{"preliminary_commentary":{"by_channel":{"x_thread":7,"youtube":4},"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\": \"NCT04134260\", \"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":[["apalutamide"]],"indication":"node-positive prostate cancer after radical prostatectomy","name":"NRG-GU008","nct_id":"NCT04134260","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nrg-gu008-nct04134260. 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":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":null,"arms":[{"description":"Patients receive standard of care hormone therapy per physician discretion for 24 months. Patients also undergo standard of care pelvis and prostate bed radiation therapy 5 days per week over 5-6 or 7-8 weeks beginning within 90 days of randomization in the absence of disease progression or unacceptable toxicity. Patients in both arms may undergo CT, MRI, bone scan, and PET as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study.","label":"Arm I (hormone therapy, radiation therapy)","type":"ACTIVE_COMPARATOR"},{"description":"Patients undergo standard of care hormone therapy and radiation therapy as in Arm I. Patients also receive apalutamide PO QD on days 1-90 of each cycle. Cycles repeat every 90 days for 8 cycles in the absence of disease progression or unacceptable toxicity. Patients in both arms may undergo CT, MRI, bone scan, and PET as clinically indicated throughout the study. Patients may also undergo blood sample collection throughout the study.","label":"Arm II (hormone therapy, radiation therapy, apalutamide)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2031-11-01","type":"ESTIMATED"},"conditions":["Prostate Adenocarcinoma","Stage I Prostate Cancer AJCC v8","Stage II Prostate Cancer AJCC v8","Stage III Prostate Cancer AJCC v8","Stage IVA Prostate Cancer AJCC v8"],"enrollment":{"count":586,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"Apalutamide","otherNames":["ARN 509","ARN-509","ARN509","Erleada","JNJ 56021927","JNJ-56021927"],"type":"DRUG"},{"name":"Biospecimen Collection","otherNames":["Biological Sample Collection","Biospecimen Collected","Specimen Collection"],"type":"PROCEDURE"},{"name":"Bone Scan","otherNames":["Bone Scintigraphy"],"type":"PROCEDURE"},{"name":"Computed Tomography","otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography"],"type":"PROCEDURE"},{"name":"Hormone Therapy","otherNames":["Chemotherapy-Hormones/Steroids","Endocrine Therapy","Hormonal","Hormonal Therapy","hormone treatment","Hormones"],"type":"DRUG"},{"name":"Magnetic Resonance Imaging","otherNames":["Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI"],"type":"PROCEDURE"},{"name":"Positron Emission Tomography","otherNames":["Medical Imaging, Positron Emission Tomography","PET","PET Scan","Positron emission tomography (procedure)","Positron Emission Tomography Scan","Positron-Emission Tomography","PT"],"type":"PROCEDURE"},{"name":"Quality-of-Life Assessment","otherNames":["Quality of Life Assessment"],"type":"OTHER"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"},{"name":"Radiation Therapy","otherNames":["Cancer Radiotherapy","Energy Type","ENERGY_TYPE","Irradiate","Irradiated","Irradiation","Radiation","Radiation Therapy, NOS","Radiotherapeutics","Radiotherapy","RT","Therapy, Radiation"],"type":"RADIATION"}],"last_update":"2026-08-17","lead_sponsor":"NRG Oncology","official_title":"Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging Into Salvage Treatment for Patients With Node-Positive Prostate Cancer After Radical Prostatectomy (INNOVATE*) *INtensifying Treatment for NOde Positive Prostate Cancer by VArying the Hormonal ThErapy","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2026-11-01","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Metastasis-free survival (MFS)","timeFrame":"From randomization to detection of metastatic disease or death from any cause, assessed up to 7.5 years"}],"references":[{"citation":"Morgan TM, Boorjian SA, Buyyounouski MK, Chapin BF, Chen DYT, Cheng HH, Chou R, Jacene HA, Kamran SC, Kim SK, Kirkby E, Luckenbaugh AN, Nathanson BJ, Nyame YA, Posadas EM, Tran PT, Chen RC. Salvage Therapy for Prostate Cancer: AUA/ASTRO/SUO Guideline Part II: Treatment Delivery for Non-metastatic Biochemical Recurrence After Primary Radical Prostatectomy. J Urol. 2024 Apr;211(4):518-525. doi: 10.1097/JU.0000000000003891. Epub 2024 Feb 29.","pmid":"38421243","type":"DERIVED"}],"start_date":{"date":"2020-04-16","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial","url":"https://clinicaltrials.gov/study/NCT04134260"},"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/nrg-gu008-nct04134260"}