The Exploration of 18F-PSMA-1007 PET/CT Imaging in Prostate Cancer Patients

Affiliated Hospital of Jiangnan University

Status: Invitation-only

Conditions: Prostate Cancer

Treatments: Drug: 18F-FDG; Drug: 18F-PSMA-1007

Study type: Interventional

Funder types: Other

Identifiers

NCT06723665

LS2024279

Details and patient eligibility

About

micro-PET imaging showed that 18F-PSMA-1007 had similar or even better pharmacokinetics and imaging performance than 18F-DCFPyL. Due to the convenience of synthesis and good imaging performance, 18F-PSMA-1007 is expected to be popularized in clinical practice.The purpose of this study is to evaluate the performance of 18F-PSMA-1007 in diagnosis, differential diagnosis and efficacy monitoring of prostate cancer.

Full description

1. Visual analysis of images: describe the location, size, shape and degree of uptake of lesions;
2. Semi-quantitative analysis: the ratio of lesion site uptake to liver uptake was measured by area of interest method (ROI);
3. Comparative analysis: Compared with clinical routine 18F-FDG PET/CT imaging, the advantages of PSMA PET/CT imaging were clarified;
4. Evaluation and analysis of efficacy: before and after treatment, to clarify the early treatment evaluation value of PSMA PET/CT imaging, and compare it with 18F-FDG PET/CT imaging;
5. Prognostic study: Through multi-factor analysis, the relationship between the level of PSMA PET/CT imaging uptake and the prognosis of patients was clarified.

Enrollment: 50 estimated patients

Sex: Male

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Prostate cancer is clinically suspected. The patient was diagnosed with prostate cancer by biopsy. Prostate cancer needs to be evaluated after treatment.

Exclusion criteria

Patients who did not meet the requirements as assessed by the investigator.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

18F-PSMA-1007

Experimental group

Description:

Subjects: Patients with suspected or diagnosed prostate cancer, or biochemical recurrence of prostate cancer. Over 40 years old (including 40 years old); Informed consent and access to follow-up; To exclude patients who are difficult to receive further diagnosis and treatment because of their serious condition. PSMA PET/CT was reviewed 7 days and 3 months after surgery. All patients were followed up once every 3 months to understand the progression and survival of the lesions.

Treatment:

Drug: 18F-PSMA-1007

18F-FDG

Active Comparator group

Description:

The corresponding patients underwent PSMAPET/CT examination within one week before and after routine 18F-FDGPCT/CT imaging (control examination). PCT/CT whole body scan was performed 45min-1h after intravenous injection of the developer, and the image processing was as usual.

Treatment:

Drug: 18F-FDG