LB-S&T-12 OPEN -LABEL PHASE II STUDY EVALUATING THE EFFICACY OF CONCURRENT ADMINISTRATION OF RADIUM RA 223 DICHLORIDE AND ABIRATERONE ACETATE IN MEN WITH CASTRATION-RESISTANT PROSTATE CANCER PATIENTS WITH SYMPTOMATIC BONE METASTASES (ERADICATE)

Abstract

You have accessJournal of UrologyLate-Breaking S&T Poster1 Apr 2016LB-S&T-12 OPEN -LABEL PHASE II STUDY EVALUATING THE EFFICACY OF CONCURRENT ADMINISTRATION OF RADIUM RA 223 DICHLORIDE AND ABIRATERONE ACETATE IN MEN WITH CASTRATION-RESISTANT PROSTATE CANCER PATIENTS WITH SYMPTOMATIC BONE METASTASES (ERADICATE) Neal Shore, Ronald Tutrone, Luke Nordquist, Neil Mariados, Bryan Mehlhaff, and Stacey Harrelson Neal ShoreNeal Shore More articles by this author , Ronald TutroneRonald Tutrone More articles by this author , Luke NordquistLuke Nordquist More articles by this author , Neil MariadosNeil Mariados More articles by this author , Bryan MehlhaffBryan Mehlhaff More articles by this author , and Stacey HarrelsonStacey Harrelson More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.03.093AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Radium Ra 223 dichloride (Ra-223), an intravenous alpha-emitting radioisotope, is a calcium mimetic, forming complexes with hydroxyapatite at sites of bone metastasis for castration-resistant prostate cancer (mCRPC) patients. Abiraterone Acetate (AA), an oral androgen biosynthesis inhibitor, decreases serum testosterone for mCRPC patients. This study evaluates safety and quality of life of concurrent use of these FDA approved CRPC therapies, and is the largest cohort of subjects reported to date. METHODS This open-label, phase II study (NCT02097303), enrolled subjects with symptomatic bone mCRPC. Subjects were assessed at baseline, day 1 of each of 6 cycles and 30 days post final Ra-223 treatment. Primary objectives were quality of life and bone pain measured by Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Bone Pain Index Short Form (BPI-SF). Secondary objectives were adverse events (AE), disease progression, performance status, total alkaline phosphatase, prostate specific antigen, skeletal related events, and more antineoplastic therapy. Safety data were analyzed for all with >/= 1 infusion of Ra-223. RESULTS 31 of 37 enrolled subjects completed the study and received Ra-223 every 4 weeks x 6 doses. + 28/37 received AA 1000 mg QD; 3/37 required dose reduction. All subjects received prednisone 5 mg BID. Median AA use before first Ra-223 dose was 31 days [95% CI 24.2-37.8]. Subjects had significant improvements in FACT-P Prostate subscales and no significant increases in pain. They reported significant pain relief from treatment. 19/31 had radiographic disease improvement or stability. Secondary endpoints also showed benefit of the combined treatment. ECOG scores remained stable. Subjects reported 72 AEs related to treatment; 44, 26, and 2 were grade 1, 2, and 3, respectively. Common AEs were fatigue and gastrointestinal issues. 4 SAEs were reported; 1 abdominal pain possibly related to AA and 3 non-related to treatment, including one death. CONCLUSIONS This prospective trial of Radium 223 and Abiraterone Acetate confirms an overall improvement in Quality of Life, and demonstrates tolerability of synergistic use of the approved mCRPC agents. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e340 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Neal Shore More articles by this author Ronald Tutrone More articles by this author Luke Nordquist More articles by this author Neil Mariados More articles by this author Bryan Mehlhaff More articles by this author Stacey Harrelson More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...