At a glance
ClinicalIndex Comparison RecordN/ACompleted· 507 enrolled
Drug / intervention
PCA3 Assayother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
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Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result
In Brief
A clinical study evaluating PCA3 Assay for Prostatic Neoplasms. Completed, enrolled 507 participants across 13 sites.
Detailed Summary
The objective of this multi-center clinical study is to determine the association of the PCA3 Score with prostate biopsy outcome and validate the assay's performance characteristics in men with previous negative prostate biopsies. An elevated PCA3 Score is thought to be associated with an increased likelihood of positive biopsy. The results of this study are intended to be used for regulatory filings for use as an in vitro diagnostic test.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedDec 2009
Primary CompletionApr 2010
TodayJul 2026
First PostedDec 3, 2009
Enrollment StartAug 1, 2009
Primary CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.6 years ago
Interventions
PCA3 Assayother
Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy