NCT05438524Completed
The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values
The Performance of MRI Prostate in Men With Different Prostate Health Index (Phi) Values: Can we Save Some MRI Scans?
Source: ClinicalTrials.gov · Last updated 22 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 159 (actual)
- First submitted
- 24 Jun 2022
- Start date
- 11 Nov 2021
- Primary completion date
- 27 Dec 2023
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Prostate cancer
- NCT number
- NCT05438524
What you commit to
- Study type: Observational
- Participants enrolled: 159
- From 11 Nov 2021 to the primary completion date, 27 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- On 5-alpha reductase inhibitor in the past 6 months (e.g. Finasteride, Dutasteride)
Other illness
- Past or current history of prostate cancer
- Contraindicated for prostate biopsy (e.g. uncorrectable coagulopathy, active infection
Lab values
- 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)
Other
- MRI prostate performed in past 5 years
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Prince of Wales Hospital, Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.