An interventional study of Systematic Transrectal biopsy (TR-Bx) and Targeted Transrectal biopsy (TR-Bx) in Prostate Cancer, PSA and Infection, sponsored by Albany Medical College. Completed at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2025-12-23.
Sponsored by Albany Medical College · Not applicable, Interventional, and Diagnostic
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.
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:
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 840 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Albany Medical College is the lead sponsor of 80 studies on the registry; 14 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ultrasound guided; needle inserted through the rectum to reach the prostate
Procedure: Systematic Transrectal biopsy (TR-Bx)
MRI-guided; needle inserted through the rectum to reach the prostate
Procedure: Targeted Transrectal biopsy (TR-Bx)
Ultrasound guided; needle inserted directly through the skin to reach the prostate
Procedure: Systematic Transperineal biopsy (TP-Bx)
MRI-guided; needle inserted directly through the skin to reach the prostate
Procedure: Targeted Transperineal biopsy (TP-Bx)
Through the rectum
Also known as: ultrasound guided
Through the rectum
Also known as: MRI guided
Through the perineal skin
Also known as: ultrasound guided
Through the perineal skin
Also known as: MRI guided
Rate of infectious complications
Whether or not patient had an infection after the biopsy
Time frame: 30 days
Clinically significant cancer detection rate
The rate of grade group 2 prostate cancer detected in each study arm
Time frame: 14 days
Rate of Bleeding complications
The type of bleeding and its severity (blood in urine or stool)
Time frame: 30 days
Tolerability under local anesthesia
Pain scores; Need for additional analgesia
Time frame: 30 days
Patient reported urinary function measures using IPSS questionaire
International Prostate Symptoms Score (IPSS) to measure urinary function
Time frame: 30 days
Cost of the procedures
Differences in the actual cost of the procedures (including supplies, time)
Time frame: 30 days
Patient reported sexual function measures using IIEF questionaire
International Index of Erectile Function (IIEF) to measure sexual dysfunction
Time frame: 30 days
Plan to share: No
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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