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To study the role of Prostate Health Index (PHI) in Prostate Cancer.

Prostate Health Index (PHI) â?? Is it a Master Key for Diagnosis of Prostate Cancer?

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/11/038267
Enrollment
800
Registered
2021-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: D291- Benign neoplasm of prostate Health Condition 2: N429- Disorder of prostate, unspecified Health Condition 3: C61- Malignant neoplasm of prostate

Interventions

None listed

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Part I (Diagnostic evaluation) - Patient visiting Tata Memorial Hospital and Memorial Centre, Parel with inclusion criteria of Males, age > 50 years, a serum total PSA > 2ng/mL and a prostate biopsy will be tested for PHI. The biopsy will be considered as gold standard for diagnosis of prostate cancer. Part II screening evaluations â?? There is a cohort of cancer screening in male candidates > 50 year of age can be screened for PHI

Exclusion criteria

Exclusion criteria: 1. Past history of any urogenital cancers 2. Acute or chronic prostatitis 3. Untreated urinary tract infection within the past three months, 4. Chronic kidney disease 5. Previous endoscopic surgery, 6. Prostate biopsy or usage of 5 alpha-reductase inhibitors as dutasteride or finasteride

Design outcomes

Primary

MeasureTime frame
To evaluate whether PHI is a better tumor marker as compared to serum total PSA to diagnose Prostate cancerTimepoint: End of the study

Secondary

MeasureTime frame
1. Establishing cut offs for PHI in Indian patients by assessing concordances rates with symptomatic patients 2. To compare the performance of PHI with existing tools for diagnosis namely (Total PSA, Free/ total PSA ratio, mp MRI and biopsy) 3. Evaluating role of PHI in screening high risk patientsTimepoint: End of the study

Countries

India

Contacts

Public ContactKinjalka Ghosh

Tata Memorial Hospital, Mumbai

kinjalka@gmail.com845191385

Outcome results

None listed

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