PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study

NCT02250313 | Terminated

• 1 other identifier: PASCUAL
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 15

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.

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (1)

• The primary objective is to demonstrate the clinical utility of the ConfirmMDx test

  The primary objective is to demonstrate a lower repeat biopsy rate by using the negative results of ConfirmMDx for Prostate Cancer in practice rather than current SOC.

  2 years

Secondary Outcomes (6)

• Compare rebiopsy rates assay negative results in cases and controls

  2 years

• Compare rebiopsy rates in assay positive group vs standard of care

  2 years

• Compare rebiopsy rates of case and controls

  2 years

• Analyse cancer detection rates

  2 years

• Evaluate clinical utility and cost savings by using the ConfirmMDx test

  2 years

Study Arms (2)

Case

All patients will have the tissue from their previous negative biopsy tested with the assay. Cases are defined as those subjects who receive the ConfirmMDx assay results.

Control

All patients will have the tissue from their previous negative biopsy tested with the assay. Controls are defined as subjects who will be blinded to the ConfirmMDx assay results.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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.

Sponsors & Collaborators

• MDx Health: lead

Study Sites (15)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

Genesis Research LLC

San Diego, California, 92123, United States

Location

Skyline Urology

Torrance, California, 90505, United States

Location

Urology Center of Colorado

Denver, Colorado, 80211, United States

Location

First Urology, PSC

Jeffersonville, Indiana, 47130, United States

Location

Regional Urology, LLC

Shreveport, Louisiana, 71106, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

Associated Medical Professionals of NY

Syracuse, New York, 13210, United States

Location

Oregon Urology Institute

Springfield, Oregon, 97477, United States

Location

Lancaster Urology

Lancaster, Pennsylvania, 17604, United States

Location

Carolina Urological Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Associates, P.C.

Nashville, Tennessee, 37209, United States

Location

Urology Clinics of North Texas, PLLC

Dallas, Texas, 75231, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Archived FFPE prostate biopsy core tissue to be analyzed for this study must have been collected from a previous, histologically confirmed cancer-negative biopsy. Patients were considered at risk for prostate cancer due to elevated serum PSA levels, abnormal digital rectal exam or other risk factor. Only archived tissues will be used in this study: no new procedures to obtain new samples from the patient will be done.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

US (15)