Evaluating radiation dose effects in prostate cancer treatment with 177Lu-PSMA-617
Optimisation and Safety of an Innovative Nuclear Medicine Treatment: Clinical and Dosimetric Study of Patients Treated With 177Lu-PSMA-617 for Prostate Cancer.
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Institut Bergonié Academic / other |
| Drugs / interventions | chemotherapy, prednisone, radiation |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06700057 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with progressive, metastatic, castration-resistant prostate cancer who have undergone prior chemotherapy and hormone therapy.
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.
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 performed: Other studies have shown promise in evaluating dosimetric approaches in radiopharmaceutical treatments, suggesting potential for success in this area.
Eligibility criteria
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 this trial is running
Bordeaux
- Institut Bergonie — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Nadège ANIZAN
- Email: n.anizan@bordeaux.unicancer.fr
- Phone: +33556333347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.