Case Study #1:

The 4Kscore™ Test Correctly Identifies a Patient’s Risk for High-Grade Prostate Cancer After MRI and PCA3 Indicated Low Risk

Prostate cancer is the second leading cause of cancer deaths in men in the United States. Prostate specific antigen (PSA) testing and abnormal digital rectal examinations (DRE) lead to over 1 million prostate biopsies being performed annually in the United States. It is well known that PSA testing does not have the ability to accurately identify those men who have the aggressive form of prostate cancer (high grade Gleason ≥ 7). Prostate biopsies detect high grade prostate cancer in 20% of men while 80% of men are found to have indolent Gleason 6 or no cancer at all. The 4Kscore Test is a 4 kallikrein biomarkers panel blood test coupled with clinical information that uses a proprietary algorithm to calculate the patient’s individual risk for aggressive prostate cancer and a high negative predictive value to exclude those patients who do not have aggressive prostate cancer.

PATIENT

An otherwise healthy 69 year-old man with no family history of prostate cancer was referred to an urologist because of a history of a rising PSA. The PSA at the time of this evaluation was 5 ng/ml and his digital rectal exam (DRE) was normal. As part of the clinical work up, a prostate magnetic resonance imaging (MRI) and a PCA3 urine test were ordered to help determine whether a prostate biopsy

was necessary. The MRI showed a normal prostate with no evidence of any suspicious lesions and the PCA3 test was negative. As a result, the patient and urologist elected to continue to monitor the patient’s PSA over time. Meanwhile, the patient heard about the 4Kscore test, and after consultation with his urologist, a 4Kscore test was ordered.

The 4Kscore Test Result

The 4Kscore test was conducted and indicated that this patient’s risk for harboring high-grade prostate cancer was 62%. Based on this new information, the patient and urologist decided to proceed with a transrectal ultrasound-guided prostate biopsy. This revealed Gleason 4+4=8 prostate cancer in 3 of 12 cores.

DISCUSSION

The OPKO 4Kscore Test is a valuable diagnostic blood test for men who have an abnormal PSA or DRE and who are being considered for prostate biopsy or in those men who have had a negative prior biopsy, but there is still concern that aggressive prostate cancer was missed.

In this clinical case, the 4Kscore test provided important, additional information that modified this patient’s management. Although the patient had an elevated PSA,

OPKOLAB2014URO020 Rev 3 10/17/14

his DRE was normal and a MRI, and PCA3 test were both negative for prostate cancer. However the 4Kscore test result was 62%, indicating a substantial risk for high-grade, aggressive prostate cancer. This finding helped the patient and urologist make a better informed decision to move forward with the prostate biopsy. Fortunately for the patient, the aggressive high-grade prostate cancer was detected and treated sooner than if the patient was actively monitored, as originally planned. The 4Kscore test is a blood test that accurately identifies the risk of aggressive prostate cancer men in men who have clinical findings suspicious for prostate cancer.

(Case submitted by Dr. Richard Shapiro, Tarzana, California,)

PSA 5 ng/ml

DRE Normal

MRI Normal

PCA3 Negative

4Kscore 62%

TRUS biopsy Gleason Score 4+4=8

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