Trials / Recruiting
RecruitingNCT06943495
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)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Jean-Mathieu Beauregard · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-08-15
- Primary completion
- 2029-03-01
- Completion
- 2033-03-01
- First posted
- 2025-04-24
- Last updated
- 2025-09-09
Locations
1 site across 1 country: Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06943495. Inclusion in this directory is not an endorsement.