{"commentary":{"count":17,"free_build_floor":8,"listing_floor":3,"by_channel":{"x_thread":9,"youtube":5,"podcast":3},"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\": \"NCT05794906\", \"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":"ARASTEP","nct_id":"NCT05794906","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=arastep-nct05794906. 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":1250,"size":"standard","size_rule":"Standard: 13–40 commentary sources"},"registry":{"acronym":"ARASTEP","arms":[{"description":"Participants will receive darolutamide plus ADT twice daily with food for a pre-specified duration of 24 months.","label":"Darolutamide+ADT","type":"EXPERIMENTAL"},{"description":"Participants will receive Placebo plus ADT twice daily with food for a pre-specified duration of 24 months.","label":"Placebo+ADT","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2030-03-29","type":"ESTIMATED"},"conditions":["Biochemically Recurrent Prostate Cancer"],"enrollment":{"count":985,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Darolutamide (BAY1841788, Nubeqa)","type":"DRUG"},{"name":"Placebo matching darolutamide","type":"OTHER"},{"name":"ADT","type":"OTHER"}],"last_update":"2026-07-07","lead_sponsor":"Bayer","official_title":"A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-07-30","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Radiological progression-free survival (rPFS) by Prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) assessed by Blinded independent central review (BICR)","timeFrame":"After randomization to after last treatment, approximately 24 months"}],"references":[{"citation":"Morgans AK, Chehrazi-Raffle A, Niazi T, Shore ND, Ross AE, Roder A, Gomes AJ, Supiot S, Barthelemy P, Hatano K, Ruiz CBC, Yoshida S, Herrera-Imbroda B, Gratton M, Gschwend JE, Hope TA, Joensuu H, Kuss I, Le Berre MA, Dimova-Dobreva M, Fizazi K. Darolutamide plus androgen-deprivation therapy in high-risk biochemical recurrence of prostate cancer (ARASTEP). Future Oncol. 2025 Nov;21(27):3491-3498. doi: 10.1080/14796694.2025.2577633. Epub 2025 Nov 11.","pmid":"41216639","type":"DERIVED"}],"start_date":{"date":"2023-04-03","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies","url":"https://clinicaltrials.gov/study/NCT05794906"},"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/arastep-nct05794906"}