Phase I/II trial of weekly doxorubicin (Doxo)/docetaxel (Doce) followed by hormone ablation (HA) in recurrent prostate cancer (PC)

4765 Background: For PC pts with PSA failure after surgery (RP) and/or XRT no standard treatments are established. An approach being piloted by our group is to give chemotherapy first, then HA. We report phase I results of an ongoing phase I/II trial of weekly Doxo/Doce followed by HA in such pts. Methods: Pts with histologically documented PC with rising PSA post RP, XRT were eligible. PSA had to be > 4 ng/ml with serum testosterone (T) in non-castrate range at entry. Positive bone scans, CT scans were not an exclusion criteria. Treatment is: weekly Doxo/Doce x 4 cycles (each cycle: Doxo d1, 8, 15 IVP; Doce d1, 8, 15 IV over 30 min, q 28 d) followed by LHRH agonist + Bicalutamide 50 mg/d x 1 yr. Two dose levels of Doxo (cohort 1: 15 mg/m2 d1, 8, 15; cohort 2: 20 mg/m2 d1, 8, 15) with fixed dose Doce (30 mg/m2 d1, 8, 15) were used. Results: 16 pts have been enrolled. Baseline characteristics (medians): age 62.5 y, PSA 19.05 ng/ml, GS 7, serum T 409 ng/dl; Baseline imaging: + bone scans 4, + CT 2. 11 pts c...