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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: therapeutic conventional surgery; Procedure: ultrasound-guided prostate biopsy; Procedure: magnetic resonance imaging

• Registration Number: NCT01764347
• Lead Sponsor: University of Southern California

Brief Summary

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

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 Timeline

• Study Start: 2010-11
• Primary Completion: 2012-09
• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (MRI-TRUS fusion image-guided biopsy)	therapeutic conventional surgery	Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
Diagnostic (MRI-TRUS fusion image-guided biopsy)	ultrasound-guided prostate biopsy	Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
Diagnostic (MRI-TRUS fusion image-guided biopsy)	magnetic resonance imaging	Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.

Primary Outcome Measures

Name	Time	Method
Number of times the first biopsy needle is placed within 3.0 mm of the center lesion	One month after last patient enrolled is taken off study	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).
Number of times the second biopsy needle is placed within 3.0 mm of the center lesion	One month after last patient enrolled is take off study	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).

Secondary Outcome Measures

Name	Time	Method
Average distance of the second needle from the first needle minus 2.0 mm	One month after last patient enrolled is taken off study	A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.
Average distance of the third needle from the first needle minus 2.0 mm	One month after last patient enrolled is taken off study	A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.
Average distance of the first needle to the center of the lesion	One month after last patient enrolled is taken off study	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.

Trial Locations

Locations (1)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States