Clincosm LogoSign in Get a demo

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

Sponsor
University of Rochester (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03597386
Collaborator
(none)
0
Enrollment
1
Location
1
Actual Duration (Days)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    ConfirmMDx Assay is Multiparametric MRI (mpMRI) PIRADS Scored Lesions After a Negative MR/US Fusion Biopsy
    Actual Study Start Date :
    Jan 23, 2019
    Actual Primary Completion Date :
    Jan 24, 2019
    Actual Study Completion Date :
    Jan 24, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    All Participants

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Correlation of PIRADS scores with ConfirmMDx testing outcomes [baseline]

    2. Correlation of prostate cancer detection on re-biopsy with ConfirmMDx testing outcomes [baseline]

    3. Compare prostate cancer detection rates for repeat MR/US fusion biopsy after prior negative biopsy [baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Medical Center Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hani Rashid, Professor, Urology, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT03597386
    Other Study ID Numbers:
    • 71689
    First Posted:
    Jul 24, 2018
    Last Update Posted:
    Mar 1, 2019
    Last Verified:
    Feb 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Diseases

    Study Results

    No Results Posted as of Mar 1, 2019