Combined Prostate-specific Antigen, Multi-parametric MRI and Targeted Prostate Biopsy for Prostate Cancer Screening

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the incidence of prostate cancer among males in Nanjing and whether a combination of PSA, multi-parametric MRI and targeted biopsy is a feasible approach for screening prostate cancer in China.

Detailed Description
-----------------
The investigators are going to collect serum samples and clinical information from men aged ≥50 years taking physical examination in community health service centers in Nanjing. The investigators will propose mpMRI for those with serum PSA ≥4 ng/mL. Transperineal systematic biopsy (TPSB) combined with MRI /ultrasound fusion targeted biopsy (TB) will be offered for those scored ≥3 on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). TPSB alone will be offered for those scored <3 and serum PSA ≥10 ng/mL. Subjects with serum PSA between 4 ng/mL and 10 ng/mL and PI-RADS score <3 points will be referred to follow-up examinations every 6 months.

Official Title
-----------------
A Clinical Study on the Efficiency of Prostate Cancer Screening by the Combination of Serum PSA Assay，Multi-parametric MRI and Targeted Prostate Biopsy Among Males in Nanjing

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: multi-parametric MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 50 (Eastern Cooperative Oncology Group)ECOG grade: 0-1 Normal organic function indexes: (absolute neutrophil count)ANC ≧1.5×109/L (platelet count)PLT ≧100×109/L Hb ≧90 g/L (total bilirubin)TBIL ≦1.5×ULN (aspartate aminotransferase)ALT≦2.5×ULN (alanine aminotransferase)AST ≦2.5×ULN (blood urea nitrogen)BUN (orUREA) and Cr ≦1.5×ULN Exclusion Criteria: Former serum PSA detection Having took Proscar in the past 3 months Suffered from any other malignant tumor in the past 5 years History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system Having took Proscar in the past 3 months Suffered from any other malignant tumor in the past 5 years History of acute urinary retention, acute or chronic bacterial or abacterial prostatitis within 6 weeks or other recent infection of the urinary system

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: participants<br>All tested serum PSA. Some conducted mpMRI with/without prostate biopsy under instruction. | Diagnostic Test: multi-parametric MRI<br>* Multi-parametric MRI will be suggested for those PSA ≥4 ng/mL, PI-RADS v2 score will be used to evaluate images.<br>* Other names: targeted prostate biopsy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of prostate cancer | Incidence of prostate cancer among males ≥50 years old | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with different gleason scores | Gleason score of prostate cancer patients, Including 7 degrees:3+3=6,3+4=7,4+3=7,4+4=8,4+5=9,5+4=9,5+5=10. | 3 years | 
| Number of participants with different clinical stages | Clinical stage of prostate cancer patients according to the eighth version of American Joint Committee on Cancer(AJCC) guideline for prostate cancer. | 3 years | 
| Number of participants with different risk groups | Devided to three risk groups(high-medium-low) according to D'Amico risk groups of prostate cancer. | 3 years | 
| Number of participants with different prognostic stage groups | Prognostic stage of prostate cancer patients according to the eighth version of American Joint Committee on Cancer(AJCC) guideline for prostate cancer. | 3 years |