Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications (ProBE-PC)

January 29, 2024 updated by: Badar M. Mian, Albany Medical College

Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)

This study evaluates the difference between 2 prostate biopsy methods, transrectal (through the rectal wall) and transperineal (through the skin) needle biopsy.

Men who are in need of prostate biopsy due to clinical suspicions of prostate cancer will be randomly assigned (1:1) to either transrectal or transperineal approach.

This research study will scientifically determine if one biopsy method is better than the other in reducing complications and improving cancer detection.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There are two ways to take biopsy (tissue) samples from the prostate. The more commonly used method is trans-rectal needle biopsy of the prostate (TR-Bx) with a needle inserted through a probe in the rectum to reach the prostate.

TR-Bx is usually performed in the office, using local anesthesia, and often using a targeted biopsy approach using MRI/ultrasound fusion technique.

Trans-perineal biopsy (TP-Bx) with a needle inserted directly through the skin to reach the prostate.

Typically, TP-BX is performed in the outpatient surgical setting due significant pain associated with the procedure, requiring the use anesthesia and/or sedation.

TP-Bx. procedure is very uncommon in the USA and is often performed using ultrasound alone (less accurate), without the benefit of MRI guided targeted biopsy.

Now, with the availability of new devices, we are able to perform both TR-Bx and TP-Bx using MRI/ultrasound fusion guided targeted approach, in the office setting, using local anesthesia alone.

With the TR-Bx, there has been increasing risk of infection related complications, sepsis and hospital admissions.

The newer approach of biopsy TP-Bx may cause fewer infections and may have a higher accuracy of finding cancer.

Using validated questionnaires such as IIEF-6, IPSS and TRUS-BxQ, this randomized study of TR-BX and TP-Bx will address these questions:

  • Differences in the risk of infectious complications
  • Differences in the overall cancer detection rate and the high-grade cancer detection rate
  • Differences in the hemorrhagic and urinary side effects
  • Tolerability of both techniques with local anesthesia alone
  • Difference in the results of of MRI/US fusion targeted biopsy
  • Differences in the cost of the procedures

Study Type

Interventional

Enrollment (Estimated)

840

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Recruiting
        • Albany Medical College
        • Contact:
          • Brenda Romeo, CCRC
        • Sub-Investigator:
          • Hugh fisher, MD
        • Sub-Investigator:
          • Ashar Ata, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients who are scheduled to undergo prostate biopsy for suspected prostate cancer as part of their regular medical care
  • Either with or without an MRI

Exclusion Criteria:

  • Patients with no access to rectum (due to previous rectal surgery)
  • Any abnormalities of the perineal skin (e.g. infection)
  • Patients whose procedure requires sedation or general anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Systematic Transrectal biopsy (TR-Bx)
Ultrasound guided; needle inserted through the rectum to reach the prostate
Procedure: Systematic Transrectal biopsy (TR-Bx)
Through the rectum
Other Names:
  • ultrasound guided
Active Comparator: Targeted Transrectal biopsy (TR-Bx)
MRI-guided; needle inserted through the rectum to reach the prostate
Procedure: Targeted Transrectal biopsy (TR-Bx)
Through the rectum
Other Names:
  • MRI guided
Experimental: Systematic Transperineal biopsy (TP-Bx)
Ultrasound guided; needle inserted directly through the skin to reach the prostate
Procedure: Systematic Transperineal biopsy (TP-Bx)
Through the perineal skin
Other Names:
  • ultrasound guided
Experimental: Targeted Transperineal biopsy (TP-Bx)
MRI-guided; needle inserted directly through the skin to reach the prostate
Procedure: Targeted Transperineal biopsy (TP-Bx)
Through the perineal skin
Other Names:
  • MRI guided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of infectious complications
Time Frame: 30 days
Whether or not patient had an infection after the biopsy
30 days
Clinically significant cancer detection rate
Time Frame: 14 days
The rate of grade group 2 prostate cancer detected in each study arm
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Bleeding complications
Time Frame: 30 days
The type of bleeding and its severity (blood in urine or stool)
30 days
Tolerability under local anesthesia
Time Frame: 30 days
Pain scores; Need for additional analgesia
30 days
Patient reported urinary function measures using IPSS questionaire
Time Frame: 30 days
International Prostate Symptoms Score (IPSS) to measure urinary function
30 days
Cost of the procedures
Time Frame: 30 days
Differences in the actual cost of the procedures (including supplies, time)
30 days
Patient reported sexual function measures using IIEF questionaire
Time Frame: 30 days
International Index of Erectile Function (IIEF) to measure sexual dysfunction
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Investigators

  • Principal Investigator: Badar M Mian, MD, Albany Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 5, 2019

First Submitted That Met QC Criteria

September 5, 2019

First Posted (Actual)

September 9, 2019

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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