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Trial Title:
Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA
NCT ID:
NCT06450548
Condition:
Prostate Cancer Metastatic
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
prostate cancer
68GA-PSMA
parametric acquisition
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Parametric acquisition
Description:
Parametric acquisition for 18F-FDG PET/CT and 68GA-PSMA PET/CT with 24 h at 15 days of
interval
Arm group label:
Dynamic and static acquisition
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.
Criteria for 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.).
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Henri Becquerel
Address:
City:
Rouen
Zip:
76000
Country:
France
Start date:
June 15, 2024
Completion date:
June 30, 2027
Lead sponsor:
Agency:
Centre Henri Becquerel
Agency class:
Other
Source:
Centre Henri Becquerel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06450548
