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

Sponsor: Roswell Park Cancer Institute • ClinicalTrials.gov ID: NCT07075705

Registry updated: 2026-09-11

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Description

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.

Interventions

Biopsy of Prostate (Procedure)
Undergo standard of care prostate biopsy
Magnetic Resonance Imaging (Procedure)
Undergo MRI
Micro-ultrasound Imaging (Procedure)
Undergo transperineal micro-ultrasound imaging
Micro-ultrasound Imaging (Procedure)
Undergo transrectal micro-ultrasound imaging

Eligibility criteria

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

Conditions

Prostate Carcinoma

Locations

Roswell Park Cancer Institute — Buffalo, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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