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Transperineal Micro-ultrasound for the Detection of Prostate Cancer During Biopsy

Investigating the Feasibility of Using Transperineal Micro-Ultrasound to Detect Clinically Significant Prostate Cancer

Who can join

Ages 18 and older · Men

Inclusion Criteria:

* Men aged ≥ 18 years
* Men scheduled for transrectal ultrasound guided prostate biopsy who have had a prebiopsy MRI. Therefore patients unable to have a prebiopsy MRI who have contraindications to MRI or unwilling to undergo MRI would be excluded
* The participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board-approved written informed consent form before receiving any study-related procedure

Exclusion Criteria:

* Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation

About the study

This clinical trial studies whether transperineal micro-ultrasound can be used to detect prostate cancer during biopsy. Transrectal ultrasound is often used during prostate biopsy. Transrectal ultrasound imaging is a procedure in which a probe that sends out high-energy sound waves is inserted into the rectum. The sound waves are bounced off internal tissues or organs and make echoes. The echoes form a picture of body tissue called a sonogram. Transrectal ultrasound is used to look for abnormalities in the rectum and nearby structures, including the prostate. The images are used to guide the prostate biopsy. Transperineal micro-ultrasound is completed by placing a probe over the skin between the scrotum and anus (perineum). It is a high-resolution ultrasound at 29 megahertz (MHz) (compared to traditional ultrasound at 6-9 MHz). This higher frequency allows for an improved spatial resolution. This improved spatial resolution is approximately the diameter of a prostatic duct, and therefore, may be able to visualize slight changes in the structure of prostatic ducts that are not possible with standard transrectal ultrasound. Transperineal micro-ultrasound may be more effective in detecting prostate cancer during biopsy.

What is being tested

• Biopsy of Prostate (procedure)
• Magnetic Resonance Imaging (procedure)
• Micro-ultrasound Imaging (procedure)
• Micro-ultrasound Imaging (procedure)

Sponsor: Roswell Park Cancer Institute · Participants: 138 · Started: Aug 18, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07075705

Locations in the U.S.

Conditions

• Prostate Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.