Androgen deprivation with radiation therapy compared with radiation therapy alone for locally advanced prostatic carcinoma: a randomized comparative trial of the radiation therapy oncology group

Miljenko V. Pilepich, William T. Sause, William U. Shipley, John M. Krall, Colleen A. Lawton, David Grignon, Muhyi Al-Sarraf, Ross A. Abrams, Richard Caplan, Madhu J. John, Marvin Rotman, James D. Cox, R. L Scotte Doggett, Philip Rubin, Mark S. Soloway

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Abstract

Objectives: Androgen deprivation therapy before and during radiation therapy could, by reducing tumor volume, increase local tumor control, disease-free survival, and overall survival in patients with locally advanced adenocarcinomas of the prostate. Methods: In a randomized controlled clinical trial, patients with large T2, T3, and T4 prostate tumors, but no evidence of osseous metastasis, were randomized to receive goserelin 3.6 mg subcutaneously every 4 weeks and flutamide 250 mg orally three times daily 2 months before and during the radiation therapy course (Arm I) compared with radiation therapy alone (Arm II). Pelvic irradiation was administered with 1.8 to 2.0 Gy per day to a total dose of 45 ± 1 Gy followed by a boost to the prostate target volume to a total dose of 65 to 70 Gy. Results: Of 471 randomized patients, 456 were evaluable, 226 on Arm I and 230 on Arm II. With a median potential follow-up of 4.5 years, the cumulative incidence of local progression at 5 years was 46% in Arm I and 71% in Arm II (P < 0.001). The 5-year incidence of distant metastasis on Arms I and II was 34% and 41 %, respectively (P = 0.09). Progression-free survival rates including normal prostate-specific antigen (PSA) levels for 396 patients with at least one PSA recorded were 36% in Arm I and 15% in Arm II at 5 years (P < 0.001 ). At this time, no significant difference in overall survival could be detected (P = 0.7). Conclusions: Short-term androgen deprivation with radiation therapy results in a marked increase in local control and disease-free survival compared with pelvic irradiation alone in patients with locally advanced carcinoma of the prostate. Long-term surveillance is required to assess effects on overall survival.

Original languageEnglish
Pages (from-to)616-623
Number of pages8
JournalUrology
Volume45
Issue number4
DOIs
StatePublished - Jan 1 1995
Externally publishedYes

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ASJC Scopus subject areas

  • Urology

Cite this

Pilepich, M. V., Sause, W. T., Shipley, W. U., Krall, J. M., Lawton, C. A., Grignon, D., Al-Sarraf, M., Abrams, R. A., Caplan, R., John, M. J., Rotman, M., Cox, J. D., Doggett, R. L. S., Rubin, P., & Soloway, M. S. (1995). Androgen deprivation with radiation therapy compared with radiation therapy alone for locally advanced prostatic carcinoma: a randomized comparative trial of the radiation therapy oncology group. Urology, 45(4), 616-623. https://doi.org/10.1016/S0090-4295(99)80053-3