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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

December 21, 2012
January 27, 2014
November 2010
September 2012   (final data collection date for primary outcome measure)
  • 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).
Same as current
Complete list of historical versions of study NCT01764347 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Prostate Cancer
  • 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
Experimental: Diagnostic (MRI-TRUS fusion image-guided biopsy)
Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
Interventions:
  • Procedure: therapeutic conventional surgery
  • Procedure: ultrasound-guided prostate biopsy
  • Procedure: magnetic resonance imaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
September 2013
September 2012   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01764347
4P-10-6, NCI-2012-03037
Yes
University of Southern California
University of Southern California
National Cancer Institute (NCI)
Principal Investigator: Osamu Ukimura University of Southern California
University of Southern California
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP