PSA testing on its own has been shown to result in a high number of unnecessary biopsies. Only 20% detect aggressive prostate cancer while 80% of prostate biopsies are either negative or detect a low-grade, non-life threatening form of prostate cancer. By providing information to improve decision making before ordering a prostate biopsy, the 4Kscore Test can help avoid an unnecessary prostate biopsy and its associated complications for men at low risk of having an aggressive cancer, while still identifying men at high-risk for having an aggressive prostate cancer. Depending on the 4Kscore result, Urologists can choose to either place a low-risk patient under active monitoring, or perform a biopsy on a high-risk patient.
The 4Kscore Test has undergone extensive clinical research and laboratory test validation. The biomarkers utilized in the 4Kscore Test are based on over a decade of research conducted by scientists in Europe and United States, encompassing over 10,000 patients. The results have recently been replicated in a prospective blinded clinical study conducted at 26 urology centers across the United States on 1,012 patients. Based on the results of this clinical study, as many as 30-58% of biopsies are avoidable using the 4Kscore Test.
The 4Kscore Test is applicable to men, who:
- are 40 to 80 years old
- have an elevated PSA level
- don’t have a previous prostate cancer diagnosis
- have not used 5α-reductase inhibitors in the past 6 months
- have not had a prostate biopsy in the past 6 months
- have not had a digital rectal exam (DRE) or other invasive prostate procedures in the past 96 hours