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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT07075705
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Jul 20, 2025
Start date
Aug 18, 2026
Status verified
Sep 2026
Primary completion
Jan 15, 2027
Completion
Jan 15, 2027

Study Design

Enrollment
138 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

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

Primary Outcome Measure

Proportion of patients with Prostate Risk Identification Using Micro-Ultrasound (PRIMUS) score (Feasibility) [ Time Frame: Up to 2 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Khurshid A. Guru
[email protected]
716-845-6844
Khurshid A. Guru (PRINCIPAL_INVESTIGATOR)

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Prostate cancer
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By research site
Roswell Park Cancer Institute· Buffalo, NY

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