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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-03037 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (MRI-TRUS fusion image-guided biopsy) | Experimental | Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic conventional surgery | Procedure | Undergo robotic radical prostatectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Osamu Ukimura | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
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| ultrasound-guided prostate biopsy | Procedure | Undergo MRI-TRUS fusion image-guided prostate biopsy |
|
| magnetic resonance imaging | Procedure | Undergo MRI-TRUS fusion image-guided prostate biopsy |
|
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| 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 |
| 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 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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