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 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 patients 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.
Arup Offers A Noninvasive Test To Determine The Risk Of Prostate Cancer In Men
The 4Kscore Test is recommended for men concerned with their risk for high-grade, aggressive prostate cancer and is especially useful when considering a prostate biopsy.
The 4Kscore Test measures four biomarkers: total PSA, free PSA, intact PSA, and hK2. Blood test results are combined in an algorithm with a patients age, optional digital rectal exam, and prior biopsy results to give physicians a personal risk score for each patient.
Unlike traditional PSA tests, 4Kscore distinguishes men with a low risk for aggressive prostate cancer from those with a high risk. Men with a low-risk 4Kscore have a more than 99 percent chance of not developing distant metastasis within the next 10 years.
Physicians can identify patients with a high probability of having aggressive prostate cancer and offer appropriate treatment, while avoiding overtreatment of low-grade prostate cancer.
While the 4Kscore Test cant provide a prostate cancer diagnosis, it can help physicians and their patients decide whether or not to perform a biopsy based on the probability of the patient having potentially life-threatening prostate cancer.
4Kscore Test highlights:
- Looks at four prostate-specific biomarkers
- Predicts risk of high-grade prostate cancer
- Predicts long-term risk of distant metastasis
- Reduces overtreatment and unnecessary biopsies
- Allows physicians to make better treatment decisions for their patients
Do not use this test on a patient who:
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What Does 4kscore Measure
The 4Kscore takes the results of four blood tests and factors in a mans age, DRE results, and if he had a prior biopsy. A number is created. It reflects the percentage likelihood that if that patient had a biopsy, an aggressive prostate cancer would be found.
The tests included in a 4Kscore assessment are measures of Total PSA , Free PSA , Intact PSA and of Human Kallikrein 2 a genetic cousin to PSA.
Depending on the result, a low-risk patient can continue to have his PSA results monitored, without proceeding to biopsy or treatment. A high-risk patient can choose to have a biopsy performed. The results of the biopsy then help guide and direct the most appropriate treatment plan.
Dr. Kryvenko offers that the 4Kscore test has also been shown to predict the presence of aggressive cancer cells not seen in a biopsy.
As pathologists, we interpret what we see under a microscope as best as we can. But sometimes, there are things we cannot see or predict. The 4Kscore test can tell us if a man may have aggressive prostate cancer cells growing somewhere else, but that have not yet surfaced. It is data, not human interpretation.
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Biomarkers Available For The Early Detection Of Aggressive Prostate Cancer
Unquestionably, the most commonly used marker for detection of prostate cancer is serum PSA. However, since its introduction in the early 1990s, the limitations of PSA in this regard have been widely recognized.4,13 Alternative methods of utilizing PSA, such as PSA velocity, have been reported to improve the specificity for prostate cancer detection.15,16 However, recent studies have also suggested that using PSA velocity can result in an increase of unnecessary biopsies, and adds very little to the predictive value of a single PSA measurement alone.17,18 Similarly, PSA density has been promoted as another method to improve prostate cancer detection.16 However, measurement of prostate volume is an invasive, time-consuming procedure. Although both PSA enhancements, at best, provide a slight improvement from PSA alone, these techniques are far from the magnitude of improvement needed to reliably discern between aggressive and indolent forms of prostate cancer.
Psa Testing Isnt Perfect
The standard screening blood test for prostate cancer is the prostate-specific antigen test.
The American Cancer Society recommends men have a discussion with their primary care provider when they turn 50 about whether or not to start routine PSA testing.
PSA testing can be very valuable, but it often leads to unnecessary biopsies because results can be difficult to interpret as a stand-alone test.
Many variables can skew a PSA level high or low, causing either concern or confusion when deciding what action to take next.
Oftentimes, a prostate biopsy will be recommended to further evaluate and try to create meaning from an abnormal PSA result. Unfortunately, a prostate biopsy is invasive and can cause adverse events. However, they are needed when prostate cancer is at risk.
We need a more sensitive, informative, non-invasive way to evaluate a mans risk of prostate cancer as well as their risk for developing an aggressive form of prostate cancer.
This is where the 4Kscore comes in.
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Better Information Forconfident Decisions
The 4Kscore® Test result assists with prostate biopsy decisions by providing an accurate assessment of the probability of finding aggressive prostate cancer in men with an abnormal PSA and/or DRE. The 4Kscore® Test results are evaluated along with other important clinical information as part of the shared decision-making process.
Before It Came Into Use The 4kscore Test Was Studied In Clinical Research Of 10000 Men And Proved To Be Extremely Accurate
After that, the test was used with an additional 1,000 patients across the country, including local patients with a consistent level of accuracy.
A retrospective study was later done, looking at men who archived their blood when they were in their 50s, says Dr. Sanoj Punnen, a urologist with Sylvester. The blood was studied 20 to 30 years later using PSA tests and configuring 4Kscore results.
We found that among those identified by their PSA tests to be at risk for prostate cancer, the 4Kscores accurately selected those who were at risk of metastatic prostate cancer 20 years later, he says.
Dr. Punnen and his colleagues also tested the 4Kscore test in African-American mena group that was not initially part of the clinical research. A total of 366 cases were reviewed from eight Veterans Affairs hospitals in Florida from July 2015 through October 2016. The result? The test was accurate for all men, regardless of race.
This finding was especially important to us, adds Dr. Punnen. African American men are more at-risk for prostate cancer, and are more than twice as likely to die of the disease than Caucasian men, and over five times as likely to die of prostate cancer than Asian Americans.
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What Are Other Tests Available For Men At Risk For Prostate Cancer
While traditionally, the options available to men at risk for prostate cancer were limited to PSA blood test and a prostate exam , a number of exciting, innovative options became available to men, and more exciting innovations are expected in the coming years.
PSA is still a useful test but is being supplanted by more informative tests such as 4KScore and PHI .
PHI is a new test that provides an incremental improvement over the PSA test alone when it comes to predicting the risk of prostate cancer. It can be used to reduce the need for unnecessary biopsies in some men.
Read more about the differences between PHI and 4KScore tests.
How The Test Works
The 4Kscore test combines four prostate-specific kallikrein assay results with clinical information in an algorithm that calculates the individual patients risk for aggressive prostate cancer.
According to developer OPKO Lab, the test has undergone extensive clinical development and confirmation. The biomarkers it utilizes are based on more than a decade of research involving more than 20,000 men in Europe and the United States. The results were recently replicated in a prospective, blinded clinical study conducted at 26 urology centers across the United States involving 1,012 patients.
When using the 4Kscore test according to the specified threshold OPKO recommends, physicians can reduce the need for prostate biopsy by 30 to 50 percent while still accurately identifying high-grade cancers, Dr. Stephenson says.
The paradigm that we have used to screen patients for prostate cancer has needed to change for a while, Dr. Stephenson says. The U.S. Preventive Service Task Force gave PSA screening a grade of D in 2012 because the harm it brings outweighs the benefits. The 4Kscore test represents a major step in the right direction to improve our prostate cancer screening practices.
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Who Should Consider Having The 4kscore Molecular Test
Every man not yet diagnosed with prostate cancer can undergo the 4Kscore® Test. Furthermore, men undergoing qualification for the first or repeat biopsy are also candidates for the 4Kscore® Test.Please, consult Urologists at HIFU CLINIC Prostate Cancer Treatment Centre using the free online consultation, to learn whether your medical history excludes you from the 4Kscore® Test.
Contraindications to the 4Kscore® Test include taking finasteride derivatives during 6 months preceding the test. Please, click below to see the list of finasteride derivatives that exclude the Patient from the test.
Prostate Cancer: What Is The 4kscore
A test, known as the 4Kscore, could help from 30- to 58-percent of men could avoid an unnecessary prostate cancer biopsy.
It has been shown to reliably predict the likelihood of a mans prostate cancer spreading to other parts of his body in the next 20 years. The results offer degrees of risk that can be shared and discussed with a patient.
This is a large step forward for the field, says Dr. Oleksandr Kryvenko, a urology specialist at Sylvester Comprehensive Cancer Center and the University of Miami Health System. More than 12 percent of all men will develop prostate cancer in their lives. A much smaller number of these men will require a biopsy, as their risk for a significant cancer is low, he explains. This test can give men the information they need to make more informed care decisions.
Until now, a mans choices were very limited, Dr. Kryvenko adds.
If you had an elevated prostate specific antigen blood test result, and your doctor felt a nodule or growth during a digital rectal exam , nine times out of 10 you would be recommended for a biopsy, he says.
How Does It Work
A patients blood sample is sent to a specific laboratory for testing. The blood is analyzed for concentrations of these four proteins in serum or K2EDTA plasma. The 4Ksore Test result is a number calculated by an algorithm based on values using results of these four proteins in combination with a patients age, previous biopsy, and digital rectal exam . A medical professional reviews the results and sends a report to the patients doctor. The doctor uses this information to help manage the care of patients with an abnormal age-specific total PSA and/or abnormal DRE.
Special Types Of Psa Tests
The PSA level from a screening test is sometimes referred to as total PSA, because it includes the different forms of PSA . If you decide to get a PSA screening test and the result isnt normal, some doctors might consider using different types of PSA tests to help decide if you need a prostate biopsy, although not all doctors agree on how to use these tests. If your PSA test result isnt normal, ask your doctor to discuss your cancer risk and your need for further tests.
Percent-free PSA: PSA occurs in 2 major forms in the blood. One form is attached to blood proteins, while the other circulates free . The percent-free PSA is the ratio of how much PSA circulates free compared to the total PSA level. The percentage of free PSA is lower in men who have prostate cancer than in men who do not.
If your PSA test result is in the borderline range , the percent-free PSA might be used to help decide if you should have a prostate biopsy. A lower percent-free PSA means that your chance of having prostate cancer is higher and you should probably have a biopsy.
Many doctors recommend a prostate biopsy for men whose percent-free PSA is 10% or less, and advise that men consider a biopsy if it is between 10% and 25%. Using these cutoffs detects most cancers and helps some men avoid unnecessary biopsies. This test is widely used, but not all doctors agree that 25% is the best cutoff point to decide on a biopsy, and the cutoff may change depending on the overall PSA level.
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The Findings Could Lead To New Therapies For Prostate Cancer Patients With Few Options
Men with prostate cancer are often given androgen deprivation therapy, which blocks the hormones that cause cancer growth. Unfortunately, over time, tumors change by increasing the number of androgen receptors and adopting other mechanisms to resist treatment.
Working with animal models, the researchers demonstrated that that S-nitrosoglutathione , a compound that increases nitric oxide levels, suppresses castration-resistant prostate cancer and has a major impact on tumor microenvironments. Their findings were published in the journal Proceedings of the National Academy of Sciences.
By using the nitric oxide donor GSNO, we increased nitric oxide levels and suppressed the growth of this particular type of prostate cancer, says Dr. Ranjith Ramasamy, senior author of the study.
According to Dr. Himanshu Arora, a researcher in urology and first author of the manuscript, the research generated another hopeful finding.
Even more important, the tumors did not develop further resistance that commonly occurs with most therapies currently available for prostate cancer.
These findings could have a significant impact in a relatively short time. GSNO is already in clinical trials for asthma and pulmonary fibrosis. With additional work, the compound could be used against castration-resistant prostate cancer, as well as other tumor types.
Cms National Coverage Policy
This local coverage determination supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations or payment policy rules and regulations for 4Kscore Test Algorithm. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for 4Kscore Test Algorithm and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant Centers for Medicare & Medicaid Services manual instructions and policies may be found in the following Internet-Only Manuals published on the CMS Web site.
Internet Only Manual Citations
- CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
- Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests
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Kscore Test Fills The Gap Between Psa And Biopsy
BioReference is pleased to offer the 4Kscore® for accurately identifying a mans 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 mans personalized risk for aggressive prostate cancer upon biopsy.
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 mans prostate cancer risk.
For additional information, including test information sheets and brochures, patient guides, specimen requirements, report samples and billing information, please visit 4Kscore.com.
Screening Tests For Prostate Cancer
Screening is testing to find cancer in people before they have symptoms. Its not clear, however, if the benefits of prostate cancer screening outweigh the risks for most men. Still, after discussing the pros and cons of screening with their doctors, some men might reasonably choose to be screened.
The screening tests discussed here are used to look for possible signs of prostate cancer. But these tests cant tell for sure if you have cancer. If the result of one of these tests is abnormal, you will probably need a prostate biopsy to know for sure if you have cancer.
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Kscore Test For Prostate Cancer Screening: Early Detection Of Prostate Cancer
Screening for prostate cancer detects prostate cancer early, which allows for timely treatment. Screening with PSA test has a number of limitations as elevated PSA can occur in the absence of prostate cancer.
Many men undergo biopsy with attended inconvenience, risks, and costs which do not have prostate cancer because with PSA test, there is a degree of uncertainty of who has prostate cancer and who does not.
What we need is a better test for predicting who has prostate cancer. Then we need to know who among the men with prostate cancer is at risk of having an aggressive disease. We know that many men with prostate cancer have a very slow-growing disease that may not cause any problems for many years. Some have a disease that is on fire. We need to tell which is which.
An ideal test would be easy to administer, inexpensive, and will tell us with a great degree of certainty if a man has prostate cancer. Just as important, a good test will also tell us with a great degree of certainty that someone does not have prostate cancer.