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A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy
Sponsor: CHU de Quebec-Universite Laval
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
177Lu-PSMA-I&T - escalating renal absorbed dose
Personalized 177Lu-PSMA-I\&T injected activity
177Lu-PSMA-I&T - recommended phase 2 regime
Personalized 177Lu-PSMA-I\&T injected activity