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Clinical Trials in France / NCT06450548
Recruiting Not applicable

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

NCT06450548 · tracked via the Priya Life Science France tracker
Sponsor
Centre Henri Becquerel
Phase
Not applicable
Started
2025-03-05
Last updated
2026-01-02

Condition(s) studied

Prostate Cancer Metastatic

Investigational drug(s) / intervention(s)

Parametric acquisition

Parametric acquisition: Parametric acquisition for 18F-FDG PET/CT and 68GA-PSMA PET/CT with 24 h at 15 days of interval

Study 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

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.).

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Centre Henri Becquerel Rouen France Recruiting

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Other trials for the same condition

Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders) Recruiting
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) Recruiting
ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable) Recruiting
Safety and Pharmacokinetics of ODM-208 in Patients With Metastatic Castration-resistant Prostate Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06450548 on ClinicalTrials.gov ↗ ← All trials in France