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

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.

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