PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study (PASCUAL)

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 600

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Urology Centers of Alabama
  • California
    • San Diego, California, United States, 92123
      • Genesis Research LLC
    • Torrance, California, United States, 90505
      • Skyline Urology
  • Colorado
    • Denver, Colorado, United States, 80211
      • Urology Center of Colorado
  • Indiana
    • Jeffersonville, Indiana, United States, 47130
      • First Urology, PSC
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Regional Urology, LLC
  • Maryland
    • Towson, Maryland, United States, 21204
      • Chesapeake Urology Research Associates
  • Michigan
    • Troy, Michigan, United States, 48084
      • Michigan Institute of Urology
  • New York
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals of NY
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Oregon Urology Institute
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster Urology
  • South Carolina
    • Myrtle Beach, South Carolina, United States, 29572
      • Carolina Urological Research Center
  • Tennessee
    • Nashville, Tennessee, United States, 37209
      • Urology Associates, P.C.
  • Texas
    • Dallas, Texas, United States, 75231
      • Urology Clinics of North Texas, PLLC
    • San Antonio, Texas, United States, 78229
      • Urology San Antonio Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare rebiopsy rates assay negative results in cases and controls	Comparison of rebiopsy rates of Cases and Controls with assay negative results at the end of follow up of 24 months from the date of the previous biopsy.	2 years
Compare rebiopsy rates in assay positive group vs standard of care	Comparison of rebiopsy rates in assay positive results group vs. SOC (blinded) positive assay group.	2 years
Compare rebiopsy rates of case and controls	Comparison of overall rates of rebiopsies of the entire Case vs. Control Cohorts	2 years
Analyse cancer detection rates	Analysis of cancer detection rates in ConfirmMDx positive and negative arms versus those of Controls	2 years
Evaluate clinical utility and cost savings by using the ConfirmMDx test	Evaluate clinical resource utilization, medical complications, and cost impact across groups	2 years
Compare rebiopsy rates assay positive results in cases and controls	Evaluate prostate cancer detection rates after repeat biopsy in the Case and Controls positive and negative groups at the end of 24 months after the previous negative biopsy date.	2 years

Collaborators and Investigators

• Sponsor: MDx Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2014
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): July 1, 2018

Study Registration Dates

• First Submitted: September 16, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (ESTIMATE): September 26, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PASCUAL