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- W2078478999 abstract "A pooled analysis of trials using conventional dose radiation (XRT) indicates 6 months androgen deprivation therapy (ADT) improves prostate cancer survival in Gleason 7 Prostate Cancer. The benefits of ADT when used in combination with dose escalated XRT remains to be determined. The purpose of the report is to evaluate the compliance, toxicity and efficacy of Dose Escalated XRT in combination with 6 months goserelin + bicalutamide (ADT) in the context of a Phase 3 Trial. Four hundred thirty-eight patients have been entered on the multi-center Phase 3 trial evaluating the optimal timing of XRT in combination with ADT. Inclusion criteria were cT1-T3, GL < 8, PSA < 30. Low risk prostate cancer patients were excluded. Patients were randomized to upfront XRT (day 1 of ADT) or XRT after 4 months ADT. CTV1 = prostate + seminal vesicles (56 Gy) CTV2 = prostate only (76 Gy). XRT toxicity was evaluated using RTOG toxicity scale and NCIC CTG v 2 and QOL using EORTC QLQ-C30 and PR25. We report on the 1st 350 patients who have mature follow-up (median follow-up of 78 months). Overall Survival (OS), Disease Free Survival (DFS) and Local Control were estimated using the Kaplan-Meier method. Clinical characteristics: mean age is 69; 69% cT1-T2A, 31% cT2B-T3; 75% Gleason 7; mean PSA = 10. Protocol compliance: 96% of patients completed 6 months TAB and 99% completed 6 months goserelin. Four percent of patients stopped bicalutamide early: 3% due to Grade 1-3 reversible liver toxicity. Three percent of patients developed Late Grade 3 XRT Proctitis. Only 1 patient has died of prostate cancer. Five-year Kaplan Meier results are the following: DFS is 91%, local relapse free survival is 96%, metastasis free survival is 98% and OS is 94%. The initial promising Local Control, DFS and OS support the benefit of ADT in combination with Dose Escalated XRT. The favorable compliance, tolerance and toxicity data support participation in RTOG 0815." @default.
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- W2078478999 date "2012-11-01" @default.
- W2078478999 modified "2023-10-13" @default.
- W2078478999 title "Preliminary Results of a Randomized Trial of Optimal Timing of Dose Escalated (76 Gy) Radiation and 6 months ADT in Prostate Cancer" @default.
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- W2078478999 doi "https://doi.org/10.1016/j.ijrobp.2012.07.956" @default.
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