{"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":null,"indication":null,"name":"INDICATE","nct_id":"NCT04423211","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=indicate-nct04423211. 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":null,"arms":[{"description":"STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.\n\nSTEP 1: Patients who are PET negative for extera pelvic metastases undergo SOC EBRT for 6 months. Patients also receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.","label":"Arm A (EBRT, short-term androgen deprivation therapy [STAD])","type":"ACTIVE_COMPARATOR"},{"description":"STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.\n\nSTEP 1: Patients who are PET negative for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD for 6 months in the absence of disease progression or unacceptable toxicity.","label":"Arm B (EBRT, STAD, apalutamide)","type":"EXPERIMENTAL"},{"description":"STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.\n\nSTEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B.","label":"Arm C (EBRT, STAD, apalutamide)","type":"EXPERIMENTAL"},{"description":"STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.\n\nSTEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo SBRT or 3D CRT, IMRT (including VMAT), and IMPT over 3-10 fractions in the absence of disease progression or unacceptable toxicity.","label":"Arm D (EBRT, STAD, apalutamide, RT)","type":"EXPERIMENTAL"}],"collaborators":["National Cancer Institute (NCI)"],"completion_date":{"date":"2032-12-31","type":"ESTIMATED"},"conditions":["Biochemically Recurrent Prostate Carcinoma","Metastatic Prostate Carcinoma","Prostate Adenocarcinoma","Stage IVB Prostate Cancer AJCC v8"],"enrollment":{"count":804,"type":"ESTIMATED"},"has_results":false,"interventions":[{"name":"3-Dimensional Conformal Radiation Therapy","otherNames":["3-dimensional radiation therapy","3D Conformal","3D CONFORMAL RADIATION THERAPY","3D CRT","3D radiotherapy","3D-CRT","Conformal Therapy","Radiation Conformal Therapy","Radiation, 3D Conformal","Three dimensional external beam radiation therapy (procedure)"],"type":"RADIATION"},{"name":"Apalutamide","otherNames":["ARN 509","ARN-509","ARN509","Erleada","JNJ 56021927","JNJ-56021927"],"type":"DRUG"},{"name":"Computed Tomography","otherNames":["CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","CT","CT Scan","tomography"],"type":"PROCEDURE"},{"name":"Degarelix","otherNames":["FE200486","Firmagon"],"type":"DRUG"},{"name":"External Beam Radiation Therapy","otherNames":["Definitive Radiation Therapy","EBRT","External Beam Radiation","External Beam Radiotherapy","External Beam Radiotherapy (conventional)","External Beam RT","external radiation","External Radiation Therapy","external-beam radiation","Radiation, External Beam","Teleradiotherapy","Teletherapy","Teletherapy Radiation"],"type":"RADIATION"},{"name":"Fluciclovine F18","otherNames":["(18F)Fluciclovine","(18F)GE-148","18F-Fluciclovine","[18F]FACBC","Anti-(18f)FABC","Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid","Anti-[18F] FACBC","Axumin","Fluciclovine (18F)","FLUCICLOVINE F-18","GE-148 (18F)","GE-148 F-18"],"type":"OTHER"},{"name":"Goserelin Acetate","otherNames":["ZDX","Zoladex"],"type":"DRUG"},{"name":"Intensity-Modulated Proton Therapy","otherNames":["IMPT"],"type":"PROCEDURE"},{"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":"Leuprolide Acetate","otherNames":["A-43818","Abbott 43818","Abbott-43818","Carcinil","Depo-Eligard","Eligard","Enanton","Enantone","Enantone-Gyn","Ginecrin","LEUP","Leuplin","Leuprorelin Acetate","Lucrin","Lucrin Depot","Lupron","Lupron Depot","Lupron Depot-3 Month","Lupron Depot-4 Month","Lupron Depot-Ped","Lutrate","Procren","Procrin","Prostap","TAP-144","Trenantone","Uno-Enantone","Viadur"],"type":"DRUG"},{"name":"Magnetic Resonance Imaging","otherNames":["Magnetic Resonance","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging"],"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","proton magnetic resonance spectroscopic imaging","PT"],"type":"PROCEDURE"},{"name":"Quality-of-Life Assessment","otherNames":["Quality of Life Assessment"],"type":"OTHER"},{"name":"Questionnaire Administration","otherNames":[],"type":"OTHER"},{"name":"Relugolix","otherNames":["N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea","Orgovyx","TAK 385","TAK-385"],"type":"DRUG"},{"name":"Stereotactic Body Radiation Therapy","otherNames":["SABR","SBRT","Stereotactic Ablative Body Radiation Therapy"],"type":"RADIATION"},{"name":"Triptorelin","otherNames":["6-D-Tryptophan-LH-RH","6-D-Tryptophanluteinizing Hormone-releasing Factor","AY-25650","CL-118,532","Detryptoreline"],"type":"DRUG"},{"name":"Volume Modulated Arc Therapy","otherNames":["VMAT","Volumetric Modulated Arc Therapy (procedure)"],"type":"RADIATION"}],"last_update":"2026-08-19","lead_sponsor":"ECOG-ACRIN Cancer Research Group","official_title":"Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)","overall_status":"RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2032-12-31","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Progression-free survival (PFS)","timeFrame":"From randomization to radiographic progression by conventional imaging or positron emission tomography (PET), symptomatic disease or death, whichever occurs first, assessed up to 10 years"},{"measure":"PFS prolongation in patients without PET-evidence of extrapelvic metastases","timeFrame":"Up to 10 years"},{"measure":"PFS prolongation in patients with PET-evidence of extrapelvic metastases","timeFrame":"Up to 10 years"},{"measure":"Quality of life (QOL)","timeFrame":"Up to 24 months"}],"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":"2020-10-08","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging","url":"https://clinicaltrials.gov/study/NCT04423211"},"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/indicate-nct04423211"}