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Androgen Suppression Plus Radiation Versus Radiation Alone for Patients With Stage D₁/Pathologic Node-Positive Adenocarcinoma of the Prostate: Updated Results Based on National Prospective Randomized Trial Radiation Therapy Oncology Group 85-31

From the Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, WI; Radiation Therapy Oncology Group Statistical Unit, Philadelphia, PA; Department of Pathology, Wayne State University, Detroit, MI; and St Joseph Mercy Hospital, Ann Arbor, MI

Address reprint requests to Colleen A. Lawton, MD, FACR, Medical College of Wisconsin, Dept of Radiation Oncology, 8701 Watertown Plank Rd, Milwaukee, WI 53226; e-mail: colleen{at}mcw.edu

PURPOSE: To update the effect of immediate androgen suppression in conjunction with standard external-beam irradiation versus radiation alone on a group of histologically lymph node-positive patients with adenocarcinoma of the prostate.

MATERIALS AND METHODS: A national prospective randomized trial (Radiation Therapy Oncology Group 85-31) of standard external-beam irradiation plus immediate androgen suppression versus external-beam irradiation alone was initiated in 1985 for patients with locally advanced adenocarcinoma of the prostate. One hundred seventy-three patients in this trial had histologically involved lymph nodes. Ninety-eight patients received radiation plus immediate androgen suppression (luteinizing hormone–releasing hormone [LHRH] agonist), whereas 75 patients received radiation alone with hormonal manipulation instituted at the time of relapse.

RESULTS: With a median follow-up of 6.5 years for all patients and 9.5 years for living patients, estimated progression-free survival with prostate-specific antigen (PSA) level less than 1.5 ng/mL at 5 and 9 years was 54% and 10%, respectively, for patients who received immediate LHRH agonist versus 33% and 4% for patients who received radiation alone with hormonal manipulation instituted at time of relapse (P < .0001). Multivariate analysis revealed radiation therapy and immediate hormonal manipulation as having a statistically significant impact on all end points analyzed: absolute survival, disease-specific failure, metastatic failure, and biochemical control with PSA less than 4 ng/mL and less than 1.5 ng/mL.

CONCLUSION: Pending the results of randomized trials, patients with adenocarcinoma of the prostate who have pathologically involved pelvic lymph nodes (pathologic node-positive or clinical stage D₁) should be considered for external-beam irradiation plus immediate hormonal manipulation rather than radiation alone with hormone manipulation at the time of relapse.

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

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