Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed no age specified NCI RTOG-7506 RTOG-75-06

Objectives

I.  Determine the value of pelvic vs. pelvic plus para-aortic nodal 
irradiation (when common iliac and para-aortic nodes are negative or 
unevaluated), and the value of pelvic plus para-aortic nodal irradiation vs. 
pelvic, para-aortic, mediastinal and supraclavicular irradiation (when common 
iliac and/or para-aortic nodes are positive) in locally advanced prostate 
cancer as measured by relapse-free survival and total survival.
II.  Determine whether radiation therapy is superior to hormonal therapy as 
measured by the relapse-free survival, total survival and complications and 
reactions.
III.  Determine the value of the rate of tumor clearance and post-irradiation 
biopsy of the prostate cancer bed in predicting long-term local control (cure).

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with Stage C adenocarcinoma 
of the prostate who have not had curative surgery and who have lymphangiogram 
or laparotomy evidence of lymph node involvement.  (Note:  lymphangiogram and 
laparotomy are used to determine treatment group in this protocol, the staging 
is clinical, and is not changed by lymphangiogram or laparotomy findings.) 
Protocol revised 11/77 to allow Stage B patients with positive pelvic nodes, 
and in 10/80 to allow Stage A2 patients with positive pelvic nodes.  Per 
February 1983 revision, all patients must have a lymphadenectomy.

Expected Enrollment

As of September 1981, 366 patients have been entered.  Protocol closed July 
1983.

Outline

Randomized study.  Randomize patients with positive pelvic nodes and negative 
common iliac and para-aortic lymph nodes or with unknown nodal status or with 
no positive nodes to Arm I, II or III and patients with positive common iliac 
and/or para-aortic lymph nodes to Arm IV, V or VI.  Arms I, IV, V and VI were 
terminated in 1977.
Arm I:  Single-agent Hormone Therapy.  Stilphostrol, NSC-10481; or 
Diethylstilbestrol, DES, NSC-3070.  (Arm terminated by 6/77 revision.)
Arm II:  Radiotherapy.  Irradiation of pelvic nodes plus prostate boost.
Arm III:  Radiotherapy.  Irradiation of pelvic and para-aortic nodes.
Arm IV:  Single-agent Hormone Therapy.  Stilphostrol or DES.  (Arm terminated 
by 6/77 revision.)
Arm V:  Radiotherapy.  Irradiation of prostate, pelvic and para-aortic nodes.  
(Arm terminated by 6/77 revision.)
Arm VI:  Radiotherapy.  Irradiation of prostate, pelvic, para-aortic, 
mediastinal and supraclavicular nodes.  (Arm terminated by 6/77 revision.)

Hanks GE, Buzydlowski J, Sause WT, et al.: Ten-year outcomes for pathologic node-positive patients treated in RTOG 75-06. Int J Radiat Oncol Biol Phys 40 (4): 765-8, 1998.[PUBMED Abstract]

Pilepich MV, Johnson RJ, Perez CA, et al.: Prognostic significance of nodal involvement in locally advanced (stage C) carcinoma of prostate--RTOG experience. Urology 30 (6): 535-40, 1987.[PUBMED Abstract]

Pilepich MV, Krall JM, Sause WT, et al.: Prognostic factors in carcinoma of the prostate--analysis of RTOG study 75-06. Int J Radiat Oncol Biol Phys 13 (3): 339-49, 1987.[PUBMED Abstract]

Pilepich MV, Krall JM, Sause WT, et al.: Correlation of radiotherapeutic parameters and treatment related morbidity in carcinoma of the prostate--analysis of RTOG study 75-06. Int J Radiat Oncol Biol Phys 13 (3): 351-7, 1987.[PUBMED Abstract]

Pilepich MV, Krall JM, Johnson RJ, et al.: Extended field (periaortic) irradiation in carcinoma of the prostate--analysis of RTOG 75-06. Int J Radiat Oncol Biol Phys 12 (3): 345-51, 1986.[PUBMED Abstract]

Roach M 3rd, Lu J, Pilepich MV, et al.: Race and survival of men treated for prostate cancer on radiation therapy oncology group phase III randomized trials. J Urol 169 (1): 245-50, 2003.[PUBMED Abstract]

Roach M 3RD, Lu J, Pilepich MV, et al.: Predicting long-term survival, and the need for hormonal therapy: a meta-analysis of RTOG prostate cancer trials. Int J Radiat Oncol Biol Phys 47 (3): 617-27, 2000.[PUBMED Abstract]

Roach M, Lu J, Pilepich MV, et al.: Four prognostic groups predict long-term survival from prostate cancer following radiotherapy alone on Radiation Therapy Oncology Group clinical trials. Int J Radiat Oncol Biol Phys 47 (3): 609-15, 2000.[PUBMED Abstract]

Valicenti R, Lu J, Pilepich M, et al.: Survival advantage from higher-dose radiation therapy for clinically localized prostate cancer treated on the Radiation Therapy Oncology Group trials. J Clin Oncol 18 (14): 2740-6, 2000.[PUBMED Abstract]

Roach M 3rd, Lu J, Pilepich MV, et al.: Long-term survival after radiotherapy alone: radiation therapy oncology group prostate cancer trials. J Urol 161 (3): 864-8, 1999.[PUBMED Abstract]

Valicenti R, Lu JD, Grignon D, et al.: Radiation dose-response is Gleason score dependent on the Radiation Therapy Oncology Group prostate cancer trials. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A1194, 311a, 1999.

Roach M, Lu J, Pilepich M, et al.: Long term survival in 1500 men treated for prostate cancer with radiotherapy alone (XRT): based on radiation therapy oncology group protocols 7706, 7506, 8531, and 8610. [Abstract] Proceedings of the American Urological Association 1998.

Roach M III, Lu J, Pilepich MV, et al.: Prognostic subgroups predict disease specific survival for men treated with radiotherapy alone on Radiation Therapy Oncology Group (RTOG) prostate cancer trials. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A1201, 312a, 1998.

Zhou R, Sause WT, Hammond EH, et al.: Correlation of survival with quantitative tissue staining of prostate specific acid phosphatase in patients with prostate carcinoma by using microscopic image analysis: a preliminary report of correlative studies on RTOG protocols 75-06, 77-06, and 83-07. Int J Radiat Oncol Biol Phys 33 (4): 823-9, 1995.[PUBMED Abstract]

Hanks GE, Krall JM, Hanlon AL, et al.: Patterns of Care and RTOG studies in prostate cancer: long-term survival, hazard rate observations, and possibilities of cure. Int J Radiat Oncol Biol Phys 28 (1): 39-45, 1994.[PUBMED Abstract]

Hanks GE, Krall JM, Pilepich MV, et al.: Comparison of pathologic and clinical evaluation of lymph nodes in prostate cancer: implications of RTOG data for patient management and trial design and stratification. Int J Radiat Oncol Biol Phys 23 (2): 293-8, 1992.[PUBMED Abstract]

Hammond ME, Sause WT, Martz KL, et al.: Correlation of prostate-specific acid phosphatase and prostate-specific antigen immunocytochemistry with survival in prostate carcinoma. Cancer 63 (3): 461-6, 1989.[PUBMED Abstract]

Pilepich MV, Krall JM, Hanks GE, et al.: Correlation of pre-treatment transurethral resection and prognosis in patients with stage C carcinoma of the prostate treated with definitive radiotherapy--RTOG experience. Int J Radiat Oncol Biol Phys 13 (2): 195-9, 1987.[PUBMED Abstract]

Pilepich MV, Asbell SO, Mulholland GS, et al.: Surgical staging in carcinoma of the prostate: the RTOG experience. Radiation Therapy Oncology Group. Prostate 5 (5): 471-6, 1984.[PUBMED Abstract]

Pilepich MV, Krall J, George FW, et al.: Treatment-related morbidity in phase III RTOG studies of extended-field irradiation for carcinoma of the prostate. Int J Radiat Oncol Biol Phys 10 (10): 1861-7, 1984.[PUBMED Abstract]

Pilepich MV, Pajak T, George FW, et al.: Preliminary report on phase III RTOG studies of extended-field irradiation in carcinoma of the prostate. Am J Clin Oncol 6 (4): 485-91, 1983.[PUBMED Abstract]

Terry R: Some questions raised by histologic study of RTOG protocols 75-06 and 77-06 as illustrated by selected samples. Prostate 3 (6): 543-54, 1982.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

James Cox, MD, Protocol chair		Ph: 713-563-2316; 800-392-1611