PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study

Prostate Cancer Clinical Trial

— PASCUAL  

Official title:

PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02250313
• Other study ID #: PASCUAL
• Status: Terminated
• Start date: September 2014
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: MDx Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 600
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
United States	Urology Clinics of North Texas, PLLC	Dallas	Texas
United States	Urology Center of Colorado	Denver	Colorado
United States	Urology Centers of Alabama	Homewood	Alabama
United States	First Urology, PSC	Jeffersonville	Indiana
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 San Antonio Research	San Antonio	Texas
United States	Genesis Research LLC	San Diego	California
United States	Regional Urology, LLC	Shreveport	Louisiana
United States	Oregon Urology Institute	Springfield	Oregon
United States	Associated Medical Professionals of NY	Syracuse	New York
United States	Skyline Urology	Torrance	California
United States	Chesapeake Urology Research Associates	Towson	Maryland
United States	Michigan Institute of Urology	Troy	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
MDx Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Compare rebiopsy rates of case and controls	Comparison of overall rates of rebiopsies of the entire Case vs. Control Cohorts	2 years
Secondary	Analyse cancer detection rates	Analysis of cancer detection rates in ConfirmMDx positive and negative arms versus those of Controls	2 years
Secondary	Evaluate clinical utility and cost savings by using the ConfirmMDx test	Evaluate clinical resource utilization, medical complications, and cost impact across groups	2 years
Secondary	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