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Can prostate biopsies be safely done without antibiotics? A study on infection risks after a common procedure in the Philippines

Post procedural infections in antibiotic prophylaxis-free transperineal prostate biopsy: a double blinded randomized controlled clinical trial, a 2 center experience in the Philippines

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17045111
Enrollment
136
Registered
2025-06-28
Start date
2024-06-04
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Urinary tract infection Urological and Genital Diseases

Interventions

Participants were assigned in a 1:1 ratio to either no prophylaxis (Group A) or prophylaxis with 1 g intravenous cefoxitin (Group B). Randomization was based on a pre-generated sequential list from ra

Sponsors

St. Luke's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Age 40-75 years 2. American Society of Anesthesiologists score of I or II 3. Those undergoing Transperineal Prostate Biopsy 4. Urine Culture Negative Patients 5. Non Tender Prostate on DRE 6. Asymptomatic Patients 7. Charlson Score <5

Exclusion criteria

Exclusion criteria: 1. Acute prostatitis within the last 6 months. 2. History of documented Urinary Tract Infection (UTI), or symptoms of UTI (painful micturition, Frequency, Urgence, suprapubic or flank pain, cloudy and foul-smelling urine) for the past 6 months. 3. Tender and boggy prostate on initial DRE 4. With ongoing antibiotics treatment for the past month 5. History of antibiotic allergy 6. Prior definitive therapy for prostate cancer, such as radiation therapy or partial gland ablation. 7. Those with uncontrolled diabetes mellitus, immunocompromised or immunosuppressed status. 8. Those with other pre-existing urinary tract conditions such as Benign Prostatic Hyperplasia in retention, Urinary retention from neurogenic causes, and those with indwelling stents or urethral catheters 9. Those with Prosthetic Heart Valves 10. Patients with ongoing infection elsewhere 11. Patients with Bleeding Disorders 12. Patients with Asymptomatic Bacteriuria

Design outcomes

Primary

MeasureTime frame
Incidence of Urinary Tract Infection or Sepsis within 30 days post biopsy. This will be measured through a symptom check list including symptoms of Fever, hematuria, dysuria, suprapubic pain, perineal pain, or foul smelling urine, with bacteria identified on urine culture. Sepsis is defined using the Sepsis 2 definition of confirmed infection through urine culture accompanied by at least two of the following: A body temperature above 38°C (100.4°F) or below 36°C (96.8°F), A heart rate greater than 90 beats per minute, A respiratory rate greater than 20 breaths per minute, or a PaCO2 less than 32 mmHg, A white blood cell count greater than 12,000 cells/µL, less than 4,000 cells/µL, or more than 10% immature (band) forms.

Secondary

MeasureTime frame
1. 30 day readmission rates measured using patient records 2. Overall 30 day complication rates measured by Clavien Dino scoring

Countries

Philippines

Contacts

Public ContactJoseph Vincent Songco
jvmsongco@stlukes.com.ph+63 9178122923

Outcome results

None listed

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