{"preliminary_commentary":{"by_channel":{"x_thread":5,"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":false},"commentary_summary":null,"drugs_tested":[["opevesostat"]],"indication":"mCRPC after NHA and taxane-based chemotherapy","name":"OMAHA-003","nct_id":"NCT06136624","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=omaha-003-nct06136624. 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":"OMAHA-003","arms":[{"description":"Participants receive opevesostat 5 mg by oral tablets twice daily (bid) plus dexamethasone 1.5 mg by oral tablets once daily (qd) and 0.1 mg fludrocortisone acetate by oral tablet qd until progression. Hydrocortisone 100 mg (oral or intramuscular \\[IM\\]) dose will also be provided to participants for use as rescue medication. Prior to study protocol amendment 9, prednisone was provided as a rescue medication during adrenal recovery, titrated at 5mg daily maintenance dose and then titrated to discontinuation.","label":"Opevesostat","type":"EXPERIMENTAL"},{"description":"Participants receive abiraterone 1000 mg qd by oral tablets plus prednisone 5 mg bid by oral tablets or enzalutamide 160 mg qd by oral tablets.","label":"Abiraterone Acetate or Enzalutamide","type":"ACTIVE_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2030-02-15","type":"ESTIMATED"},"conditions":["Prostate Cancer Metastatic"],"enrollment":{"count":1310,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Opevesostat","otherNames":["MK-5684"],"type":"DRUG"},{"name":"Abiraterone acetate","otherNames":["ZYTIGA","YONSA"],"type":"DRUG"},{"name":"Enzalutamide","otherNames":["XTANDI"],"type":"DRUG"},{"name":"Hydrocortisone","otherNames":[],"type":"DRUG"},{"name":"Fludrocortisone acetate","otherNames":[],"type":"DRUG"},{"name":"Prednisone","otherNames":[],"type":"DRUG"},{"name":"Dexamethasone","otherNames":[],"type":"DRUG"}],"last_update":"2026-10-06","lead_sponsor":"Merck Sharp & Dohme LLC","official_title":"A Phase 3 Randomized, Open-label Study of MK-5684 Versus Alternative Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Previously Treated With Next-generation Hormonal Agent (NHA) and Taxane-based Chemotherapy (OMAHA-003)","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2028-08-02","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Overall Survival (OS) in Androgen Receptor Ligand Binding Domain (AR LBD) Mutation-Positive Participants","timeFrame":"Up to ~54 months"},{"measure":"OS in AR LBD Mutation-Negative Participants","timeFrame":"Up to ~54 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":"2023-12-31","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)","url":"https://clinicaltrials.gov/study/NCT06136624"},"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-003-nct06136624"}