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NOT YET RECRUITING
NCT05896371
PHASE1/PHASE2

A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

Sponsor: CHU de Quebec-Universite Laval

View on ClinicalTrials.gov

Summary

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.

Official title: PROstate-specific Membrane Antigen DosImetry-Guided EndoradiotherapY: a Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy (PRODIGY-1)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2028-03

Completion Date

2034-03

Last Updated

2025-03-30

Healthy Volunteers

No

Interventions

DRUG

177Lu-PSMA-I&T - escalating renal absorbed dose

Personalized 177Lu-PSMA-I\&T injected activity

DRUG

177Lu-PSMA-I&T - recommended phase 2 regime

Personalized 177Lu-PSMA-I\&T injected activity