Clinical trial · Observational
PASCUAL (Prostate Assay Specific Clinical Utility at Launch) Study
NCT02250313CI-TRIAL-00033988PASCUALterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Pending final analysis for termination
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Case
- description
- 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.
- label
- Control
- description
- 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.
Primary outcomes (1)
- measure
- The primary objective is to demonstrate the clinical utility of the ConfirmMDx test
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.