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NCT Number: NCT04081636

Prostate Biopsy, Transrectal vs. Transperineal: Efficacy and Complications

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Systematic Transrectal biopsy (TR-Bx)

Procedure

Through the rectum

Other names: ultrasound guided

Targeted Transrectal biopsy (TR-Bx)

Procedure

Through the rectum

Other names: MRI guided

Systematic Transperineal biopsy (TP-Bx)

Procedure

Through the perineal skin

Other names: ultrasound guided

Targeted Transperineal biopsy (TP-Bx)

Procedure

Through the perineal skin

Other names: MRI guided

Primary outcomes

  1. Rate of infectious complications

    Time frame: 30 days

    Whether or not patient had an infection after the biopsy

  2. Clinically significant cancer detection rate

    Time frame: 14 days

    The rate of grade group 2 prostate cancer detected in each study arm

Secondary outcomes

  1. Rate of Bleeding complications

    Time frame: 30 days

    The type of bleeding and its severity (blood in urine or stool)

  2. Tolerability under local anesthesia

    Time frame: 30 days

    Pain scores; Need for additional analgesia

  3. Patient reported urinary function measures using IPSS questionaire

    Time frame: 30 days

    International Prostate Symptoms Score (IPSS) to measure urinary function

  4. Cost of the procedures

    Time frame: 30 days

    Differences in the actual cost of the procedures (including supplies, time)

  5. Patient reported sexual function measures using IIEF questionaire

    Time frame: 30 days

    International Index of Erectile Function (IIEF) to measure sexual dysfunction

Sponsors and collaborators

Lead sponsor

Albany Medical College

Other

Registry information

Official study title

Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)

Acronym: ProBE-PC

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Sep 9, 2019
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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