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Docetaxel Followed by Hormone Therapy in Men Experiencing Increasing Prostate-Specific Antigen After Primary Local Treatments for Prostate Cancer

From the Greenebaum Cancer Center and Department of Radiology, University of Maryland School of Medicine and the Baltimore VA Medical Center; and Department of Radiation Oncology, University of Maryland School of Medicine, Baltimore, MD

Address reprint requests to Arif Hussain, MD, Greenebaum Cancer Center, University of Maryland School of Medicine, 22 S Greene St, Baltimore, MD 21201; e-mail: ahussain{at}som.umaryland.edu

PURPOSE: Prostatectomy or radiation for localized prostate cancer (PC) can fail in up to 15% to 30% of patients. The purpose of this study was to determine feasibility, tolerability, and outcome of docetaxel followed by hormone therapy in men experiencing an increasing prostate-specific antigen (PSA) after their primary local treatments for PC.

PATIENTS AND METHODS: Men with increasing serum PSA after prostatectomy or/and radiation were eligible. Serum PSA had to be 4 ng/mL and serum testosterone had to be in the noncastrate range. Treatment included docetaxel 70 mg/m² every 3 weeks for up to six cycles, followed by total androgen suppression (luteinizing hormone-releasing hormone agonist plus bicalutamide) and peripheral androgen blockade (finasteride plus bicalutamide) for 12 to 20 months.

RESULTS: Thirty-nine men were enrolled; 32 had PSA-only failure, seven also had clinical metastasis. Baseline median PSA was 13.7 ng/mL. Serum PSA decreased 50% in 17 of 35 patients (48.5%) and 75% in seven of 35 patients (20%) with docetaxel. The PSA decreased to a median of 0.1 ng/mL with subsequent hormone therapy. In 28 of 33 patients the PSA increased (median, 0.41 ng/mL) at a median follow-up of 2.3 months after treatment. In contrast, in five of 33 men the PSA remains at 0.1 ng/mL at a median of 18.9 months after therapy; three of these five men had soft tissue metastasis at entry but remain in complete remission. The most common grade 3 to 4 toxicity was neutropenia (61.5%).

CONCLUSION: Docetaxel followed by hormone therapy of limited duration may provide disease control in subgroups of men experiencing failure after local treatments for PC.

Supported in part by a Merit Review Award from the Department of Veterans Affairs (A.H.) and Aventis Pharmaceuticals (A.H.).

Presented at the 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12-15, 2001; American Urologic Association, Anaheim, CA, June 2-7, 2001; and Chemotherapy Foundation Symposium XX, New York, NY, November 13, 2003, as preliminary data.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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