NCT03585660

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable prostate-cancer

Timeline
Completed

Started Aug 2018

Typical duration for not_applicable prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 28, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

May 1, 2024

Enrollment Period

4.8 years

First QC Date

June 19, 2018

Results QC Date

May 13, 2024

Last Update Submit

September 4, 2024

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

  • Accuracy of HM-MRI

    The accuracy of HM-MRI is defined as the proportion of correctly diagnosed participants for prostate cancer using HM-MRI.

    12 months

  • Area Under the ROC Curve (AUC) of HM-MRI

    In the case of a binary predictor (HM-MRI), the area under a receiver operating characteristic (ROC) curve is equivalent to the average of sensitivity and specificity. The area under an ROC curve ranges from 0 to 1.

    12 months

Secondary Outcomes (4)

  • Sensitivity of HM-MRI

    12 months

  • Specificity of HM-MRI

    12 months

  • Positive Predictive Value (PPV) of HM-MRI

    12 months

  • Negative Predictive Value (NPV) of HM-MRI

    12 months

Study Arms (1)

Interventional Arm

EXPERIMENTAL

Participants will undergo diagnostic MRI exam followed by clinical biopsies of suspected prostate cancer tumors.

Procedure: Diagnostic MRIProcedure: Diagnostic Prostate BiopsyDevice: Risk Map DSS tool

Interventions

Diagnostic MRIPROCEDURE

Participants will be scanned using a standard clinical prostate MRI protocol.

Interventional Arm
Diagnostic Prostate BiopsyPROCEDURE

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.

Interventional Arm
Risk Map DSS toolDEVICE

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.

Interventional Arm

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • Chatterjee A, Yousuf AN, Engelmann R, Harmath C, Lee G, Medved M, Jamison EB, Lorente Campos A, Gundogdu B, Gerber G, Reynolds LF, Modi PK, Antic T, Giurcanu M, Eggener S, Karczmar GS, Oto A. Prospective Validation of an Automated Hybrid Multidimensional MRI Tool for Prostate Cancer Detection Using Targeted Biopsy: Comparison with PI-RADS-based Assessment. Radiol Imaging Cancer. 2025 Jan;7(1):e240156. doi: 10.1148/rycan.240156.

    PMID: 39836080DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Dr. Aytekin Oto, MD, MBA
Organization
Department of Radiology, University of Chicago
aoto@bsd.uchicago.edu
1-773-702-8553

Study Officials

  • Aytekin Oto, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

July 13, 2018

Study Start

August 28, 2018

Primary Completion

June 9, 2023

Study Completion

November 6, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-05

Locations

US(1)