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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01764347
• Other study ID #: 4P-10-6
• Secondary ID: NCI-2012-03037
• Status: Completed
• Phase: N/A
• First received: December 21, 2012
• Last updated: January 27, 2014
• Start date: November 2010
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• therapeutic conventional surgery
Undergo robotic radical prostatectomy
• ultrasound-guided prostate biopsy
Undergo MRI-TRUS fusion image-guided prostate biopsy
• magnetic resonance imaging
Undergo MRI-TRUS fusion image-guided prostate biopsy

Locations

Country	Name	City	State
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No