Prostate Cancer Clinical Trial

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Prostate Cancer IMAGing IN Early Detection (IMAGINED Trial)

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Summary

The researchers hope to learn if specific types of MRI software and techniques can help improve early prostate cancer detection at time of a MRI-guided prostate biopsy.

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Full Description

A phase 2 prospective, interventional, non-randomized clinical trial design to investigate whether Restricted Spectrum Maps (RSM) attained from RSI-MRI (On-Q Prostate) improves PI-RADS accuracy compared to PI-RADS alone for the detection of clinically significant prostate cancer. Patients who have agreed to undergo an MRI and subsequent prostate needle biopsy will be approached to participate in the trial.

The aims of the study are as follows:

Goal 1. Validate RSI-MRI imaging biomarker performance using a prospective clinical trial.

Goal 2. Calibrate the RSM values across different MRI scanner manufacturers. Goal 3. Translate RSI using a net clinical benefit model.

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Eligibility Criteria

Inclusion Criteria:

Selected to undergo an MRI-fusion prostate needle biopsy of the prostate.
Able to provide informed consent

Exclusion Criteria:

prior diagnosis of prostate cancer (Grade Group >1)
metastatic prostate cancer
prior prostate cancer treatment
contraindication to prostate biopsy (e.g., on anticoagulation that cannot be safely discontinued)
inability to undergo MRI (e.g., too large to be accommodated in a scanner or with an implant incompatible with MRI).
Bilateral hip replacement
Unable to provide informed consent.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

225

Study ID:

NCT05882253

Recruitment Status:

Recruiting

Sponsor:

The University of Texas Health Science Center at San Antonio

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There is 1 Location for this study

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Audie Murphie VA
San Antonio Texas, 78229, United States More Info
Michael A Liss, MD, PhD
Contact
210-567-0548
[email protected]
Brandi Weaver, BA
Contact
210-567-0178
[email protected]
The University of Texas Health Science Center at San Antonio, Medical Arts and Research Center
San Antonio Texas, 78229, United States More Info
Michael Liss, MD
Contact
210-567-5676
[email protected]
Brandi Weaver, BA
Contact
210-567-0178
[email protected]
Michael Liss, MD
Principal Investigator
University Health System
San Antonio Texas, 78229, United States More Info
Michael A Liss, MD, PhD
Contact
210-567-0548
[email protected]
Brandi Weaver, BA
Contact
210-567-0178
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

225

Study ID:

NCT05882253

Recruitment Status:

Recruiting

Sponsor:


The University of Texas Health Science Center at San Antonio

How clear is this clinincal trial information?

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