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

Prostatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05958004
• Other study ID #: XJTU1AF2023LSK-367
• Status: Recruiting
• Start date: June 15, 2023
• Est. completion date: May 20, 2025

Study information

• Verified date: June 2023
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Xiaoyi Duan, Ph.D.
• Phone: 0086-029-85324741
• Email: duanxy[@]xjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to establish an evaluation system for accurate identification of prostate cancer and prostatic hyperplasia 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; develop a nomogram of biomarkers (PSA) + imaging (PSMA) to predict the likelihood of clinically significant prostate cancer in men pre-biopsy. Participants will: 1. undergo PSMA PET/CT and multiparameter MRI; 2. undergo biopsy; and 3. undergo radical prostatectomy for biopsy-proven clinically significant prostate cancer. Researchers will compare the PSMA PET/CT-based features between prostate cancer and benign prostatic hyperplasia to see if there are differences in semiquantitative parameters.

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 prostatic hyperplasia in patients in the PSA gray zone. Participants will: 1. undergo PSMA PET/CT and multiparameter MRI; 2. undergo biopsy; and 3. undergo radical prostatectomy for biopsy-proven clinically significant prostate cancer. Researchers will compare the PSMA PET/CT-based features between prostate cancer and benign prostatic hyperplasia to see if there are differences in semiquantitative parameters.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 20, 2025
• Est. primary completion date: May 20, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• PSA (4-20ng/mL)
• Abnormal digital rectal examination
• 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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Procedure:
• Radical prostatectomy (RP)
Radical prostatectomy will be done by experienced urologists using Da Vinci Xi robotic surgical system

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of SUVmax	Maximum Standardized Uptake Value (SUVmax) is the most commonly used semi-quantitative parameter in PET/CT, which is used to assess tumor burden of PCa.	From the time the participants first go to the hospital without treatment and through study completion, an average of 1 year. If the patient undergoes radical prostatectomy, an additional scan will be added within 3-6 months after surgery
Primary	PSA	Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man's blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood.	Through study completion, an average of 1 year
Primary	Gleason Score of Biopsy	The cells are graded on a scale of 1 to 5. Grade 1 cells resemble normal prostate tissue. Cells closest to 5 are considered "high-grade" and have mutated so much that they barely resemble normal cells.	Within one week after prostate cancer biopsies
Primary	Gleason Score of Radical Prostatectomy	The cells are graded on a scale of 1 to 5. Grade 1 cells resemble normal prostate tissue. Cells closest to 5 are considered "high-grade" and have mutated so much that they barely resemble normal cells.	Within one week after prostate cancer biopsies