Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-21

Study Completion Date

2025-09-01

Brief Summary

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This trial studies the ability of micro-ultrasound to detect and characterize prostate cancer tumors in patients undergoing radical prostatectomy (removal of the entire prostate and some of the tissue around it). Usually multiparametric magnetic resonance imaging is used for the detection and targeted therapy of prostate cancer, but its accuracy remains imperfect. Micro-ultrasound may be superior as it provides real-time tumor visualization which may simplify and improve prostate cancer targeted therapy. This may also reduce the need for and substantial costs of radical prostatectomy.

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Detailed Description

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PRIMARY OBJECTIVE:

I. Determine if micro-ultrasound (US) can be used to identify prostate cancer foci with equivalent (non-inferior) performance relative to multiparametric magnetic resonance imaging (mpMRI).

SECONDARY OBJECTIVE:

I. Determine if micro-US can be used to contour prostate cancer foci with equivalent (non-inferior) accuracy to mpMRI.

TERTIARY OBJECTIVE:

I. Determine if ex vivo micro-US images have quality comparable to in vivo micro-US images.

QUATERNARY OBJECTIVE:

I. Determine if micro-US can be used to evaluate suspicion of extracapsular extension (ECE) with equivalent (non-inferior) accuracy to mpMRI.

OUTLINE:

Patients may undergo transrectal micro-ultrasound scan (TRUS) prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (TRUS)

Patients may undergo TRUS prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.

Group Type EXPERIMENTAL

Digital Image Analysis

Intervention Type DEVICE

Analysis of images

Radical Prostatectomy

Intervention Type PROCEDURE

Undergo standard of care radical prostatectomy

Transrectal Ultrasound

Intervention Type PROCEDURE

Undergo transrectal ultrasound

Interventions

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Digital Image Analysis

Analysis of images

Intervention Type DEVICE

Radical Prostatectomy

Undergo standard of care radical prostatectomy

Intervention Type PROCEDURE

Transrectal Ultrasound

Undergo transrectal ultrasound

Intervention Type PROCEDURE

Other Intervention Names

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Prostatovesiculectomy endorectal ultrasound ERUS (endorectal ultrasound) TRUS

Eligibility Criteria

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Inclusion Criteria

* Standard-of-care mpMRI within the past 12 months
* Biopsy-proven prostate cancer, Gleason grade \>= 3+3
* Maximum posterior-to-anterior prostate dimension of =\< 6 cm
* Scheduled to receive standard-of-care radical prostatectomy

Exclusion Criteria

* Maximum posterior-to-anterior prostate dimension greater than 6 cm
* Prior radiation or focal treatment for prostate cancer
* Inability to have a transrectal ultrasound scan
* Prostate biopsy \< 4 weeks prior to surgery

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No