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Clinical Trials (PDQ®)

Phase III Randomized Comparison of Zoladex/Flutamide plus Radiotherapy vs Radiotherapy Alone in Patients with Clinical Stages B2 and C Carcinoma 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-8610
RTOG-86-10

Objectives

I.  Compare locoregional tumor control in patients with clinical Stages B2 and 
C carcinoma of the prostate treated with radiotherapy alone vs. 
zoladex/flutamide prior to and during radiotherapy.

II.  Compare tumor clearance rates, disease-free survival, survival, time to 
appearance of metastasis, serum testosterone levels, sexual function, and 
toxicity/morbidity of treatment in these two treatment groups.

Entry Criteria

Disease Characteristics:


Histologically confirmed, locally advanced adenocarcinoma of
the prostate, including the following:

  Bulky primary tumors confined to the prostate (clinical
  Stage B2) with product of palpable tumor dimensions at
  least 25 sqcm

  Tumor extending beyond the capsule (clinical Stage C)

Nodal involvement below the common iliac level allowed except
involvement of common iliac and/or para-aortic lymph nodes

  Lymph node evaluation must be determined by CT scan,
  lymphangiogram, or surgical sampling

No evidence of distant metastasis allowed


Prior/Concurrent Therapy:


Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy for current malignancy

Endocrine therapy:
  No prior hormonal manipulation

Radiotherapy:
  No prior radiotherapy for current malignancy

Surgery:
  No prior major surgery for current malignancy


Patient Characteristics:


Age:
  Any age

Performance status:
  Karnofsky 60-100%

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No prior second cancer except basal cell skin carcinoma
  No major medical or psychiatric condition precluding
     completion of treatment or follow-up


Expected Enrollment

455 patients will be entered over about 5 years.

Outline

Randomized study.

Arm I:  Radiotherapy.  Irradiation of prostate and regional nodes including 
pelvic and para-aortic nodes using megavoltage equipment with effective photon 
energies greater than 1 MeV.

Arm II:  Hormonal Manipulation plus Radiotherapy.  Zoladex, ZDX, NSC-606864; 
Flutamide, FLUT, NSC-147834; plus Radiotherapy as in Arm I.  ZDX and FLUT 
administered for 2 months prior to and during Radiotherapy.

Published Results

Okera M, Bae K, Bernstein E, et al.: Evaluation of nuclear factor κB and chemokine receptor CXCR4 co-expression in patients with prostate cancer in the Radiation Therapy Oncology Group (RTOG) 8610. BJU Int 108 (2 Pt 2): E51-8, 2011.[PUBMED Abstract]

Zhang M, Ho A, Hammond EH, et al.: Prognostic value of survivin in locally advanced prostate cancer: study based on RTOG 8610. Int J Radiat Oncol Biol Phys 73 (4): 1033-42, 2009.[PUBMED Abstract]

Khor LY, Bae K, Al-Saleem T, et al.: Protein kinase A RI-alpha predicts for prostate cancer outcome: analysis of radiation therapy oncology group trial 86-10. Int J Radiat Oncol Biol Phys 71 (5): 1309-15, 2008.[PUBMED Abstract]

Roach M 3rd, Bae K, Speight J, et al.: Short-term neoadjuvant androgen deprivation therapy and external-beam radiotherapy for locally advanced prostate cancer: long-term results of RTOG 8610. J Clin Oncol 26 (4): 585-91, 2008.[PUBMED Abstract]

Torres-Roca JF, DeSilvio M, Mora LB, et al.: Activated STAT3 as a correlate of distant metastasis in prostate cancer: a secondary analysis of Radiation Therapy Oncology Group 86-10. Urology 69 (3): 505-9, 2007.[PUBMED Abstract]

Khor LY, Desilvio M, Li R, et al.: Bcl-2 and bax expression and prostate cancer outcome in men treated with radiotherapy in Radiation Therapy Oncology Group protocol 86-10. Int J Radiat Oncol Biol Phys 66 (1): 25-30, 2006.[PUBMED Abstract]

Shipley WU, DeSilvio M, Pilepich MV, et al.: Early initiation of salvage hormone therapy influences survival in patients who failed initial radiation for locally advanced prostate cancer: a secondary analysis of RTOG phase III protocol 86-10. [Abstract] 2006 Prostate Cancer Symposium, February 24-26, 2006, San Francisco, CA. A-186, 2006.

Shipley WU, Desilvio M, Pilepich MV, et al.: Early initiation of salvage hormone therapy influences survival in patients who failed initial radiation for locally advanced prostate cancer: A secondary analysis of RTOG protocol 86-10. Int J Radiat Oncol Biol Phys 64 (4): 1162-7, 2006.[PUBMED Abstract]

Khor LY, Desilvio M, Al-Saleem T, et al.: MDM2 as a predictor of prostate carcinoma outcome: an analysis of Radiation Therapy Oncology Group Protocol 8610. Cancer 104 (5): 962-7, 2005.[PUBMED Abstract]

Konski A, Sherman E, Krahn M, et al.: Economic analysis of a phase III clinical trial evaluating the addition of total androgen suppression to radiation versus radiation alone for locally advanced prostate cancer (Radiation Therapy Oncology Group protocol 86-10). Int J Radiat Oncol Biol Phys 63 (3): 788-94, 2005.[PUBMED Abstract]

Torres-Roca JF, Desilvio M, Mora-Diaz LB, et al.: Stat3 as a correlate of distant metastasis in RTOG 86-10. [Abstract] J Clin Oncol 23 (Suppl 16): A-4656, 416s, 2005.

Abdel-Wahab M, Berkey B, Krishan A, et al.: Influence of number of CAG repeats on local control in the RTOG 86-10 protocol. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-1118, S326, 2004.

Khor L, DeSilvio ML, Al-Saleem T, et al.: MDM2 as a predictor of prostate cancer outcome: an analysis of RTOG 8610. [Abstract] Int J Radiat Oncol Biol Phys 60 (Suppl 1): A-2227, S472, 2004.

Li R, Heydon K, Hammond ME, et al.: Ki-67 staining index predicts distant metastasis and survival in locally advanced prostate cancer treated with radiotherapy: an analysis of patients in radiation therapy oncology group protocol 86-10. Clin Cancer Res 10 (12 Pt 1): 4118-24, 2004.[PUBMED Abstract]

Chakravarti A, Heydon K, Wu CL, et al.: Loss of p16 expression is of prognostic significance in locally advanced prostate cancer: an analysis from the Radiation Therapy Oncology Group protocol 86-10. J Clin Oncol 21 (17): 3328-34, 2003.[PUBMED Abstract]

Hughes LA, Heydon K, Edmonds P, et al.: Vascular endothelial growth factor (VEGF) expression in locally advanced prostate cancer (LAPC): secondary analysis of Radiation Therapy Oncology Group (RTOG) 8610. [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S201-2, 2003.

Konski AA, Sherman E, Krahn M, et al.: Monte Carlo simulation of a Markov Model for a phase III clinical trial evaluating the addition of total androgen suppression (TAS) to radiation versus radiation alone for locally advanced prostate cancer (RTOG 86-10). [Abstract] Int J Radiat Oncol Biol Phys 57 (2 Suppl): S215-6, 2003.

Pollack A, Grignon DJ, Heydon KH, et al.: Prostate cancer DNA ploidy and response to salvage hormone therapy after radiotherapy with or without short-term total androgen blockade: an analysis of RTOG 8610. J Clin Oncol 21 (7): 1238-48, 2003.[PUBMED Abstract]

Pilepich MV, Winter K, John MJ, et al.: Phase III radiation therapy oncology group (RTOG) trial 86-10 of androgen deprivation adjuvant to definitive radiotherapy in locally advanced carcinoma of the prostate. Int J Radiat Oncol Biol Phys 50 (5): 1243-52, 2001.[PUBMED Abstract]

Shipley WU, Heydon KH, Pilepich MV, et al.: A secondary analysis of RTOG 86-10: does the extent of progression at the time of initiating salvage hormone therapy influence survival in patients with prostate cancer who failed initial treatment with irradiation? [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-726, 182a, 2001.

Shipley W, Lu JD, Pilepich MV, et al.: Does neoadjuvant hormone treatment compromise subsequent androgen suppression in prostate cancer patients who fail initial radiation therapy: a secondary analysis of RTOG-8610. [Abstract] Int J Radiat Oncol Biol Phys 48 (3 suppl): A-115, 169-170, 2000.

Scott C, Roach M, Lawton C, et al.: Q-twist analysis for prostate cancer treated with radiation therapy with or without hormonal therapy: RTOG 86-10. [Abstract] Qual Life Res 8 (7): A-48, 568, 1999.

Hammond EH, Lu JD, Doggett RL, et al.: Microvessel density in prostatic biopsies in a phase III trial (RTOG 86-10). [Abstract] Lab Invest 78: A-481, 84a, 1998.

Pilepich ML, Winter K, Roach M, et al.: Phase III Radiation Therapy Oncology Group (RTOG) trial 86-10 of androgen deprivation before and during radiotherapy in locally advanced carcinoma of the prostate. [Abstract] Int J Radiat Oncol Biol Phys 42 (suppl 1): A-105, 177, 1998.

Grignon DJ, Caplan R, Sarkar FH, et al.: p53 status and prognosis of locally advanced prostatic adenocarcinoma: a study based on RTOG 8610. J Natl Cancer Inst 89 (2): 158-65, 1997.[PUBMED Abstract]

Grignon D, Won M, Hammond E, et al.: DNA content as a prognostic indicator in prostate cancer (PCA): a study based on RTOG protocol 86-10. [Abstract] Proceedings of the United States and Canadian Academy of Pathology Meeting 9(1): A419, 75a, 1996.

Grignon D, Caplan R, Sarkar F, et al.: p53 suppressor gene mutations predict for failure following combined neoadjuvant total androgen ablation and external beam radiation therapy for locally advanced prostate cancer: a study based on RTOG protocol 86-10. [Abstract] Proceedings of the American Urological Association 153(suppl 1): A293, 1995.

Pilepich MV, Krall JM, al-Sarraf M, et al.: 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): 616-23, 1995.[PUBMED Abstract]

Pilepich MV, Krall J, Al-Sarraf M, et al.: A phase III trial of androgen suppression before and during radiation therapy (RT) for locally advanced prostatic carcinoma: preliminary report of RTOG protocol 8610. [Abstract] Proceedings of the American Society of Clinical Oncology 12: A-703, 229, 1993.

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]

Roach M 3rd, Waldman F, Pollack A: Predictive models in external beam radiotherapy for clinically localized prostate cancer. Cancer 115 (13 Suppl): 3112-20, 2009.[PUBMED Abstract]

Antonarakis ES, Eisenberger MA: Does short-term ADT before and during radiation therapy improve outcomes in locally advanced prostate cancer? Nat Clin Pract Urol 5 (9): 480-1, 2008.[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.

Paner GP, Bae K, Grignon DJ, et al.: Trends in Gleason grading of prostate cancer (PCa): analysis of reporting by institutional and central review pathologists in four Radiation Therapy Oncology Group (RTOG) protocols spanning 17 years and 2094 needle biopsies (bxs). [Abstract] United States and Canadian Academy of Pathology 96th Annual Meeting, March 24-30, 2007, San Diego, CA. A-766, 2007.

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.

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.

Pajak TF, Clark GM, Sargent DJ, et al.: Statistical issues in tumor marker studies. Arch Pathol Lab Med 124 (7): 1011-5, 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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