Phase II Study of Docetaxel with Radiation Therapy for Post Prostatectomy Rising PSA

Aims: To determine the tolerability of adding docetaxel to radiation therapy in patients with a rising PSA post prostatectomy for prostate cancer. Study design: Phase II study of the combination of docetaxel and radiation therapy. Place and duration of study: University and Veterans Association Hospital from 2007- 2009. Methodology: Patients eligible to receive “salvage” radiation therapy were enrolled in a prospective study to receive concomitant weekly docetaxel (20 mg/m2) and then 4 cycles of full dose (75 mg/m2) docetaxel. Results: All 19 patients were able to complete the concomitant therapy, with just one patient not receiving all 7 cycles of weekly chemotherapy (missing one). Sixteen of 19 completed all four cycles, 2 completed 3 cycles and 1 completed 1 cycle of full dose docetaxel. During combined treatment, there were 3 transient grade 3 toxicities (diarrhea, hemoglobin decline, and hyperglycemia). There was no grade 4 toxicity. During full dose docetaxel, 3 patients suffered a grade 3 decline in WBC count and 2 went on to grade 4. Other single incidents of grade 3 toxicity were anxiety, fatigue, hyperglycemia, diarrhea, febrile neutropenia, port infection and abscess. All the toxicities were transient. By the end of treatment, 89% had a decline in PSA. Conclusion: This is the first report of combined docetaxel and radiation in the post prostatectomy setting. Patients tolerated the combined treatment very well. Toxicities of the full dose docetaxel are consistent with what’s reported in the literature and appear tolerable.