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

University of Rochester

Status: Withdrawn

Conditions: Prostate Disease

Study type: Observational

Funder types: Other

Identifiers

NCT03597386

71689

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

All Participants