Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01964638|
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : October 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Targeted Biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Analysis of Software-based MRI-Ultrasound Image Fusion Against Cognitive Targeting of Multi-Parametric MRI Findings With Prostate Biopsy|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
Men being evaluated for prostate cancer based upon standard of care clinical parameters (e.g. elevated PSA levels, abnormal DRE, mpMRI) will be considered for enrollment. Men who have undergone prostate mpMRI that has revealed an area(s) of suspicion for prostate cancer are eligible for enrollment. All men enrolled in the study undergo fusion targeted biopsy, visual estimation biopsy, and systematic biopsy. As a result the study includes a single arm with direct comparison of biopsy techniques.
Procedure: Targeted Biopsy
- Evaluation of rates of prostate cancer diagnosis [ Time Frame: One week after biopsy ]The primary endpoint of the study is the evaluation of the rates of prostate cancer diagnosis using software based MRI-TRUS imaging fusion targeting of mpMRI lesions as compared to cognitive co-registration and targeting of mpMRI lesions.
- Evaluation of Rate of cancer diagnosis using targeted biopsy [ Time Frame: One week after biopsy ]The secondary endpoint of the study is the evaluation of the rate of cancer diagnosis using targeted biopsy (software or cognitive targeting) as compared to standard of care prostate biopsy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964638
|United States, New York|
|NYU Smilow Prostate Cancer Center|
|New York, New York, United States, 10016|
|Principal Investigator:||Samr S Taneja, MD||Co-Director, Smilow Comprehensive Prostate Cancer Center|