A multi-institutional pilot study of adjuvant docetaxel for patients with prostate cancer at high risk for relapse after radical prostatectomy

The management of patients with high-risk, early-stage, prostate cancer represents a major challenge to all disciplines involved in the treatment of this common malignant neoplasm. A definition of the natural history of this disease-including the identification of key prognostic factors-and the availability of active systemic therapeutic modalities for patients with advanced disease are among the basic requirements needed to provide for early intervention in high-risk patients. Several cytotoxic chemotherapy regimens have demonstrated significant antitumor effects in patients with hormone-refractory disease. Docetaxel (Taxotere(R), Aventis Pharmaceuticals, Bridgewater, NJ), a widely used taxane with broad antitumor activity, likely represents the most active single agent in prostate cancer treatment. Current data indicate that 40%-60% of patients treated with docetaxel have exhibited evidence of benefit from treatment with docetaxel, both alone and in combination with estramustine, with acceptable toxicity. In this review we describe a pilot study that is currently entering patients at high risk for relapse after radical prostatectomy. This study was designed to evaluate the safety, feasibility, and preliminary efficacy of docetaxel given postoperatively for 6 months. The main study endpoint is time-to-biochemical-relapse, which will be assessed against a matched group of historical controls.