Clinical trial NCT05958004: The Application Value of Prostate Specific Membrane Antigen PET/CT in Biopsy Free of PSA Grey Area Prostate Cancer
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Neoplasms
Keywords: PET/CT
PSMA
PSA grey area
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 92
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: -Patients with elevated PSA levels in the First Affiliated Hospital of Xi'an Jiaotong University be included in this study with signed informed consent.

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.

Eligibility criteria: 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

Primary outcomes:
measure: detection rate of prostate cancer
timeFrame: about 1 year
measure: detection rate of clinical significant prostate cancer
timeFrame: about 1 year
Secondary outcomes:
measure: gleason score group prediction
timeFrame: about 1 year
measure: expression level of survival-related genes
timeFrame: about 1 year
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Zhuonan Wang, Ph.D.
role: STUDY_CHAIR
References: