RecruitingPhase 1NCT06943495

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

PROstate-specific Membrane Antigen DosImetry- Guided endoradiotherapY: A Randomized- Controlled, Single-blind, Pilot Study of Personalized vs. Fixed-activity 177Lu-PSMA-617 Radiopharmaceutical Therapy (PRODIGY-2)


Sponsor

Jean-Mathieu Beauregard

Enrollment

60 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two dosing strategies for lutetium-177 PSMA-617 (a targeted radioactive treatment for prostate cancer) — a fixed dose versus a personalised dose based on each patient's body — to see which approach is safer and more effective. **You may be eligible if...** - You are a man aged 18 or older - You have metastatic castration-resistant prostate cancer (cancer that has spread and continues to grow despite testosterone-lowering treatment) - Your cancer is PSMA-positive on a PET scan - Your PSA level is rising and is at least 2 ng/mL - You have received at least one prior hormone therapy for resistant disease - Your kidney function and blood counts are adequate **You may NOT be eligible if...** - Your cancer has extensive bone-only spread on PSMA PET (so-called "superscan") - You have severe kidney impairment (eGFR below 45) - You have active or progressing brain metastases - You have had prior lutetium-177 PSMA therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG177Lu-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

DRUG177Lu-PSMA-617

6 cycles of 7.4 GBq every 6 weeks


Locations(1)

CHU de Québec-Université Laval

Québec, Quebec, Canada

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NCT06943495


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