Skip to main content
OpenTrials
Completed

NCT Number: NCT05958004

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

45 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. detection rate of prostate cancer

    Time frame: about 1 year

    detection rate of prostate cancer

  2. detection rate of clinical significant prostate cancer

    Time frame: about 1 year

    detection rate of clinical significant prostate cancer

Secondary outcomes

  1. gleason score group prediction

    Time frame: 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

  2. expression level of survival-related genes

    Time frame: about 1 year

    Using RNA sequence to evaluate the expression level of survival-related genes

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

Application Value of Biopsy Free Technique for Prostate Specific Antigen Grey Area Prostate Cancer Based on 18F-Prostate Specific Membrane Antigen-1007 Positron Emission Tomography/Computerized Tomography

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 24, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.