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Journal of Clinical Oncology, Vol 21, Issue 21 (November), 2003: 3972-3978
© 2003 American Society for Clinical Oncology

Phase III Trial of Long-Term Adjuvant Androgen Deprivation After Neoadjuvant Hormonal Cytoreduction and Radiotherapy in Locally Advanced Carcinoma of the Prostate: The Radiation Therapy Oncology Group Protocol 92–02

Gerald E. Hanks, Thomas F. Pajak, Arthur Porter, David Grignon, Harmart Brereton, Varagur Venkatesan, Eric M. Horwitz, Colleen Lawton, Seth A. Rosenthal, Howard M. Sandler, William U. Shipley

From the Fox Chase Cancer Center and the Radiation Therapy Oncology Group, Philadelphia, and Mercy Hospital of Scranton, Scranton, PA; Harper Hospital, Wayne State University, Detroit, MI; University of Western Ontario, London, Ontario, Canada; Medical College of Wisconsin, Milwaukee, WI; Radiological Associates of Sacramento, Sacramento, CA; University of Michigan Medical School, Ann Arbor, MI; and Massachusetts General Hospital, Boston, MA.

Address reprint requests to Thomas F. Pajak, PhD, Statistical Department, Radiation Oncology Therapy Group, 1101 Market St, Philadelphia, PA 19107; e-mail: tpajak{at}phila.acr.org.

Purpose: Radiation Therapy Oncology Group (RTOG) Protocol 92–02 was a randomized trial testing long-term (LT) adjuvant androgen deprivation (AD) after initial AD with external-beam radiotherapy (RT) in patients with locally advanced prostate cancer (PC; T2c-4) and with prostate-specific antigen level less than 150 ng/mL.

Patients and Methods: Patients received a total of 4 months of goserelin and flutamide, 2 months before and 2 months during RT. A radiation dose of 65 to 70 Gy was given to the prostate and a dose of 44 to 50 Gy to the pelvic lymph nodes. Patients were randomly assigned to receive no additional therapy (short-term [ST]AD-RT) or 24 months of goserelin (LTAD-RT); 1,554 patients were entered onto the study.

Results: The LTAD-RT arm showed significant improvement in all efficacy end points except overall survival (OS; 80.0% v 78.5% at 5 years, P = .73), compared with the STAD-RT arm. In a subset of patients not part of the original study design, with tumors assigned Gleason scores of 8 to 10 by the contributing institutions, the LTAD-RT arm had significantly better OS (81.0% v 70.7%, P = .044). There was a small but significant increase in the frequency of late radiation grades 3, 4, and 5 gastrointestinal toxicity ascribed to the LTAD-RT arm (2.6% v 1.2% at 5 years, P = .037), the cause of which is not clear.

Conclusion: The RTOG 92–02 trial supports the addition of LT adjuvant AD to STAD with RT for T2c-4 PC. In the exploratory subset analysis of patients with Gleason scores 8 to 10, LT adjuvant AD resulted in a survival advantage.

Supported by National Cancer Institute grant CA-21661 and National Institutes of Health grant CA-32115. Presented at the Annual Meetings of the American Society of Clinical Oncology, May 2000, and the American Society of Therapeutic Radiation Oncology, October 2000.


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