A Study of the Experimental ConfirmMDx and SelectMDx Test for Prostate Cancer

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 40 to 85 years old
Gender:
Male
Healthy Volunteers: No
Keywords: prostate cancer, diagnostic study, prostate cancer biomarkers
Type: Diagnostic Test study
Target:
32 Participants
Investigator:
Description
We invite you to take part in a research because you had a negative prostate biopsy using tissue and urine. This study will test the ConfirmMDx and SelectMDx test for Prostate Cancer. It identifies patients with increased risk for significant disease and lowers the rate of repeat biopsies.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Males, aged 40 years to 85, who underwent a previous cancer-negative prostate biopsy within 30 months of being scheduled for a repeat biopsy.
  • 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.
  • Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue is available (40 microns preferable).
  • 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.
  • Tissue was extracted using standard TRUS guided biopsy core extraction (and not transurethral resection of the prostate (TURP).
  • 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:

  • Patient who has undergone previously testing by ConfirmMDx from the same biopsy
  • Patients with prior diagnosis of prostate cancer in any previous biopsy.
  • Patients with a limited life expectancy and generally not considered for a repeat Tissue extracted using transurethral resection of the prostate (TURP) procedures
  • Patients with a history of cancer (except basal cell carcinoma)
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
You will be in the study for a few months.
Recruitment period
From June 25, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Randev Sandhu
Research Topic
Conditions:
  • Prostate Cancer