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

Study Overview
=================
Brief 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.

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 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.

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

Conditions
-----------------
Prostatic Neoplasms

Intervention / Treatment
-----------------
* Procedure: Radical prostatectomy (RP)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Benign Prostatic Hyperplasia<br>Participants who are suspected of prostate cancer due to elevated PSA but have not received any treatment and eventually confirmed benign prostatic hyperplasia after biopsies | |
| Prostate Cancer<br>Participants who are suspected of prostate cancer due to elevated PSA but have not received any treatment and eventually confirmed prostate cancer after biopsies | Procedure: Radical prostatectomy (RP)<br>* Radical prostatectomy will be done by experienced urologists using Da Vinci Xi robotic surgical system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET/CT, PSMA, PSA grey area