Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03585660|
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: Diagnostic MRI Procedure: Diagnostic Prostate Biopsy Device: Risk Map DSS tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy|
|Actual Study Start Date :||June 19, 2018|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: Interventional Arm
Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.
Procedure: Diagnostic MRI
Participants will be scanned using a standard clinical prostate MRI protocol.
Procedure: Diagnostic Prostate Biopsy
Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.
Device: Risk Map DSS tool
The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.
- Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by receiver operating characteristic curve [ Time Frame: 12 months ]
- Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by area under the curve [ Time Frame: 12 months ]
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): NCT03585660
|Contact: Ambereen Yousuf||(773) firstname.lastname@example.org|
|United States, Illinois|
|University of Chicago Medical Center||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Ambereen Yousuf 773-702-6003 email@example.com|
|Principal Investigator:||Aytekin Oto, MD||University of Chicago|