Prostate Disease
Conditions
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.
Interventions
None listed
Sponsors
University of Rochester
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
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
Design outcomes
Primary
| 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
| 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 |
Countries
United States
Outcome results
None listed