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Spots Global Cancer Trial Database for A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

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Trial Identification

Brief Title: A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

Official Title: PROstate-specific Membrane Antigen DosImetry-Guided endoradiotherapY: A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy (PRODIGY-1)

Study ID: NCT05896371

Study Description

Brief 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.

Detailed Description:

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Jean-Mathieu Beauregard, MD,MSc,FRCPC

Affiliation: CHU de Québec - Université Laval

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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