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

Not Applicable

• Conditions: Prostate Cancer

• 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.

Study Timeline

• Study First Submitted: 2020-01-27
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Study First Posted: 2020-03-26
• Last Update Posted: 2020-03-26
• Study Start: 2020-04
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10000

Inclusion Criteria

• 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

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
• 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

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 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.
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.

Trial Locations

Locations (1)

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University; 🇨🇳 Nanjing, Jiangsu, China