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

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

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 Overview

• Status: Withdrawn
• Conditions: Prostate Disease

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Subjects were selected due to increased risk of prostate cancer with prior elevated prostate specific antigen (PSA), mpMRI, prostatic lesions and negative MRI-ultrasound guided fusion biopsy due to the potential for prostate cancer that was not detected prior.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All Participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): January 24, 2019
• Study Completion (Actual): January 24, 2019

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 1, 2019
• Last Update Submitted That Met QC Criteria: February 27, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Prostatic Diseases
• Other Study ID Numbers: 71689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No