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

Accuracy of Targeted Biopsies Using MRI-TRUS Fusion Guidance: Pilot Study on Ex Vivo Radical Prostatectomy Specimens

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

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: therapeutic conventional surgery; Procedure: ultrasound-guided prostate biopsy; Procedure: magnetic resonance imaging

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Norris Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (MRI-TRUS fusion image-guided biopsy); Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.	Procedure: therapeutic conventional surgery; Undergo robotic radical prostatectomy; Procedure: ultrasound-guided prostate biopsy; Undergo MRI-TRUS fusion image-guided prostate biopsy; Procedure: magnetic resonance imaging; Undergo MRI-TRUS fusion image-guided prostate biopsy; Other Names: MRI; NMRI; nuclear magnetic resonance imaging; NMR imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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).	One month after last patient enrolled is take off study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	One month after last patient enrolled is taken off study

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Osamu Ukimura, University of Southern California

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 21, 2012
• First Submitted That Met QC Criteria: January 7, 2013
• First Posted (Estimate): January 9, 2013

Study Record Updates

• Last Update Posted (Estimate): January 28, 2014
• Last Update Submitted That Met QC Criteria: January 27, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 4P-10-6; NCI-2012-03037 (Registry Identifier: CTRP (Clinical Trial Reporting Program))