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Usefulness of combining Prostate Health Index with MRI of the prostate for the diagnosis of prostate cancer in patients with inconclusive PSA levels

Clinical utility of combining Prostate Health Index with multiparametric MRI for diagnosis of prostate cancer with grey zone PSA levels - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/03/064175
Enrollment
174
Registered
2024-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C61- Malignant neoplasm of prostate

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Christian Medical College, Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with PSA levels of 4-10 ng/ml, even those detected at surveillance

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
To determine the performance of Prostate Health Index combined with MRI for the diagnosis of prostate cancer and clinically significant prostate cancer in patients with grey zone PSA levelsTimepoint: At the time of diagnosis—

Secondary

MeasureTime frame
1. To determine the best threshold for PHI in Southeast Asian population in patients with PSA levels of 4-10 ng/ml 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 patients with PSA levels of 4-10 ng/ml 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—

Countries

India

Contacts

Public ContactSantosh Kumar

Christian Medical College

ektasantosh@cmcvellore.ac.in8754230369

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026