PRIORITY Study

Principal Investigator: Will  Lowrance
Keywords: prostate , biopsy Department: Urology Adult Research
IRB Number: 00097767 Co Investigator:  
Specialty: Urology
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Elizabeth Lignell
Elizabeth.Lignell@hsc.utah.edu
801-213-2780

Brief Summary

 

The purpose of this study is to improve the stratification of patients being considered for repeat prostate biopsy.

For patients who have had a previous negative prostate biopsy, but are still considered at risk for

prostate cancer due to risk factors consistent with harboring occult cancer, use of the ConfirmMDx and

SelectMDx assays may improve patient management decisions and result in a lower rate of repeat

biopsy and therapeutic burden than in patients managed with current patient care techniques.

 

The study objectives are:

The primary objectives of this study are twofold:

1) Validate the use of ConfirmMDx for Prostate Cancer to predict the outcome of a repeat biopsy in men with a previous negative prostate biopsy using tissue.  The study will evaluate the performance of the test to differentiate a participant's risk for no or Gleason Sum less than or equal to 6 prostate cancer versus Gleason Sum greater than or equal to 7 cancer. 

2) Validate use of the SelectMDx for Prostate Cancer to predict the outcome of a repeat biopsy in men with a previous negative prostate biopsy using urine.  The study will evaluate the performance of the test to differentiate a participant's risk for no or Gleason Sum less than or equal to 6 prostate cancer versus Gleason Sum greater than or equal to 7 cancer.

Secondary Objectives

1) Subset analyses will be conducted in appropriate groups, e.g. a comparison between clinical and pathological outcomes, for those participants with available data from radical prostatectomy, and how this correlates to the ConfirmMDx and SelectMDx results.

2) Evaluate rate of cancer detection on repeat biopsy and associated complications.

3) Evaluate the findings of MRI fusion biopsy with standard 12 core TRUS guided biopsy (if available).

 

 

 

Inclusion Criteria

Inclusion Criteria

1. Males, aged 40 years to 85, who underwent a previous cancer-negative prostate

biopsy within 30 months of being scheduled for a repeat biopsy.

2. The initial TRUS guided negative prostate biopsy must have collected a minimum

of 10 tissue cores and sections from all prostate biopsy cores collected by the

physician must be submitted to MDxHealth in order to allow for full

comprehensive testing/evaluation of all the sections of the patient’s prostate

prior to the scheduled repeat biopsy.

3.  Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue is

available (40 microns preferable).

4. Previous biopsy histology may include the presence of high-grade prostatic

intraepithelial neoplasia (HGPIN), proliferative inflammatory atrophy (PIA),

glandular inflammation, atypical small acinar proliferation (ASAP) or atypical

cells.

5. Tissue was extracted using standard TRUS guided biopsy core extraction (and not

transurethral resection of the prostate (TURP).

6. Pre-DRE serum sample, pre-DRE plasma sample, and Post-DRE urine sample to

be collected in advance of the repeat biopsy. Samples can be collected within

three months of the scheduled repeat biopsy, up until the day of, but prior

to, the procedure.

Exclusion Criteria

Exclusion Criteria

1. Patients who has undergone previously testing by ConfirmMDx from the same

biopsy samples or similar molecular test.

2. Patients being managed by active surveillance for low stage prostate cancer.

3. Patients with prior diagnosis of prostate cancer in any previous biopsy.

4. Patients with a limited life expectancy and generally not considered for a repeat

biopsy.

5. Tissue extracted using transurethral resection of the prostate (TURP) procedures

rather than standard patterned TRUS guided biopsy.

6. Patients with a history of cancer (except basal cell carcinoma)