Clinical trial NCT02250313: PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study
Official title: PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prostate Cancer
Keywords: prostate cancer
Lead sponsor: MDx Health
Sponsor class: INDUSTRY
First posted: 2014-09-26
Enrollment: 600
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males aged 40 to 75 years old\* that underwent a previous cancer-negative prostate biopsy within 15 months and being considered for a repeat biopsy due to persistent or elevated cancer-risk factors

Brief summary: The main hypothesis of this study is to demonstrate that the use of the ConfirmMDx for Prostate Cancer test in previously biopsied patients improves urologists' patient management by reducing unnecessary repeat biopsies, attendant procedure costs, and potential adverse events in men being considered for a repeat procedure.

Detailed description: The results of the study will reveal the clinical utility of this test by analyzing the physicians' use of negative or positive assays compared to patients managed using SOC methods without assay findings. The repeat biopsy rate at 12 months from study entry will be used for the primary endpoint analysis. All patients will be followed for 24 months from the date of the previous negative biopsy to evaluate an extended period of observation to track repeat biopsies and cancer detection.

The primary objective of this study is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC. All patients will have the tissue from their previous negative biopsy tested with the assay. Only data from Cases (informed of ConfirmMDx assay results) and Controls (blinded of the ConfirmMDx assay result) patients with negative test results will be used for the primary objective.

Eligibility criteria: Inclusion Criteria:

* Males aged 40 to 75 years old\* that underwent a previous cancer-negative prostate biopsy within 15 months and being considered for a repeat biopsy due to persistent or elevated cancer-risk factors
* The previous negative prostate biopsy must have collected a minimum of 8 tissue cores and remaining FFPE tissue from all cores should be available for testing
* Minimum tissue volume criteria of 20 microns of prostate biopsy core tissue should be available (40 microns preferable)
* The presence of HGPIN (high-grade prostatic intraepithelial neoplasia), PIA (proliferative inflammatory atrophy), or glandular inflammation reported in the first biopsy histopathology report is acceptable for entry.

Exclusion Criteria:

* Prior diagnosis of prostate cancer or cellular atypia suspicious for cancer (ASAP) in a previous biopsy histology report.
* Patients being managed by Active Surveillance for low stage prostate cancer
* Men greater than 75 years old (generally not considered for repeat biopsy)
* Most recent biopsy was a saturation biopsy (\> 24 tissue cores).
* Tissue extracted using transurethral resection of the prostate (TURP) procedures rather than standard patterned biopsy core extraction.
* Subjects who had been previously tested with ConfirmMDx.

Primary outcomes:
measure: The primary objective is to demonstrate the clinical utility of the ConfirmMDx test
timeFrame: 2 years
Secondary outcomes:
measure: Compare rebiopsy rates assay negative results in cases and controls
timeFrame: 2 years
measure: Compare rebiopsy rates in assay positive group vs standard of care
timeFrame: 2 years
measure: Compare rebiopsy rates of case and controls
timeFrame: 2 years
measure: Analyse cancer detection rates
timeFrame: 2 years
measure: Evaluate clinical utility and cost savings by using the ConfirmMDx test
timeFrame: 2 years
measure: Compare rebiopsy rates assay positive results in cases and controls
timeFrame: 2 years
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Urology Centers of Alabama
state: Alabama
city: San Diego
country: United States
facility: Genesis Research LLC
state: California
city: Torrance
country: United States
facility: Skyline Urology
state: California
city: Denver
country: United States
facility: Urology Center of Colorado
state: Colorado
city: Jeffersonville
country: United States
facility: First Urology, PSC
state: Indiana
city: Shreveport
country: United States
facility: Regional Urology, LLC
state: Louisiana
city: Towson
country: United States
facility: Chesapeake Urology Research Associates
state: Maryland
city: Troy
country: United States
facility: Michigan Institute of Urology
state: Michigan
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY
state: New York
city: Springfield
country: United States
facility: Oregon Urology Institute
state: Oregon
city: Lancaster
country: United States
facility: Lancaster Urology
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urological Research Center
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates, P.C.
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas, PLLC
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research
state: Texas
Study officials:
References: