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

Not Applicable

Active, not recruiting

• Conditions: Prostate Carcinoma
• Interventions: Device: Digital Image Analysis; Procedure: Radical Prostatectomy; Procedure: Transrectal Ultrasound

• Registration Number: NCT04299620
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-03-04
• Study First Posted: 2020-03-09
• Study Start: 2020-10-21
• Primary Completion: 2022-06-14
• Status Verified: 2022-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (TRUS)	Radical Prostatectomy	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.
Diagnostic (TRUS)	Transrectal Ultrasound	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.
Diagnostic (TRUS)	Digital Image Analysis	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.

Primary Outcome Measures

Name	Time	Method
Identification of prostate cancer foci	Up to 3 years	Will be evaluated by comparing sensitivity and positive predictive value of multiparametric magnetic resonance imaging (mpMRI) and micro-ultrasound (US) for identification of prostate cancer (CaP) foci.; Measurement tool = chi squared test

Secondary Outcome Measures

Name	Time	Method
Contours of prostate cancer foci	Up to 3 years	evaluated by measuring the dice similarity coefficient (DSC) and Hausdorff distances (Hd) between micro-ultrasound (US) and whole mount (WM) tumor contours, and between mpMRI and WM tumor contours. The difference between tumor diameter and volume will be computed between WM and mpMRI, and between WM and US. All measures will then be used to compare accuracy of US versus mpMRI.; Wilcoxon signed-rank tests: Signed rank tests are nonparametric matched pair tests, here mostly used to compare correlation of mpMRI and WM v. correlation of US and WM. Minimum and maximum input values will depend on the metric being tested; min and max output values will vary between zero and one. A higher output indicates less difference in performance between mpMRI and US. A lower score indicates that more a difference between mpMRI and US. Whether a lower score is a better outcome or worse outcome depends on which modality (mpMRI vs US) is more strongly correlated with WM.

Trial Locations

Locations (1)

UCLA / Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States