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

Prostate Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04299620
• Other study ID #: 19-001136
• Secondary ID: NCI-2019-0578419
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: September 1, 2025

Study information

• Verified date: October 2022
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: September 1, 2025
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Carcinoma
• Prostatic Neoplasms

Intervention

Device:
• Digital Image Analysis
Analysis of images

Procedure:
• Radical Prostatectomy
Undergo standard of care radical prostatectomy
• Transrectal Ultrasound
Undergo transrectal ultrasound

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	Exact Imaging, Phase One Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ex vivo and in vivo micro-US images	Differences in in vivo versus ex vivo image quality will be evaluated by testing for systematic differences in tumor contouring accuracy. The measures will be identical to those listed under "secondary outcome measures" above, but for comparison between ex vivo micro ultrasound and in vivo micro ultrasound (instead of MRI).	Up to 3 years
Other	Suspicion of extracapsular extension (ECE)	Micro ultrasound and mpMRI ECE suspicion scores will be compared for ECE-positive tumors. Micro ultrasound and mpMRI ECE suspicion scores will also be compared for ECE-negative tumors.; Measurement tool(s) = Wilcoxon signed-rank test and one-sided non-inferiority t-test.; Notes on the use of Wilcoxon signed-rank tests: (see outcome 2 description above)	Up to 3 years
Primary	Identification of prostate cancer foci	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	Up to 3 years
Secondary	Contours of prostate cancer foci	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.	Up to 3 years