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• W2604183016 abstract "You have accessJournal of UrologyProstate Cancer: Advanced (including Drug Therapy) I1 Apr 2017PD24-10 INTERIM ANALYSIS OF NCT02458716: FEASIBILITY OF CYTOREDUCTIVE PROSTATECTOMY IN MEN NEWLY DIAGNOSED WITH METASTATIC PROSTATE CANCER Bertram Yuh, Young Suk Kwon, Brian Shinder, Sinae Kim, Nara Lee, Nora Ruel, Shigeo Horie, Seok-Soo Byun, Dong Hyeon Lee, Robert Dipaola, and Isaac Yi Kim Bertram YuhBertram Yuh More articles by this author , Young Suk KwonYoung Suk Kwon More articles by this author , Brian ShinderBrian Shinder More articles by this author , Sinae KimSinae Kim More articles by this author , Nara LeeNara Lee More articles by this author , Nora RuelNora Ruel More articles by this author , Shigeo HorieShigeo Horie More articles by this author , Seok-Soo ByunSeok-Soo Byun More articles by this author , Dong Hyeon LeeDong Hyeon Lee More articles by this author , Robert DipaolaRobert Dipaola More articles by this author , and Isaac Yi KimIsaac Yi Kim More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2017.02.1087AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Emerging evidence has suggested that local tumor control may enhance the effect of subsequent therapies in patients with metastatic prostate cancer. However, little is known about surgical safety of cytoreductive prostatectomy (CRP). In this study, we report the first interim analysis of a phase I study evaluating the safety and feasibility of CRP. METHODS The study was approved by the IRB and activated in June, 2015. Individuals with newly diagnosed clinical metastatic prostate cancer to lymph node and bones (cT1-3N1M0 or cT1-3N0M1a-b) were recruited. Men with visceral metastasis (M1c) or ECOG PS ≥ 2 were not eligible. Following surgery, all patients received androgen deprivation therapy. The primary endpoint is the major complication rate. The secondary outcome measures are the time to PSA nadir and rate of incontinence (pad-free). RESULTS A total of 21 patients from two institutions have been enrolled and undergone CRP. Of the 20 patients with complete data, the median (range) age at surgery was 62 (53-73). Overall, six (35.3%) perioperative complications were observed, including one major complication (Clavien III or higher). There were five minor complications, including deep venous thrombus (Clavien II), postoperative ileus (Clavien II), and three cases of urethral anastomotic leaks (Clavien I). In men with minimum of 6 month follow-up, 63.6% of men had PSA < 0.2 ng/ml, and 50% of men were pad free (Table 1). CONCLUSIONS CRP is surgically feasible in carefully selected patients. However, early incontinence rate is high. Further studies are warranted to further define long-term complications and verify the oncologic benefits of the surgery. © 2017FiguresReferencesRelatedDetails Volume 197Issue 4SApril 2017Page: e455-e456 Advertisement Copyright & Permissions© 2017MetricsAuthor Information Bertram Yuh More articles by this author Young Suk Kwon More articles by this author Brian Shinder More articles by this author Sinae Kim More articles by this author Nara Lee More articles by this author Nora Ruel More articles by this author Shigeo Horie More articles by this author Seok-Soo Byun More articles by this author Dong Hyeon Lee More articles by this author Robert Dipaola More articles by this author Isaac Yi Kim More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ..." @default.
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