Recruiting

Transperineal Micro-Ultrasound

Sponsor:

Roswell Park Cancer Institute

Code:

NCT07075705

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy of Prostate

Magnetic Resonance Imaging

Micro-ultrasound Imaging

Micro-ultrasound Imaging

Study Details

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.

Conditions

Prostate Carcinoma

Study ID

NCT07075705

Start date

Aug 18, 2026

Status verified date

Sep, 2026

Completion date

Jan 15, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

138 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

Biopsy of Prostate

Undergo standard of care prostate biopsy

Magnetic Resonance Imaging

Undergo MRI

Micro-ultrasound Imaging

Undergo transperineal micro-ultrasound imaging

Micro-ultrasound Imaging

Undergo transrectal micro-ultrasound imaging

Primary outcome measure

  • Proportion of patients with Prostate Risk Identification Using Micro-Ultrasound (PRIMUS) score (Feasibility) [ Time Frame: Up to 2 months ]
  • Visualization of the prostate from base to apex with adequate image quality for PRIMUS scoring [ Time Frame: Up to 2 months ]
  • Visualization of the prostate from right and left lateral margins with adequate image quality for PRIMUS scoring [ Time Frame: Up to 2 months ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Principal Investigator:

Khurshid A. Guru

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Sep 11, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-12. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-09-11.