How the 4Kscore® Test is Helping Reduce Unnecessary Prostate Biopsies

According to the American Cancer Society, there will be roughly 160,000 new cases of prostate cancer diagnosed in the US this year alone, with over 26,000 deaths estimated from this disease. [1] It is essential that aggressive forms of prostate cancer, that are more likely to spread and lead to death, are diagnosed early when they may still be treatable.  Traditionally this has been done through screening with PSA, followed by a prostate biopsy for men with an abnormal result. Unfortunately, in many cases PSA is elevated in men without prostate cancer.  As a result, there are many unnecessary prostate biopsies, which has led to a push to reduce or eliminate prostate cancer screening.

The PSA Dilemma

The PSA test is a widely used blood screening test for prostate cancer, that measures the amount of prostate-specific antigen (PSA).  During the time since its widespread adoption, there has been a significant reduction in metastasis and death due to prostate cancer.  However, most men getting a prostate biopsy after screening with PSA will not have aggressive prostate cancer, and many will not have any cancer at all.  Due to the complications associated with prostate biopsy, including hospitalization, bleeding, sepsis, and pain, it is important to reduce the number of unnecessary biopsies done. [2, 3, 4] There is a clear need to both continue to find men with a higher risk for aggressive prostate cancer early, and reduce biopsies in men with a low risk.

The True Cost of Unnecessary Prostate Biopsy

Unnecessary prostate biopsies include a range of medical expenses due to procedural and diagnostic costs, but the true cost reaches beyond that. Patients and their families experience anxiety around the side effects of prostate biopsies, as well as the fear of the detection of cancer.  The harms from over-diagnosis and over-treatment of benign conditions and indolent prostate cancer can be very significant.

4Kscore & the Prostate Biopsy Decision

The 4Kscore Test is a simple blood test, used after an abnormal PSA, that reduces unnecessary prostate biopsies by providing the risk of aggressive prostate cancer before a biopsy decision is made.  It measures four prostate-specific proteins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2), and combines them with clinical findings (age, prior biopsy history, and optionally a digital rectal examination) to provide a risk score. By asking for a 4Kscore test, men and their physicians can make a biopsy decision knowing the personal risk for aggressive prostate cancer, and avoid unnecessary procedures in low risk men.

At BioReference, we are committed to helping reduce the number of unnecessary biopsies performed annually, while helping men at high risk get the proper evaluation they need. If you, or a loved one, have recently received news of an abnormal PSA score, we encourage you to speak to your doctor about undergoing a 4Kscore Test. If you are a physician interested in offering the 4Kscore Test in your practice, we encourage you to contact us today. Learn more about how this simple blood test is helping to reduce unnecessary biopsies.

If you are interested in learning more about prostate health, follow our blog and connect with us on Facebook, Twitter, Google+ and LinkedIn.

  • American Cancer Society. Key Statistics for Prostate Cancer. (Access June 12, 2017)
  • National Cancer Institute. Prostate-Specific Antigen (PSA) Test. (Access June 12, 2017)
  • Parekh DJ, Punnen Sm, Sjoberg DDm et al. A Multi-institutional Prospective Trial in the USA Confirms that the 4Kscore Accurately Identifies Men with High-grade Prostate Cancer. Eur Urol. 2015; 68:464-70.
  • Liss, M. A., et al. (2017). “An Update of the American Urological Association White Paper on the Prevention and Treatment of the More Common Complications Related to Prostate Biopsy.” J Urol.

Why the 4Kscore is Important to Physicians and Patients

Nearly 3 million men live with prostate cancer in the US, with more than 160,000 new cases diagnosed each year[1].  Prostate cancer remains the second leading cause of cancer death in men[2], which is why it’s important to find aggressive prostate cancers early when treatment can still be effective.  Unfortunately, current methods for screening and evaluating men for this disease have led to overuse of prostate biopsies, which can also lead to unnecessary complications.  This is why physicians are now using the 4Kscore, which is a simple blood test used after an abnormal screening test, to provide the risk of aggressive prostate cancer.

4Kscore Provides The Risk Of Aggressive Prostate Cancer

Screening with PSA and a digital rectal examination (DRE) is a routine part of many men’s regular examinations, and has led to a significant drop in prostate cancer deaths.  Screening with PSA is normally done in age appropriate men, and earlier in men with additional risk factors.  While PSA has been successful in finding many prostate cancers at a stage early enough to treat, it does a poor job of differentiating aggressive prostate cancers from indolent cancer, and can even be elevated in many benign conditions like Benign Prostatic Hyperplasia (BPH: a common condition for most men as they get older) [3].  As a result, there is significant controversy about continuing to use PSA as a routine screening test.

This is why a test like 4Kscore is so important to physicians and men concerned about their risk of aggressive prostate cancer.  4Kscore is a blood test performed after an abnormal PSA or DRE result.  It measures the values of 4 prostate specific biomarkers in the blood and combines them with clinical results, resulting in a score that accurately predicts an individual’s risk of aggressive cancer.  It can help avoid unnecessary prostate biopsies in low risk men, while higher risk men will continue to be appropriately evaluated with a biopsy.  4Kscore has been extensively evaluated in numerous published clinical studies, including a large US based prospective study at 26 centers around the country.  It has been shown to provide risk for high-grade cancer and also categorizes risk for developing distant metastasis.

Making An Informed Decision About Prostate Biopsies

With the 4Kscore, patients and physicians can make a more informed decision about the benefits and risks of getting a prostate biopsy.  Prostate biopsies can in some cases have complications like pain, bleeding, sepsis, and may lead to hospitalization, with its associated costs.  Currently, screening with PSA and DRE alone has resulted in the majority of biopsies having no or indolent cancer.  By using the 4Kscore in men with an abnormal screening result, many of these unnecessary biopsies can be avoided.  This leads to better clinical decision making, while also reducing costs to the patient and the healthcare system.

Is the 4Kscore Test Available at Your Practice?

At GenPath and BioReference, OPKO Health companies, we often hear from physicians and patients alike inquiring about the 4Kscore Test. If you are a physician interested in offering the 4Kscore Test in your practice, we encourage you to contact us today. Begin offering the 4Kscore Test to your patients and get listed in our physician locater tool. If you are a patient who would like to encourage your physician to begin offering the 4Kscore Test, we also encourage you to reach out to us. Together we can make the 4Kscore Test even more readily available.

If you are interested in learning more about prostate health through precision medicine, follow our blog and connect with us on Facebook, Twitter, Google+ and LinkedIn.


The Importance of Staying Fit During the Holidays

For many, the holiday season symbolizes a time to give thanks, spend time with family, and to reflect on the past year. The winter months are also full of indulgence and celebration. While we all try our best to stay on track during the holidays, it is not uncommon to pick-up unhealthy habits while allowing some of our healthier habits to momentarily take a backseat.

Holiday Weight Gain

According to a recent study published in the New England Journal of Medicine, holiday weight gain is an issue in America and abroad. It found that the American participants experienced a 0.2% increase in weight over the Thanksgiving holiday followed by a 0.4% increase over Christmas.  Our German counterparts experienced an increase in body weight by 0.6% over Christmas and an incremental 0.2% over Easter. Finally, Japanese participants saw a 0.5% increase in body weight over Christmas and 0.3% boost over Golden Week, a period which includes four national holidays.[1]

It’s Not Just About the Scale

The ramifications of over indulging and allowing your fitness routine to slip during the holidays can go far beyond a few pounds on the scale or an extra notch on your belt. There are a myriad of health risks associated with sudden weight gain. According to the National Institute of Diabetes and Digestive and Kidney Disease, being overweight can put you at risk of developing type 2 diabetes, high blood pressure, heart disease, certain types of cancer and more.[2]

Physical Activity May Reduce Cancer Risk

The list of benefits of physical activity goes on and on; helping to maintain a healthy weight, producing natural endorphins, fighting heart disease and more. To add to those benefits, research findings have reported a link between regular physical activity and a reduced risk of certain types of cancers.[3] A study completed by a team of researchers at the University of Vermont, Burlington, found that physically fit men, in their midlife, have a reduced risk level of dying of cancer-related deaths as they age.[4] Medical research not only tells us that exercise can reduce the risk of certain types of cancer in men, but that it may also help to keep it at bay. Another study found that regular vigorous physical activity may help to slow the progression of prostate cancer in men age 65 and up.[5]

Battle the Bulge this Holiday Season

Rather than simply allowing yourself to gain a few extra pounds this holiday season, get moving! Make the commitment now to stick to your workout and/or activity routine. Hit the gym a little harder the day before and the day after a major holiday splurge and consider skipping the occasional sweet or cocktail – or opt for healthier food options. By taking a few measures now, you will be doing yourself and your body a lot of favors.

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  • New England Journal of Medicine. Weight Gain over the Holidays in Three Countries. Available at (Accessed November 15, 2016).
  • National Institute of Diabetes and Digestive and Kidney Disease. Health Risks of Being Overweight. Available at (Accessed November 16, 2016).
  • National Cancer Institute. Physical Activity and Cancer. Available at (Accessed December 1, 2016)
  • JAMA Oncology. Midlife Cardiorespiratory Fitness, Incident Cancer, and Survival After Cancer in Men. Available at (Accessed December 1, 2016)
  • National Cancer Institute. Physical Activity and Cancer. Available at (Accessed December 1, 2016)

Elevated PSA – What’s Next?

If you, or a loved one, have received news of an elevated PSA score, you might be feeling a bit scared, intimidated, or lost at what to do next. However we are happy to let you know that an elevated PSA score is not always indicative of a high-risk prostate cancer diagnosis. Let’s take a closer look at the PSA score and what it really tells us.

What is a PSA Score?

A PSA score is the result of a blood screen that tests for Prostate-Specific Antigens (PSA) in the bloodstream. While elevated PSA levels can indicate a higher risk level of developing prostate cancer, and has helped many men find prostate cancer early enough to treat, it poorly differentiates between prostate cancer and other less serious health conditions. In many cases, an elevated PSA score is not indicative of the presence of prostate cancer.
In fact, PSA testing alone can lead to false positives which have been found to result in many unnecessary biopsies. Biopsies which can lead to the discovery of non-life threatening cancers followed, in some cases, by treatments that can result in side effects such as erectile dysfunction and incontinence. Now that’s scary!

Know Your 4Kscore®

Modern medicine has advanced far beyond using a simple PSA test by itself. Today the 4Kscore is revolutionizing the way urologists approach prostate cancer diagnosis by being more specific for aggressive prostate cancer. The 4Kscore is the result of research conducted by Memorial Sloan-Kettering Cancer Center on over 10,000 patients. The test provides a percentage risk score, from <1% to >95%, of a man’s likelihood of having aggressive prostate cancer in men with a high PSA result or abnormal digital rectal exam. To arrive at the 4Kscore, a blood sample is tested for four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The results are then combined in an algorithm with patient age, prostate biopsy history and an optional digital rectal exam to arrive at the 4Kscore.
The 4Kscore Test ultimately helps improve the decision making process for both physicians and their patients. Test results can help avoid unnecessary and painful biopsies while more effectively identifying when a man is at an elevated risk of having aggressive prostate cancer.

Don’t Be Scared

If you, or a loved one, in fact have an elevated PSA score, don’t be scared. Instead, ask your doctor about the 4Kscore. By undergoing this simple blood test, you can determine your risk level with a much higher degree of accuracy. Ready to know your score? Contact your physician or find a laboratory in your area.
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If you are interested in learning more about the 4Kscore and prostate health, follow our blog and connect with us on Facebook, Twitter, Google+ and LinkedIn.