Clinical trial NCT04081636: Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications
Official title: Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
PSA
Infection
Keywords: Prostate biopsy
PSA
infection
bleeding
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 840
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1 to either trans-rectal needle biopsy (TR-Bx) or Trans-perineal biopsy (TP-Bx) of the prostate.

Both arms, either with or without MRI guided biopsy
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: Rate of infectious complications
timeFrame: 30 days
measure: Clinically significant cancer detection rate
timeFrame: 14 days
Secondary outcomes:
measure: Rate of Bleeding complications
timeFrame: 30 days
measure: Tolerability under local anesthesia
timeFrame: 30 days
measure: Patient reported urinary function measures using IPSS questionaire
timeFrame: 30 days
measure: Cost of the procedures
timeFrame: 30 days
measure: Patient reported sexual function measures using IIEF questionaire
timeFrame: 30 days
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical College
state: New York
Study officials:
affiliation: Albany Medical College
name: Badar M Mian, MD
role: PRINCIPAL_INVESTIGATOR
References:
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