Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications
Conditions
Prostate Cancer, PSA, InfectionSummary
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
Clinically significant cancer detection rate
Secondary Outcome Measures
Rate of Bleeding complications
Tolerability under local anesthesia
Patient reported urinary function measures using IPSS questionaire
Cost of the procedures
Patient reported sexual function measures using IIEF questionaire
Timeline
Last Updated
January 30, 2024Start Date
September 9, 2019Today
May 11, 2025Completion Date ( Estimated )
December 31, 2025
Sponsors of this trial
Lead Sponsor
Albany Medical College