A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

The goal of this clinical trial is to study a personalized regime of lutetium-177 (177Lu) prostate-specific membrane antigen (PSMA) radiopharmaceutical therapy (RPT) in patients with progressive and/or symptomatic, inoperable PSMA-expressing cancers of prostatic or other origins. The main questions it aims to answer are: * To establish a dosimetry-based, personalized regime of 177Lu-PSMA * To report on the efficacy of personalized 177Lu-PSMA Participants (stratified by risk factors of toxicity) will receive up to 6 cycles of a personalized activity of 177Lu-PSMA based on renal dosimetry. In the phase 1, the prescribed absorbed dose to the kidney will be escalated, to determine the regime that will be administered in the phase 2. The best response within 12 months after the first cycle will be assessed. Salvage treatment of 3 cycles may be offered to responders after re-progression.

NCT Number	NCT05896371
Lead Sponsor	CHU de Quebec-Universite Laval Collaborators: Canadian Institutes of Health Research (CIHR)
Conditions	Cancer, Prostate Cancer, Metastatic Cancer, Metastatic Prostate Cancer
Enrollment	500 participants
Start Date	2028-03
Primary Completion	2033-03 (estimated)
Study Completion	2034-03 (estimated)
Updated on ClinicalTrials.gov	2025-03-30