ConfirmMDx Assay in Multiparametric MRI (mpMRI) PIRADS Scored Lesions After a Negative MR/US Fusion Biopsy

University of Rochester

Overview

The purpose of this study is to see if the ConfirmMDx assay is useful in finding prostate cancer in patients who are at increased risk for prostate cancer based on elevated PSA and prostate lesion identified on mpMRI.

Study Type

OBSERVATIONAL

Conditions

Prostate Disease

Eligibility

Sex: MALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Prior documented elevated PSA (\> 4.0 ng/ml) * MRI lesion based on PIRADS scoring within the past 3 years * Completed MR/US fusion prostate biopsy with concurrent systematic biopsy for PIRADS score 2-5 with negative pathological findings completed subsequent ConfirmMDx assay (regardless of result). The most recent biopsy can be within 4 years if ConfirmMDx already completed. * May have had prior negative biopsy sessions prior to the most recent MR/US fusion biopsy * Must be able to stop anticoagulation/antiplatelet therapy 5-7 days prior to obtaining biopsy * Ability to give informed consent Exclusion Criteria: * Any metastatic cancer * Any prostate cancer * Active infection: urinary tract infection or prostate infection precluding prostate biopsy * Anal stenosis or severe anal disease preventing prostate biopsy

Locations (1)

University of Rochester Medical Center

Rochester, New York, United States

Outcomes

Primary Outcomes

Detection of prostate cancer based on rebiopsy of lesions on multiparametric MRI (mpMRI) following a negative MR/US fusion biopsy with concurrent systematic biopsy with correlation of ConfirmMDx assay testing performed on negative MR/US fusion biopsy

Time frame: baseline

Secondary Outcomes

Correlation of PIRADS scores with ConfirmMDx testing outcomes

Time frame: baseline

Correlation of prostate cancer detection on re-biopsy with ConfirmMDx testing outcomes

Time frame: baseline

Compare prostate cancer detection rates for repeat MR/US fusion biopsy after prior negative biopsy

Time frame: baseline

Data from ClinicalTrials.gov

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