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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01764347
First received: December 21, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Prostate Cancer
Procedure: therapeutic conventional surgery
Procedure: ultrasound-guided prostate biopsy
Procedure: magnetic resonance imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Accuracy of Targeted Biopsies Using MRI-TRUS Fusion Guidance: Pilot Study on Ex Vivo Radical Prostatectomy Specimens

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Number of times the first biopsy needle is placed within 3.0 mm of the center lesion [ Time Frame: One month after last patient enrolled is taken off study ] [ Designated as safety issue: No ]
    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 [ Time Frame: One month after last patient enrolled is take off study ] [ Designated as safety issue: No ]
    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:
  • Average distance of the first needle to the center of the lesion [ Time Frame: One month after last patient enrolled is taken off study ] [ Designated as safety issue: No ]
    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.

  • Average distance of the second needle from the first needle minus 2.0 mm [ Time Frame: One month after last patient enrolled is taken off study ] [ Designated as safety issue: No ]
    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 [ Time Frame: One month after last patient enrolled is taken off study ] [ Designated as safety issue: No ]
    A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.


Enrollment: 24
Study Start Date: November 2010
Study Completion Date: September 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • NMR imaging
  • NMRI
  • nuclear 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764347

Locations
United States, California
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Osamu Ukimura University of Southern California
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01764347     History of Changes
Other Study ID Numbers: 4P-10-6, NCI-2012-03037
Study First Received: December 21, 2012
Last Updated: January 27, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 16, 2014