Status:
TERMINATED
PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study
Lead Sponsor:
MDx Health
Conditions:
Prostate Cancer
Eligibility:
MALE
40-75 years
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 unnecess...
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 find...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT02250313
Start Date
September 1 2014
End Date
July 1 2018
Last Update
July 26 2018
Active Locations (15)
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1
Urology Centers of Alabama
Homewood, Alabama, United States, 35209
2
Genesis Research LLC
San Diego, California, United States, 92123
3
Skyline Urology
Torrance, California, United States, 90505
4
Urology Center of Colorado
Denver, Colorado, United States, 80211