Clinical trial Recruiting at 1 site Observational Ages 18 and up Men only

Evaluating radiation dose effects in prostate cancer treatment with 177Lu-PSMA-617

Official title: Optimisation and Safety of an Innovative Nuclear Medicine Treatment: Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.

Run by Institut Bergonié · NCT06700057 · Data updated 2026-11-12

This study is testing how much radiation is given to tumors and nearby organs in patients with advanced prostate cancer who are being treated with a specific drug called 177Lu-PSMA-617.

More Prostate Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexMen only
Enrollment50 (estimated)
SponsorInstitut Bergonié
Academic / other
Drugs / interventionschemotherapy, prednisone, radiation
Locations1 site (Bordeaux)
StatusRecruiting
StartedNovember 1, 2023
Main results expectedNovember 30, 2026
Study endsDecember 31, 2027
Registry record updatedJanuary 30, 2026
Trial IDNCT06700057 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 with progressive, metastatic, castration-resistant prostate cancer who have undergone prior chemotherapy and hormone therapy.

Probably not a fit

Patients who do not have PSMA overexpression or those who are not undergoing treatment with 177Lu-PSMA-617 may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the radiation dose delivered to tumors and surrounding organs in patients treated with 177Lu-PSMA-617 for metastatic castration-resistant prostate cancer. It involves both retrospective and prospective data collection, utilizing scintigraphic images to perform dosimetric calculations. The treatment regimen consists of six cycles administered at a fixed dose, with patient selection based on PSMA expression evaluated through PET/CT scans. The study is conducted at the Institut Bergonié, where standard treatment protocols are followed without modification.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of radiation dosimetry in prostate cancer treatment, potentially improving patient outcomes and minimizing toxicities.

How similar studies have gone: Other studies have shown promise in evaluating dosimetric approaches in radiopharmaceutical treatments, suggesting potential for success in this area.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patient aged 18 and over.
2. Patient with indication for or having started or completed treatment with 177Lu-PSMA-617 since 01/11/2023:

   1. Progressive, metastatic, castration-resistant prostate cancer,
   2. overexpressing prostate specific membrane antigen (PSMA)
   3. treated with taxane chemotherapy and at least one 2nd generation hormone therapy (apalutamide, enzalutamide, darolutamide, abiraterone-prednisone).
3. Patient able to lie still for 1 hour for image acquisition.
4. Patient's place of residence \< 2 hours' drive from the Institut Bergonié.
5. Patient has not expressed any opposition to the use of his/her medical data for research purposes.

Exclusion Criteria:

None

Where it's running

  • Institut Bergonie
    Bordeaux, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.