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

NCT ID: NCT07075705

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-07-15

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.

Conditions

Prostate Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Biopsy of Prostate

Intervention Type: PROCEDURE

Undergo standard of care prostate biopsy

Magnetic Resonance Imaging

Intervention Type: PROCEDURE

Undergo MRI

Micro-ultrasound Imaging

Intervention Type: PROCEDURE

Undergo transperineal micro-ultrasound imaging

Micro-ultrasound Imaging

Intervention Type: PROCEDURE

Undergo transrectal micro-ultrasound imaging

Interventions

Biopsy of Prostate

Undergo standard of care prostate biopsy

Intervention Type: PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

Intervention Type: PROCEDURE

Micro-ultrasound Imaging

Undergo transperineal micro-ultrasound imaging

Intervention Type: PROCEDURE

Micro-ultrasound Imaging

Undergo transrectal micro-ultrasound imaging

Intervention Type: PROCEDURE

Other Intervention Names

Prostate Biopsy; Prostatic Biopsy; 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; Micro ultrasound; Micro ultrasound Imaging; Micro-ultrasound; microUS; Micro ultrasound; Micro ultrasound Imaging; Micro-ultrasound; microUS

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khurshid A Guru

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Facility Contacts

Khurshid A. Guru

Role: primary

Khurshid.guru@roswellpark.org

716-845-6844

Other Identifiers

NCI-2025-04490

Identifier Type: REGISTRY

Identifier Source: secondary_id

I-4290824

Identifier Type: OTHER

Identifier Source: secondary_id

I-4290824

Identifier Type: -

Identifier Source: org_study_id