 mg/m 2 , 20 mg/m 2 , and 30 mg/m 2 . The dose escalation continued to a planned dose of 30 mg/m 2 or until 1 or more patients per cohort experienced a DLT, defined as greater than Grade 3 nonhematologic (excluding hyperglycemia) or Grade 4 hematologic toxicity. Results: Twelve patients were accrued between April 2006 and March 2008. All planned treatments were administered. The maximum planned dose of 30 mg/m 2 was reached without DLTs. There were three Grade 3 toxicities in three different men (lymphopenia, hyperglycemia, and low hemoglobin). Grade 4 hyperglycemia occurred in 1 patient. There were no DVTs, rectal or ureteral injuries. Pathologic staging was: T2 - 9 patients, T3 - 3 patients, and node positive - 3 patients. Surgical margins were negative in 75% of cases. Post-op PSA levels were undetectable (\0.1 ng/mL) in all patients. Conclusions: Preoperative radiation and docetaxel before prostatectomy is feasible with acceptable toxicity. Based on these findings, a Phase II study continuing with IMRT to 45 Gy and 30 mg/m2 docetaxel weekly for 5 weeks has been initiated. Additional studies are needed to determine whether this combinedmodality approach will reduce cancer recurrence rates in this high-risk population. Author Disclosure: M. Garzotto, Sanofi-Aventis, B. Research Grant; A. Hung, None; T.M. Beer, Sanofi-Aventis, B. Research Grant; P. Farris, None.