The Application Value of Prostate Specific Membrane Antigen PET/CT in Biopsy Free of PSA Grey Area Prostate Cancer

Completed

• Conditions: Prostatic Neoplasms

• Registration Number: NCT05958004
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the PSA gray zone. The main questions it aims to answer are: proportion of men who could have avoided biopsy with positive PSMA-PET and no clinically significant cancer detected on biopsy.

Participants will: 1. undergo PSMA PET/CT and multiparametric MRI; and 2. undergo prostate biopsy

Researchers will compare the diagnostic performance of PSMA PET/CT and multiparametric MRI for prostate cancer and clinical significant prostate cancer to see if there are differences.

Detailed Description

Prostate Specific Antigen (PSA) is a serine protease secreted by prostate epithelial cells, which is a tumor marker of prostate cancer. At present, PSA\<4 ng/ml is considered as the normal value, and PSA 4-10 ng/ml is considered as the gray value. PSA\>10 ng/ml should be highly suspected of prostate cancer. Prostate biopsy is still the gold standard for the diagnosis of prostate cancer. However, as an invasive procedure, it can cause many complications such as pain, bleeding, lower urinary tract symptoms and infection. There is a growing trend to reduce unnecessary prostate biopsies.

Prostate specific membrane antigen (PSMA) is a membrane-bound enzyme that is highly expressed in more than 90% of prostate cancer lesions and has become an important target for molecular imaging of prostate cancer. In recent years, radioactive nuclide 18F labeling targeting PSMA positron emission tomography/computed tomography (PET/CT) has shown important clinical application value in prostate cancer recurrence monitoring.

The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and clinical significant prostate cancer in patients in the PSA gray zone.

Participants will: 1. undergo PSMA PET/CT and multiparametric MRI; and 2. undergo biopsy

Researchers will compare the diagnostic performance of PSMA PET/CT and multiparametric MRI for prostate cancer and clinical significant prostate cancer to see if there are differences.

Study Timeline

• Study Start: 2023-06-15
• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-14
• Study First Posted: 2023-07-24
• Primary Completion: 2024-03-30
• Study Completion: 2024-03-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 92

Inclusion Criteria

• PSA (4-10 ng/mL)
• MRI and PSMA PET/CT were not contraindicated
• Did not receive prostate-related treatment
• There are no contraindications to biopsy

Exclusion Criteria

• Coexisting with other malignancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
detection rate of clinical significant prostate cancer	about 1 year	detection rate of clinical significant prostate cancer
detection rate of prostate cancer	about 1 year	detection rate of prostate cancer

Secondary Outcome Measures

Name	Time	Method
gleason score group prediction	about 1 year	Using biopsy histopathology as standard, patients will be classified as gleason score 6-10. We use PSMA PET and genomics to predict gleason score group
expression level of survival-related genes	about 1 year	Using RNA sequence to evaluate the expression level of survival-related genes

Trial Locations

Locations (1)

First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China