Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA
ConditionProstate Cancer Metastatic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorCentre Henri Becquerel
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.).
Trial design
Design model
Single group
Treatments tested in this trial
Parametric acquisition
Other interventionParametric acquisition for 18F-FDG PET/CT and 68GA-PSMA PET/CT with 24 h at 15 days of interval
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Dynamic and static acquisitionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Comparative analysis of data from dynamic parametric analysis (volume of distribution Vd) and static analysis
Time frame
15 days2
Comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki) and static analysis
Time frame
15 daysSecondary outcomes
1
compare the number of lesions detected as PSMA positive/negative and FDG positive/negative
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).
Time frame
15 daysSponsors and contacts
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Source ClinicalTrials.gov