An interventional study of therapeutic conventional surgery and ultrasound-guided prostate biopsy in Prostate Cancer, sponsored by University of Southern California. Completed at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2014-01-28.
Sponsored by University of Southern California · Not applicable, Interventional, and Diagnostic
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 24 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
Procedure: therapeutic conventional surgery · Procedure: ultrasound-guided prostate biopsy · Procedure: magnetic resonance imaging
Undergo robotic radical prostatectomy
Undergo MRI-TRUS fusion image-guided prostate biopsy
Undergo MRI-TRUS fusion image-guided prostate biopsy
Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
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).
Time frame: One month after last patient enrolled is taken off study
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).
Time frame: One month after last patient enrolled is take off study
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.
Time frame: One month after last patient enrolled is taken off study
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.
Time frame: One month after last patient enrolled is taken off study
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.
Time frame: One month after last patient enrolled is taken off study
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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University of Southern California