Ignite Creation Date:
2024-05-05 @ 10:05 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01024959
Status:
COMPLETED
Last Update Posted:
2012-11-12
First Post:
2009-12-01
Brief Title:
Clinical Evaluation of the PROGENSARegistered Trademark Prostate Cancer Gene 3 PCA3 Assay in Men With a Previous Negative Biopsy Result
Sponsor:
Gen-Probe Incorporated
Organization:
Gen-Probe Incorporated
Study Overview
Official Title:
Clinical Evaluation of the PROGENSAR PCA3 Assay in Men With a Previous Negative Biopsy Result
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PCA3
Brief 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 assays 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-Probes PROGENSAR PCA3 assay is the first urine-based molecular diagnostic assay for prostate cancer
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None