Clinical trial NCT06450548: Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA
Official title: Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis of Metastatic Prostatic Adenocarcinomas Prior to 177Lu-PSMA Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer Metastatic
Keywords: prostate cancer
68GA-PSMA
parametric acquisition
Lead sponsor: Centre Henri Becquerel
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.).

Primary outcomes:
measure: Comparative analysis of data from dynamic parametric analysis (volume of distribution Vd) and static analysis
timeFrame: 15 days
measure: Comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki) and static analysis
timeFrame: 15 days
Secondary outcomes:
measure: compare the number of lesions detected as PSMA positive/negative and FDG positive/negative
timeFrame: 15 days
Other outcomes:
Locations:
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Centre Henri Becquerel
name: Pierre Decazes, MD,PhD
role: STUDY_DIRECTOR
References: