Clinical Trial

Radiometabolic Therapy With 177Lu PSMA in PSMA PET/CT Positive Advanced/Metastatic Tumours:

Study acronym: LUBASKET
Active, Not Recruiting Phase 2
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Summary
Phase 2 study, single arm trial enrolling patients with a Gallium-68/Fluorine-18 prostate-specific membrane antigen (PSMA) positive positron emission tomography/Computed Tomography (PET/CT) in order to be treated with Lutetium-177 (177Lu) PSMA. Patients without risk factors for toxicity will receive 7.4 GBq of 177Lu-PSMA while patients with at least 1 risk factor for toxicity will receive 5.5 GBq of 177Lu-PSMA. Patients will receive 4 cycles every 8 weeks (+- 2 weeks)
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2023-05-10; most recent amendment 2025-12-02.
Status change: Recruiting → Active, Not Recruiting 2025-06-11
Status change: Not Yet Recruiting → Recruiting 2023-11-16
Trial Details
NCT Number NCT05867615
Lead Sponsor Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Conditions Cancer
Enrollment 83 participants
Start Date 2023-05-25
Primary Completion 2026-08 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2025-12-03