Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
USC/Norris Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01764347
First received: December 21, 2012
Last updated: January 7, 2013
Last verified: January 2013
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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 USC/Norris Comprehensive Cancer Center:
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.
| Estimated Enrollment: | 35 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (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:
|
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
USC/Norris Comprehensive Cancer Center
Investigators
| Principal Investigator: | Osamu Ukimura | USC/Norris Comprehensive Cancer Center |
More Information
No publications provided
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| 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 7, 2013 |
| 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 May 22, 2013