Phase I/II study of neoadjuvant docetaxel plus intensity-modulated radiotherapy (IMRT) prior to surgery for high-risk prostate cancer.

4662 Background: High-risk localized prostate cancer remains a considerable therapeutic challenge in part due to an inability to attain local control with either surgical or radiation monotherapy. Neoadjuvant chemoradiation improves local relapse rates of several tumor types but has not been evaluated in prostate cancer. The primary objectives were to assess the safety and pathologic complete response rate of pre-operative docetaxel and IMRT. Secondary aims included biochemical recurrence-free survival (PSA >0.4ng/ml) and PSA response to chemo-IMRT. Methods: Eligible patients had: 1) T2b or resectable T3a disease, 2) PSA ≥15 ng/ml or 3) or primary Gleason grade ≥4. Pts received 45 Gy over 25 fractions to the prostate and seminal vesicles with 7-field IMR. In phase I, cohorts of 3 pts were accrued at weekly doses of 0 mg/m2, 10 mg/m2, 20 mg/m2 and 30 mg/m2. Docetaxel and standard oral dexamethasone were given weekly until reaching max planned dose or confirmed DLT. No DLTs were observed at the max planned ...