How Does The 4kscore Test Work
The 4Kscore test is a blood test and incorporates a panel of four buckle your seatbelts kallikrein protein biomarkers: total PSA, free PSA, intact PSA, and human kallikrein-related peptidase. It looks at these biomarkers as well as other clinical information and provides a percentage risk for high-grade cancer on biopsy.
In 10 peer-reviewed studies, the four kallikrein biomarkers of the 4Kscore Test have been shown to improve the prediction not only of biopsy accuracy, but also surgical pathology and occurrence of aggressive, metastatic disease.
Instead of a PSA-style range value of normalcy, the 4Kscore result is a percentage with personalized positive predictive value of finding Gleason score 7 cancer on a subsequent biopsy. This is key because the PSA normal range value of 0 to 4.0 ng/ml is extremely inaccurate. I see many patients with a PSA higher than 4.0 without prostate cancer and undergoing excessive prostate biopsies.
Lymph Node Biopsy As A Separate Procedure
A lymph node biopsy is rarely done as a separate procedure. Its sometimes used when a radical prostatectomy isnt planned , but when its still important to know if the lymph nodes contain cancer.
Most often, this is done as a needle biopsy. To do this, the doctor uses an image to guide a long, hollow needle through the skin in the lower abdomen and into an enlarged node. The skin is numbed with local anesthesia before the needle is inserted to take a small tissue sample. The sample is then sent to the lab and looked at for cancer cells.
Kscore: A Better Mousetrap
4KScore provides the key to what was missing with the PSA test alone. It allows us to separate men who are at high risk for high-risk, aggressive prostate cancer from those who may never experience symptoms of prostate cancer.
#4KScore is a simple blood test. 4KScore is actually a combination of PSA test with a hK2 and a few other related tests .
4KScore can be used in combination with PHI to gain a better understanding of the risks associated with prostate cancer.
In our practice, we recommend the 4KScore test to all our patients who are at risk for prostate cancer. New York Urology Specialists is the first practice in the New York Metro area to offer 4KScore tests to our patients.
We see patients from all parts of New York City , Long Island, Westchester and New Jersey as well as other parts of the USA. We also see from Canada, Japan, South America, Russia, Asia, Europe, Middle East, Africa, the Caribbean and other parts of the world.
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Kscore 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
Positron Emission Tomography Scan
A PET scan is similar to a bone scan, in that a slightly radioactive substance is injected into the blood, which can then be detected with a special camera. But PET scans use different tracers that collect mainly in cancer cells. The most common tracer for standard PET scans is FDG, which is a type of sugar. Unfortunately, this type of PET scan isnt very useful in finding prostate cancer cells in the body.
However, newer tracers, such as fluciclovine F18, sodium fluoride F18, and choline C11, have been found to be better at detecting prostate cancer cells.
Other newer tracers, such as Ga 68 PSMA-11 and 18F-DCFPyl , attach to prostate-specific membrane antigen , a protein that is often found in large amounts on prostate cancer cells. Tests using these types of tracers are sometimes referred to as PSMA PET scans.
These newer types of PET scans are most often used if its not clear if prostate cancer has spread. For example, one of these tests might be done if the results of a bone scan arent clear, or if a man has a rising PSA level after initial treatment but its not clear where the cancer is in the body.
The pictures from a PET scan arent as detailed as MRI or CT scan images, but they can often show areas of cancer anywhere in the body. Some machines can do a PET scan and either an MRI or a CT scan at the same time, which can give more detail about areas that show up on the PET scan.
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Prostate Cancer: Advancements In Screenings
Dr. Christian Paul Pavlovich
You may know thatprostate canceris one of the most common cancer types in men. The good news is that thereare many treatment and management options, even if the cancer is caught ata later stage.
What you may not know: There are several options when it comes toprostate cancer screening. After considering multiple factors, your doctor may recommend theprostate-specific antigen test, and/or one of the newer screeningtests that are now available.
Johns Hopkins urologistChristian Pavlovich, M.D., explains what you should know.
A New Test Shows Promise
Now there is a new generation of PSA testing available, which many primary doctors are still unaware of, that can alleviate many of the concerns that arose from the original test. It doesnt replace the PSA, but adds another level of screening that doctors can use to make a much more informed decision about follow-up measures.
The proprietary test, known as the OPKO 4K score, measures four different PSA proteins in the blood. A similar test offered by a different company is known as Prostate Health Index.
Instead of testing just for total PSA, the 4K measures four biomarkers, and then puts the results in an algorithm that includes age, previous biopsies and digital rectal exam results to produce a percent risk for the presence of cancer.
According to a number of recent research studies, that gives doctors a much more accurate picture of who is likely to have cancer.
The 4k does a better a job of distinguishing PSA rises due to BPH versus PSA rises that could indicate cancer, says Dr. Eric Klein, chair of the Glickman Urological and Kidney Institute at the Cleveland Clinic.
Perhaps more importantly, the test helps urologists distinguish between aggressive cancers and indolent cancers before making a decision on whether to conduct a biopsy, says Sanoj Punnen, an assistant professor of urology at the University of Miami Miller School of Medicine, who was the lead author in a 2015 research study that validated the use of the 4K test.
What Is The 4kscore Test
The test was named 4KScore for the four prostate-specific kallikrein assay results: total PSA free PSA intact PSA and Human Kallikrein-2 or hK2.
According to Daniel Lin, MD in this Medscape.com article, he notes the blood test is an assay panel that is able to combine three PSA measures total, free, and intact with another prostate-specific measure human kallikrein 2 . Using an algorithm combining the patients age, previous biopsy status and digital rectal exam result, a spectrum of risk can be assessed, from 1% to 95%.
According to the company, the test is a simplistic blood test which is intended to help reduce the needs for unnecessary biopsies in the future. If the test determines the risk factor is low, for example, then the physician, depending on his or her recommendation, may avoid a biopsy. In the end, the test was designed to help avoid costly biopsies and reduce any associated side effects/complications which comes with these tests.
Santis Health notes the test is very new and has emerged within the last decade, only available in the United States. As of 2017, UK insurance corporations will not pay for the test, but in the doctors mind, it is expensive, but it is a test worth doing to determine whether to have ongoing monitoring or to have radiotherapy after an operation if the biopsy of the prostate after the surgery shows a great risk.
The test is said to have a 94% accuracy rate when detecting aggressive cancer.
About The 4k Score Test
Filed in Testing & Diagnosis
Update March 2020: weve written another article on the SelectMDx test a similar biomarker test to the 4K score test that is more accurate. You can read it here for a comparison. Its now our favoured biomarker test at Santis and we do not offer the 4K score test any more.
The 4K score test is little known at present the PSA test is probably the best known test for prostate cancer, and is the first test usually administered to men suspected of having prostate cancer. However, as many of our readers will know, it is not perfect. It is a simple blood test, and it checks the levels in the blood of a protein produced by the prostate gland that sometimes can be produced in larger quantities when there are tumours in the prostate. However, it is only a potential indicator plenty of men without prostate cancer have higher-than-normal PSA due to their age, and men have been diagnosed with prostate cancer without raised PSA levels. So, the search goes on for the perfect test.
What would the perfect test look like? Well, the perfect test for prostate cancer would be one that is 100% specific and 100% sensitive . Such a test currently doesnt exist, but that hasnt stopped many researchers from trying. For instance, here are the specificities and sensitivities of several tests for prostate cancer:
- PSA: specificity of 17% and sensitivity of 83%
- Prostate Cancer Gene 3 test : the figures are 75% and 57%
- The EN2 test : 88% and 66% .
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Imaging Tests For Prostate Cancer
Imaging tests use x-rays, magnetic fields, sound waves, or radioactive substances to create pictures of the inside of your body. One or more imaging tests might be used:
- To look for cancer in the prostate
- To help the doctor see the prostate during certain procedures
- To look for spread of prostate cancer to other parts of the body
Which tests you might need will depend on the situation. For example, a prostate biopsy is typically done with transrectal ultrasound and/or MRI to help guide the biopsy. If you are found to have prostate cancer, you might need imaging tests of other parts of your body to look for possible cancer spread.
The imaging tests used most often to look for prostate cancer spread include:
Improving Sensitivity Of Psa Testing
Prostate-specific antigen testing with a cutoff of 4.0 ng/mL has a sensitivity of 67.5-80%, which implies that 20-30% of cancers are missed when only the PSA level is obtained. Sensitivity can be improved by lowering the cutoff or by monitoring PSA values so that a rise in PSA level of more than 20-25% per year or an increase of 0.75 ng/mL in 1 year would trigger performance of a biopsy regardless of the PSA value.
The specificity of PSA at levels higher than 4.0 ng/mL is 60-70%. Specificity can be improved by using age-adjusted values, PSA velocity , and the ratio of free PSA to total PSA . Another method is to adjust the PSA according to the size of the prostate or volume determinations of the transitional zone, which produces most of the PSA, and the peripheral zone, which produces less PSA but a majority of prostate cancers.
In the European Randomized Study of Screening for Prostate Cancer, Schroder et al studied a strategy for the early detection of prostate cancer that excluded digital rectal examination results and used a PSA cutoff of 3.0 ng/mL as the only indication for a biopsy. This protocol was compared with one in which a PSA level of 4.0 ng/mL or higher or the presence of a positive DRE or transrectal ultrasound was the indication for a biopsy. In a follow-up study, Schroder et al confirmed a substantial reduction in mortality from prostate cancer as a result of PSA testing.
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My Take On The 4kscore Test For Prostate Cancer
Anything that helps to prevent unnecessary procedure and helps the patient make an informed decision is fine by me.
Not only do we now have a test superior to the PSA and even PCA3, but when a biopsy is necessary, we can do a targeted biopsy, which is available in many institutions. This helps to detect only bad cancer cells.
If Screening Test Results Arent Normal
If you are screened for prostate cancer and your initial blood PSA level is higher than normal, it doesnt always mean that you have prostate cancer. Many men with higher than normal PSA levels do not have cancer. Still, further testing will be needed to help find out what is going on. Your doctor may advise one of these options:
- Waiting a while and having a second PSA test
- Getting another type of test to get a better idea of if you might have cancer
- Getting a prostate biopsy to find out if you have cancer
Its important to discuss your options, including their possible pros and cons, with your doctor to help you choose one you are comfortable with. Factors that might affect which option is best for you include:
- Your age and overall health
- The likelihood that you have prostate cancer
- Your own comfort level with waiting or getting further tests
If your initial PSA test was ordered by your primary care provider, you may be referred to a urologist for this discussion or for further testing.
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What Do The Test Results Mean
PSA tests can be difficult to interpret. Tests can also vary from laboratory to laboratory. To ensure accurate comparison, its important to use the same lab each time youre tested.
If your PSA level is low and not rising after repeated tests, its probably not a cancer recurrence. Thats because other cells in your body can produce small amounts of PSA.
Ideally, your post-prostatectomy PSA will be undetectable, or less than 0.05 or 0.1 nanograms of PSA per milliliter of blood . If thats the case, your doctor may call it a remission.
If the result is greater than or equal to 0.2 ng/mL and its risen on two separate tests taken at least two weeks apart, its called a biochemical relapse. You still have PSA in your bloodstream. Theres a chance that cancer has recurred.
A PSA level higher than that may indicate a locally advanced tumor.
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Kscore Plus Mri Outperforms Selectmdx In Detecting Disease
A recent NYU Langone study, led by urologic oncologist Dr. James S. Wysock, demonstrated that further head-to-head biomarker studies are required to better guide clinical decision-making for men with elevated PSA levels.
Prostate-specific antigen screening has helped propel a 50 percent decline in prostate cancer mortality over the past 20 years. However, universal routine PSA testing is no longer recommended because, used in isolation, the test often triggers unnecessary biopsies, over-diagnosis, and potentially unwarranted treatment of low-risk, indolent disease.
As a result, clinicians now employ risk stratification tools such as prostate MRI and novel biomarkers in conjunction with PSA screening to inform decisions about biopsies. In a recent study published in Urology, Department of Urology researchers at NYU Langones Perlmutter Cancer Center and NYU Grossman School of Medicine assessed the accuracy of two commonly used tests4Kscore and SelectMDxin predicting detection of clinically significant disease in men with elevated PSA levels.
The investigators found that the two tests often yield conflicting guidance on whether to proceed with biopsy. However, the 4Kscore performs significantly better than SelectMDx when combined with MRI. Although further comparative studies are needed, the findings suggest that the 4Kscore may be a better option to guide clinical decision-making.
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What Is Digital Rectal Examination
Most prostate cancers are located in the peripheral zone of the prostate and may be detected by DRE. During this examination a doctor inserts a finger into the rectum to feel the prostate for lumps, size, shape, tenderness, and hardness. A suspect DRE is an absolute indication for prostate biopsy, regardless of the PSA level. In about 18% of patients with abnormal DRE, prostate cancer will be detected regardless of the PSA level.
Better Information Forconfident Decisions
The 4Kscore® Test result assists with prostate biopsy decisions by providing an accurate assessment of risk for aggressive prostate cancer in men with an abnormal PSA and/or DRE. 4Kscore® Test results are evaluated along with other important clinical information as part of the shared decision-making process.
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What Can You Expect To Learn About Your Health From The 4kscore Blood Test
The primary aim of the 4Kscore test is to provide a view on a mans risk of aggressive prostate cancer. The test will provide a man with a number. The number is based on an equation. The equation takes all the factors previously discussed into account.
It is estimated that the prediction of the 4Kscore blood test is for the next ten years. In some cases, it may yield effective results for up to 20 years ahead.
A man can learn whether they are at risk of serious cancer in their prostate cancer with the use of this test. This test also helps to avoid overtreatment in a man who is at a low risk of aggressive prostate cancer.