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A Phase 1/2 Study of Personalized PSMA Radiopharmaceutical Therapy

NCT05896371 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-03-30

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Jean-Mathieu Beauregard, MD,MSc,FRCPC · CHU de Québec - Université Laval

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2028-03-31
Primary Completion
2033-03-31
Completion
2034-03-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05896371 on ClinicalTrials.gov