Pilot trial of adjuvant paclitaxel plus androgen deprivation for patients with high-risk prostate cancer after radical prostatectomy: results on toxicity, side effects and quality-of-life.

Therapeutic strategy remains unclear with no clear consensus for men with high-risk prostate cancer (PCa) after radical prostatectomy. We aimed to evaluate into a prospective randomized trial the effectiveness and feasibility of adjuvant weekly paclitaxel combined with androgen deprivation therapy (ADT) in these patients. A total of 47 patients with high-risk PCa were randomized 6 weeks after radical prostatectomy: ADT alone versus combination of ADT and weekly paclitaxel. Toxicity, quality-of-life and functional results were compared between the two arms. All 23 patients completed eight cycles of paclitaxel. Toxicity was predominantly of grade 1-2 severity. There were no differences in EORTC QLQ-C30 scores between the two groups and between baseline and last assessment at 24 months after surgery. Urinary continence was complete at 1 year after surgery for all patients and no significant differences were noted at each assessment between the two groups. The interim analysis of this trial confirms the feasibility of weekly paclitaxel in combination with ADT in men at high-risk PCa with curative intent. This adjuvant combined therapy does not alter quality-of-life and continence recovery after surgery plus ADT. A larger cohort is awaited to determine the oncological outcomes of this strategy.