Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer

University of Southern California

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: ultrasound-guided prostate biopsy; Procedure: therapeutic conventional surgery; Procedure: magnetic resonance imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01764347

4P-10-6

NCI-2012-03037 (Registry Identifier)

Details and patient eligibility

About

This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy may help find and diagnose prostate cancer

Full description

PRIMARY OBJECTIVES:

I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo human prostate as obtained from fresh radical prostatectomy specimens.

OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.

Enrollment: 24 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) >= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
• Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
• Subjects must have decided to have their prostate surgically removed

Exclusion criteria

• Patients who do not give informed consent
• Patients with extracapsular extension of their prostate cancer

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Diagnostic (MRI-TRUS fusion image-guided biopsy)

Experimental group

Description:

Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.

Treatment:

Procedure: therapeutic conventional surgery

Procedure: ultrasound-guided prostate biopsy

Procedure: magnetic resonance imaging