The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values

Prostate Cancer Clinical Trial

Official title: The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values: Can we Save Some MRI Scans?

Status Recruiting

Clinical Trial Summary

This study is to investigate, in a larger cohort of consecutive men, the proportion of abnormal MRI prostate in different phi ranges, and the cancer detected in Chinese men with abnormal MRI. This study aims to evaluate whether MRI prostate can be omitted in men with lower suspicion of prostate cancer.

Clinical Trial Description

This is a prospective cohort study recruiting consecutive men with elevated blood test PSA 4-10 ng/mL, normal prostate on digital rectal examination, and result for blood Prostate Health Index (phi) known. A multi-parametric MRI prostate with contrast will be performed in all subjects. MRI prostate will be reported according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations[10] and scored from 1 to 5. A PI-RADS score of 3-5 is considered abnormal. The proportion of abnormal MRI in different phi ranges (primary outcome) will be compared. The subjects will be offered a prostate biopsy according to usual clinical indications in our hospital: In men with phi >35 (higher risk of significant prostate cancer), prostate biopsy (systematic biopsy, plus MRI-guided if abnormal MRI) will be offered. In men with phi < 35 (lower risk of prostate cancer), prostate biopsy (systematic plus MRI-guided) will be offered only if MRI is abnormal. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT05438524
• Study type: Observational
• Source: Chinese University of Hong Kong
• Contact: Peter Ka-Fung CHIU, FRCS, PhD
• Phone: 35052625
• Email: peterchiu@surgery.cuhk.edu.hk
• Status: Recruiting
• Start date: November 11, 2021
• Completion date: June 30, 2024