Screening for Prostate Cancer Among Those Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: mpMRI scanning
- Registration Number
- NCT04317625
- Lead Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 232
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description participants mpMRI scanning All of the participants tested serum PSA, some of them conducted mpMRI with/without prostate biopsy under instruction.
- Primary Outcome Measures
Name Time Method Incidence of prostate cancer 3 years among PSA between 2.5 and 4.0 ng/ml
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
🇨🇳Nanjing, Jiangsu, China