4Kscore Using Serum Stored Uncentrifuged

Study Overview
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Brief Summary
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The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure

Official Title
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Demonstrating the Stability of the Analytes Measured for 4Kscore: Total PSA (tPSA), Free PSA (fPSA), Intact PSA (iPSA), and Human Kallikrein 2 (hk2) in Clinical Serum Samples Stored Uncentrifuged Before Testing

Conditions
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Prostate Cancer

Intervention / Treatment
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* Diagnostic Test: Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men capable of donating five 5 mL tubes of whole blood 40 to 80 years old No prior diagnosis of prostate cancer; prior negative prostate biopsy included Total PSA (tPSA) value measured within last year to be: at 1.5 ng/mL to 4 ng/mL, 4.1 ng/mL to 10 ng/mL and 10 ng/mL and above Exclusion Criteria: In the previous 96 hours (4 days), underwent a digital rectal exam Any invasive urologic procedure in the 6 months prior to study participation Underwent any procedure to treat symptomatic benign prostatic hyperplasia in the last 6 months Radical prostatectomy since tPSA measurement Received within the previous 6 months 5-alpha reductase inhibitor (5-ARI) therapy such as Avodart (dutasteride) or Proscar (finasteride)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged|The 4Kscore Test helps clarify the biopsy decision-making process by determining a patient specific probability for finding aggressive, Gleason score 7 or higher prostate cancer upon biopsy. These are the aggressive prostate cancers that always require medical treatment or intervention. The 4Kscore Test relies on the measurement of four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, digital rectal exam (nodules, no nodules), and prior negative biopsy (yes, no) to give physicians a personal score for each patient. The 4Kscore Test predicts the risk percent score from <1% to >95% of a man having aggressive cancer in a prospective biopsy.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tPSA changes in 3 days | Measure tPSA in serum samples at day 0, 1, 2 and 3 | Day 0, 1, 2 and 3 | 
| fPSA changes in 3 days | Measure fPSA in serum samples at day 0, 1, 2 and 3 | Day 0, 1, 2 and 3 | 
| iPSA changes in 3 days | Measure iPSA in serum samples at day 0, 1, 2 and 3 | Day 0, 1, 2 and 3 | 
| hK2 changes in 3 days | Measure hK2 in serum samples at day 0, 1, 2 and 3 | Day 0, 1, 2 and 3 |