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

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

Sponsors

Lead Sponsor: Chinese University of Hong Kong

Source 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.

Overall Status Recruiting
Start Date 2021-11-11
Completion Date 2023-12-31
Primary Completion Date 2023-09-30
Study Type Observational
Primary Outcome
Measure Time Frame
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 lower risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges Baseline (only one-time point)
Secondary Outcome
Measure Time Frame
Sensitivity of various phi cutoffs to predict PI-RADS score ≥3 in MRI prostate Baseline (only one-time point)
Sensitivity of various phi cutoffs to predict PI-RADS score ≥4 in MRI prostate Baseline (only one-time point)
Proportion of low risk group diagnosis of clinically significant prostate cancer with abnormal MRI Baseline (only one-time point)
Enrollment 159
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

Male

Gender Based:

Yes

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Peter Ka-Fung CHIU, FRCS, PhD Principal Investigator Chinese University of Hong Kong
Overall Contact

Last Name: Peter Ka-Fung CHIU, FRCS, PhD

Phone: 35052625

Email: [email protected]

Location
Facility: Status: Contact: Prince of Wales Hospital, Chinese University of Hong Kong Peter Ka-Fung CHIU, FRCP, PhD 852-3505-2625 [email protected]
Location Countries

Hong Kong

Verification Date

2022-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chinese University of Hong Kong

Investigator Full Name: CHIU Ka Fung Peter

Investigator Title: Associate Professor

Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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