{"preliminary_commentary":{"by_channel":{"x_thread":6,"youtube":1,"podcast":1},"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\": \"NCT06136650\", \"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":[["opevesostat"]],"indication":"metastatic castration-resistant prostate cancer post one NHA","name":"OMAHA-004","nct_id":"NCT06136650","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=omaha-004-nct06136650. 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":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Participants receive opevesostat 5 mg by oral tablets twice daily (BID) plus dexamethasone 1.5 mg by oral tablets and fludrocortisone acetate 0.1 mg oral tablet once daily (QD) continuously until disease progression. Hydrocortisone 100 mg (oral or intramuscular \\[IM\\]) will also be provided to participants for use as rescue medication.","label":"Daily Corticosteroids + Opevesostat","type":"EXPERIMENTAL"},{"description":"Participants receive abiraterone 1000mg QD by oral tablets plus prednisone 5 mg BID by oral tablets or enzalutamide 160 mg QD by oral tablets until disease progression.","label":"Alternative Next-Generation Hormonal Agent (NHA)","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2030-12-02","type":"ESTIMATED"},"conditions":["Metastatic Castration-resistant Prostate Cancer (mCRPC)","Prostatic Neoplasms"],"enrollment":{"count":1314,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Opevesostat","otherNames":["MK-5684"],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"},{"name":"Fludrocortisone acetate","otherNames":[],"type":"DRUG"},{"name":"Hydrocortisone","otherNames":[],"type":"DRUG"},{"name":"Abiraterone acetate","otherNames":["Zytiga","Yonsa"],"type":"DRUG"},{"name":"Prednisone acetate","otherNames":[],"type":"DRUG"},{"name":"Enzalutamide","otherNames":["Xtandi"],"type":"DRUG"}],"last_update":"2026-10-20","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"MK-5684-004: A Phase 3, Randomized, Open-label Study of Opevesostat Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) That Progressed On or After Prior Treatment With One Next-generation Hormonal Agent (NHA) (OMAHA-004)","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2028-05-10","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall Survival (OS)","timeFrame":"Up to approximately 82 months"}],"references":[{"citation":"Yu EY, Gratzke C, Burotto M, Zhang AY, Levesque E, Ortega F, Peer A, Vile D, Chen ZH, Song Y, Schloss C, Todoric J, Garratt C, Poehlein C, Antonarakis ES, Fizazi K. Steroidogenesis inhibitor opevesostat (MK-5684) for metastatic castration-resistant prostate cancer: OMAHA-003 and OMAHA-004 trial designs. Future Oncol. 2026 Mar;22(7):765-772. doi: 10.1080/14796694.2025.2595914. Epub 2026 Feb 23.","pmid":"41732008","type":"DERIVED"}],"start_date":{"date":"2023-12-18","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)","url":"https://clinicaltrials.gov/study/NCT06136650"},"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/omaha-004-nct06136650"}