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

Withdrawn

• Conditions: Prostate Disease

• Registration Number: NCT03597386
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-24
• Study Start: 2019-01-23
• Primary Completion: 2019-01-24
• Study Completion: 2019-01-24
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-27
• Last Update Posted: 2019-03-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	baseline

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States