Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA
NCT ID: NCT06450548
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-03-05
2028-03-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Dynamic and static 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
Parametric acquisition
Parametric acquisition for 18F-FDG PET/CT and 68GA-PSMA PET/CT with 24 h at 15 days of interval
Interventions
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Parametric acquisition
Parametric acquisition for 18F-FDG PET/CT and 68GA-PSMA PET/CT with 24 h at 15 days of interval
Eligibility Criteria
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Inclusion Criteria
* 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 undergo the examinations and/or maintain a prolonged lying position (due to back pain, etc.).
18 Years
MALE
No
Sponsors
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Centre Henri Becquerel
OTHER
Responsible Party
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Principal Investigators
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Pierre Decazes, MD,PhD
Role: STUDY_DIRECTOR
Centre Henri Becquerel
Locations
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Centre Henri Becquerel
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHB23.04
Identifier Type: -
Identifier Source: org_study_id
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