{"preliminary_commentary":{"by_channel":{"x_thread":3},"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":[["niraparib"]],"indication":"high-risk prostate cancer","name":"NADIR","nct_id":"NCT04037254","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nadir-nct04037254. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. 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_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity.\n\n\\*Niraparib dose level 1: 100 mg.","label":"Phase I, Dose Level 1 (niraparib, GnRH, IMRT)","type":"EXPERIMENTAL"},{"description":"Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity.\n\n\\*Niraparib dose level 2: 100 mg during IMRT 200 mg otherwise.","label":"Phase I, Dose Level 2 (niraparib, GnRH, IMRT)","type":"EXPERIMENTAL"},{"description":"Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD\\* for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment given in the absence of disease progression or unacceptable toxicity.\n\n\\*Niraparib dose level 3: 200 mg.","label":"Phase I, Dose Level 3 (niraparib, GnRH, IMRT)","type":"EXPERIMENTAL"},{"description":"Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months. Beginning 8-28 weeks after starting GnRH agonist, patients undergo IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity.","label":"Phase II, Arm I (GnRH, IMRT)","type":"ACTIVE_COMPARATOR"},{"description":"Patients undergo standard of care GnRH agonist androgen suppression therapy for 24 months and concurrent niraparib PO QD (phase I determined dose level) for the first 12 months. Beginning 8 weeks after starting niraparib, patients undergo standard of care IMRT 5 days per week for about 6-9 weeks depending on type of radiation therapy. Treatment is given in the absence of disease progression or unacceptable toxicity.","label":"Phase II, Arm II (niraparib, GnRH, IMRT)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2025-12-23","type":"ACTUAL"},"conditions":["Prostate Adenocarcinoma","Stage IIC Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IIIA Prostate Cancer AJCC v8","Stage IIIB Prostate Cancer AJCC v8","Stage IIIC Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8"],"enrollment":{"count":22,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"Gonadotrophin Releasing Hormone","otherNames":["AY-24031","D-His-6-Pro-8-NEt-LHRH","Follicle Stimulating Hormone-Releasing Factor","GN-RH","GnRH","Gonadoliberin","Gonadorelin","Gonadorelinum","gonadotropin-releasing hormone","Hoe- 471","LH-RF","LH-RH","LH/FSH-RF","LH/FSH-RH","LHRH","Luliberin","Luteinising Hormone-Releasing Factor","Luteinizing Hormone-Releasing Factor","Luteinizing Hormone-Releasing Hormone"],"type":"BIOLOGICAL"},{"name":"Intensity-Modulated Radiation Therapy","otherNames":["IMRT","Intensity modulated radiation therapy (procedure)","Intensity Modulated RT","Intensity-Modulated Radiotherapy","Radiation, Intensity-Modulated Radiotherapy"],"type":"RADIATION"},{"name":"Niraparib","otherNames":["MK 4827","MK-4827","MK4827"],"type":"DRUG"}],"last_update":"2026-07-10","lead_sponsor":"NRG Oncology","official_title":"Randomized Phase II Trial of Niraparib With Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (With Initial Phase I) (NADIR*) *Randomized Phase II Trial of Niraparib With Standard Combination Androgen DeprIvation Therapy (ADT) and Radiotherapy in High Risk Prostate Cancer (With Initial Phase I)","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2024-07-01","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Participants Disease-free Until Completion of Treatment (2 Years From Start of ADT)","timeFrame":"Baseline to completion of treatment (two years from start of ADT)"}],"references":[],"start_date":{"date":"2019-10-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Testing the Addition of a New Anti-Cancer Drug, Niraparib, to the Usual Treatment (Hormone and Radiation Therapy) for Prostate Cancer With a High Chance of Recurring","url":"https://clinicaltrials.gov/study/NCT04037254"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/nadir-nct04037254"}