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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Men only |
| Enrollment | 50 (estimated) |
| Sponsor | Institut Bergonié Academic / other |
| Drugs / interventions | chemotherapy, prednisone, radiation |
| Locations | 1 site (Bordeaux) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | November 30, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | January 30, 2026 |
| Trial ID | NCT06700057 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
- Study coordinator: Nadège ANIZAN
- Email: n.anizan@bordeaux.unicancer.fr
- Phone: +33556333347
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating PSMA PET/CT Imaging for Prostate Cancer Patients
This study is testing a special type of imaging called PSMA PET/CT to see if it can help find cancer in adults who have or might have prostate cancer.
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Targeted alpha therapy for B7-H3 expressing solid tumors using AKY-2519
This phase 1b trial tests a radiolabeled drug (AKY-2519) to see if it's safe and tolerable in adults with B7-H3 positive advanced solid tumors, including NSCLC and SCLC, with imaging to help guide use.
-
PSMA-guided surgery and tissue-resident T cells in node-positive prostate cancer
This study tests whether PSMA-guided surgery can help identify and study tissue-resident T cells in prostate cancer that has spread to lymph nodes.
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Predictive factors for response to Lu-177 PSMA therapy in metastatic castration-resistant prostate cancer
This study tests whether imaging, dose measurements, and blood tests can predict which men with metastatic castration-resistant prostate cancer will respond to Lu-177 PSMA therapy.
-
Salvage high-dose-rate brachytherapy for locally recurrent prostate cancer
This observational study tests whether salvage HDR brachytherapy can help men with locally recurrent prostate cancer after initial radiotherapy, using advanced imaging and biopsy to guide treatment.
-
Multi-peptide Vaccination and PSMAxCD3 Antibody Therapy for Prostate Cancer with Biochemical Recurrence
This phase 2 trial tests whether a PSMA-targeted bispecific antibody (CC-1), a prostate cancer peptide vaccine (VAC-XS15-PC01), or both can be given safely and help control biochemical recurrence after local therapy in men with prostate cancer.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.