Prostate Cancer
Conditions
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.
Interventions
DIAGNOSTIC_TESTmpMRI scanning
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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of prostate cancer | 3 years | among PSA between 2.5 and 4.0 ng/ml |
Countries
China
Contacts
Primary ContactXiaozhi Zhao
Backup ContactHongqian Guo
Outcome results
None listed