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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
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.
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.
Age
50 - No limit years
Sex
MALE
Healthy Volunteers
Yes
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
Start Date
April 1, 2020
Primary Completion Date
December 1, 2022
Completion Date
December 1, 2022
Last Updated
March 26, 2020
10,000
ESTIMATED participants
multi-parametric MRI
DIAGNOSTIC_TEST
Lead Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
NCT05691465
NCT06842498
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04550494