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

NCT ID: NCT05438524

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 159 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2024-02-01

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

CHIU Ka Fung Peter

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Ka-Fung CHIU, FRCS, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital, Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

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Related Links

http://www3.ha.org.hk/cancereg/pdf/factsheet/2017/prostate_.pdf

Hong Kong Cancer Statistics

Other Identifiers

CRE 2021.256

Identifier Type: -

Identifier Source: org_study_id