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

November 20, 2024 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital, Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Men with elevated PSA of 4-10 ng/mL who were referred to the Urology clinic without prior prostate biopsy, will be included.

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Peter Ka-Fung CHIU, FRCS, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Actual)

December 27, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

June 24, 2022

First Submitted That Met QC Criteria

June 29, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Estimated)

November 22, 2024

Last Update Submitted That Met QC Criteria

November 20, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE 2021.256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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