Albany Medical College
Albany, New York, 12208, United States
NCT Number: NCT04081636
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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Interventional
Not applicable
Albany, New York, 12208, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Through the rectum
Other names: ultrasound guided
Through the rectum
Other names: MRI guided
Through the perineal skin
Other names: ultrasound guided
Through the perineal skin
Other names: MRI guided
Time frame: 30 days
Whether or not patient had an infection after the biopsy
Time frame: 14 days
The rate of grade group 2 prostate cancer detected in each study arm
Time frame: 30 days
The type of bleeding and its severity (blood in urine or stool)
Time frame: 30 days
Pain scores; Need for additional analgesia
Time frame: 30 days
International Prostate Symptoms Score (IPSS) to measure urinary function
Time frame: 30 days
Differences in the actual cost of the procedures (including supplies, time)
Time frame: 30 days
International Index of Erectile Function (IIEF) to measure sexual dysfunction
Albany Medical College
Other
Prospective, Randomized Study Comparing Transperineal and Transrectal Prostate Biopsy Efficacy and Complications (ProBE-PC Trial)
Acronym: ProBE-PC
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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