Clinical Evaluation of the PCA3 Assay in Men Requiring a Repeat Biopsy

• Conditions: prostate cancer / adenocarcinoma of the prostate; 10036958

• Registration Number: NL-OMON29886
• Lead Sponsor: Gen-Probe Incorporated, European Office

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

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

• 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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The performance characteristics (specificity, sensitivity, and positive and<br /><br>negative predictive values) of the PCA3 Assay using prostate biopsy as the<br /><br>reference method.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>