{"commentary":{"count":16,"free_build_floor":8,"listing_floor":3,"by_channel":{"youtube":7,"podcast":6,"x_thread":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\": \"NCT04557059\", \"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":"PRIMORDIUM","nct_id":"NCT04557059","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=primordium-nct04557059. 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":"PRIMORDIUM","arms":[{"description":"Participants will receive radiotherapy (RT) which is defined as prostate-bed plus pelvic lymph node salvage external-beam radiotherapy with or without optional stereotactic body radiation therapy (SBRT), along with a luteinizing hormone-releasing hormone agonist (LHRHa) as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization.","label":"Interventional Cohort (Group 1): RT+ LHRHa","type":"ACTIVE_COMPARATOR"},{"description":"Participants will receive prostate-bed plus pelvic lymph node salvage external-beam radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), along with a LHRHa as a 3-monthly depot preparation within 3 days after randomization and the end of Week 12, or as a 6-monthly depot preparation within 3 days after randomization. Participants will also receive 240 milligram (mg) of apalutamide starting within 3 days after randomization as film-coated tablets, to be swallowed whole and together once daily with or without food, for a period of 180 Days.","label":"Interventional Cohort (Group 2): RT+LHRHa + Apalutamide","type":"EXPERIMENTAL"},{"description":"Enrollment into this cohort will be stopped further. Participants who were PSMA-PET-negative at screening and were already enrolled in the Observational Cohort will continue in this cohort. Data collected in the course of routine clinical practice during this period will include clinical evaluations, disease progression, therapies administered as per standard-of-care at the study-sites and survival status. For Observational Cohort, information will be entered into the electronic case report form (eCRF) from the medical records at least twice a year. The use of any medicinal product(s) for the treatment and management of participants will be at discretion of the treating physician.","label":"Observational Cohort(Group3) PSMA-PET Negative Participants","type":"NO_INTERVENTION"}],"collaborators":[],"completion_date":{"date":"2031-09-15","type":"ESTIMATED"},"conditions":["Prostatic Neoplasms"],"enrollment":{"count":691,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Radiotherapy","type":"RADIATION"},{"name":"LHRHa","type":"DRUG"},{"name":"Apalutamide","type":"DRUG"}],"last_update":"2026-09-25","lead_sponsor":"Janssen Pharmaceutica N.V., Belgium","official_title":"A Randomized, Controlled, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET With an Observational Cohort","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2029-08-27","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Prostate specific Membrane Antigen-Positron Emission Tomography (PSMA-PET) Metastatic Progression-free Survival (ppMPFS)","timeFrame":"Up to 9 years"}],"references":[],"start_date":{"date":"2020-11-12","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer","url":"https://clinicaltrials.gov/study/NCT04557059"},"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/primordium-nct04557059"}