Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Los Angeles, California
Dates
study started
completion around
Principal Investigator
by Leonard S Marks

Description

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.

Official Title

Micro-Ultrasound to Whole Mount Image Correlation for Detection and Localization of Prostate Cancer

Details

PRIMARY OBJECTIVE:

  1. 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:

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

TERTIARY OBJECTIVE:

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

QUATERNARY OBJECTIVE:

  1. 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.

Keywords

Prostate Carcinoma, Prostatic Neoplasms, Digital Image Analysis, Radical Prostatectomy, Transrectal Ultrasound

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Location

  • UCLA / Jonsson Comprehensive Cancer Center
    Los Angeles California 90095 United States

Lead Scientist at UCLA

  • Leonard S Marks
    Dr. Leonard Marks holds the Jean B. deKernion, M.D., Endowed Chair in Urology.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT04299620
Study Type
Interventional
Participants
About 86 people participating
Last Updated