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

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.

NCT Number	NCT06943495
Lead Sponsor	Jean-Mathieu Beauregard Collaborators: CHU de Quebec-Universite Laval, Novartis, Canadian Institutes of Health Research (CIHR)
Conditions	Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Enrollment	60 participants
Start Date	2025-08-15
Primary Completion	2029-03 (estimated)
Study Completion	2033-03 (estimated)
Updated on ClinicalTrials.gov	2025-09-09