Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications

Not Applicable

Recruiting

• Conditions: PSA; Infection; Prostate Cancer
• Interventions: Procedure: Targeted Transrectal biopsy (TR-Bx); Procedure: Targeted Transperineal biopsy (TP-Bx); Procedure: Systematic Transrectal biopsy (TR-Bx); Procedure: Systematic Transperineal biopsy (TP-Bx)

• Registration Number: NCT04081636
• Lead Sponsor: Albany Medical College

Brief 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

Study Timeline

• Study Start: 2019-09-02
• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 840

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeted Transrectal biopsy (TR-Bx)	Targeted Transrectal biopsy (TR-Bx)	MRI-guided; needle inserted through the rectum to reach the prostate
Targeted Transperineal biopsy (TP-Bx)	Targeted Transperineal biopsy (TP-Bx)	MRI-guided; needle inserted directly through the skin to reach the prostate
Systematic Transrectal biopsy (TR-Bx)	Systematic Transrectal biopsy (TR-Bx)	Ultrasound guided; needle inserted through the rectum to reach the prostate
Systematic Transperineal biopsy (TP-Bx)	Systematic Transperineal biopsy (TP-Bx)	Ultrasound guided; needle inserted directly through the skin to reach the prostate

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Albany Medical College; 🇺🇸 Albany, New York, United States