Status:
COMPLETED
The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
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 stu...
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) k...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 11 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT05438524
Start Date
November 11 2021
End Date
February 1 2024
Last Update
November 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Prince of Wales Hospital, Chinese University of Hong Kong
Hong Kong, Hong Kong