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

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT05438524
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-29
• Study First Posted: 2022-06-30
• Primary Completion: 2023-12-27
• Study Completion: 2024-02-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 159

Inclusion Criteria

• Ethnically Chinese Men ≥18 years of age
• Clinical suspicion of prostate cancer and indicated for prostate biopsy
• Serum Prostate-specific antigen (PSA) 4-10 ng/mL
• Serum Prostate health index (phi) result available
• Normal Digital rectal examination
• Able to provide written informed consent

Read More

Exclusion Criteria

• Past or current history of prostate cancer
• On 5-alpha reductase inhibitor in the past 6 months (e.g. Finasteride, Dutasteride)
• MRI prostate performed in past 5 years
• Contraindicated to undergo MRI scan (e.g. pacemaker in-situ, claustrophobia, estimated glomerular filtration rate < 50ml/min in serum renal function test within 3 months)
• Contraindicated for prostate biopsy (e.g. uncorrectable coagulopathy, active infection

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In men with higher risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges	Baseline (only one-time point)	In men with higher risk (phi\>35) of significant prostate cancer), proportion of men with abnormal MRI.
In men with lower risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges	Baseline (only one-time point)	In men with lower risk (phi\<35) of significant prostate cancer), proportion of men with abnormal MRI.

Secondary Outcome Measures

Name	Time	Method
Sensitivity of various phi cutoffs to predict PI-RADS score ≥3 in MRI prostate	Baseline (only one-time point)	Assessed by phi values and PI-RADS score in MRI prostate
Sensitivity of various phi cutoffs to predict PI-RADS score ≥4 in MRI prostate	Baseline (only one-time point)	Assessed by phi values and PI-RADS score in MRI prostate
Proportion of low risk group diagnosis of clinically significant prostate cancer with abnormal MRI	Baseline (only one-time point)	Diagnosis of clinically significant prostate cancer (Gleason 3+4 or above) in men with abnormal MRI and phi \<35

Trial Locations

Locations (1)

Prince of Wales Hospital, Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong