NCT04322045

Combined Prostate-specific Antigen, Multi-parametric MRI and Targeted Prostate Biopsy for Prostate Cancer Screening

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,000 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	multi-parametric MRI	Multi-parametric MRI will be suggested for those PSA ≥4 ng/mL, PI-RADS v2 score will be used to evaluate images.

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-03-26
• Last updated: 2020-03-26

Locations

1 site across 1 country: China