Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA
PYPET
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2024
CompletedFirst Posted
Study publicly available on registry
June 10, 2024
CompletedStudy Start
First participant enrolled
March 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 5, 2028
January 2, 2026
December 1, 2025
3 years
May 28, 2024
December 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (1)
compare the number of lesions detected as PSMA positive/negative and FDG positive/negative
15 days
Study Arms (1)
Dynamic and static acquisition
EXPERIMENTALDynamic 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
Interventions
Parametric acquisition for 18F-FDG PET/CT and 68GA-PSMA PET/CT with 24 h at 15 days of interval
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Henri Becquerel
Rouen, 76000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pierre Decazes, MD,PhD
Centre Henri Becquerel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2024
First Posted
June 10, 2024
Study Start
March 5, 2025
Primary Completion (Estimated)
March 5, 2028
Study Completion (Estimated)
March 5, 2028
Last Updated
January 2, 2026
Record last verified: 2025-12