Screening for Prostate Cancer Among Those Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL

Study Overview
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Brief Summary
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The study aims to evaluate the detection rate and characteristics of prostate cancer among males with PSA values between 2.5 and 4.0 ng/mL in Nanjing, meanwhile, to access the effectiveness of conducting multi-parametric MRI (mpMRI) after PSA assay.

Detailed Description
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The investigators are going to collect serum samples and clinical information from men aged ≥50 years in community health service centers in Nanjing. The investigators will propose mpMRI for those met our criteria of PSA values between 2.5 and 4.0 ng/ml. Transperineal systematic biopsy and MRI/ultrasound fusion targeted biopsy will be offered for those who scored ≥3 points on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). Follow-up examinations annually will be offered for those with a PI-RADS score <3. Sequences obtained while conducting mpMRI included T2-weighted imaging, diffusion-weighted imaging, and dynamic contrast-enhanced using a 3.0-T system.

Official Title
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Screening for Prostate Cancer Among Those Initial Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: mpMRI scanning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 PSA between 2.5 and 4.0ng/ml (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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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 of the participants tested serum PSA, some of them conducted mpMRI with/without prostate biopsy under instruction. | Diagnostic Test: mpMRI scanning<br>* The patients whose PSA levels are between 2.5 and 4.0ng/ml will be recommended to mpMRI scanning at first but not biopsy or active surveillance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of prostate cancer | among PSA between 2.5 and 4.0 ng/ml | 3 years |