PD61-11 A PHASE II STUDY OF 6-MONTHS APALUTAMIDE PRIOR TO RADICAL PROSTATECTOMY IN INTERMEDIATE RISK PATIENTS TO REDUCE THE FREQUENCY OF PATHOLOGIC FEATURES THAT DRIVE POST-OPERATIVE RADIATION THERAPY

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy V (PD61)1 Sep 2021PD61-11 A PHASE II STUDY OF 6-MONTHS APALUTAMIDE PRIOR TO RADICAL PROSTATECTOMY IN INTERMEDIATE RISK PATIENTS REDUCE THE FREQUENCY PATHOLOGIC FEATURES THAT DRIVE POST-OPERATIVE RADIATION THERAPY John Davis, Brian Chapin, Curtis Pettaway, Lisly Chery, Louis Pisters, Ward, Papadopoulos, Ashish Kamat, Marisa Lozano, Patricia Troncoso, and Christopher Logothetis DavisJohn Davis More articles by this author , ChapinBrian Chapin PettawayCurtis Pettaway CheryLisly Chery PistersLouis Pisters WardJohn Ward PapadopoulosJohn Papadopoulos KamatAshish Kamat LozanoMarisa Lozano TroncosoPatricia Troncoso LogothetisChristopher View All Author Informationhttps://doi.org/10.1097/JU.0000000000002098.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Combination surgery followed radiation is often required effectively treat intermediate risk localized prostate cancer. In unfavorable treated radical prostatectomy, histopathology will show approximately 50% with at least one adverse feature, 35% drive post-operative therapy--pT3a/b and/or positive surgical margins (PSM). This study was designed explore the hypothesis that 6-months neoadjuvant apalutamide monotherapy (a potent nonsteroidal antiandrogen) prior prostatectomy would reduce such risk, minimal short-term side effects. The overall goal need for without compromising efficacy. METHODS: a single center, phase II, open label, therapeutic evaluation trial apalutamide, robot-assisted extended pelvic lymphadenectomy. Eligible patients had disease selected node dissection. primary aim determine if an aggregate 15% rate high-risk pathology (pT3a/b PSM) compared expected from historical controls. Secondary aims included safety/tolerability, quality life, biochemical failure, planned exploratory biomarker studies. RESULTS: completed May, 2018-February 2020 accrual 43 completing surgery. drug tolerated well patient discontinuing early grade 3 rash. >50% decline in PSA elevations testosterone while on drug, normalization after discontinuation mean 408 ng/dL. For aim: 18 (42%) high pathology. Other pathologic observations 9.3% PSM (0 pT2, 4 pT3a/b). were focal. Only 1 (2%) template. As 2/2021, 93% are disease-free median 13 months follow-up. There postoperative death unrelated (cardiac), BCR no treatment (pT2 disease), 2 leading salvage RT disease). CONCLUSIONS: strategy pre-operative anti-androgen (non-castrating) therapy did not achieve endpoint reducing frequency showed proof-of-principle can be enrolled novel trials. rates lymph lower than expected. Further follow-up needed any actual reduction radiation, provide further insight into whether findings effective surrogate markers paradigm. Source Funding: Janssen Pharmaceuticals © 2021 American Urological Association Education Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1070-e1071 Advertisement Copyright & Permissions© Inc.MetricsAuthor Information Expand Loading ...