{"commentary":{"count":52,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":28,"podcast":20,"x_thread":4},"note":"Indexed podcasts, YouTube videos and X posts that name this trial. A report screens them, searches for more and cites what clinicians said when it is built."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT02043678\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's public preview; the full report is still bought."},"name":"ERA 223","nct_id":"NCT02043678","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=era-223-nct02043678. The price is fixed at order. We build the report after the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1950,"size":"deep","size_rule":"Deep: 41+ commentary sources"},"registry":{"acronym":"ERA 223","arms":[{"description":"Participants received 6 intravenous (IV) administrations of radium-223 dichloride 50 kiloBecquerel per kilogram (kBq/kg) (55 kBq/kg after implementation of National Institute of Standards and Technology \\[NIST\\] update) body weight at intervals of 4 weeks, along with oral abiraterone acetate tablets 1000 milligrams (mg) every day plus prednisone/prednisolone 5 mg twice daily (abi/pred) for 6 cycles, followed by abi/pred until an on-study symptomatic skeletal event (SSE) occurred (or other withdrawal criteria were met)","label":"Radium-223 dichloride + Abi/Pred","type":"EXPERIMENTAL"},{"description":"Participants received 6 IV administrations of placebo matched to radium-223 dichloride at intervals of 4 weeks, along with abi/pred for 6 cycles, followed by abi/pred until an on-study SSE occurred (or other withdrawal criteria were met)","label":"Placebo + Abi/Pred","type":"PLACEBO_COMPARATOR"}],"collaborators":["Janssen Research & Development, LLC"],"completion_date":{"date":"2024-02-08","type":"ACTUAL"},"conditions":["Prostatic Neoplasms"],"enrollment":{"count":806,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Radium-223 dichloride (Xofigo, BAY88-8223)","type":"DRUG"},{"name":"Matching placebo (normal saline)","type":"DRUG"},{"name":"Abiraterone","type":"DRUG"},{"name":"Prednisone/Prednisolone","type":"DRUG"}],"last_update":"2025-02-19","lead_sponsor":"Bayer","official_title":"A Phase III Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Abiraterone Acetate and Prednisone/Prednisolone in the Treatment of Asymptomatic or Mildly Symptomatic Chemotherapy-naïve Subjects With Bone Predominant Metastatic Castration-resistant Prostate Cancer(CRPC)","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2018-02-15","type":"ACTUAL"},"primary_outcomes":[{"measure":"Symptomatic Skeletal Event Free Survival (SSE-FS)","timeFrame":"From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 months"}],"references":[{"citation":"Smith M, Parker C, Saad F, Miller K, Tombal B, Ng QS, Boegemann M, Matveev V, Piulats JM, Zucca LE, Karyakin O, Kimura G, Matsubara N, Nahas WC, Nole F, Rosenbaum E, Heidenreich A, Kakehi Y, Zhang A, Krissel H, Teufel M, Shen J, Wagner V, Higano C. Addition of radium-223 to abiraterone acetate and prednisone or prednisolone in patients with castration-resistant prostate cancer and bone metastases (ERA 223): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Mar;20(3):408-419. doi: 10.1016/S1470-2045(18)30860-X. Epub 2019 Feb 6.","pmid":"30738780","type":"RESULT"},{"citation":"Shore N, Higano CS, George DJ, Sternberg CN, Saad F, Tombal B, Miller K, Kalinovsky J, Jiao X, Tangirala K, Sartor O. Concurrent or layered treatment with radium-223 and enzalutamide or abiraterone/prednisone: real-world clinical outcomes in patients with metastatic castration-resistant prostate cancer. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):680-688. doi: 10.1038/s41391-020-0236-0. Epub 2020 May 13.","pmid":"32404868","type":"DERIVED"},{"citation":"Matsubara N, Kimura G, Uemura H, Uemura H, Nakamura M, Nagamori S, Mizokami A, Kikukawa H, Hosono M, Kinuya S, Krissel H, Siegel J, Kakehi Y. A randomized, double-blind, comparison of radium-223 and placebo, in combination with abiraterone acetate and prednisolone, in castration-resistant metastatic prostate cancer: subgroup analysis of Japanese patients in the ERA 223 study. Int J Clin Oncol. 2020 Apr;25(4):720-731. doi: 10.1007/s10147-019-01589-6. Epub 2019 Dec 10.","pmid":"31823152","type":"DERIVED"}],"start_date":{"date":"2014-03-30","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms","url":"https://clinicaltrials.gov/study/NCT02043678"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"2.0","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/era-223-nct02043678"}