Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer Metastatic
• Interventions: Other: Parametric acquisition

• Registration Number: NCT06450548
• Lead Sponsor: Centre Henri Becquerel

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-06-07
• Last Update Submitted: 2024-06-07
• Study First Posted: 2024-06-10
• Last Update Posted: 2024-06-10
• Study Start: 2024-06-15
• Primary Completion: 2027-06-15
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 60

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dynamic and static acquisition	Parametric acquisition	Dynamic and static PET acquisitions with 18F-FDG and 68Ga-PSMA will be performed with a minimum of 24 hours and a maximum of 15 days between the two

Primary Outcome Measures

Name	Time	Method
Comparative analysis of data from dynamic parametric analysis (volume of distribution Vd) and static analysis	15 days
Comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki) and static analysis	15 days

Secondary Outcome Measures

Name	Time	Method
compare the number of lesions detected as PSMA positive/negative and FDG positive/negative	15 days	Comparison of the number of lesions detected as PSMA positive/negative and FDG positive/negative through factorial analysis versus the visual analysis obtained from dynamic and static images (results from the main objective analysis).

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France