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

Research output: Contribution to journalArticle

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

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Radiation Oncology
Androgens
Radiotherapy
Prostate
Carcinoma
Disease-Free Survival
Prostate-Specific Antigen
Survival
Goserelin
Neoplasm Metastasis
Flutamide
Incidence
Tumor Burden
Neoplasms
Adenocarcinoma
Survival Rate
Randomized Controlled Trials

ASJC Scopus subject areas

  • Urology

Cite this

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

In: Urology, Vol. 45, No. 4, 1995, p. 616-623.

Research output: Contribution to journalArticle

Pilepich, MV, Sause, WT, Shipley, WU, Krall, JM, Lawton, CA, Grignon, D, Al-Sarraf, M, Abrams, RA, Caplan, R, John, MJ, Rotman, M, Cox, JD, Doggett, RLS, Rubin, P & Soloway, MS 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, vol. 45, no. 4, pp. 616-623. https://doi.org/10.1016/S0090-4295(99)80053-3
Pilepich, Miljenko V. ; Sause, William T. ; Shipley, William U. ; Krall, John M. ; Lawton, Colleen A. ; Grignon, David ; Al-Sarraf, Muhyi ; Abrams, Ross A. ; Caplan, Richard ; John, Madhu J. ; Rotman, Marvin ; Cox, James D. ; Doggett, R. L Scotte ; Rubin, Philip ; Soloway, Mark S. / 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. In: Urology. 1995 ; Vol. 45, No. 4. pp. 616-623.
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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.",
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T1 - Androgen deprivation with radiation therapy compared with radiation therapy alone for locally advanced prostatic carcinoma

T2 - a randomized comparative trial of the radiation therapy oncology group

AU - Pilepich, Miljenko V.

AU - Sause, William T.

AU - Shipley, William U.

AU - Krall, John M.

AU - Lawton, Colleen A.

AU - Grignon, David

AU - Al-Sarraf, Muhyi

AU - Abrams, Ross A.

AU - Caplan, Richard

AU - John, Madhu J.

AU - Rotman, Marvin

AU - Cox, James D.

AU - Doggett, R. L Scotte

AU - Rubin, Philip

AU - Soloway, Mark S.

PY - 1995

Y1 - 1995

N2 - 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.

AB - 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.

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