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

Albany Medical College

Status: Enrolling

Conditions: Infection; Prostate Cancer; PSA

Treatments: Procedure: Systematic Transrectal biopsy (TR-Bx); Procedure: Systematic Transperineal biopsy (TP-Bx); Procedure: Targeted Transperineal biopsy (TP-Bx); Procedure: Targeted Transrectal biopsy (TR-Bx)

Study type: Interventional

Funder types: Other

Identifiers

NCT04081636

5479

Details and patient eligibility

About

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.

Full 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

Enrollment: 840 estimated patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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840 participants in 4 patient groups

Systematic Transrectal biopsy (TR-Bx)

Active Comparator group

Description:

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

Treatment:

Procedure: Systematic Transrectal biopsy (TR-Bx)

Targeted Transrectal biopsy (TR-Bx)

Active Comparator group

Description:

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

Treatment:

Procedure: Targeted Transrectal biopsy (TR-Bx)

Systematic Transperineal biopsy (TP-Bx)

Experimental group

Description:

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

Treatment:

Procedure: Systematic Transperineal biopsy (TP-Bx)

Targeted Transperineal biopsy (TP-Bx)

Experimental group

Description:

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

Treatment:

Procedure: Targeted Transperineal biopsy (TP-Bx)