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RTOG 85-31 (PROSTATE)

See pages: Prostate/Node Positive, Prostate/Hormones

  • Title: Phase III Comparison of Adjuvant Therapy with Zoladex vs Observation Only Following Definitive Radiotherapy for Unfavorable Prognosis Adenocarcinoma of the Prostate
  • Objectives:
    • 1) 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)
    • 2) Assess the side effects associated with long-term administration of Zoladex.
  • Protocol:
    • Arm 1: 65-70 Gy EBRT
    • Arm 2: 65-70 Gy EBRT + indefinite AST started during last week of RT
  • Eligibility:
    • (A2 and B with LN+) or (C) with no "bulky" (>25cc) disease unless spread to extra-pelvic nodes, M0
    • If s/p RP, must have +SM and/or +SVI
  • Enrolled: 977 patients
  • Conclusion:
    • PMID 15817329 -- Androgen suppression adjuvant to definitive radiotherapy in prostate carcinoma--long-term results of phase III RTOG 85-31. (Pilepich MV, IJRBOP 2005). Conclusion: In a population of patients with unfavorable prognosis carcinoma of the prostate, androgen suppression applied as an adjuvant after definitive RT was associated not only with a reduction in disease progression but in a statistically significant improvement in absolute survival. The improvement in survival appeared preferentially in patients with a Gleason score of 7-10.
  • Publications:
    • PMID 15681524 -- 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. (Lawton CA, JCO 2005). Conclusion: Pending the results of randomized trials, patients with adenocarcinoma of the prostate who have pathologically involved pelvic lymph nodes (pathologic node-positive or clinical stage D1) should be considered for external-beam irradiation plus immediate hormonal manipulation rather than radiation alone with hormone manipulation at the time of relapse.
    • PMID 12478146 -- Race and survival of men treated for prostate cancer on radiation therapy oncology group phase III randomized trials. (Roach M, J Urol 2003). Conclusion: As previously reported, tumor grade (Gleason score), palpation T stage, lymph node status, pretreatment PSA and treatment type are major predictors of overall and disease specific survival. We noted no evidence that race has independent prognostic significance in patients treated for prostate cancer in Radiation Therapy Oncology Group prospective randomized trials.
    • ASCO Abstract -- Phase III trial of androgen suppression adjuvant to definitive radiotherapy. Long term results of RTOG study 85-31. (Pilepich MV, ASCO 2003). Conclusion: Adjuvant androgen suppression has resulted in significant improvement in all end points.
    • PMID 11240235 -- 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. (Horwitz EM, IJRBOP 2001). Conclusion: Based on this analysis, adjuvant long-term hormones compared to short-term hormones resulted in statistically significant improvements in bNED control, DMF, and CSF rates for patients with locally advanced nonmetastatic prostate cancer.
    • PMID 11240234 -- 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. (Lawton CA, IJRBOP 2001). Conclusion: Use of long-term adjuvant androgen deprivation in addition to definitive radiation therapy results in a highly significant improvement in regards to local control, freedom from distant metastasis, and biochemical free survival in unfavorable prognosis patients with carcinoma of the prostate.
    • ASCO Abstract -- 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. (Horwitz EM, ASCO 2001). Conclusion: Based on this analysis, adjuvant long-term hormones compared to short-term hormones resulted in statistically significant improvements in bNED control, DMF, and CSF rates for patients with locally advanced nonmetastatic prostate cancer.
    • 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. Int J Radiat Oncol Biol Phys 48(3 suppl): A-187, 205-206, 2000.
    • PMID 11146150 -- Statistical power for a long-term survival trial with a time-dependent treatment effect. (Lu J, Control Clin Trials 2000). Conclusion: Having examined the loss in statistical power by the interim analyses under the alternative hypothesis with a lag time, we recommend that the lower sequential boundary not be used in a long-term survival clinical trial.
    • PMID 10837944 -- Predicting long-term survival, and the need for hormonal therapy: a meta-analysis of RTOG prostate cancer trials. (Roach M, IJRBOP 2000). Conclusion: Based on this meta-analysis of RTOG trials, subsets of patients can be identified who either do not appear to benefit from the use of hormonal therapy, benefit from short-term hormonal therapy, or who benefit only from long-term hormonal therapy. These observations should be confirmed by prospective randomized trials before they can be considered conclusive. In the meantime, however, these observations provide rational guidelines for deciding who should receive hormonal therapy and for how long.
    • PMID 10894874 -- Survival advantage from higher-dose radiation therapy for clinically localized prostate cancer treated on the Radiation Therapy Oncology Group trials. (Valicenti R, JCO 2000). Conclusion: These data demonstrate that higher-dose radiation therapy can significantly reduce the risk of dying from prostate cancer in men with clinically localized disease. This survival benefit is restricted to men with poorly differentiated cancers.
    • 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. Int J Radiat Oncol Biol Phys 48(3 suppl): A-114, 169.
    • PMID 10475361 -- Does androgen suppression enhance the efficacy of postoperative irradiation? A secondary analysis of RTOG 85-31. Radiation Therapy Oncology Group. (Corn BW, Urology 1999). Conclusion:Patients with prostate cancer and indications for postoperative RT should be considered for combined RT and hormonal manipulation. Because statistically significant advantages for this experimental approach could not be defined for all end points studied (in particular, overall survival), efforts should be made to enroll these patients in the recently activated RTOG trial (96-01) comparing RT plus placebo to the combination of RT plus Casodex in the postoperative setting.
    • 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. Int J Radiat Oncol Biol Phys 45(3 suppl): A142, 220-221, 1999.
    • ASCO Abstract -- 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. (Lawton CA, ASCO 1999; Proceedings of the American Society of Clinical Oncology 18: A1195, 311a, 1999.). Conclusion:Use of long term adjuvant androgen deprivation in addition to definitive radiation therapy results in a highly significant improvement with regards to local control, freedom from distant metastasis, and biochemical disease free survival in unfavorable prognosis patients with carcinoma of the prostate.
    • PMID 10022702 -- Long-term survival after radiotherapy alone: radiation therapy oncology group prostate cancer trials. (Roach M, J Urol 1999). Conclusion: In the first 10 years Gleason score was the single most important predictor of death. Gleason score should be incorporated into the current clinical staging system.
    • 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, 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, Mod Pathol 10: A436, 77a, 1997.
    • PMID 9276357 -- 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. (Lawton CA, IJRBOP 1997). Conclusion: Patients with adenocarcinoma of the prostate and pathologically involved pelvic lymph nodes (pN+ or clinical stage D1) should be seriously considered for external beam irradiation plus immediate hormonal manipulation over radiation alone with hormonal manipulation at the time of relapse.
    • PMID 9060541 -- 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. (Pilepich MV, JCO 1997). Conclusion: Application of androgen suppression as an adjuvant to definitive radiotherapy has been associated with a highly significant improvement in local control and freedom from disease progression. At this point, with a median follow-up time of 4.5 years, a significant improvement in survival has been observed only in patients with centrally reviewed tumors with a Gleason score of 8 to 10.
    • 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. Int J Radiat Oncol Biol Phys 39(suppl 2): A1007, 219, 1997.
    • 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.
    • 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). Int J Radiat Oncol Biol Phys 36(suppl 1): A139, 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). Int J Radiat Oncol Biol Phys 32(suppl 1): A95, 188, 1995.
    • ASCO Abstract -- 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). (Pilepich MV, ASCO 1995); Proceedings of the American Society of Clinical Oncology 14: A631, 239, 1995). Conclusion: Adjuvant androgen suppression with goserelin has been associated with a significant improvement in local control and progression-free survival. Longer follow-up will be necessary to substantiate an impact on overall survival.
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