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Reduction of Prostate Biopsy Morbidity

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ClinicalTrials.gov Identifier: NCT03913039
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
Ariel Schulman, Maimonides Medical Center

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.

Condition or disease Intervention/treatment
Prostate Cancer Procedure: Transperineal biopsy Protocol

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.

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Study Type : Observational
Estimated Enrollment : 154 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Reduction of Prostate Biopsy Morbidity and Hospitalization Through a Modified Biopsy Protocol Bundle and Region-specific Antibiogram
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 15, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
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.
Procedure: Transperineal biopsy 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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 1. Number of individual complications within 30 days [ Time Frame: 30 Days ]
    1. Individual complications within 30 days including urinary retention, hematuria, urinary tract infection, hospitalization



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Assessment of Prostate Cancer treatment - - only males qualify.
Sampling Method:   Non-Probability Sample
Study Population
Males with clinical indication for a prostate biopsy.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913039


Contacts
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Contact: Ariel Schulman, MD 7182836903 ASchulman@maimonidesmed.org
Contact: Sara Meeder 7182837253 smeeder@maimonidesmed.org

Locations
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United States, New York
Maimonides Medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Ariel Schulman, MD         
Sponsors and Collaborators
Maimonides Medical Center
  Study Documents (Full-Text)

Documents provided by Ariel Schulman, Maimonides Medical Center:

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Responsible Party: Ariel Schulman, Principal Investigator, Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT03913039     History of Changes
Other Study ID Numbers: 2019-03-03
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Anti-Bacterial Agents
Anti-Infective Agents