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Transperineal Micro-ultrasound for Prostate Cancer Detection

This study is looking at a new way to detect prostate cancer during a biopsy using transperineal micro-ultrasound. Currently, doctors often use transrectal ultrasound, where a probe is inserted into the rectum to create images of the prostate. Transperineal micro-ultrasound uses a probe placed on the skin between the scrotum and anus (perineum) instead. The study wants to see if this new method can create good images of the prostate and help find prostate cancer effectively. You may be able to join if you are a man aged 18 or older and are scheduled for a prostate biopsy, and have already had an MRI. The study plans to enroll 138 participants, but its current status is unclear.

Study design
This interventional study plans to enroll 138 men. It aims to compare transperineal micro-ultrasound with transrectal micro-ultrasound for detecting prostate cancer.
What's involved
You would undergo transperineal micro-ultrasound imaging for about 3 minutes, followed by transrectal micro-ultrasound imaging during your standard prostate biopsy. You would also have an MRI during screening.
Compensation
Not stated in the trial record.
Follow-up
The study will measure certain outcomes, like image quality, for up to 2 months after your procedure.

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NCT07075705

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

Not Yet Recruiting
NAAges 18+InterventionalDiagnostic
Roswell Park Cancer Institute
~138 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Biopsy of ProstateMagnetic Resonance ImagingMicro-ultrasound Imaging

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of patients with Prostate Risk Identification Using Micro-Ultrasound (PRIMUS) score (Feasibility)
Measured over Up to 2 months
+2 more outcomes measured

Conditions

Prostate Carcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Khurshid A Guru · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Khurshid A. Guru
[email protected]
716-845-6844
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Proportion of patients with Prostate Risk Identification Using Micro-Ultrasound (PRIMUS) score (Feasibility)Up to 2 months

    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.

  • Visualization of the prostate from base to apex with adequate image quality for PRIMUS scoringUp to 2 months

    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.

  • Visualization of the prostate from right and left lateral margins with adequate image quality for PRIMUS scoringUp to 2 months

    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.