NCT06450548 Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA
| NCT ID | NCT06450548 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Henri Becquerel |
| Condition | Prostate Cancer Metastatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-05 |
| Primary Completion | 2028-03-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-03-05 with a primary completion date of 2028-03-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prostate cancer is a significant health issue, representing 21.8% of male cancer cases in France with over 449,000 new cases in 2018. It's the cause of 10% of cancer deaths in Europe. The PSMA is a target for mCRPC treatment, with therapies like 177Lu-PSMA-617 delivering radiation to cancer cells. The Vision study showed that 177Lu-PSMA-617, combined with standard care, improved survival rates significantly compared to standard care alone.The French ANSM authorized 177Lu-PSMA-617 for mCRPC under certain conditions. Patients must have histologically confirmed mCRPC, be progressive despite treatment, and have PSMA-positive imaging. Imaging assessments include PSMA PET/CT and 18F-FDG PET/CT to identify FDG-positive and PSMA-negative sites, which are associated with a poorer prognosis. Parametric analysis using dynamic PET could improve lesion characterization, aiding in treatment decisions. This is the focus of the PyPET study. The main objective focuses on a comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki, volume of distribution Vd) and static analysis (standard at 1 hour) using 18F-FDG and 68Ga-PSMA PET/CT for diagnosing metastases, especially in the liver, lymph nodes, and bones. It aims to assess the effectiveness of these imaging techniques in accurately identifying metastatic sites.
Eligibility Criteria
Inclusion Criteria: * Signed informed consent. * Progressive metastatic castration-resistant prostate adenocarcinoma, which has been treated with taxane chemotherapy and at least one anti-androgen hormone therapy. * Evaluated by 18F-FDG and 68Ga-PSMA PET/CT prior to potential treatment with 177Lu-PSMA. * Affiliated with or beneficiary of a social protection scheme. * WHO stage 0 or 1. Exclusion Criteria: * Patients unable to understand the study for any reason or comply with the trial requirements (due to language barriers, psychological issues, geographical constraints, etc.). * Patients unable to undergo the examinations and/or maintain a prolonged lying position (due to back pain, etc.).
Contact & Investigator
Pierre Decazes, MD,PhD
STUDY DIRECTOR
Centre Henri Becquerel
Frequently Asked Questions
Who can join the NCT06450548 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer Metastatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06450548 currently recruiting?
Yes, NCT06450548 is actively recruiting participants. Contact the research team at pierre.decazes@chb.unicancer.fr for enrollment information.
Where is the NCT06450548 trial being conducted?
This trial is being conducted at Rouen, France.
Who is sponsoring the NCT06450548 clinical trial?
NCT06450548 is sponsored by Centre Henri Becquerel. The principal investigator is Pierre Decazes, MD,PhD at Centre Henri Becquerel. The trial plans to enroll 60 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.