---
title: Reduction of Prostate Biopsy Morbidity
nct_id: NCT03913039
overall_status: COMPLETED
sponsor: Maimonides Medical Center
study_type: OBSERVATIONAL
primary_condition: Prostate Cancer
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03913039.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03913039"
ct_last_update_post_date: 2022-02-10
last_seen_at: "2026-05-12T06:27:45.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Reduction of Prostate Biopsy Morbidity

**Official Title:** Reduction of Prostate Biopsy Morbidity and Hospitalization Through a Modified Biopsy Protocol Bundle and Region-specific Antibiogram

**NCT ID:** [NCT03913039](https://clinicaltrials.gov/study/NCT03913039)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 157
- **Lead Sponsor:** Maimonides Medical Center
- **Conditions:** Prostate Cancer
- **Start Date:** 2019-05-01
- **Completion Date:** 2021-12-31
- **CT.gov Last Update:** 2022-02-10

## Brief Summary

Prostate biopsy is typically performed via either the transrectal or transperineal approach. This study is a case-control study being done to determine if a novel prostate biopsy protocol incorporating a transperineal approach, rectal swab to detect resistant bacteria and broad antibiotic prophylaxis will reduce infectious complications and hospital readmission compared to current biopsy practices.

## Detailed Description

This will be a prospective multi-center cohort case-control study comparing a novel transperineal prostate biopsy protocol integrating measures to reduce post procedural infection (Cases) to traditional transrectal prostate biopsies (Controls). Eligible subjects will be identified through administrative records in the Urology clinics affiliated with Maimonides Medical Center. Eligible patients will be counseled about the risks and benefits of participation and offered enrollment into the study. Demographic data including age, comorbidities and past medical history will be extracted from the medical record.

Men meeting inclusion/exclusion criteria will be prospectively enrolled. The novel transperineal protocol will include the following: (Cases)

1. Transperineal biopsy approach with avoidance of rectal flora
2. MRI-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated
3. Rectal swab to identify the presence of fluoroquinolone resistant (FQR) bacteria
4. Multi-antibiotic prophylaxis
5. Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

Traditional biopsy protocol includes: (Controls)

1. Transrectal approach
2. Standard 12-core template
3. Surgeon-specific antibiotic prophylaxis
4. Urine culture, prostate tissue culture and FQR rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 120 Years
- **Sex:** MALE

```
Inclusion Criteria:

* Male patients greater than 18 years of age
* Indication for prostate biopsy

Exclusion Criteria:

* Female patients
* Male patients under 18 years of age
* No indication for prostate biopsy
```

## Arms

- **transperineal protocol** — 1. Transperineal biopsy approach with avoidance of rectal flora
2. MRI-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated
3. Rectal swab to identify the presence of fluoroquinolone resistant (FQR) bacteria
4. Multi-antibiotic prophylaxis
5. Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.
- **Traditional biopsy** — 1. Transrectal approach
2. Standard 12-core template
3. Surgeon-specific antibiotic prophylaxis
4. Urine culture, prostate tissue culture and FQR rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

## Interventions

- **Transperineal biopsy Protocol** (PROCEDURE) — 1. Transperineal biopsy approach with avoidance of rectal flora
2. MRI-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated
3. Rectal swab to identify the presence of fluoroquinolone resistant (FQR) bacteria
4. Multi-antibiotic prophylaxis
5. Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns.

## Primary Outcomes

- **Rate of clinically significant post-biopsy complications** _(time frame: 30 Days)_ — 1\. Rate of any clinically significant post-biopsy complications including infectious complications and hospital readmissions within 30 days.

## Secondary Outcomes

- **1. Number of individual complications within 30 days** _(time frame: 30 Days)_

## Locations (1)

- Maimonides Medical Center, Brooklyn, New York, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.maimonides medical center|brooklyn|new york|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03913039.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03913039*  
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