NCT07075705

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Biopsy of Prostate	Undergo standard of care prostate biopsy
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
PROCEDURE	Micro-ultrasound Imaging	Undergo transperineal micro-ultrasound imaging
PROCEDURE	Micro-ultrasound Imaging	Undergo transrectal micro-ultrasound imaging

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-01-15
• Completion: 2027-01-15
• First posted: 2025-07-20
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study