prostate cancer / adenocarcinoma of the prostate
Conditions
Interventions
None listed
Sponsors
Gen-Probe Incorporated, European Office
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: The subject*s last prostate biopsy must have been performed greater than 3 months prior to enrollment and must have been negative for cancer. The previous biopsy must have included at least 6 cores and the pathology report must be available.
Exclusion criteria
Exclusion criteria: • More than 2 previous prostate biopsies • Use of finasteride, dutasteride, leuprolide acetate, or other medications or hormones (within the past 3 months) that are known to affect serum PSA levels • Symptoms of urinary tract infection (including prostatitis) at the time of enrollment • History of prostate cancer • History of invasive treatments for BPH or lower urinary tract symptoms (LUTS), eg, transurethral resection of the prostate (TURP), heat, laser, or ultrasound treatments in the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The performance characteristics (specificity, sensitivity, and positive and negative predictive values) of the PCA3 Assay using prostate biopsy as the reference method. | — |
Countries
Netherlands
Outcome results
None listed