Prostate Cancer Clinical Trial

MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy

Summary

The purpose of this study is to find out how best to detect clinically significant lesions of prostate cancer by using micro-ultrasound technology (ExactVu) and by multiparametric magnetic-resonance imaging (mpMRI).

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Full Description

This is a pilot clinical trial with 30 patients with either: 1) suspected prostate cancer (based on elevated PSA or abnormal digital rectal exam (DRE), or 2) known low-risk prostate cancer being managed with active surveillance.

Enrolled patients will undergo MRI fusion biopsy and standard-template 12 core TRUS biopsy as the standard-of-care. Patients will also undergo micro-ultrasound evaluation and targeted biopsy if lesions are identified. Detection rates of clinically significant lesions by ExactVu and by MRI will be compared.

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Eligibility Criteria

Inclusion Criteria:

Patients scheduled to undergo biopsy and with one of the following:

Men with suspicion of prostate cancer
Men on active surveillance
Age ≥18 [30]
Have available multiparametric prostate MRI
Able to provide written, informed consent
No significant medical illness which in the opinion of the Investigator would preclude entry to study procedures
Be willing and able to comply with scheduled visits

Exclusion Criteria:

Previously confirmed prostate cancer diagnosis with Grade Group >= 2
Unable to undergo prostate biopsy
Prostate MRI unable to be evaluated using the PI-RADS v2 criteria
Men with contraindication for MRI or a prostate biopsy
Prostate biopsy within 8 weeks prior to mpMRI.
Any history of prostate treatment

Study is for people with:

Prostate Cancer

Estimated Enrollment:

30

Study ID:

NCT05471128

Recruitment Status:

Not yet recruiting

Sponsor:

University of Oklahoma

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There is 1 Location for this study

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Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Andrew McIntosh, MD
Contact
405-271-8001
[email protected]
Andrew McIntosh, MD
Principal Investigator

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

30

Study ID:

NCT05471128

Recruitment Status:

Not yet recruiting

Sponsor:


University of Oklahoma

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