Screening for Prostate Cancer Among Those Prostate-specific Antigen Value Between 2.5 and 4.0 ng/mL

Nanjing University

Status: Unknown

Conditions: Prostate Cancer

Treatments: Diagnostic Test: mpMRI scanning

Study type: Interventional

Funder types: Other

Identifiers

NCT04317625

IUNU-PC-103

Details and patient eligibility

About

The study aims to evaluate the detection rate and characteristics of prostate cancer among males with PSA values between 2.5 and 4.0 ng/mL in Nanjing, meanwhile, to access the effectiveness of conducting multi-parametric MRI (mpMRI) after PSA assay.

Full description

The investigators are going to collect serum samples and clinical information from men aged ≥50 years in community health service centers in Nanjing. The investigators will propose mpMRI for those met our criteria of PSA values between 2.5 and 4.0 ng/ml. Transperineal systematic biopsy and MRI/ultrasound fusion targeted biopsy will be offered for those who scored ≥3 points on the Prostate Imaging-Reporting and Data System Version 2 (PI-RADS v2). Follow-up examinations annually will be offered for those with a PI-RADS score <3. Sequences obtained while conducting mpMRI included T2-weighted imaging, diffusion-weighted imaging, and dynamic contrast-enhanced using a 3.0-T system.

Enrollment: 232 estimated patients

Sex: Male

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥ 50
• PSA between 2.5 and 4.0ng/ml
• (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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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232 participants in 1 patient group

participants

Experimental group

Description:

All of the participants tested serum PSA, some of them conducted mpMRI with/without prostate biopsy under instruction.

Treatment:

Diagnostic Test: mpMRI scanning