{"entity":{"id":"lutectomy","kind":"trial","name":"LuTectomy","aka":["Neoadjuvant 177Lu-PSMA-617 before radical prostatectomy"],"tldr":"In men about to have their prostate removed for high-risk cancer, giving one or two doses of the radioactive drug lutetium-PSMA beforehand delivered a meaningful radiation dose straight to the tumour, was well tolerated, and did not make the surgery harder or riskier.","summary":"LuTectomy was a single-centre, single-arm phase 1/2 study at the Peter MacCallum Cancer Centre investigating neoadjuvant 177Lu-PSMA-617 in men with high-risk localised prostate cancer (PSA >20 ng/mL, ISUP grade group 3-5, or ≥cT2c) with high tumour uptake on 68Ga-PSMA-11 PET, scheduled for robotic radical prostatectomy. Cohort A (n=10) received one cycle and cohort B (n=10) received two cycles of 177Lu-PSMA-617 (5 GBq), with surgery six weeks after the last dose. The primary endpoint was tumour radiation absorbed dose, measured by three-timepoint SPECT-CT dosimetry.\n\nAcross 20 patients, the treatment delivered a median highest-lesion dose of 35.5 Gy (19.6 Gy to the prostate, with lymph node doses up to a median of 38-48 Gy in relevant patients), and 45% achieved a PSA decline of 50% or more. Toxicity was low grade only (fatigue, nausea, dry mouth, mild thrombocytopenia), with no grade 3-4 events and no Clavien-Dindo grade 3-5 surgical complications; surgeons reported no unexpected intraoperative difficulty. On pathology, 80% of specimens showed a partial histological response, but no patient achieved a complete pathological response.\n\nLuTectomy is one of the first trials to test PSMA radioligand therapy in the neoadjuvant, potentially curative setting rather than in metastatic disease. It establishes feasibility and biological activity but not yet a benefit in metastasis-free or overall survival; larger trials of multi-cycle or combination regimens are the logical next step, and neoadjuvant PSMA radioligand therapy is not currently part of any clinical guideline.","status":"active","asOf":"2026-09-22","links":[{"label":"European Urology 2024: LuTectomy primary results (Eapen et al.)","url":"https://pubmed.ncbi.nlm.nih.gov/37891072/"},{"label":"ClinicalTrials.gov: NCT04430192","url":"https://clinicaltrials.gov/study/NCT04430192"}],"tags":["radioligand therapy","prostate cancer","neoadjuvant","dosimetry"],"related":["pluvicto","prostate-high-risk","prostatectomy","psma-pet","ga-68","lu-177"],"indications":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04430192","phase":"1/2","setting":"Men with high-risk localised prostate cancer and high PSMA uptake, scheduled for radical prostatectomy; neoadjuvant, pre-surgical setting","sponsor":"Peter MacCallum Cancer Centre, Australia","result":"A single dose of neoadjuvant 177Lu-PSMA-617 delivered a median tumour absorbed dose of 35.5 Gy (19.6 Gy to the prostate), with 45% of patients achieving a >50% PSA decline; no grade 3/4 toxicity and no surgical complications attributable to the drug (Eapen et al., Eur Urol 2024)","yearReported":2023,"enrolled":20,"enrolledBasis":"registry","outcomes":[{"endpoint":"Highest tumour radiation absorbed dose after cycle 1","primary":true,"unit":"Gy","arms":[{"name":"177Lu-PSMA-617 (5 GBq), one or two cycles before prostatectomy","n":20,"value":35.5,"note":"median, IQR 19.5-50.1; 19.6 Gy (IQR 11.3-48.4) delivered to the prostate specifically"}],"source":"https://pubmed.ncbi.nlm.nih.gov/37891072/"},{"endpoint":"PSA50 response","unit":"%","arms":[{"name":"177Lu-PSMA-617 before prostatectomy","n":20,"value":45,"note":"9/20 patients achieved a >50% PSA decline"}]},{"endpoint":"Pathological complete response","unit":"%","arms":[{"name":"177Lu-PSMA-617 before prostatectomy","n":20,"value":0,"note":"0 of 20 patients; 80% showed a partial histological response (fibrosis, reduced tumour cell density)"}]},{"endpoint":"Grade 3/4 toxicity and Clavien-Dindo grade 3-5 surgical complications","unit":"%","arms":[{"name":"177Lu-PSMA-617 before prostatectomy","n":20,"value":0,"note":"none observed; surgery was feasible and safe in all patients"}]}]},"route":"/trials/lutectomy/","neighbours":{"drug":[{"id":"pluvicto","kind":"drug","name":"Lutetium-177 vipivotide tetraxetan","route":"/drugs/pluvicto/"}],"indication":[{"id":"prostate-high-risk","kind":"indication","name":"Localised prostate cancer, high and very high risk","route":"/indications/prostate-high-risk/"}],"term":[{"id":"prostatectomy","kind":"term","name":"Radical prostatectomy","route":"/terms/prostatectomy/"}],"technology":[{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"}],"isotope":[{"id":"ga-68","kind":"isotope","name":"Gallium-68","route":"/isotopes/ga-68/"},{"id":"lu-177","kind":"isotope","name":"Lutetium-177","route":"/isotopes/lu-177/"}]}}