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

University of Southern California24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

therapeutic conventional surgeryPROCEDURE

Undergo robotic radical prostatectomy

ultrasound-guided prostate biopsyPROCEDURE

Undergo MRI-TRUS fusion image-guided prostate biopsy

magnetic resonance imagingPROCEDURE

Undergo MRI-TRUS fusion image-guided prostate biopsy

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Locations (1)

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Number of times the first biopsy needle is placed within 3.0 mm of the center lesion

A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).

Time frame: One month after last patient enrolled is taken off study

Number of times the second biopsy needle is placed within 3.0 mm of the center lesion

Time frame: One month after last patient enrolled is take off study

Secondary Outcomes

Average distance of the first needle to the center of the lesion

A nested (random effects) analysis of variance (ANOVA) will be used to analyze the distance of the first needle from the center of the lesion. Standard error or 95% confidence interval will be calculated.

Time frame: One month after last patient enrolled is taken off study

Average distance of the second needle from the first needle minus 2.0 mm

A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.

Time frame: One month after last patient enrolled is taken off study

Average distance of the third needle from the first needle minus 2.0 mm

A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.

Time frame: One month after last patient enrolled is taken off study

Data from ClinicalTrials.gov

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