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Serum PSP94 Utility in Management of Patients with Raised PSA in Multicentric Study

Utility of estimating serum PSP94 levels in management of patients with raised PSA in clinical setting: A multicentric study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/11/076259
Enrollment
600
Registered
2024-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms Health Condition 2: N403- Nodular prostate with lower urinary tract symptoms Health Condition 3: C61- Malignant neoplasm of prostate

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Indian Council of Medical Research (ICMR)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Men above 40 years of age presenting with lower urinary tract symptoms and PSA values 4-10 ng/ml would be recruited as study subjects. Participants willing to provide a written informed consent will be included in the study

Exclusion criteria

Exclusion criteria: Men with any urological malignancy other than prostate, those who had previous prostatic surgery or pelvic radiotherapy or complications of urinary obstruction due to bladder stones, renal failure, and recurrent urinary tract infection will be excluded from the study

Design outcomes

Primary

MeasureTime frame
Differentiate between benign prostate hyperplasia and prostate cancerTimepoint: Baseline

Secondary

MeasureTime frame
Using an adjunct marker like PSP94 along with PSA will aid clinicians in better decision making for referring patients for prostate biopsies & will also be cost-effective option as compared to other diagnostic tests like PHI, 4K score & multiparametric MRITimepoint: Baseline

Countries

India

Contacts

Public ContactDr Dhanashree Jagtap

ICMR-National Institute for Research in Reproductive and Child Health (ICMR-NIRRCH)

jagtapd@nirrch.res.in02224192014

Outcome results

None listed

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