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NCT01024959 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result
A NA study, sponsored by Gen-Probe, Incorporated.
- Completed
- Registry status
- NA
- Development phase
- 507
- Enrollment target
NCT01024959: Completed NA study, sponsored by Gen-Probe, Incorporated.
NCT01024959 is a NA study that has completed, run by Gen-Probe, Incorporated. The registered enrollment target is 507 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01024959, a NA study, has completed, sponsored by Gen-Probe, Incorporated.
- COMPLETED
- Registry status
- NA
- Development phase
- 507 participants
- Enrollment target
Study 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.
Primary Outcome
The likelihood of positive biopsy was determined by the PCA3 Score expressed as a binary categorical variable: PCA3 Score \>=25 was positive, PCA3 Score \<25 was negative
Interventions
- OTHER PCA3 Assay
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 507 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-04 |
| Phase | NA |
What the finished NCT01024959 record still lists
NCT01024959 is an interventional study that assigns participants to a tested intervention. The registered 507 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 1 intervention - of which PCA3 Assay is the first listed.
NCT01024959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01024959 about?
NCT01024959 is a clinical study titled "Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result". 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 ...
What is the current status of trial NCT01024959?
This trial is currently completed. It is a NA study. The enrollment target is 507 participants. The study started on 2009-08. Estimated completion is 2010-04.
What interventions are being tested in trial NCT01024959?
The interventions under investigation include: PCA3 Assay (OTHER).
Who is sponsoring clinical trial NCT01024959?
This trial is sponsored by Gen-Probe, Incorporated, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01024959's enrollment target sits among peer trials
507 193rd of 2000 higher than 1,808 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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