Clinical trial NCT05438524: The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values
Official title: The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values: Can we Save Some MRI Scans?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 159
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: In men with higher risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges
timeFrame: Baseline (only one-time point)
measure: In men with lower risk of significant prostate cancer, proportion of men with abnormal MRI at different Prostate Health Index (phi) ranges
timeFrame: Baseline (only one-time point)
Secondary outcomes:
measure: Sensitivity of various phi cutoffs to predict PI-RADS score ≥3 in MRI prostate
timeFrame: Baseline (only one-time point)
measure: Sensitivity of various phi cutoffs to predict PI-RADS score ≥4 in MRI prostate
timeFrame: Baseline (only one-time point)
measure: Proportion of low risk group diagnosis of clinically significant prostate cancer with abnormal MRI
timeFrame: Baseline (only one-time point)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Peter Ka-Fung CHIU, FRCS, PhD
role: PRINCIPAL_INVESTIGATOR
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