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

Nanjing University

Status: Unknown

Conditions: Prostate Cancer

Treatments: Diagnostic Test: multi-parametric MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT04322045

IUNU-PC-102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10,000 participants in 1 patient group

participants

Experimental group

Description:

All tested serum PSA. Some conducted mpMRI with/without prostate biopsy under instruction.

Treatment:

Diagnostic Test: multi-parametric MRI