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

Lead Sponsor: Chinese University of Hong Kong

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.

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.

• Prostate Cancer

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

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

Phone: 35052625

Email: [email protected]

Hong Kong

2022-06-01

Type: Principal Investigator

Investigator Affiliation: Chinese University of Hong Kong

Investigator Full Name: CHIU Ka Fung Peter

Investigator Title: Associate Professor

• Prostatic Neoplasms

Observational Model: Cohort

Time Perspective: Prospective