Radiation Oncology/RTOG Trials/7706

RTOG 77-06 (PROSTATE)
 * Title: Phase III Prostatic Irradiation vs Pelvic Irradiation plus Prostate Boost for Stage A2/B Prostatic Adenocarcinoma
 * Objectives:
 * (1) Determine the value of irradiation of the prostate only vs. pelvic irradiation with prostate boost in patients with Stages A2 and B adenocarcinoma of the prostate.
 * (2) Compare the morbidity and complications of these two radiotherapeutic regimens.
 * Eligibility: Stage A2 and B, N0M0
 * Protocol:
 * Arm 1: 65 Gy prostate field EBRT
 * Arm 2: 45 Gy pelvic field EBRT + 20 Gy prostate boost
 * Enrolled: 453 patients
 * Conclusion:
 * PMID 3058656 -- Elective pelvic irradiation in stage A2, B carcinoma of the prostate: analysis of RTOG 77-06. (Asbell, IJRBOP 1988). Conclusion: The results of the study revealed no statistically significant benefit of elective pelvic irradiation.
 * Publications:
 * PMID 12478146 -- Race and survival of men treated for prostate cancer on radiation therapy oncology group phase III randomized trials. (Roach, 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.
 * PMID 10837944 -- Predicting long-term survival, and the need for hormonal therapy: a meta-analysis of RTOG prostate cancer trials. (Roach, 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 10837943 -- Four prognostic groups predict long-term survival from prostate cancer following radiotherapy alone on Radiation Therapy Oncology Group clinical trials. (Roach, IJRBOP 2000). Conclusion: Recognition of these four risk groups provides a basis for estimating the long-term DSS for men treated with XRT alone and should facilitate the design of future prospective randomized trials.
 * PMID 10894874 -- Survival advantage from higher-dose radiation therapy for clinically localized prostate cancer treated on the Radiation Therapy Oncology Group trials. (Valicenti, 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.
 * 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.
 * ASCO Abstract -- Radiation Dose-Response Is Gleason Score Dependent on the Radiation Therapy Oncology Group Prostate Cancer Trials (Meeting abstract). (Valicenti R, ASCO 1999). Conclusion: These data suggest a significant effect for higher radiation dose to reduce the probability of dying from prostate cancer in men with poorly differentiated disease.
 * PMID 9531360 -- Impact of surgical staging in evaluating the radiotherapeutic outcome in RTOG #77-06, a phase III study for T1BN0M0 (A2) and T2N0M0 (B) prostate carcinoma. (Asbell, IJRBOP 1998). Conclusion: At 12-year median follow-up, there still was no survival difference in those patients treated prophylactically to the pelvic nodes and prostatic bed vs. the prostatic bed alone. Those patients not surgically staged with only LAG for lymph node evaluation were less accurately staged, as reflected by a statistically significant reduced survival and earlier metastases.
 * 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.
 * ASCO Abstract -- Prognostic subgroups predict disease specific survival for men treated with radiotherapy alone on Radiation Therapy Oncology Group (RTOG) prostate cancer trials. (Roach M, ASCO 1998; Proceedings of the American Society of Clinical Oncology 17: A1201, 312a, 1998.
 * ASCO Abstract -- Impact of surgical staging in evaluating the radiotherapeutic outcome in RTOG phase III study for T1b-T2NOMO prostatic carcinoma: RTOG #77-06. (Asbell SO, ASCO 1995; Proceedings of the American Society of Clinical Oncology 14: A-1681, 512, 1995
 * PMID 7591889 -- 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. (Zhou, IJRBOP 1995). Conclusion: Quantitative image analysis of the IPSAP stain predicts survival in patients treated with external beam radiotherapy with and without prior hormonal therapy
 * PMID 7523341 -- PSA confirmation of cure at 10 years of T1B, T2, N0, M0 prostate cancer patients treated in RTOG protocol 7706 with external beam irradiation. (Hanks GE, IJRBOP 1994). Conclusion: Prostatic specific antigen adds to the accuracy of determining clinical long-term cure and shows that 65-88% of patients who are clinical no evidence of disease are "biochemical" cures as well. These correlation percentages are quite similar to the largest contemporary surgical series, and strongly support the concept and fact of cure of prostate cancer with radiation.
 * PMID 8270458 -- Patterns of Care and RTOG studies in prostate cancer: long-term survival, hazard rate observations, and possibilities of cure. (Hanks GE, IJRBOP 1994). Conclusion: These data make a strong argument for the long-term cure of prostate cancer by external beam radiation, and support the continued use and study of radiation therapy as a curative modality in prostate cancer. No similar national data is available for any other method of management.
 * PMID 1587749 -- Comparison of pathologic and clinical evaluation of lymph nodes in prostate cancer: implications of RTOG data for patient management and trial design and stratification. (Hanks GE, IJRBOP 1992). Conclusion: The clinical determination of nodal status, therefore, has no prognostic value in contrast to pathologic determination and should not be used for stratifying patients in clinical trials. The CT scans often used to evaluate nodal status are more useful if delayed until they can be done as part of the treatment planning process where the CT has value. When imaging tests suggest positive lymph nodes in prostate cancer patients, the imaging finding is confirmed by biopsy.
 * PMID 1917621 -- The effect of overall treatment time on the outcome of definitive radiotherapy for localized prostate carcinoma: the Radiation Therapy Oncology Group 75-06 and 77-06 experience. (Lai PP, IJRBOP 1991). Conclusion: The incidence of late complications was not related to the number of elapsed treatment days. Therefore, the overall treatment time does not have an impact on the outcome of definitive radiotherapy for localized prostate carcinoma. It is hypothesized that prostate carcinoma behaves as late-reacting tissue in which there is little, if any, accelerated repopulation of clonogenic tumor cells during the later half of a protracted course of radiotherapy.
 * PMID 1917610 -- Outcome for lymph node dissection negative T-1b, T-2 (A-2,B) prostate cancer treated with external beam radiation therapy in RTOG 77-06. (Hanks GE, IJRBOP 1991). Conclusion: The outcome of this group is equal or superior to reports of radical prostatectomy in similar stage patients.
 * PMID 2808056 -- Impact of surgical staging in evaluating the radiotherapeutic outcome in RTOG phase III study for A2 and B prostate carcinoma. (Asbell, IJRBOP 1989). Conclusion: Compared to the lymphangiography group, the staging lymphadenectomy group showed better overall survival (87% to 76% at 5 years, p = .02), better disease-free survival (76% to 63% at 5 years, p = .008) and better metastases-free survival (88% to 82% at 5 years, p = .04). There was no difference between the groups in local control. The lymphangiography evaluation of pelvic nodes was clearly inferior for demonstration of the absence of pelvic node metastasis as reflected by reduced survival and increased metastasis.
 * PMID 3597142 -- Correlation of radiotherapeutic parameters and treatment related morbidity--analysis of RTOG Study 77-06. (Pilepich, IJRBOP 1987). Conclusion: Within the range of pelvic doses used in this study a significant dose effect could not be detected. Total doses to the prostate of more than 7000 cGy were associated with an increased risk of rectal bleeding. Certain treatment techniques, (AP/PA irradiation of the pelvic lymphatics) were associated with an increased incidence of bowel complications.
 * PMID 6483687 -- Surgical staging in carcinoma of the prostate: the RTOG experience. Radiation Therapy Oncology Group. (Pilepich, Prostate 1984). Conclusion: The incidence of postirradiation lymphedema was found to be strongly dependent upon the extent of dissection.
 * PMID 6346857 -- Preliminary report on phase III RTOG studies of extended-field irradiation in carcinoma of the prostate. (Pilepich, Am J Clin Oncol 1983). Conclusion: The use of paraaortic fields in RTOG 75-06 and pelvic fields in RTOG 77-06 have not resulted in a significant increase of GI or GU morbidity at this time. The only statistically significant trend was the incidence of postirradiation genital and lower extremity edema which strongly correlated with the extent of staging lymphadenectomy.
 * PMID 7155987 -- Some questions raised by histologic study of RTOG protocols 75-06 and 77-06 as illustrated by selected samples. (Terry, Prostate 1982).