Developing an Imaging-Based Tool to Identify Areas for Prostate Cancer Biopsy

Prostate Cancer Clinical Trial

Official title:

MRI Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03585660
• Other study ID #: IRB17-1694
• Status: Recruiting
• Phase: N/A
• Start date: June 19, 2018
• Est. completion date: December 2025

Study information

• Verified date: August 2023
• Source: University of Chicago
• Contact: Ambereen Yousuf
• Phone: (773) 702-6003
• Email: ayousuf[@]radiology.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the proposed research is to test and validate a Risk Map decision-support system (DSS) for prostate cancer Magnetic Resonance Imaging (MRI) interpretation and identification of clinically significant tumor site(s).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with known or suspected prostate cancer who have been referred to the Department of Radiology at the University of Chicago Medical Center for a diagnostic MRI exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
• Written informed consent.

Exclusion Criteria:

• Patients incapable of giving informed written consent;
• Patients who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
• Patients with psychiatric disorders that affect their ability to consent for themselves will be excluded and not the entire population of patients with psychiatric disorders.
• Prisoners;
• Minor children (under the age of 18 years old).

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Procedure:
• Diagnostic MRI
Participants will be scanned using a standard clinical prostate MRI protocol.
• 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.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by receiver operating characteristic curve		12 months
Primary	Rate of biopsy samples positive for prostate cancer versus those that are negative as assessed by area under the curve		12 months