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

Not Applicable

Not yet recruiting

• Conditions: Prostate Carcinoma

• Registration Number: NCT07075705
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVES:

I. To investigate the feasibility and validity of using transperineal micro-ultrasound to image the prostate and detect clinically significant prostate cancer.

II. To test the quality of visualization of the prostate gland using micro-ultrasound via the transperineal approach.

SECONDARY OBJECTIVE:

I. To compare micro-ultrasound images done via the transperineal method to micro-ultrasound images done via the transrectal method to see if transperineal ultrasound has similar ability to detect suspicious prostate lesions as transrectal micro-ultrasound.

OUTLINE:

Patients undergo transperineal micro-ultrasound imaging over 3 minutes followed by transrectal micro-ultrasound imaging during standard of care prostate biopsy. Patients also undergo magnetic resonance imaging (MRI) during screening.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Study First Posted: 2025-07-20
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-01
• Study Start: 2025-09-15
• Primary Completion: 2026-07-15
• Study Completion: 2026-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of patients with Prostate Risk Identification Using Micro-Ultrasound (PRIMUS) score (Feasibility)	Up to 2 months	At the first stage, 28 patients will be enrolled. If the procedure was successful in at least 18 patients, the procedure will be considered feasible, and the study will proceed to the next stage. If less than 18 successes were observed, the study team will determine whether to continue the trial based on the data collected.
Visualization of the prostate from base to apex with adequate image quality for PRIMUS scoring	Up to 2 months	Will decide yes or no for whether the prostate can be assessed using transperineal micro ultrasound in order to evaluate for possible prostate cancer using the PRIMUS scoring system. This includes being able to visualize the prostate from base to apex with adequate image quality for PRIMUS scoring.
Visualization of the prostate from right and left lateral margins with adequate image quality for PRIMUS scoring	Up to 2 months	Will decide yes or no for whether the prostate can be assessed using transperineal micro ultrasound in order to evaluate for possible prostate cancer using the PRIMUS scoring system. This includes being able to visualize the prostate from right and left lateral margins with adequate image quality for PRIMUS scoring.

Secondary Outcome Measures

Name	Time	Method
Successful generation of PRIMUS score in transperineal and transrectal ultrasound images	Up to 7 months	Will compare transrectal and transperineal micro-ultrasound assessment of PRIMUS score. This will be a yes/no comparison. Summary statistics in frequencies and relative frequencies will be provided.
Ability to visualize the whole prostate using transperineal micro-ultrasound	Up to 7 months	This will be a yes/no comparison. Summary statistics in frequencies and relative frequencies will be provided.
Quality of images of transperineal ultrasound and transrectal ultrasound of the prostate	Up to 7 months	The quality of images of transperineal ultrasound will be compared to transrectal ultrasound of the prostate. Summary statistics in frequencies and relative frequencies will be provided.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States