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Completed

NCT Number: NCT03585660

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

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).

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Diagnostic MRI

Procedure

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

Diagnostic Prostate Biopsy

Procedure

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.

Risk Map DSS tool

Device

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.

Primary outcomes

  1. Accuracy of HM-MRI

    Time frame: 12 months

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

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

    Time frame: 12 months

    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.

Secondary outcomes

  1. Sensitivity of HM-MRI

    Time frame: 12 months

    Sensitivity of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using HM-MRI among the participants who were found positive of prostate cancer using biopsy.

  2. Specificity of HM-MRI

    Time frame: 12 months

    Specificity of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using HM-MRI among the participants who were found negative using biopsy.

  3. Positive Predictive Value (PPV) of HM-MRI

    Time frame: 12 months

    Positive predictive value (PPV) of HM-MRI is defined as the proportion of participants who were found positive of prostate cancer using biopsy among the participants who were found positive using HM-MRI.

  4. Negative Predictive Value (NPV) of HM-MRI

    Time frame: 12 months

    Negative predictive value (NPV) of HM-MRI is defined as the proportion of participants who were found negative of prostate cancer using biopsy among the participants who were found negative using HM-MRI.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 13, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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