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Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result

NCT01024959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 507

Last updated 2012-11-12

Study results available
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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.

Conditions

  • Prostatic Neoplasms

Interventions

OTHER

PCA3 Assay

Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy

Sponsors & Collaborators

  • Gen-Probe, Incorporated

    lead INDUSTRY

Principal Investigators

  • Jennifer Reid, PhD · Gen-Probe, Incorporated

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01024959 on ClinicalTrials.gov