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

NCT07075705 | Not Yet Recruiting FDA Device

• 2 other identifiers: I-4290824NCI-2025-04490
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Proportion of patients with Prostate Risk Identification Using Micro-Ultrasound (PRIMUS) score (Feasibility)

  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.

  Up to 2 months

• Visualization of the prostate from base to apex with adequate image quality for PRIMUS scoring

  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.

  Up to 2 months

• Visualization of the prostate from right and left lateral margins with adequate image quality for PRIMUS scoring

  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.

  Up to 2 months

Secondary Outcomes (3)

• Successful generation of PRIMUS score in transperineal and transrectal ultrasound images

  Up to 7 months

• Ability to visualize the whole prostate using transperineal micro-ultrasound

  Up to 7 months

• Quality of images of transperineal ultrasound and transrectal ultrasound of the prostate

  Up to 7 months

Study Arms (1)

Diagnostic (transperineal micro-ultrasound)

EXPERIMENTAL

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.

Procedure: Biopsy of Prostate; Procedure: Magnetic Resonance Imaging; Procedure: Micro-ultrasound Imaging

Interventions

Biopsy of Prostate PROCEDURE

Undergo standard of care prostate biopsy

Also known as: Prostate Biopsy, Prostatic Biopsy

Diagnostic (transperineal micro-ultrasound)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Diagnostic (transperineal micro-ultrasound)

Micro-ultrasound Imaging PROCEDURE

Undergo transperineal micro-ultrasound imaging

Also known as: Micro ultrasound, Micro ultrasound Imaging, Micro-ultrasound, microUS

Diagnostic (transperineal micro-ultrasound)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any condition which in the investigator's opinion deems the participant an unsuitable candidate for study participation

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Khurshid A Guru

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 20, 2025
• Study Start: April 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)