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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    60
  • sponsor
    Jonsson Comprehensive Cancer Center
Updated on 6 November 2021

Summary

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.

Description

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.

Details
Condition prostate carcinoma, Prostate Cancer, Early, Recurrent, Prostate Cancer, Malignant neoplasm of prostate
Treatment Radical Prostatectomy, Transrectal Ultrasound, Digital Image Analysis
Clinical Study IdentifierNCT04299620
SponsorJonsson Comprehensive Cancer Center
Last Modified on6 November 2021

Eligibility

Yes No Not Sure

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
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