PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study

Stopped early

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02250313

Run by

MDx Health

People needed

600

Starts

2014-09-01

Expected to finish

2018-07-01

Last updated by the study team

2018-07-26

Who can join

Age: 40 and older, up to 75. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Urology Centers of Alabama — Homewood, Alabama, United States
• Genesis Research LLC — San Diego, California, United States
• Skyline Urology — Torrance, California, United States
• Urology Center of Colorado — Denver, Colorado, United States
• First Urology, PSC — Jeffersonville, Indiana, United States
• Regional Urology, LLC — Shreveport, Louisiana, United States
• Chesapeake Urology Research Associates — Towson, Maryland, United States
• Michigan Institute of Urology — Troy, Michigan, United States
• Associated Medical Professionals of NY — Syracuse, New York, United States
• Oregon Urology Institute — Springfield, Oregon, United States
• Lancaster Urology — Lancaster, Pennsylvania, United States
• Carolina Urological Research Center — Myrtle Beach, South Carolina, United States
• Urology Associates, P.C. — Nashville, Tennessee, United States
• Urology Clinics of North Texas, PLLC — Dallas, Texas, United States
• Urology San Antonio Research — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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