NCT01024959

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

Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 507 (actual)
• Sponsor: Gen-Probe, Incorporated · Industry
• Sex: Male
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PCA3 is a gene that is highly over-expressed in more than 90% of prostate cancers, and that can be quantified in urine specimens following a digital rectal examination. Studies have shown that because PCA3 is highly specific for prostate cancer, it predicts the results of repeat biopsies more accurately than traditional prostate-specific antigen (PSA) testing. Gen-Probe's PROGENSA(R) PCA3 assay is the first urine-based molecular diagnostic assay for prostate cancer.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
OTHER	PCA3 Assay	Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2009-12-03
• Last updated: 2012-11-12
• Results posted: 2012-11-07

Locations

13 sites across 1 country: United States