NCT04299620

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
DEVICE	Digital Image Analysis	Analysis of images
PROCEDURE	Radical Prostatectomy	Undergo standard of care radical prostatectomy
PROCEDURE	Transrectal Ultrasound	Undergo transrectal ultrasound

Timeline

• Start date: 2020-10-21
• Primary completion: 2022-06-14
• Completion: 2025-09-01
• First posted: 2020-03-09
• Last updated: 2023-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study