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

Prostate Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03597386
• Other study ID #: 71689
• Status: Withdrawn
• Start date: January 23, 2019
• Est. completion date: January 24, 2019

Study information

• Verified date: February 2019
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 24, 2019
• Est. primary completion date: January 24, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Disease
• Prostatic Diseases

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation of PIRADS scores with ConfirmMDx testing outcomes		baseline
Secondary	Correlation of prostate cancer detection on re-biopsy with ConfirmMDx testing outcomes		baseline
Secondary	Compare prostate cancer detection rates for repeat MR/US fusion biopsy after prior negative biopsy		baseline