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Phase III Comparison of Adjuvant Therapy with Zoladex vs Observation Only Following Definitive Radiotherapy for Unfavorable Prognosis Adenocarcinoma of the Prostate

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedany ageNCIRTOG-8531
RTOG-85-31

Objectives

I.  Evaluate the relative effectiveness of elective vs. therapeutic androgen 
deprivation with Zoladex with regard to disease progression and survival among 
patients with adenocarcinoma of the prostate who are at high risk for relapse 
and tumor-related death, including patients with evidence of involvement of 
regional lymphatics or gross extension of palpable tumor beyond the prostate 
(clinical or pathological Stage C).
II.  Assess the side effects associated with long-term administration of 
Zoladex.

Entry Criteria

Disease Characteristics:


Histologically confirmed andenocarcinoma of the prostate with
regional lymphatic involvement or gross extension of the
palpable primary tumor beyond the prostate

Clinical Stage A2 and B must have radiographic or histologic
evidence of spread to regional lymph nodes (obturator,
external and/or internal iliac, common iliac, and/or
periaortic)

Clinical Stage C allowed regardless of status of regional
nodes

No bulky disease (product of palpable tumor dimension of 25
sqcm or more) unless there is evidence of spread to regional
nodes outside the pelvis, i.e., to common iliac and
periaortic nodes
  Others may be eligible for cytoreduction protocol
  (RTOG-8610)

No distant metastasis
No lymph node involvement beyond periaortic area

Histologic documentation of penetration through the prostatic
capsule to margin of resection and/or seminal vesicle
involvement required if prior radical prostectomy performed


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy

Endocrine therapy:
  No prior hormone manipulation

Radiotherapy:
  No prior radiotherapy

Surgery:
  Prior radical prostatectomy allowed provided there is
  histologically documented penetration through the prostatic
  capsule to margin of resection and/or seminal vesicle
  involvement


Patient Characteristics:


Age:
  Any age

Performance status:
  Karnofsky 60-100%

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No second malignancy except basal cell carcinoma of the skin
  No major medical or psychiatric illness that could
  interfere with treatment and follow-up


Expected Enrollment

A total of 931 patients will be entered in order to have 287 evaluable 
patients on each arm.  Accrual as of 3-27-90 was 460 cases; at the present 
accrual rate, the study should remain open until May 1992.

Outline

Randomized study.
Arm I:  Radiotherapy.  Involved field irradiation using megavoltage equipment 
(effective photon energies greater than 1 MeV).
Arm II:  Radiotherapy plus Endocrine Therapy.  Radiotherapy as in Arm I; plus 
androgen deprivation with Zoladex, ZDX, NSC-606864.

Published Results

Souhami L, Bae K, Pilepich M, et al.: Timing of salvage hormonal therapy in prostate cancer patients with unfavorable prognosis treated with radiotherapy: a secondary analysis of Radiation Therapy Oncology Group 85-31. Int J Radiat Oncol Biol Phys 78 (5): 1301-6, 2010.[PUBMED Abstract]

Efstathiou JA, Bae K, Shipley WU, et al.: Cardiovascular mortality after androgen deprivation therapy for locally advanced prostate cancer: RTOG 85-31. J Clin Oncol 27 (1): 92-9, 2009.[PUBMED Abstract]

Souhami L, Bae K, Pilepich M, et al.: Impact of the duration of adjuvant hormonal therapy in patients with locally advanced prostate cancer treated with radiotherapy: a secondary analysis of RTOG 85-31. J Clin Oncol 27 (13): 2137-43, 2009.[PUBMED Abstract]

Efstathiou JA, Bae K, Shipley WU, et al.: Obesity and prostate cancer-specific mortality following radiation therapy and androgen suppression for locally advanced prostate cancer: an analysis of RTOG 85-31. [Abstract] American Society of Clinical Oncology 2007 Prostate Cancer Symposium, 22-24 February 2007, Orlando, FL. A-112, 2007.

Efstathiou JA, Bae K, Shipley WU, et al.: Body mass index and mortality in men treated for locally advanced prostate cancer: an analysis of RTOG 85-31. [Abstract] J Clin Oncol 25 (Suppl 18): A-5128, 266s, 2007.

Efstathiou JA, Bae K, Shipley WU, et al.: Cardiovascular mortality following androgen deprivation therapy in men with locally advanced prostate cancer: an analysis of RTOG 85-31. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-1060, S170-171, 2007.

Efstathiou JA, Bae K, Shipley WU, et al.: Obesity and mortality in men with locally advanced prostate cancer: analysis of RTOG 85-31. Cancer 110 (12): 2691-9, 2007.[PUBMED Abstract]

Souhami L, Bae K, Pilepich MV, et al.: The impact of the duration of adjuvant hormonal therapy in patients with unfavorable prognosis prostate cancer treated with radiotherapy: secondary analysis of RTOG 85-31. [Abstract] J Clin Oncol 25 (Suppl 18): A-5062, 250s, 2007.

Souhami L, Bae K, Pilepich MV, et al.: Impact of adjuvant hormonal therapy duration and timing of salvage hormonal therapy in prostate cancer patients with unfavorable prognosis treated by radiotherapy: a secondary analysis of RTOG 8531. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-1059, S170, 2007.

Lawton CA, Winter K, Grignon D, et al.: 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. J Clin Oncol 23 (4): 800-7, 2005.[PUBMED Abstract]

Pilepich MV, Winter K, Lawton CA, et al.: Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. Int J Radiat Oncol Biol Phys 61 (5): 1285-90, 2005.[PUBMED Abstract]

Roach M 3rd: Radiotherapy plus adjuvant goserelin improves survival in men with poor prognosis prostate cancer. Cancer Treat Rev 31 (7): 582-6, 2005.[PUBMED Abstract]

Pilepich MV, Winter K, Lawton C, et al.: Phase III trial of androgen suppression adjuvant to definitive radiotherapy. Long term results of RTOG study 85-31. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1530, 2003.

Pilepich MV, Winter K, Lawton C, et al.: Androgen suppression adjuvant to radiotherapy in carcinoma of the prostate: long-term results of phase III RTOG study 85-31. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S172-3, 2003.

Lawton CA, Winter K, Murray K, et al.: Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen suppression following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. Int J Radiat Oncol Biol Phys 49 (4): 937-46, 2001.[PUBMED Abstract]

Corn BW, Winter K, Pilepich MV: Does androgen suppression enhance the efficacy of postoperative irradiation? A secondary analysis of RTOG 85-31. Radiation Therapy Oncology Group. Urology 54 (3): 495-502, 1999.[PUBMED Abstract]

Lawton C, Winter K, Murray K, et al.: Updated results of the phase III Radiation Therapy Oncology Group (RTOG) trial 85-31 evaluating the potential benefit of androgen deprivation following standard radiation therapy for unfavorable prognosis carcinoma of the prostate. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A1195, 311a, 1999.

Grignon D, Pajak T, Winter K, et al.: Central review vs. institutional gleason grading and its impact on phase III clinical trial analysis: a review of RTOG protocol 85-31. [Abstract] Proceedings of the United States and Canadian Academy of Pathology Meeting 10: A436, 77a, 1997.

Grignon D, Pajak T, Winter K, et al.: Central review vs. institutional gleason grading and its impact on phase III clinical trial analysis: a review of RTOG protocol 8531. [Abstract] Mod Pathol 10: A-439, 77a, 1997.

Lawton CA, Winter K, Byhardt R, et al.: Androgen suppression plus radiation versus radiation alone for patients with D1 (pN+) adenocarcinoma of the prostate (results based on a national prospective randomized trial, RTOG 85-31). Radiation Therapy Oncology Group. Int J Radiat Oncol Biol Phys 38 (5): 931-9, 1997.[PUBMED Abstract]

Pilepich MV, Caplan R, Byhardt RW, et al.: Phase III trial of androgen suppression using goserelin in unfavorable-prognosis carcinoma of the prostate treated with definitive radiotherapy: report of Radiation Therapy Oncology Group Protocol 85-31. J Clin Oncol 15 (3): 1013-21, 1997.[PUBMED Abstract]

Winter K, Grignon D, Pajak T, et al.: Subjective pathology tumor grading: impact on design and analysis of Radiation Therapy Oncology Group prostate trial 85-31. [Abstract] Proceedings of the Society for Clinical Trials and the International Society for Clinical Biostatistics 18: A124, 186S-187S, 1997.

Winter K, Grignon D, Pajak TF, et al.: The need for central pathology tumor grading in prostate cancer using Radiation Therapy Oncology Group (RTOG) 85-31. [Abstract] Int J Radiat Oncol Biol Phys 39 (suppl 2): A-1007, 219, 1997.

Lawton CA, Pajak TF, Byhardt R, et al.: Androgen suppression plus radiation vs. radiation alone for patients with D1 (pN+) adenocarcinoma of the prostate (results based on a national prospective randomized trial RTOG 85-31). [Abstract] Int J Radiat Oncol Biol Phys 36 (suppl 1): A-139, 228, 1996.

Pilepich M, Caplan R, Byhardt R, et al.: Phase III trial of adjuvant androgen suppression using goserelin in patients with carcinoma of the prostate treated with definitive radiotherapy (results of RTOG 85-31). [Abstract] Int J Radiat Oncol Biol Phys 32 (suppl 1): A-95, 188, 1995.

Pilepich MV, Caplan R, Byhardt RW, et al.: Phase III trial of androgen suppression using goserelin in unfavorable prognosis carcinoma of the prostate treated with definitive radiotherapy (report of RTOG protocol 85-31). [Abstract] Proceedings of the American Society of Clinical Oncology 14: A631, 239, 1995.

Related Publications

Hamstra DA, Bae K, Pilepich MV, et al.: Older age predicts decreased metastasis and prostate cancer-specific death for men treated with radiation therapy: meta-analysis of radiation therapy oncology group trials. Int J Radiat Oncol Biol Phys 81 (5): 1293-301, 2011.[PUBMED Abstract]

Lawton CA, Bae K, Pilepich M, et al.: Long-term treatment sequelae after external beam irradiation with or without hormonal manipulation for adenocarcinoma of the prostate: analysis of radiation therapy oncology group studies 85-31, 86-10, and 92-02. Int J Radiat Oncol Biol Phys 70 (2): 437-41, 2008.[PUBMED Abstract]

Lawton CA, Michalski J, El- Naqa I, et al.: RTOG: genitourinary radiation oncology specialists reach consensus on pelvic lymph node volumes for high risk prostate cancer. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-6, 2008.

Lawton CA, Bae K, Pilepich M, et al.: Long-term treatment sequelae following external beam irradiation + hormonal manipulation for adenocarcinoma of the prostate: analysis of RTOG studies 85-31, 86-10, and 92-02. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-191, 2006.

Carroll PR: Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma: long-term results of phase III RTOG 85-31. Urol Oncol 23 (6): 462-3, 2005.

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]

Horwitz EM, Winter K, Hanks GE, et al.: Subset analysis of RTOG 85-31 and 86-10 indicates an advantage for long-term vs. short-term adjuvant hormones for patients with locally advanced nonmetastatic prostate cancer treated with radiation therapy. Int J Radiat Oncol Biol Phys 49 (4): 947-56, 2001.[PUBMED Abstract]

Anderson PR, Winter KA, Hanks GE, et al.: Gleason score 4+3 prostate cancer patients have worse bNED outcome compared to Gleason score 3+4 treated with radiation therapy alone: subset analysis of RTOG 85-31 and 86-10. [Abstract] Int J Radiat Oncol Biol Phys 48 (3 suppl): A-187, 205-206, 2000.

Lu J, Pajak TF: Statistical power for a long-term survival trial with a time-dependent treatment effect. Control Clin Trials 21 (6): 561-73, 2000.[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]

Horwitz EM, Winter K, Hanks GE, et al.: Long-term outcome for patients with locally advanced non-metastatic prostate cancer treated with adjuvant hormones and radiation therapy versus radiation therapy alone: subset analysis of RTOG 85-31 and 86-10. [Abstract] Int J Radiat Oncol Biol Phys 45 (3 suppl): A-142, 220-221, 1999.

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.

Grignon D, Pajak T, Hammond E, et al.: Application of the gleason grading system: a comparison of institutional and central review grading using RTOG protocols 85-31 and 86-10. [Abstract] Proceedings of the United States and Canadian Academy of Pathology Meeting 9(1): A418, 73a, 1996.

Pilepich MV, Winter K, Byhardt R, et al.: Androgen ablation adjuvant to definitive radiotherapy in carcinoma of the prostate: year 2000 update of RTOG phase III studies 86-10 and 85-31. [Abstract] Int J Radiat Oncol Biol Phys 48 (3 suppl): A-114, 169.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Miljenko Pilepich, MD, Protocol chair (Contact information may not be current)
Ph: 734-712-5658; 888-474-4673

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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