USPSTF Releases Draft Recommendations for PSA Testing

With the release of a new draft document, the U.S. Preventative Services Task Force (USPSTF) has proposed a change in its stance on the advisability of PSA prostate cancer screening for men ages 55 to 69. The new recommendations are based on evidence that supports some benefit to such screenings for the early detection of aggressive prostate cancer. However, the USPSTF also acknowledges offsetting harms from the invasive testing and treatment that may follow a positive PSA screen.

USPSTF Draft of Updated Recommendation on Prostate Cancer Screening

The USPSTF draft document details proposed revisions to the 2012 recommendations concerning prostate-specific antigen (PSA) screenings for prostate cancer. These recommendations revise the USPSTF grades assigned to the use of routine PSA-based prostate cancer screening in two age categories:

  1. Men ages 55 to 69 years
  2. Men ages 70 years & older

The previous grade for both age groups was “D,” recommending against such routine screening. The new draft recommendation retains the “D” designation for men 70 and older but revises the grade to “C” for men in the younger category.

Informed Decision-Making by Individual Patients

The USPSTF makes recommendations on the effectiveness of preventative care services such as PSA prostate cancer screening based on evidence of both benefit and harm. For men 55 to 69 years, the proposed grade of “C” indicates a balance between potential benefit from early cancer detection and the possible harmful outcomes that may result from screening. These include:

  • False-positive results leading to additional testing
  • Overdiagnosis & overtreatment
  • Treatment complications

The USPSTF urges clinicians to discuss the advantages and potential risks of PSA screening with their patients, so individuals in the 55 to 69 age category have the information they need to make an informed decision about proceeding with PSA testing.

Limited Potential Benefits from Standard PSA Screening

Although prostate cancer is one of the most common cancers in men, not all prostate cancers are aggressive or likely to metastasize. Some men who have been screened and identified as having cancer showed no symptoms and may not have been aware of the condition if they had not been screened. Autopsies performed on men who died of other causes reveal an incidence of prostate cancer by age group of:

  • 25% for men ages 55 to 69
  • 33% for men ages 70 & over

The USPSTF has found adequate data from random clinical trials that screening may prevent some cases of metastasized cancer deaths: up to three cases per 1000 men (55 to 69 years of age) screened over a 13-year period. The draft recommendation notes that PSA screening is ineffective at distinguishing between aggressive cancers that are likely to metastasize and cancer that either does not progress or progresses so slowly that the patient never experiences symptoms. The proposed recommendation also notes that further research is needed for developing and studying different diagnostic tests and protocols.

False-Positive Cancer Diagnosis & Overdiagnosis

According to the draft recommendation of the USPSTF, the potential benefit of routine PSA screening for men ages 55 to 69 is offset by these severe shortcomings in test interpretation:

  • Conditions like an enlarged prostate (benign prostatic hyperplasia) and inflammation of the prostate (prostatitis) also deliver elevated PSA readings. A false-positive PSA reading puts men at risk for side effects and complications from further diagnostic testing procedures.
  • A positive PSA screening result may lead to overdiagnosis and overtreatment of cancer in men whose prostate cancer would never have become symptomatic while they lived. In such cases, these men would receive no benefit from treatment. The USPSTF draft cites large randomized trials that indicate that 20% to 50% of men diagnosed with prostate cancer through screening may represent overdiagnosis of the condition.1

Harmful Outcomes from Additional Diagnostic Tests & Overtreatment

According to the USPSTF draft document, there is adequate evidence that further diagnostic testing and cancer treatment may result in a moderate chance of harm. Additional testing and biopsy due to false-positive PSA results may include pain, infection, hematospermia (blood in semen or ejaculate), and complications severe enough to require hospitalization. Men undergoing prostate cancer treatment are also subject to unpleasant health and lifestyle side effects including long-term sexual impotence, urinary incontinence, and bowel urgency or bowel incontinence.

USPSTF Grade-Change Considerations

Data from random trials, cohort studies and decision analysis models reviewed by USPSTF support the conclusion that the benefit of PSA-based screening for men ages 55 to 69 depends on the value judgments of individual men. Although PSA screening has the potential for early detection and treatment that may save lives, that potential is balanced by the possibility of overdiagnosis, false-positive indications, and complications of treatment that could affect quality of life.

USPSTF’s recommended grade change to “C” for men in the younger screening age group is an acknowledgment that men should have an opportunity to make informed decisions about PSA screening results and the need for further tests or treatments following a positive result. The draft proposal also provides study information for men with a higher risk of developing prostate cancer, including African American men and men with a family history of the disease. The USPSTF supports the role of the clinician in providing updated, evidence-based information and providing all groups with the full picture for making decisions about PSA-based prostate cancer screening.

 

1  Fenton JJ, Weyrich MS, Durbin S, Liu Y, Bang H, Melnikow J. Prostate-Specific Antigen-Based Screening for Prostate Cancer: A Systematic Evidence Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 154. AHRQ Publication No. 17-05229-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2017.

Coping With a Prostate Cancer Diagnosis

If you’ve received a recent prostate cancer diagnosis, it’s normal to feel numb, grief-stricken, shocked or angry as you process the reality that cancer is now part of your story. Though all these reactions are normal, they can slowly drain your emotional and mental energy if you allow them to consume you. To understand clinical recommendations and make informed choices about prostate cancer treatment, you first need to deal constructively with the thoughts and feelings that threaten to overwhelm you.       

What Does Constructive Coping Look Like?  

Everyone copes in his own way, and it takes time and practice to recalibrate your thoughts and find your equilibrium after a cancer diagnosis. As you work through this process, try incorporating these coping methods:

  • Be informed & proactive. Prostate cancer can send you reeling. For many men, reestablishing a healthy sense of control is the first step to making peace with a diagnosis. Begin by asking questions, drawing from clinical resources and taking time to research what your results mean—and what options you have. Depending on your family history, PSA, Gleason score and 4Kscore results, your cancer care team can help you develop a treatment strategy tailored to you. Possible treatments may include watchful surveillance, surgery or radiation therapy.
  • Draw strength from community. Though you may want to avoid people or withdraw into yourself after a prostate cancer diagnosis, it is painful to handle the journey on your own. If you are not comfortable with a traditional support group format, consider a health and wellness Meetup group. Your gym or local hospital may also host community wellness programs that blend camaraderie, fitness and education. With over 170 worldwide locations, the Cancer Support Community offers workshops, online forums and recreational programs where prostate cancer survivors receive social and emotional support throughout all stages of their disease.
  • Create a holistic self-care plan. It’s easy to focus on the physical part of prostate cancer treatment, but remember that emotional and spiritual well-being also factor into an effective self-care strategy. Pursue balance in the form of healthy eating, positive sleep habits, recommended exercise, and meditation or relaxation techniques. While there is no single right way to eat, exercise or feel better, working with a multi-disciplinary team of dietitians, social workers, spiritual advisors and physical therapists can help you make the best decisions.
  • Maintain normalcy. When your world seems upside down, there’s something to be said for routine. Taking life one day (or moment) at a time, do your best to pursue your career, engage in hobbies, and enjoy time with family and friends—with the understanding that you may need to modify from time to time. Continually remind yourself that cancer doesn’t define you, even when it seems ever-present.

Stay Informed With 4Kscore

This year alone, the American Cancer Society reports that more than 160,000 American men will deal with a prostate cancer diagnosis [1] and weather its impact on their lives, families and careers. Subscribe to the 4Kscore blog to learn more about advances in the world of prostate cancer testing.

  • American Cancer Society. Key Statistics for Prostate Cancer. (Access Sept. 15, 2017) https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

This Valentine’s Day, Show Your Loved Ones You Care About Your Health

Valentine’s Day is one of those holidays that comes with a certain amount of trepidation for most of us. The stress of selecting the right gift can take the fun out of the sentiment. However, we might just have the perfect gift idea for the special person in your life; peace of mind for your prostate health with the 4Kscore Test.

Show Them You Care About Your Health

It is not uncommon for men to forgo preventative healthcare services and to avoid medical treatment altogether. In fact, research from the Centers for Disease Control and Prevention (CDC) found that women are 33% more likely than their male counterparts to visit their doctor and 100% more likely to seek preventative services. 1 If your loved one has encouraged you to take a more proactive approach to health screenings, maybe it’s time to listen. This Valentine’s Day, why not show your loved ones just how much you care by getting a 4Kscore Test?

What is the 4Kscore Test?

The 4Kscore is a simple blood test that is performed after an abnormal screening test such as PSA, leveraging cutting edge advances in medical science to determine a patient’s risk for aggressive prostate cancer. The test measures four prostate-specific biomarkers in the blood, which are combined with clinical findings into an algorithm to provide a man’s risk of having aggressive prostate cancer on a scale from <1% to >95%. By getting a simple blood test, you and your special Valentine can rest assured that you are taking an active role in your prostate health.

Who Should get the 4Kscore Test?

The 4Kscore Test is intended for any man after an abnormal PSA or other prostate cancer testing, as a means to provide his risk of high-grade, aggressive prostate cancer before making a biopsy decision. If you have had an abnormal PSA, the 4Kscore can provide the answers you and your loved ones are seeking. Contact your physician, ask the right questions, and get tested at a 4Kscore test laboratory in your area.
Have questions about the 4Kscore test? We encourage you to peruse our website for answers to a wide variety of frequently asked questions, or email us directly at 4kscoreinquiry@bioreference.com. Would you like more tips to help you take an active role in your prostate health? Subscribe to our blog for insights and information throughout the year.

 

1) Centers for Disease Control and Prevention (CDC). Women more likely than men to visit the doctor, more likely to have annual exams. Available at https://www.cdc.gov/nchs/pressroom/01news/newstudy.htm. (Accessed on January 24, 2017).

4Kscore Test: A Clinically Proven Prostate Cancer Test

The 4Kscore accurately provides the risk of aggressive prostate cancer, reducing the number of unnecessary prostate biopsies performed annually. The accuracy of the 4Kscore algorithm to provide the risk of high grade prostate cancer is based on over a decade of research completed by scientists at Memorial Sloan Kettering Cancer Center and other leading international cancer research centers.

4Kscore Test: A Clinically Proven Prostate Cancer Test

The 4Kscore Test has undergone a wide variety of clinical studies in reputable research facilities, in the US and abroad. Some highlights:

  • The 4Kscore was validated in a prospective blinded clinical study conducted at 26 urology centers across the United States on more than 1,012 patients. The 4Kscore demonstrated a near perfect calibration to actual prostate biopsy results, with a significantly higher accuracy than PSA for high grade prostate cancer.1
  • In a landmark case-control study including 12,542 men, the 4Kscore’s ability to predict risk of developing distant metastasis in men with a suspicious PSA for their age was evaluated. Men who had a suspicious PSA and a 4Kscore of 7.5% or less had a very low risk (< 0.3%) of developing distant metastasis within 10 years.2
  • In a retrospective study, where the 4Kscore was provided to 611 patients seen by 35 academic and community urologists across the United States, a reduction in prostate biopsies of 64.6% was reported.  There was a 94% reduction in prostate biopsies in men with a low risk 4Kscore (< 7.5%).3

Additional studies include:

Accurately Identify Risk of Aggressive Prostate Cancer with the 4Kscore

Prostate cancer is the second most common cancer among men, and it is estimated that nearly three million men are living with the disease in the United States. Having the ability to accurately identify a man’s risk of having aggressive prostate cancer not only saves lives but dramatically decreases the number of unnecessary biopsies, which can be both painful and costly.  The 4Kscore Test measures 4 prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2), which are combined with important clinical findings to provide the risk of aggressive prostate cancer. With  extensive research and validation to back it up, the 4Kscore Test is revolutionizing the way doctors and patients approach prostate cancer diagnosis.

If you would like to learn more about the 4Kscore Test, we encourage you to contact us today or find a laboratory in your area.

 

  1. A Multi-institutional Prospective Trial in the USA Confirms that the 4Kscore Accurately Identifies Men with High-grade Prostate Cancer. Eur Urol 2014; 68(3):464-470
  2. Improving the Specificity of Screening for Lethal Prostate Cancer Using Prostate-specific Antigen and a Panel of Kallikrein Markers: A Nested Case–Control Study. Eur Urol 2015; 68 (2): 207-213
  3. The 4Kscore® Test Reduces Prostate Biopsy Rates in Community and Academic Urology Practices. Reviews in Urology 2015. 17(4): 231-240

 

What Happens If Your Physician Does Not Offer 4Kscore™ Test?

This time of year, health is a core focus for many of us. With a new year comes new beginnings and the opportunity to refocus our attention on the people and areas of our lives that matter most. If you aim to take a more proactive approach to your health in 2017, we congratulate you.

At BioReference Laboratories and GenPath Diagnostics [OPKO Health Companies], we work year-round to help men and their physicians determine their risk for aggressive prostate cancer. With nearly 3 million men living with prostate cancer in the United States, it is our goal to arm physicians with the information they need to help identify and treat men with aggressive prostate cancer. If you, or a loved one, have reason to believe you are at an elevated risk of having prostate cancer, be it from family history or an elevated PSA, the 4Kscore can help provide the answers you need.

What is the 4Kscore Test?

The 4Kscore is a simple blood that is performed after an abnormal screening test such as PSA, leveraging cutting edge advances in medical science to determine a patient’s risk for aggressive prostate cancer. The test measures 4 prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2), which are combined with clinical findings into an algorithm to provide a patient’s risk of aggressive prostate cancer. This test is more specific than PSA for aggressive prostate cancer, providing an accurate risk of having high grade cancer along with the long-term risk of developing metastasis. Using the 4Kscore will help your doctor make an informed decision about whether or not you need a prostate biopsy. The test can also help your physician find aggressive prostate cancer earlier, or help to avoid an unnecessary prostate biopsy if you are low risk.

What if Your Doctor Does Not Offer the 4Kscore Test?

If you are interested in undergoing a 4Kscore test, we encourage you to first speak to your physician Should you discover that they do not offer the 4Kscore test, encourage your doctor to sign up to offer the 4Kscore test or provide us with their information and we can have on of our dedicated account executives can follow-up to discuss their practice needs. Alternatively, you can use our online search function to find an offering physician in your area who currently offers the 4Kscore test. If our search directory does not return a viable option near you, contact our Customer Service team at 1- 1-833-4Kscore for additional assistance. It is our goal to educate patients and physicians about the benefits of the 4Kscore and to make it readily available from coast to coast.
If you are concerned about the cost of the 4Kscore test, we encourage you to read our recent post on the topic to learn about insurance coverage. Also learn about the self-pay and payment plan options we offer to patients who do not have health insurance or for those who choose not to submit a claim to their insurance company. Finally, download our patient brochure to learn what you need to know about the 4Kscore test or download our PDF with questions to ask your doctor about your prostate health during your next visit.

What Is the Cost of a 4Kscore Test and Will Insurance Cover It?

We often hear from patients and physicians interested in learning more about the cost associated with the 4Kscore test, and whether the test is covered under Medicare, Medicaid or other health insurance plans. This is a confusing area and the answers always vary – because of different insurance carriers and plans.

Bridging the Gap Between PSA and Biopsies

With nearly 3 million men currently living with prostate cancer in the United States, early detection of the disease is paramount.  Early detection of prostate cancer begins with screening the Prostate Specific Antigen (PSA) to assess the health of the prostate. If a PSA test result is high, often times a doctor may recommend a biopsy. However, because the PSA test cannot distinguish between aggressive prostate cancer and other less serious conditions, many men with a high PSA may be subjected to unnecessary prostate biopsies.

The 4Kscore is a simple blood test intended to help reduce the need for unnecessary biopsies. If the 4Kscore determines that a patient’s risk factor of having aggressive prostate cancer is low, the patient, in consultation with his physician, may decide not to have a prostate biopsy. The 4Kscore is helping many to avoid the cost of a biopsy, as well as reduce associated pain and complications, which can include: fever, bleeding, infection, and transient urinary difficulties.

The Cost of the 4Kscore Test

We are proud to offer 4Kscore tests at reasonable prices as part of our Patient Health Advocacy Program to increase access to comprehensive testing for patients who do not have health insurance or for those who choose not to submit a claim to their insurance company.  If you would like to discuss your specific situation and our self-pay and payment plan options, please call our specialized billing hotline at 855-4KBILLING (855-452-4554) between the hours of 9am and 9pm EST, Monday-Friday.

Is It Covered By My Insurance?

Because all insurance plans are different, coverage for laboratory testing depends on your particular insurance company and plan. We like to personally address specific needs to determine if the cost of the 4Kscore is covered under your insurance plan. Please call our specialized billing hotline at 855-4KBILLING (855-452-4554) between the hours of 9am and 9pm EST, Monday-Friday to discuss insurance coverage.

Once a patient has undergone the 4Kscore test, if an insurance company does not pay the filed claim because the insurance company deems the test investigational, not a covered service or an out-of network service, we will file an appeal on the patient’s behalf. The patient will only be responsible for applicable copayment, coinsurance and/or deductible amounts, unless prior written arrangements have been made with the patient.

The Cost of Unnecessary Biopsies

Beyond the cost of the 4Kscore test, it is also important to consider the cost of undergoing unnecessary biopsy. As a result of rising coinsurance, copayments, and deductibles, in many cases, insurance companies do not fully reimburse for the cost of a biopsy. In addition to the cost of the procedure itself, prostate biopsies require resources in the Urologist’s practice and at the pathology lab, costs which are passed onto patients and insurance companies alike. The 4Kscore has the ability to reduce unnecessary biopsies and overtreatment of indolent prostate cancer saving the US healthcare system billions of dollars – that is some serious savings!

Still Have A Billing Question?

Insurance cost and coverage can be tricky to navigate, but we are always here to help to ensure the 4Kscore test is an affordable option for men at risk of developing prostate cancer. If you have more questions about the 4Kscore test, email us at 4KscoreInquiry@BioReference.com.

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