Clinical trial NCT03082274: Prospective Validation of Prostate Biomarkers for Repeat Biopsy
Official title: Prospective Validation of Prostate Biomarkers for Repeat Biopsy: The PRIORITY Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: MDx Health
Sponsor class: INDUSTRY
First posted: 2017-03-17
Enrollment: 1000
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ConfirmMDx assay will be utilized to blindly test the needle biopsy cores of the index negative prostate biopsy (all cores) of men about to undergo repeat prostate biopsy. It is postulated that the test may aid in improved patient risk stratification for repeat biopsy, discriminating patients with no cancer/low grade prostate cancer (GS6) who are at sufficiently low risk to avoid repeat biopsy, while also identifying patients at increased risk for clinical significant disease (≥ GS7) who may benefit from early intervention.

In this current study, SelectMDx will be used to blindly test urine samples obtained preceding a repeat prostate biopsy to validate the test's ability to predict risk for high-grade disease. The intent is to demonstrate the test's ability to non-invasively stratify those patients at risk for aggressive disease, who require a repeat prostate biopsy, versus those at sufficiently low risk who may avoid unnecessary repeat biopsy.

Brief summary: Target enrollment is 1000 prospectively enrolled subjects with an initial negative biopsy scheduled for repeat biopsy.

Subjects must have had their negative index prostate biopsy procedure within 30 months of being scheduled for their repeat biopsy.

All enrolled subjects will have all core tissues from the initial negative biopsy blinded and tested with the assay.

All subjects will have serum and plasma samples obtained prior to DRE, and a urine sample collected immediately following DRE but in advance of the repeat biopsy; samples will be blinded and sent to MDxHealth for evaluation.


Eligibility criteria: 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)

Primary outcomes:
measure: Validate ConfirmMDx for Prostate Cancer to predict the outcome of repeat biopsy
timeFrame: 1 year
Secondary outcomes:
measure: Comparison between clinical and pathological outcomes
timeFrame: 1 year
Other outcomes:
Locations:
city: Irvine
country: United States
facility: MDxHealth
state: California
Study officials:
References: