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

University of Rochester1 site in 1 countryJanuary 23, 2019

ConditionsProstate Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate Disease
Sponsor: University of Rochester
Locations: 1
Primary Endpoint: 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
Status: Withdrawn
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 23, 2019

End Date

January 24, 2019

Last Updated

7 years ago

Study Type

Observational

Sex

Male

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

Hani Rashid

Professor, Urology

University of Rochester

Eligibility Criteria

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

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 prostate cancer detection on re-biopsy with ConfirmMDx testing outcomes(baseline)
Correlation of PIRADS scores with ConfirmMDx testing outcomes(baseline)
Compare prostate cancer detection rates for repeat MR/US fusion biopsy after prior negative biopsy(baseline)