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Not yet recruiting NCT07075705

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

No phase Interventional Prostate Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biopsy of Prostate, Magnetic Resonance Imaging, Micro-ultrasound Imaging, Micro-ultrasound Imaging.
Who it may be relevant to
Registry conditions: Prostate Carcinoma. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Investigating the Feasibility of Using Transperineal Micro-Ultrasound to Detect Clinically Significant Prostate Cancer

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Successful generation of PRIMUS score in transperineal and transrectal ultrasound images [Time frame: Up to 7 months]
  • Ability to visualize the whole prostate using transperineal micro-ultrasound [Time frame: Up to 7 months]
  • Quality of images of transperineal ultrasound and transrectal ultrasound of the prostate [Time frame: Up to 7 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Roswell Park Cancer Institute — Buffalo

Identifiers

NCT: NCT07075705 · I-4290824 · NCI-2025-04490 · I-4290824

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗