MedTrace Logo

Personalized vs. Fixed-Activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)

NCT06943495 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-09

No results posted yet for this study

Summary

The goal of this clinical trial is to assess if a personalized regime of 177Lu-PSMA-617 (Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto) is feasible and safe in a population of patients with metastatic castrate-resistant prostate cancer (mCRPC). The main questions it aims to answer are:

1. Can the administered activity (cumulative or per-cycle) be increased in a majority of participants?
2. What is the incidence of some specific adverse reactions during the treatment?

Researchers will compare participants receiving a personalized regime to participants receiving the standard fixed-activity regime of 177Lu-PSMA-617 to see if the activity can be safely increased through personalization based on renal dosimetry (i.e. the measure of how much radiation is actually delivered to the kidney).

Participants will receive up to 6 treatments of 177Lu-PSMA-617 every 6 weeks and be regularly evaluated with imaging and laboratory tests, as well as with questionnaires.

Conditions

  • Metastatic Castrate Resistant Prostate Cancer (mCRPC)

Interventions

DRUG

177Lu-PSMA-617

6 cycles of personalized activity (1st cycle based on BSA and eGFR; cycles 2-6 based on renal dosimetry), maximum 22.2 GBq, every 6 weeks

DRUG

177Lu-PSMA-617

6 cycles of 7.4 GBq every 6 weeks

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    collaborator OTHER

  • Novartis

    collaborator INDUSTRY

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Jean-Mathieu Beauregard

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2029-03-31
Completion
2033-03-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT06943495 on ClinicalTrials.gov