{"preliminary_commentary":{"by_channel":{"x_thread":40,"youtube":4},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT01809691\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["orteronel"]],"indication":"newly diagnosed metastatic hormone-sensitive prostate cancer","name":"SWOG-1216","nct_id":"NCT01809691","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=swog-1216-nct01809691. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming 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: 301+ verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"S1216","arms":[{"description":"LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.\n\nTAK-700, 300 mg, PO, twice daily","label":"ADT + TAK-700","type":"EXPERIMENTAL"},{"description":"LHRH agonist - given as approved for androgen deprivation at a dose necessary to maintain castrate levels and equivalent to 22.5 mg of Leuprolide IM every 3 months.\n\nBicalutamide, 50 mg, PO, q daily","label":"ADT + Bicalutamide","type":"ACTIVE_COMPARATOR"}],"collaborators":["Millennium Pharmaceuticals, Inc.","National Cancer Institute (NCI)"],"completion_date":{"date":"2025-09-09","type":"ACTUAL"},"conditions":["Prostate Cancer"],"enrollment":{"count":1313,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"TAK-700","otherNames":["Orteronel"],"type":"DRUG"},{"name":"Bicalutamide","otherNames":["Casodex"],"type":"DRUG"}],"last_update":"2025-12-31","lead_sponsor":"SWOG Cancer Research Network","official_title":"A Phase III Randomized Trial Comparing Androgen Deprivation Therapy + TAK-700 With Androgen Deprivation Therapy + Bicalutamide in Patients With Newly Diagnosed Metastatic Sensitive Prostate Cancer","overall_status":"COMPLETED","phases":["PHASE3"],"primary_completion_date":{"date":"2022-03-08","type":"ACTUAL"},"primary_outcomes":[{"measure":"Overall Survival","timeFrame":"Duration of treatment and follow-up until death or 9 years after study start"}],"references":[{"citation":"Gebrael G, Jo Y, Swami U, Plets M, Hage Chehade C, Narang A, Gupta S, Myint ZW, Sayegh N, Tangen CM, Hussain M, Dorff T, Lara PN Jr, Lerner SP, Thompson I, Agarwal N. Bone Pain and Survival Among Patients With Metastatic, Hormone-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG-1216 Trial. JAMA Netw Open. 2024 Jul 1;7(7):e2419966. doi: 10.1001/jamanetworkopen.2024.19966.","pmid":"38980676","type":"DERIVED"},{"citation":"Lara PN Jr, Mayerson E, Gertz E, Tangen C, Goldkorn A, van Loan M, Hussain M, Gupta S, Zhang J, Parikh M, Twardowski P, Quinn DI, LeBlanc M, Thompson I, Agarwal N. Markers of bone metabolism and overall survival in men with bone-metastatic hormone sensitive prostate cancer (HSPC): A subset analysis of SWOG S1216, a phase III trial of androgen deprivation with or without orteronel. Prostate Cancer Prostatic Dis. 2024 Sep;27(3):566-570. doi: 10.1038/s41391-024-00813-3. Epub 2024 Feb 29.","pmid":"38424319","type":"DERIVED"},{"citation":"Sayegh N, Swami U, Jo Y, Gebrael G, Haaland B, Gupta S, Plets M, Hussain MHA, Quinn DI, Lara PN Jr, Thompson IM Jr, Agarwal N. Race and Treatment Outcomes in Patients With Metastatic Castration-Sensitive Prostate Cancer: A Secondary Analysis of the SWOG 1216 Phase 3 Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2326546. doi: 10.1001/jamanetworkopen.2023.26546.","pmid":"37526936","type":"DERIVED"},{"citation":"Agarwal N, Tangen CM, Hussain MHA, Gupta S, Plets M, Lara PN, Harzstark AL, Twardowski PW, Paller CJ, Zylla D, Zibelman MR, Levine E, Roth BJ, Goldkorn A, Vaena DA, Kohli M, Crispino T, Vogelzang NJ, Thompson IM Jr, Quinn DI. Orteronel for Metastatic Hormone-Sensitive Prostate Cancer: A Multicenter, Randomized, Open-Label Phase III Trial (SWOG-1216). J Clin Oncol. 2022 Oct 1;40(28):3301-3309. doi: 10.1200/JCO.21.02517. Epub 2022 Apr 21.","pmid":"35446628","type":"DERIVED"}],"start_date":{"date":"2013-03-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"S1216, Phase III ADT+TAK-700 vs. ADT+Bicalutamide for Metastatic Prostate Cancer","url":"https://clinicaltrials.gov/study/NCT01809691"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/swog-1216-nct01809691"}