Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result
Public ClinicalTrials.gov record NCT01024959. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Clinical Evaluation of the PROGENSA(R) PCA3 Assay in Men With a Previous Negative Biopsy Result
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01024959
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 507 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2009
- Primary completion
- Mar 31, 2010
- Completion
- Mar 31, 2010
- Last update posted
- Nov 11, 2012
2009 – 2010
United States locations
- U.S. sites
- 13
- U.S. states
- 8
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HealthCare Partners Medical Group | Los Angeles | California | 90015 | — |
| San Diego Clinical Trials | San Diego | California | 92120 | — |
| South Florida Medical Research | Aventura | Florida | 33180 | — |
| Specialists in Urology | Naples | Florida | 34102 | — |
| Florida Urology Specialists | Sarasota | Florida | 34237 | — |
| Metropolitan Urology, PSC | Jeffersonville | Indiana | 47130 | — |
| Regional Urology Specialists, LLC | Shreveport | Louisiana | 71106 | — |
| AccuMed Research Associates | Garden City | New York | 11530 | — |
| TriState Urologic Services PSC Inc. dba The Urology Group | Cincinnati | Ohio | 45212 | — |
| Columbus Urology Research, LLC | Columbus | Ohio | 43220 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Urology San Antonio Research | San Antonio | Texas | 78229 | — |
| Virginia Urology | Richmond | Virginia | 23235 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01024959, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 11, 2012 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01024959 live on ClinicalTrials.gov.