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

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)3972-3978
Number of pages7
JournalJournal of Clinical Oncology
Volume21
Issue number21
DOIs
StatePublished - Nov 1 2003

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Hanks, G. E., Pajak, T. F., Porter, A., Grignon, D., Brereton, H., Venkatesan, V., Horwitz, E. M., Lawton, C., Rosenthal, S. A., Sandler, H. M., & Shipley, W. U. (2003). 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. Journal of Clinical Oncology, 21(21), 3972-3978. https://doi.org/10.1200/JCO.2003.11.023