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You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy IV (PD61)1 May 2024PD61-05 ONCOLOGICAL OUTCOMES OF NEOADJUVANT DEGARELIX WITH APALUTAMIDE (ARNEO TRIAL) VERSUS STANDARD OF CARE PRIOR TO RADICAL PROSTATECTOMY FOR HIGH-RISK PROSTATE CANCER: A PROPENSITY SCORE MATCHED ANALYSIS Alexander Giesen, Gaëtan Devos, Lorenzo Tosco, Marcella Baldewijns, Thomas Gevaert, Karolien Goffin, Petit Valentin, Mai Cindy, Raskin Yannic, Van Haute Carl, Lieven Goeman, De Meerleer Gert, Berghen Charlien, Devlies Wout, Claessens Frank, Van Poppel Hendrik, Everaerts Wouter, and Joniau Steven Alexander GiesenAlexander Giesen , Gaëtan DevosGaëtan Devos , Lorenzo ToscoLorenzo Tosco , Marcella BaldewijnsMarcella Baldewijns , Thomas GevaertThomas Gevaert , Karolien GoffinKarolien Goffin , Petit ValentinPetit Valentin , Mai CindyMai Cindy , Raskin YannicRaskin Yannic , Van Haute CarlVan Haute Carl , Lieven GoemanLieven Goeman , De Meerleer GertDe Meerleer Gert , Berghen CharlienBerghen Charlien , Devlies WoutDevlies Wout , Claessens FrankClaessens Frank , Van Poppel HendrikVan Poppel Hendrik , Everaerts WouterEveraerts Wouter , and Joniau StevenJoniau Steven View All Author Informationhttps://doi.org/10.1097/01.JU.0001009352.31737.3d.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Patients with high-risk prostate cancer (PCa) are at high risk of biochemical recurrence (BCR) and metastatic progression after local treatment. There is an unmet need for better treatments in this patient group. The double-blind, placebo-controlled ARNEO trial investigates the role of neoadjuvant degarelix with or without apalutamide (APA) before radical prostatectomy (RP) in men with high-risk PCa. Previously, we showed that patients receiving neoadjuvant degarelix+APA had significantly better pathological response (pT2 disease and minimal residual disease). However, the study did not include a control arm that received the current standard of care (SOC) in the form of surgery without neoadjuvant therapy. METHODS: In the ARNEO trial, high-risk PCa patients were randomly assigned 1:1 to degarelix with (n=45) or without (n=44) APA for 12 weeks, followed by RP. A propensity score-matched cohort that received the current SOC in the same period was extracted using age, ISUP score of the biopsy, iPSA, cN status and MRI T-stage as matching factors for ARNEO patients treated with degarelix with APA. We decided to compare the oncological results between these two cohorts. RESULTS: We matched 38 patients from the degarelix+APA arm of the ARNEO study with 38 patients who were treated with SOC in our hospital during the same period. Median follow-up was 3 years. A total of 15 (39%) patients in the degarelix+APA arm developed a PSA increase after full testosterone recovery compared to 23 (61%) patients in the SOC arm (p=0.07). In the degarelix+APA arm, 7 (18%) patients received salvage treatment, compared to 15 (39%) patients in the matched cohort (p=0.04). In addition, no patients (0%) in the degarelix+APA arm developed metastatic disease, compared to 4 patients (11%) in the SOC arm (p=0.04). CONCLUSIONS: After 3 years of follow-up, no statistically significant difference in terms of rising PSA was observed between patients treated with neoadjuvant degarelix+APA or SOC. However, patients treated with intensified neoadjuvant treatment experienced improved metastatic disease-free survival and reduced need for adjuvant treatment. We await results after full follow-up of the ARNEO study to fully compare these cohorts. Download PPT Source of Funding: The ARNEO trial was sponsored by Janssen Pharmaceutical and Ferring Pharmaceuticals (product and budget funding). This had however no impact on this project and data was never in possession of these companies © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e1281 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Alexander Giesen More articles by this author Gaëtan Devos More articles by this author Lorenzo Tosco More articles by this author Marcella Baldewijns More articles by this author Thomas Gevaert More articles by this author Karolien Goffin More articles by this author Petit Valentin More articles by this author Mai Cindy More articles by this author Raskin Yannic More articles by this author Van Haute Carl More articles by this author Lieven Goeman More articles by this author De Meerleer Gert More articles by this author Berghen Charlien More articles by this author Devlies Wout More articles by this author Claessens Frank More articles by this author Van Poppel Hendrik More articles by this author Everaerts Wouter More articles by this author Joniau Steven More articles by this author Expand All Advertisement PDF downloadLoading ...
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Alexander Giesen
Gaëtan Devos
Lorenzo Tosco
The Journal of Urology
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Giesen et al. (Mon,) studied this question.
www.synapsesocial.com/papers/68e6f174b6db64358766c671 — DOI: https://doi.org/10.1097/01.ju.0001009352.31737.3d.05
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