{"preliminary_commentary":{"by_channel":{"youtube":2,"podcast":1,"x_thread":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":[["177Lu-PSMA-617"]],"indication":"metastatic hormone-sensitive prostate cancer","name":"UpFrontPSMA","nct_id":"NCT04343885","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=upfrontpsma-nct04343885. 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":"UpFrontPSMA","arms":[{"description":"7.5 GBq (± 10%) 177Lu-PSMA every 6 weeks x 2 cycles. Docetaxel 75 mg/m2 commencing 6 weeks later, every 3 weeks x 6 cycles","label":"177Lu-PSMA+ Docetaxel","type":"EXPERIMENTAL"},{"description":"Docetaxel 75 mg/m2 every 3 weeks x 6 cycles","label":"Docetaxel (Control)","type":"OTHER"}],"collaborators":["Movember Foundation","Prostate Cancer Research Alliance","United States Department of Defense","Advanced Accelerator Applications","Australia's Nuclear Science and Technology Organisation (ANSTO)","Australian and New Zealand Urogenital and Prostate Cancer Trials Group","Australasian Radiopharmaceutical Trials network (ARTnet)","Centre for Biostatistics and Clinical Trials (BaCT)"],"completion_date":{"date":"2026-03","type":"ESTIMATED"},"conditions":["Metastatic Hormone Naive Prostate Cancer"],"enrollment":{"count":130,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"177Lu-PSMA-617","otherNames":["177Lu-PSMA-617 also referred to as 177Lu-PSMA"],"type":"DRUG"},{"name":"Docetaxel","otherNames":["Taxotere (trade name)"],"type":"DRUG"}],"last_update":"2025-07-11","lead_sponsor":"Peter MacCallum Cancer Centre, Australia","official_title":"UpFrontPSMA : A Randomised Phase 2 Study of Sequential 177Lu-PSMA617 and Docetaxel Versus Docetaxel in Metastatic Hormone-Naive Prostate Cancer","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE2"],"primary_completion_date":{"date":"2026-03","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Undetectable prostate specific antigen (PSA) rate at 12 months after commencement of protocol therapy","timeFrame":"Upto 32 months assuming 18 months to complete recruitment, a maximum of 1.6 months from consent to commencement of treatment for last patient and then 12 months from commencement of treatment for last patient."}],"references":[{"citation":"Azad AA, Bressel M, Tan H, Voskoboynik M, Suder A, Weickhardt AJ, Guminski A, Francis RJ, Saghebi J, Dhiantravan N, Joshua AM, Emmett L, Horvath L, Murphy DG, Hsiao E, Balakrishnar B, Lin P, Redfern A, Macdonald W, Ng S, Lee ST, Pattison DA, Nadebaum D, Kirkwood ID, Hofman MS; UpFrontPSMA Study Team. Sequential [177Lu]Lu-PSMA-617 and docetaxel versus docetaxel in patients with metastatic hormone-sensitive prostate cancer (UpFrontPSMA): a multicentre, open-label, randomised, phase 2 study. Lancet Oncol. 2024 Oct;25(10):1267-1276. doi: 10.1016/S1470-2045(24)00440-6. Epub 2024 Sep 15.","pmid":"39293461","type":"DERIVED"}],"start_date":{"date":"2020-04-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"In Men With Metastatic Prostate Cancer, What is the Safety and Benefit of Lutetium-177 PSMA Radionuclide Treatment in Addition to Chemotherapy","url":"https://clinicaltrials.gov/study/NCT04343885"},"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/upfrontpsma-nct04343885"}