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Clinical Trials/NCT06450548
NCT06450548
Recruiting
Not Applicable

Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis of Metastatic Prostatic Adenocarcinomas Prior to 177Lu-PSMA Treatment

Centre Henri Becquerel1 site in 1 country60 target enrollmentMarch 5, 2025

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer Metastatic
Sponsor
Centre Henri Becquerel
Enrollment
60
Locations
1
Primary Endpoint
Comparative analysis of data from dynamic parametric analysis (volume of distribution Vd) and static analysis
Status
Recruiting
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 5, 2025
End Date
March 5, 2028
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

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.).

Outcomes

Primary Outcomes

Comparative analysis of data from dynamic parametric analysis (volume of distribution Vd) and static analysis

Time Frame: 15 days

Comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki) and static analysis

Time Frame: 15 days

Secondary Outcomes

  • compare the number of lesions detected as PSMA positive/negative and FDG positive/negative(15 days)

Study Sites (1)

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