{"preliminary_commentary":{"by_channel":{"x_thread":2,"youtube":1},"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":"NCT03042468","nct_id":"NCT03042468","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=nct03042468. 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":"1. 177Lu-PSMA-617 \\[50mCi (1.85GBq) - 300mCi (11.1GBq)\\] intravenous X2 doses, 2 weeks apart (Visit 1 and 2)\n2. 68Ga-PSMA-HBED-CC \\[5 ±2mCi or 185 ±74MBq\\] intravenous during screening and at 12 weeks with standard imaging","label":"All subjects","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2026-06-04","type":"ACTUAL"},"conditions":["Prostate Cancer"],"enrollment":{"count":50,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"177Lu-PSMA-617","otherNames":[],"type":"DRUG"},{"name":"68Ga-PSMA-HBED-CC","otherNames":[],"type":"DRUG"}],"last_update":"2026-09-14","lead_sponsor":"Weill Medical College of Cornell University","official_title":"Phase I/ll Dose-escalation Study of Fractionated Dose 177Lu-PSMA-617 for Progressive Metastatic Castration Resistant Prostate Cancer","overall_status":"COMPLETED","phases":["PHASE1","PHASE2"],"primary_completion_date":{"date":"2021-09-30","type":"ACTUAL"},"primary_outcomes":[{"measure":"Number of Subjects With Dose Limiting Toxicity (DLT) of Fractionated Dose of 177Lu-PSMA-617","timeFrame":"Assessed throughout the DLT period, up to 92 days after starting study drug."},{"measure":"Number of Subjects That Achieved Cumulative Maximum Tolerated Dose (MTD) Phase II Dose of 177Lu-PSMA-617","timeFrame":"from first dose of study drug to at least 12 weeks of subsequent follow-up evaluations, up to 92 days"},{"measure":"Recommended Phase II Dose of 177Lu-PSMA-617 in a 2-week Dose-fractionation Regimen","timeFrame":"Duration of Phase I, up to 47 months"}],"references":[{"citation":"Vlachostergios PJ, Niaz MJ, Skafida M, Mosallaie SA, Thomas C, Christos PJ, Osborne JR, Molina AM, Nanus DM, Bander NH, Tagawa ST. Imaging expression of prostate-specific membrane antigen and response to PSMA-targeted beta-emitting radionuclide therapies in metastatic castration-resistant prostate cancer. Prostate. 2021 Apr;81(5):279-285. doi: 10.1002/pros.24104. Epub 2021 Jan 19.","pmid":"33465252","type":"DERIVED"}],"start_date":{"date":"2016-12"},"study_type":"INTERVENTIONAL","title":"Phase I Dose-escalation Study of Fractionated 177Lu-PSMA-617 for Progressive Metastatic CRPC","url":"https://clinicaltrials.gov/study/NCT03042468"},"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/nct03042468"}