Prostate Cancer
Conditions
Brief summary
The purpose of the study is to evaluate whether storage of serum uncentrifuged is an allowable preanalytical procedure
Interventions
DIAGNOSTIC_TESTMeasurement 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.
Sponsors
OPKO Health, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tPSA changes in 3 days | Day 0, 1, 2 and 3 | Measure tPSA in serum samples at day 0, 1, 2 and 3 |
| fPSA changes in 3 days | Day 0, 1, 2 and 3 | Measure fPSA in serum samples at day 0, 1, 2 and 3 |
| iPSA changes in 3 days | Day 0, 1, 2 and 3 | Measure iPSA in serum samples at day 0, 1, 2 and 3 |
| hK2 changes in 3 days | Day 0, 1, 2 and 3 | Measure hK2 in serum samples at day 0, 1, 2 and 3 |
Countries
United States
Outcome results
None listed