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

Jonsson Comprehensive Cancer Center

Status: Active, not recruiting

Conditions: Prostate Carcinoma

Treatments: Procedure: Transrectal Ultrasound; Procedure: Radical Prostatectomy; Device: Digital Image Analysis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04299620

NCI-2019-05784 (Registry Identifier)

19-001136 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Diagnostic (TRUS)

Experimental group

Description:

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.

Treatment:

Device: Digital Image Analysis

Procedure: Transrectal Ultrasound

Procedure: Radical Prostatectomy