MP24-11 LOCAL THERAPY TO THE PRIMARY TUMOR FOR NEWLY DIAGNOSED, OLIGO-METASTATIC PROSTATE CANCER: A PROSPECTIVE RANDOMIZED, PHASE 2, OPEN-LABEL TRIAL

Abstract

You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) II (MP24)1 Sep 2021MP24-11 LOCAL THERAPY TO THE PRIMARY TUMOR FOR NEWLY DIAGNOSED, OLIGO-METASTATIC PROSTATE CANCER: A PROSPECTIVE RANDOMIZED, PHASE 2, OPEN-LABEL TRIAL Bo Dai, Junyu Zhang, Sheng Zhang, Hongkai Wang, Qifeng Wang, Yunyi Kong, Yao Zhu, Xiaojian Qin, Guowen Lin, and Dingwei Ye Bo DaiBo Dai More articles by this author , Junyu ZhangJunyu Zhang More articles by this author , Sheng ZhangSheng Zhang More articles by this author , Hongkai WangHongkai Wang More articles by this author , Qifeng WangQifeng Wang More articles by this author , Yunyi KongYunyi Kong More articles by this author , Yao ZhuYao Zhu More articles by this author , Xiaojian QinXiaojian Qin More articles by this author , Guowen LinGuowen Lin More articles by this author , and Dingwei YeDingwei Ye More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002015.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Oligo-metastatic prostate cancer is recognized as an intermediate stage between localized disease and widespread metastases. The role of radical local therapy (RLT) to the primary tumor for these patients is unclear. We conducted this phase 2 randomized trial to investigate if radical prostatectomy (RP) or prostate radiotherapy (RT) benefits these patients (NCT02742675). METHODS: Oligo-metastases was defined as ≤5 bone or extra-pelvic lymph node metastases and no visceral metastases. Patients were randomly assigned (1:1) to receive androgen deprivation therapy (ADT) or ADT plus RLT. For patients allocated to ADT+RLT group, RP was recommended with priority, while RT was administrated to those refused RP and those with unresectable primary tumor after 1-3 months induced ADT. The primary outcome was radiographic progression-free survival (rPFS) and the secondary outcome was overall survival (OS). RESULTS: A total of 200 patients were enrolled between Sept 1, 2015 and Mar 10, 2019. The median age was 68 years and the median PSA at diagnosis was 98.8 ng/ml. Bone metastases and distant lymph node metastases exited in 96% and 15% of all patients. 96 of 100 patients in ADT+RLT group received RLT including 85 RP and 11 RT. After a median follow-up of 28 months, radiographic progression was observed in 19 of 100 patients in ADT+RLT group and 33 of 100 patients in ADT group. The median rPFS was not reached in ADT+RLT group and 50 months in ADT group (HR=0.50; 95% CI, 0.28 to 0.87; p=0.015). RLT related complications occurred in 24 of 85 RP patients (including 3 grade 3-4 complications) and 5 of 11 RT patients. In order to evaluate the OS, longer follow-up period is required. CONCLUSIONS: Local therapy to the primary tumor improves rPFS in patients with newly diagnosed, oligo-metastatic prostate cancer. Source of Funding: This study was supported in part by a grant from National Key R&D Program of China (No. 2017YFC0114303), a grant from the Natural Science Foundation of Shanghai Municipality (No. 16ZR1406500), a grant from the Guide Project of Science and Technology Commission of Shanghai Municipality (No.17411963100) © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e416-e416 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Bo Dai More articles by this author Junyu Zhang More articles by this author Sheng Zhang More articles by this author Hongkai Wang More articles by this author Qifeng Wang More articles by this author Yunyi Kong More articles by this author Yao Zhu More articles by this author Xiaojian Qin More articles by this author Guowen Lin More articles by this author Dingwei Ye More articles by this author Expand All Advertisement Loading ...