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Antibiotics for High PSA: Can They Help Avoid Unnecessary Prostate Biopsies?

A Randomized Controlled Study on the Effect of Antibiotic Therapy in Patients with Elevated PSA and its impact on decision-making for Prostate Biopsy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088676
Enrollment
40
Registered
2025-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: R972- Elevated prostate specific antigen[PSA]

Interventions

Intervention1: use of empirical antibiotics: The study group was advised to take antibiotic medication for 3 weeks. Preferred agents included fluroquilonones like Tablet. Levofloxacin 500 mg od. This

Sponsors

All India Institute of Medical Sciences Bhopal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male patients presenting with LUTS with elevated Serum PSA levels more than or equal to 4ng per ml

Exclusion criteria

Exclusion criteria: Documented prostate cancer or any other malignancy Documented metastatic disease Patients with hard nodule on DRE Patients with documented Urolithiasis. Patients with history of recurrent Urinary Tract Infection Patients with documented urethral stricture disease Patients with history of any prostate surgery in last 2 years Patients who do not consent to participate in study

Design outcomes

Primary

MeasureTime frame
To determine whether use of antibiotics in patients with elevated PSA leads to decrease in prostate biopsy ratesTimepoint: Baseline, 3 weeks and 5 weeks

Secondary

MeasureTime frame
Compare the decrease in serum PSA levels between patients receiving antibiotic therapy & those who do not. Assess the histopathological findings of prostate biopsies in patients with elevated PSA, correlating them with the use of antibiotics. To analyse mpMRI findings in study group & control group Timepoint: Baseline, 3 weeks & 5 weeks

Countries

India

Contacts

Public ContactAmrut Phonde

All India Institute of Medical Sciences Bhopal

devashish.urology@aiimsbhopal.edu.in9013518570

Outcome results

None listed

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