MP72-01 IMPROVEMENTS IN FREEDOM FROM PROGRESSION WITH SHORT TERM ANDROGEN DEPRIVATION THERAPY AND PELVIC LYMPH NODE TREATMENT ADDED TO PROSTATE BED SALVAGE RADIOTHERAPY: THE NRG ONCOLOGY/RTOG 0534 SPPORT TRIAL

You have accessJournal of UrologyProstate Cancer: Localized: Radiation Therapy (MP72)1 Apr 2019MP72-01 IMPROVEMENTS IN FREEDOM FROM PROGRESSION WITH SHORT TERM ANDROGEN DEPRIVATION THERAPY AND PELVIC LYMPH NODE TREATMENT ADDED TO PROSTATE BED SALVAGE RADIOTHERAPY: THE NRG ONCOLOGY/RTOG 0534 SPPORT TRIAL Alan Pollack, Theodore Karrison, Alexander G. Balogh, Daniel Low, Deborah W. Bruner, Jeffrey S. Wefel, PhD Leonard G. Gomella*, André-Guy Martin, Jeff M. Michalski, Steve J. Angyalfi, Himansu Lukka, Sergio L. Faria, George B. Rodrigues, Marie-Claude Beauchemin, R. Jeffrey Lee, Samantha A. Seaward, Aaron M. Allen, Petah Tikva, Drew C. Monitto, Wendy Seiferheld, and Howard M. Sandler Alan PollackAlan Pollack More articles by this author , Theodore KarrisonTheodore Karrison More articles by this author , Alexander G. BaloghAlexander G. Balogh More articles by this author , Daniel LowDaniel Low More articles by this author , Deborah W. BrunerDeborah W. Bruner More articles by this author , Jeffrey S. WefelJeffrey S. Wefel More articles by this author , Leonard G. Gomella*Leonard G. Gomella* More articles by this author , André-Guy MartinAndré-Guy Martin More articles by this author , Jeff M. MichalskiJeff M. Michalski More articles by this author , Steve J. AngyalfiSteve J. Angyalfi More articles by this author , Himansu LukkaHimansu Lukka More articles by this author , Sergio L. FariaSergio L. Faria More articles by this author , George B. RodriguesGeorge B. Rodrigues More articles by this author , Marie-Claude BeaucheminMarie-Claude Beauchemin More articles by this author , R. Jeffrey LeeR. Jeffrey Lee More articles by this author , Samantha A. SeawardSamantha A. Seaward More articles by this author , Aaron M. AllenAaron M. Allen More articles by this author , Petah TikvaPetah Tikva More articles by this author , Drew C. MonittoDrew C. Monitto More articles by this author , Wendy SeiferheldWendy Seiferheld More articles by this author , and Howard M. SandlerHoward M. Sandler More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000557133.04919.daAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: Salvage prostate bed radiotherapy (PBRT) results in about 70% 5 yr freedom from progression (FFP). A three arm randomized trial was designed to determine whether there are incremental gains in FFP by adding (i) 4-6 mo of short term androgen deprivation therapy (STAD) to PBRT and (ii) the combination of STAD and pelvic lymph node treatment (PLNRT) to PBRT. METHODS: Patients were randomized to PBRT alone (Arm 1), PBRT + STAD (Arm 2), and PLNRT + PBRT + STAD (Arm 3). The FFP primary endpoint included PSA nadir+2, clinical failure, or death from any cause. The sample size provided 90% power to detect a 10% absolute FFP improvement at 5 yr in Arm 2 compared to Arm 1 and another 10% improvement in Arm 3 compared to Arm 2 (overall alpha of 0.025). Based on 1191 eligible patents with 5 yr minimum follow-up on the third planned interim analysis for efficacy and futility, stepwise comparisons were made to determine if the Haybittle-Peto (HP) threshold boundary of p < 0.001 (one sided) was crossed. Futility evaluation tested the alternative hypotheses at p < 0.001. Adverse events were graded using CTCAEv3.0. RESULTS: From 2008-2015, 1792 patients were enrolled. Of these, 1736 were eligible with a median age of 64 yr, black in 13%, baseline Zubrod status of 0 in 93%, seminal vesicle involvement in 15%, pre-radiotherapy PSA of ≤1.0 ng/ml in 89%, Gleason score <8 in 83%, and pT2 margin positive or pT3 in 72%. Median follow-up for those living is 5.4 yr. For the 1191 patients in the interim analysis cohort, the 5 yr FFP rates for Arms 1, 2, and 3 were 71%, 83% and 89%. When compared to Arm 1, Arm 3 exceeded the HP boundary with a hazard ratio (HR) 0.44 (95% CI: 0.32-0.59). Arm 3 was then compared to Arm 2, yielding a difference of 6% (p = 0.0063) and an HR of 0.71 (95% CI: 0.51-0.98). In all eligible patients followed for up to 8 years, there were 45, 38 and 25 patients who developed distant metastasis (DM) in Arms 1, 2 and 3. The HR was 0.52 (95% CI: 0.32-0.85) for Arm 3 vs Arm 1 and 0.64 (95% CI: 0.39-1.06) for Arm 3 vs. Arm 2. With IMRT use in 87% of cases, there were no significant differences in late grade 2+ or 3+ renal/GU or GI events; only grade 2+ blood/bone marrow events attributable to PLNRT were significant (p<0.044). CONCLUSIONS: These are the first randomized findings to demonstrate that extending salvage radiotherapy to cover the pelvic lymph nodes results in early, meaningful, reductions in progression when combined with STAD. Follow-up of patients will further elucidate the magnitude of the differences in DM and in FFP between arms 2 and 3. Source of Funding: This project was supported by grants U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), UG1CA189867 (NCORP), U24CA180803 (IROC) from the National Cancer Institute (NCI) Miami, FL; Philadelphia, PA; Calgary, Canada; Los Angeles, CA; Atlanta, GA; Houston, TX; Philadelphia, PA; Quebec, Canada; St. Louis, MO; Calgary, Canada; Hamilton Ontario, Canada; Montreal, Canada; London, Canada; Montreal, Canada; Riverton, UT; Oakland, CA; Israel; Spartanburg, SC; Philadelphia, PA; Los Angeles, CA© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e1054-e1055 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Alan Pollack More articles by this author Theodore Karrison More articles by this author Alexander G. Balogh More articles by this author Daniel Low More articles by this author Deborah W. Bruner More articles by this author Jeffrey S. Wefel More articles by this author Leonard G. Gomella* More articles by this author André-Guy Martin More articles by this author Jeff M. Michalski More articles by this author Steve J. Angyalfi More articles by this author Himansu Lukka More articles by this author Sergio L. Faria More articles by this author George B. Rodrigues More articles by this author Marie-Claude Beauchemin More articles by this author R. Jeffrey Lee More articles by this author Samantha A. Seaward More articles by this author Aaron M. Allen More articles by this author Petah Tikva More articles by this author Drew C. Monitto More articles by this author Wendy Seiferheld More articles by this author Howard M. Sandler More articles by this author Expand All Advertisement PDF downloadLoading ...

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