sefulness of combining Prostate Health Index with MRI of the prostate for the diagnosis of prostate cancer in patients with inconclusive PSA levels
Not Applicable
- Conditions
- Health Condition 1: C61- Malignant neoplasm of prostate
- Registration Number
- CTRI/2024/03/064175
- Lead Sponsor
- Christian Medical College, Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with PSA levels of 4-10 ng/ml, even those detected at surveillance
Exclusion Criteria
Patients who have cardiac pacemakers, Patients who have metallic implants in any part of the body, Extracapsular prostatic cancer on MpMRI Prostatitis, Prior TURP, Patients on 5a reductase inhibitors within the last three months, Patients who have coagulation disorders, Patients who had received prior hormonal therapy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the performance of Prostate Health Index combined with MRI for <br/ ><br>the diagnosis of prostate cancer and clinically significant prostate cancer in <br/ ><br>patients with grey zone PSA levelsTimepoint: At the time of diagnosis
- Secondary Outcome Measures
Name Time Method 1. To determine the best threshold for PHI in Southeast Asian population in patients with PSA levels of 4-10 ng/ml <br/ ><br>2. To determine the performance of other PSA variables like PSA density, free PSA, free/total PSA ratio, p2PSA, p2PSA/fPSA ratio, PHI density for the diagnosis of prostate cancer and clinically significant prostate cancer in <br/ ><br>patients with PSA levels of 4-10 ng/ml <br/ ><br>3, To assess the correlation of mpMRI in the diagnosis of prostate cancer and detection of clinically significant prostate cancer in PSA range of 4-10ng/ml.Timepoint: At diagnosis