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NCT05710380 | Recruiting | Prostate Cancer

MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Sponsor:

University of Chicago

Brief Summary:

Doctors leading this study hope to learn about a software that researchers at the University of Chicago have developed to help analyze radiographic images (different techniques for taking images that allow doctors to visualize the body's internal structures) of the prostate. Participation in this research will last about 12 months. There is a one-time MRI and 1-2 biopsies and then the investigator would like to follow the participant's progress.

Condition or disease

Prostate Cancer

Prostate Adenocarcinoma

Prostate Neoplasm

Intervention/treatment

Risk Map Decision Support System (DSS).

Magnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI) Guided Biopsy

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 180 participants
Masking : None (Open Label)
Primary Purpose : Screening
Official Title : Magnetic Resonance Imaging (MRI) Derived Quantitative Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy
Actual Study Start Date : April 26, 2023
Estimated Primary Completion Date : May 1, 2026
Estimated Study Completion Date : May 1, 2026
Arm Intervention/treatment

Experimental: All Participants (Single Arm)

All participants in this trial will be provided with routine instructions and precaution information before starting the magnetic resonance (MRI) scan. After the MRI, participants will undergo an MRI-guided fusion biopsy of the prostate as ordered by their doctor. During this prostate MRI-guided fusion biopsy, the research team will obtain tissue from up to two additional biopsy targets selected by the Risk Map DSS tool. Ultimately, the clinical radiologist will make the final decision on the targets to be biopsied.

Other: Risk Map Decision Support System (DSS).

Radiation: Magnetic Resonance Imaging (MRI)

Procedure: Magnetic Resonance Imaging (MRI) Guided Biopsy
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Patients with known or suspected prostate cancer who have been referred for a diagnostic magnetic resonance imaging (MRI) exam of the prostate, to be followed by an MRI-guided fusion biopsy of the prostate.
  • Voluntary written informed consent before the MRI examination.
Exclusion Criteria
  • Subjects incapable of giving informed written consent.
  • Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher;
  • Subjects 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).
  • Patients with previous treatments (surgery, radiation, focal ablation, hormone or other chemotherapy) for prostate cancer.
MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

Location Details

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MRI Risk Maps for Prostate Cancer Diagnosis Using Targeted Biopsy

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

United States, Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States, 60637