The Prostate Cancer Dilemma

Prostate-specific antigen (PSA) screening has led to a nearly 50% decrease in metastatic prostate cancer over the past 20 years. However, PSA screening is not specific and cannot distinguish between indolent disease and aggressive cancer. In addition, benign prostatic hyperplasia (BPH), prostatitis, and trauma can all cause elevated PSA levels, making interpretation of results difficult.

Current standards of care force the healthcare provider to subjectively determine if a patient with an abnormal PSA level should undergo a prostate biopsy for definitive cancer diagnosis. Almost a million prostate biopsies are performed every year in the US, exposing many men to the inconvenience, discomfort and potential complications that accompany this surgical procedure. And since the majority of prostate cancers are indolent and require no treatment, many patients undergo unnecessary prostate biopsies resulting in overtreatment of the indolent form of the disease. Furthermore, prostate biopsies miss or undergrade cancer in 20-30% of cases. These factors suggest that a better test is needed for more accurate diagnosis.

4Kscore® Test Fills the Gap between PSA and Biopsy

BioReference® is pleased to offer the 4Kscore® for accurately identifying a man’s risk of aggressive prostate cancer. The 4Kscore® test can distinguish men with a low risk of having aggressive prostate cancer on biopsy from those with a high risk, helping to avoid unnecessary biopsies and overtreatment of indolent disease.

The 4Kscore® blood test uses a clinically validated algorithm combining biomarker data with clinical information to determine a man’s personalized risk for aggressive prostate cancer upon biopsy.

Infographic depicting Laboratory and Clinical Information being entered into OPKO algorithm and the 4Kscore being produced

The 4Kscore® test is included in prostate cancer early detection guidelines as a follow-up test to help improve the specificity of PSA screening, and should be used in an overall evaluation for a man’s prostate cancer risk.

For additional information, including test information sheets and brochures, patient guides, specimen requirements, report samples and billing information, please visit

Interpretation of Results

The 4Kscore® test helps provide diagnostic clarity for patients with an elevated PSA result or other clinical finding suggestive of prostate cancer.

Flowchart: Abnormal PSA or DRE leads to either Biopsy Naive or Prior negative biopsy. Both lead to 4Kscore. Leads to elevated risk consider biopsy or MRI, or low risk routine follow up

Patient management should be based on clinical judgment. Other clinical information (health status, medical history, family history of prostate cancer, PSA history, etc.) along with the 4Kscore® test result should be considered in the shared healthcare provider and patient decision regarding prostate biopsy.

4Kscore® Test Benefits – A Simple Blood Test Providing Clinically Meaningful Information

The 4Kscore® test offers you and your patient important benefits in determining the best course of treatment to manage prostate cancer risk. The 4Kscore® test can:

  • Distinguish men with a low risk of having aggressive prostate cancer on biopsy from those with an elevated risk
  • Reduce avoidable biopsies and overtreatment of indolent prostate cancer, producing savings for the healthcare system and minimizing risk to patients
  • Prompt early intervention in patients that would most benefit from timely diagnosis and treatment
  • Allow for improved decision making between the healthcare provider and patient to develop personalized treatment plan

Patient Considerations

The 4Kscore® test is especially useful for biopsy decision clarification in patients whose other test results are equivocal. Based on the patient’s 4Kscore® test results, healthcare providers can add new, patient-specific risk information to bring into the discussion with the patient, and together make a rational decision about whether or not to perform a prostate biopsy. Additional considerations for testing include patients who are reluctant or anxious about having a biopsy, are facing a second or subsequent biopsy, or those who have concerns about the side effects of prostate biopsy, including pain, bleeding and infection.

The 4Kscore® test is not indicated in men:

  • Previously diagnosed with prostate cancer
  • Younger than 40 or older than 80 years of age
  • Who have had a Digital rectal Exam (DRE) performed in the previous 96 hours before phlebotomy. A DRE performed after the phlebotomy is acceptable
  • Who have received 5-alpha reductase inhibitor (5-ARI) medication, such as Avodart® (dutasteride) or Proscar® (finasteride), within the previous six (6) month
  • Who have undergone a prostate procedure within the previous 6 months

Looking for more information?

With the 4Kscore®, healthcare providers can improve clinical decision making and give patients peace of mind regarding their risk for aggressive prostate cancer. Please speak with your sales representative or click the link below to download the 4Kscore® healthcare provider resource.


Full test information can also be found using the Test Directory.