NCT05896371

A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cancer
• Prostate Cancer
• Metastatic Cancer
• Metastatic Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2028-03-01
• Primary completion: 2033-03-01
• Completion: 2034-03-01
• First posted: 2023-06-09
• Last updated: 2025-03-30