N/A
N=507
Clinical Evaluation of the PROGENSA(Registered Trademark) Prostate Cancer Gene 3 (PCA3) Assay in Men With a Previous Negative Biopsy Result
Prostatic Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01024959 ↗Enrolled (actual)
507
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) — 466; 102; 364; 235 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- PCA3 Assay (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Male
- Sponsor
- Gen-Probe, Incorporated
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Association of PCA3 Score With Prostate Biopsy Outcome (PCA3 Score Using Cutoff of 25.) |
466; 102; 364; 235; 79; 156 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men 40+ years of age who have had at least 1 previous negative prostate biopsy, who have never had a positive prostate biopsy, and who have been recommended for a repeat biopsy by their clinician.
- The subject must be able to comprehend and sign an approved informed consent form and other applicable study enrollment documents
Exclusion Criteria
- Use of medications or hormones that are known to affect serum PSA levels within 3 - 6 months of study enrollment
- Clinical symptoms of urinary tract infection (including prostatitis) at the time of enrollment
- History of prostate cancer
- History of invasive treatments for benign prostatic hypertrophy (BPH) or lower urinary tract symptoms within 6 months of study enrollment
- Medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
- Participation in pharmaceutical or treatment related clinical study within 6 months of study enrollment. Exception: Trials for non-prostate conditions may be acceptable, with approval by the investigator and Sponsor
Data sourced from ClinicalTrials.gov (NCT01024959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.