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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014