Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications

Clinicaltrials.gov ID: NCT04081636
db-list-check Status RECRUITING
b-loader Phase NA
b-people Age All Ages
b-bullseye-arrow Enrollments 840

Conditions

Prostate Cancer, PSA, Infection

Summary

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.

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

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

  • Brenda Romeo, CCRC

Principal Investigator

  • Badar M Mian, MD

Eligibility Criteria

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

Systematic Transrectal biopsy (TR-Bx)

ACTIVE_COMPARATOR

Ultrasound guided; needle inserted through the rectum to reach the prostate

  • PROCEDURE:

    Systematic Transrectal biopsy (TR-Bx)

    Description:

    Through the rectum

Targeted Transrectal biopsy (TR-Bx)

ACTIVE_COMPARATOR

MRI-guided; needle inserted through the rectum to reach the prostate

  • PROCEDURE:

    Targeted Transrectal biopsy (TR-Bx)

    Description:

    Through the rectum

Systematic Transperineal biopsy (TP-Bx)

EXPERIMENTAL

Ultrasound guided; needle inserted directly through the skin to reach the prostate

  • PROCEDURE:

    Systematic Transperineal biopsy (TP-Bx)

    Description:

    Through the perineal skin

Targeted Transperineal biopsy (TP-Bx)

EXPERIMENTAL

MRI-guided; needle inserted directly through the skin to reach the prostate

  • PROCEDURE:

    Targeted Transperineal biopsy (TP-Bx)

    Description:

    Through the perineal skin

Outcome Measures

Primary Outcome Measures

Rate of infectious complications

Time Frame: 30 days

Clinically significant cancer detection rate

Time Frame: 14 days

Secondary Outcome Measures

Rate of Bleeding complications

Time Frame: 30 days

Tolerability under local anesthesia

Time Frame: 30 days

Patient reported urinary function measures using IPSS questionaire

Time Frame: 30 days

Cost of the procedures

Time Frame: 30 days

Patient reported sexual function measures using IIEF questionaire

Time Frame: 30 days

Timeline

  • Last Updated
    January 30, 2024
  • Start Date
    September 9, 2019
  • Today
    May 11, 2025
  • Completion Date ( Estimated )
    December 31, 2025

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