Combined Prostate-specific Antigen, Multi-parametric MRI and Targeted Prostate Biopsy for Prostate Cancer Screening
- Conditions
- Prostate Cancer
- Interventions
- Diagnostic Test: multi-parametric MRI
- Registration Number
- NCT04322045
- Lead Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 10000
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description participants multi-parametric MRI All tested serum PSA. Some conducted mpMRI with/without prostate biopsy under instruction.
- Primary Outcome Measures
Name Time Method Incidence of prostate cancer 3 years Incidence of prostate cancer among males ≥50 years old
- Secondary Outcome Measures
Name Time Method Number of participants with different gleason scores 3 years 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.
Number of participants with different clinical stages 3 years Clinical stage of prostate cancer patients according to the eighth version of American Joint Committee on Cancer(AJCC) guideline for prostate cancer.
Number of participants with different risk groups 3 years Devided to three risk groups(high-medium-low) according to D'Amico risk groups of prostate cancer.
Number of participants with different prognostic stage groups 3 years Prognostic stage of prostate cancer patients according to the eighth version of American Joint Committee on Cancer(AJCC) guideline for prostate cancer.
Trial Locations
- Locations (1)
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
🇨🇳Nanjing, Jiangsu, China