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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic and static acquisition | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parametric acquisition | Other | Parametric acquisition for 18F-FDG PET/CT and 68GA-PSMA PET/CT with 24 h at 15 days of interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Decazes, MD,PhD | Contact | +3276673059 | pierre.decazes@chb.unicancer.fr | |
| Doriane Richard, PhD | Contact | +3232082985 | doriane.richard@chb-unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pierre Decazes, MD,PhD | Centre Henri Becquerel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Henri Becquerel | Recruiting | Rouen | 76000 | France |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |