Will the Prostate Cancer 4Kscore Test Help You?

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blood testWill the Prostate Cancer 4Kscore Test Help You?

The Takeaway First

The newest available blood test, 4Kscore® Test (OPKO Lab, Nashville, TN) is better at detecting potential deadly prostate cancer than a PSA test.

The Details

Since the prostate-specific antigen (PSA) test first became available in the early ‘90s, there have been significantly fewer deaths from prostate cancer. However, it also has led to overdiagnosis and overtreatment. As a result, about one million prostate biopsies are done yearly in the U.S. alone, and most of it has been from unnecessary overtreatment of indolent cancer in order to rule out the possibility of death.

Numerous studies from Europe and the U.S. indicate that the 4Kscore could be used to distinguish between the less deadly form of prostate cancer (pathologically indolent, as a doctor calls it) and the more dangerous form of the disease — all while reducing excess biopsies.

If that’s true, I’m a fan.

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 (Gleason score 7 or higher) 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.

How does the 4Kscore compare to the urine PCA3 test?

The PCA3 test looks at a urine sample produced immediately after a vigorous prostatic massage. PCA3 is a gene that expresses genetic material in urine. This material is found only in prostate tumor tissue, not normal prostate tissue.

The problem with the PCA3 test is that the results can be difficult to interpret, partly due to lack of an optimal cutoff for a positive test result. The other issue is that the PCA3 is that there’s not a lot of evidence that it actually helps to detect disease. So, while a reading higher than 35 on a PCA3 test may mean prostate cancer is present, a reading of 100 does not necessarily mean that the cancer is aggressive or deadly. In other words, a higher number does not necessarily mean bad cancer.

Remember: a man is only interested on knowing if he has bad cancer that may eventually kill him – not cancer that’s indolent and non-threatening.

Should I get a 4Kscore test?

No, if you:

  • have been diagnosed with prostate cancer
  • are taking 5-alpha reductase inhibitors like Finesteride (Proscar) or Dutesteride (Avodart)
  • have undergone a prostate procedure within 6 months, e.g., TURP for prostate enlargement

Yes, if you are an otherwise healthy, risk-averse man. The 4Kscore test allows you to gauge your risk and decide, based on reliable, personalized results, whether or not to pursue a biopsy. The level of individualized risk prediction afforded by the 4Kscore test is not only helpful to the patient but also to the urologist (me!), who shares in the patient’s decision making.

My take on the 4Kscore Test for Prostate Cancer

Thumbs up. (Where’s my emoji thumbs-up button?)

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.

References

Ankerst DP, Hoefler J, Bock S, et al. Prostate Cancer Prevention Trial risk calculator 2.0 for the prediction of low- vs high-grade prostate cancer. Urology. 2014;83:1362–1367.

Vickers AJ, Gupta A, Savage CJ, et al. A panel of kallikrein marker predicts prostate cancer in a large, population-based cohort followed for 15 years without screening. Cancer Epidemiol Biomarkers Prev. 2011;20:255–261

Useful Links:

OPKO Labs

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by Dr. Geo

33 comments… add one
  • BOb Dellacona ,

    Thanks for a great piece of information Dr. Geo. I’m confused about one point – you say one should not get this test if one is already diagnosed with PCA. I was diagnosed almost 7 years ago – psa then of 6 with a gleason of 7 ( 4 and 3). I was told I was a poor risk for watchful waiting. My psa is now 28. I’m for the most part symptom free. I have been doing watching waiting all of this time. I have not had surgery or radiation or any other radical Western treatments. I would find it valuable to know if my particular prostate cancer is aggressive and would like to take this test. If there is a test that can determine if my cancer is indolent or aggressive, I would really like to know this information. If it’s indolent, I can begin the awesome task of getting cancer out of my mind. If I will most likely die of this cancer and sooner rather than later, I most certainly want to know this. So there you have it – now why shouldn’t I get this test?

    Reply
    • The 4K Score would not be useful to you , Bob, because we already know you have a gleason 7 – so the result would show a high percentage (or a high probability) of having a gleason 7 or higher , which we already know you do. It would not tell us much more than that.

      Reply
  • Wallace Dickson ,

    This is great news, Dr. Geo. I have been confronted with a “probable” prostate cancer diagnose by my Urologist at the VA Medical Center, based upon a high PSA score. But I have no symptoms, other than an enlarged prostate. The urologist’s assistant did a DPE and reported that he found it “smooth and firm with no irregularities.” I have nocturnal urination issues, but that is all; no pain, no other symptoms. I have had a progressively enlarged prostate since 1984, and have been self-treating it basically with Saw Palmetto and Stinging Nettle. Of late I have added other nutritional protocols as well. So I refused his urging for a biopsy, considering I did not want traditional treatment anyway. No chemo, no radiation, no surgery! I’m chewing on apricot seeds, and following the Budwig Protocol (for the past 8 years).
    So this new non-intrusive test is welcome if it will give me a more definitive assay of prostate cancer, if in fact there is any there. Thanks for reporting on this development!

    Reply
    • Thanks for that report, Wallace. Look out for my book coming out in three weeks- Thrive Don’t Only Survive – its a prostate cancer lifestyle book that will keep you well beyond prostate cancer.

      Reply
  • Robert Toth ,

    What about testing for recurrence after a 10 year radical prostectomy ?

    Reply
    • After prostate cancer treatment, the PSA is actually very useful. There are other genetic tests, like Decipher from GenomeDx that is available to assess the possibility of metastasis in 3 to 5 years. But if your treatment was 10 years ago then the best method to determine recurrence is PSA.

      Reply
  • Ron Allen ,

    Why can’t this test be used to predict more aggressive prostate cancer? As you know, I do have PC but would like to know how aggressive it is. Is there a test other than a biopsy that will show this?

    Reply
    • Without a biopsy there is no good way of assessing the “aggressivity” of prostate cancer at this time after diagnosis.
      MRI, PSA velocity are still useful.

      Reply
  • Donald Noone ,

    Dr. Geo,

    I have had my prostate removed and on subsequent PSA tests in the past couple of years found no detectable signs of disease. Since I want to be sure of no metastasis, should my next PSA be a 4K Score Test?

    Reply
    • Hi Donald, the 4K Score test is only beneficial for men who have NOT had prostate cancer. It is a good screening to tool for such patient. The PSA test is actually a very good test for men after prostate cancer treatment to assess recurrence of cancer.

      Reply
  • Robert Chemtob ,

    HI
    I’m 62 with a PSA of 4.2 but a free PH of 5.7%. I saw the doctor today and he did a DR3 adn found it to be normal,and said my prostate was a little small.
    He did want to rush me into a biopsy,(which he’ll do) and when I suggested doing a blood test he said that would be done after the biopsy.
    I’m a bit dubious of doing the biopsy, wondering why I can’t first do an MRI to see if any tumor is present? What do you think?
    thanks
    Robert

    Reply
    • Hi Robert, I am not sure why your practitioner would want to do a biopsy before an MRI – it sounds counter-intuitive. He may not have access to a pelvic MRI or able to do a targeted biopsy. I am just speculating. I would suggest an MRI first then a targeted biopsy – if a biopsy is what you have to do. Good luck.

      Reply
      • Robert ,

        Thank you. I did the MRI then a biopsy which showed 2 tumors of Gleason 6 and 7.
        Going to speak to urologist Friday.

        Reply
        • I don’t know the details of your situation, Robert, but visit with at least 3 urologist before making a final decision on treatment. Let me know if I can help in anyway as I am a prostate cancer navigator with newly diagnosed patients. Good luck.

          Reply
  • Jim Ahearn ,

    Dr. Geo,

    I am a 69 year old patient with a PSA of 4.2 and a 4K score of 33% (high risk) and a slightly enlarged prostate. Over a two year period, my PSA has elevated from 2.5 to 3.1 to its current 4.2. I also have a 65 year old brother who is a prostate cancer survivor of more than 5 years. Based on this evidence, my urologist is recommending a prostate biopsy. Without any symptoms or problems, I am hesitant to have this procedure. What would be your recommendation? Thank you.

    Reply
    • If you are a robust, healthy 69-year-old, a biopsy might be the way to go. However, I do understand the undesirability of avoiding a prostate biopsy – its no fun, possible risk of infection and blood in your urine and semen. If you do not undergo a prostate biopsy, there will always be some uncertainty as to whether or not you have prostate cancer – you may or may not be OK with that uncertainty. I hope my response helps, Jim.

      Reply
  • Michael ,

    I have had are cent PSA of 1.6, with a negative DRE. One year ago it was a PSA of .6. I take Dutasteride once a day. In 2010, the PSA was .5, and in 2011 it went up to 1.6. It went back down to 1.2, then 1.1, then 1.0.
    I am concerned because my older brother had prostate cancer, with a Gleason 3 plus 4.
    I am planning to take the 4K test soon. Any thoughts on this would be welcome.
    I have taken prophecies for many years, and just started Avodart seven months ago.

    Reply
    • Avodart may falsely reduce your PSA by 50%. The 4 K score should help determine possible cancer in your prostate. Pelvic MRI is also helpful.

      Reply
  • Jim ,

    if you take a 4K score test and the reults say you have a 95% chance of developing prostate cancer does this maen I have prostate cancer already??? I would really like to know exactly what this means?? please..

    Reply
  • Francois ,

    Dear Doctor,
    I had a prostate biopsy in April 2016, result negative. DRE showed little nodule.
    My urologist suggested a 4 k score test, but I am taking Proscar 5 mg, once a day.
    Questions
    1. DO I NEED to stop taking Proscar 6 months BEFORE date of blood draw for 4k score test? And
    2. What other RESTRICTIONS I should follow before blood draw date?
    Thank you Sir,

    Reply
    • The main restriction is stopping Proscar. I do not know of another.

      Reply
  • Martin Silver ,

    i am a vigorous athletic 77-year-old, latest PSA 2.38; 4K –22%.
    Should I have a Prostate Biopsy now?

    Reply
    • I cannot play doctor on the internet but I can make a suggestion. At 77 years-old and with a low PSA relatively to your age, I think you can avoid a biopsy – particularly at your age. The physical exam (DRE) by your physician can also determine if you should do a biopsy or not.

      Reply
  • James ,

    I recently had a 4K score done. The doctor told me I should do this test since my P S A is 6.3.
    I am 61 and the 4 K score was 7. His nurse call me to tell the 4K score number. What does the 4K score mean? Thanks James

    Reply
  • paul ,

    How does finesteride for alopercia affect the evaluation of the 4K score.
    My urologist says it does not.

    Reply
  • paul ,

    psa has been < .1 for 15 years straight never changed
    been on finesteride for alopercia 1 mg. for 15 years
    age 72
    never had any prostate symptoms
    never been to a urologist until this week.
    he found 1 mm nodule on 1 side of prostate.
    suggested a 4K score since I did not want any biopsy.
    Said that 4K score is not affected by my finesteride use.
    lab slip says you shouldn't be on finestride but he has done test on hundreds of people on finesteride for alopecia and does not matter for interpretation of results.

    Reply
  • Rick ,

    Want to ask Dr. Geo about my own experience.
    I recently had my annual checkup with my Urologist. I am 58 years old and have been injecting Testosterone Cypionate for about four years and rubbed Testosterone Gel into my shoulders for two years before that. I was diagnosed with Low T when I was approximately 50 years old.

    In my recent check-up, my Urologist wanted to check my prostate – something she had not done for two years. After her exam, she indicated that she felt a “small nodule” and wanted to schedule a biopsy. I noted that my PSA test (obtained the day before) was only 1.2. She agreed that it was low, but she insisted that I schedule a biopsy procedure with her. I did not schedule immediately – told her I want to wait until later this summer. After returning home that day, I browsed the internet and found the 4K Score Test. I called the manufacturer and spoke with an on staff physician. Although he noted that he could not assess me (over the phone), he indicated that I was a perfect example of someone who should get the 4K Score Exam. I called my Urologist later that week and told her I had found out about the 4K Score Test. She replied that she knew about it and could write a script for me, but that she didn’t think the 4K Score test was reliable – that only a biopsy could determine if my “small nodule” was at risk. She did not mention a “pelvic MRI” which, I read about on your website. I called her office back and asked the office manager to have her write me a script for the 4K Score test. The Dr called me back later in the day, but I was unavailable. I “kinda” feel she is delaying getting that script to me. To refer back to her exam, she said the nodule was small, and that a biopsy was the only way to determine. With a PSA of only 1.2, I feel the 4K Score would be better for me. And then if needed, I would consider a Pelvic MRI before a biopsy. Why do I get the feeling from my physician that she only wants to do a biopsy?

    Thx in advance for your reply.

    Rick

    Reply
  • Rick ,

    Follow up to my previous post…
    My Urologist has written a script for the 4K Score test. However, after she scolded me asking me what I thought I was going to get. I couldn’t believe it! I wasn’t questioning her judgment, I just wanted to take this exam and then determine what I should do next. Again, she was very reluctant, but in the end told me I could pick up the script. Picking up tomorrow.
    Also, as a follow-up, I’ve read additional information and literature about Pelvic MRIs. Why would I not get a Pelvic MRI before a biopsy? My Urologist, despite my low PSA score (1.2), insists that I come in for the biopsy. I don’t want a biopsy! Especially if the 4K Score test results indicate that I’m not at high risk and if I can obtain a Pelvic MRI instead. Am I wrong? Why the push for the biopsy?

    Reply
    • I am not sure why your urologist wanted to biopsy you with a low PSA. Maybe she felt an abnormality on your prostate…
      Biopsies without MRI are barbaric these days. MRI help to better target the areas of interest,

      Reply
  • Two questions:

    Since a PSA test cannot determine if a high psa number
    is due to BPH or cancer, would it not follow that the 4K test which relies upon a psa number for one of its markers would be similarly flawed. (As an aside I wonder if there has ever been a study done to check how many people with a 4K over 20 are actually found to have aggressive cancer. If the answer is almost everyone , then the 4K itself may be as invalid for determining cancer as the Psa.
    My statistics: I am seventy four years of age, in exceptionally good health and only within the last two years have I had a psa over four… last two 5.2 and 8.2(4K test for the latter psa number). Digital rectal exam normal.
    Is it likely that I would get an aggressive cancer so late in life . Even if I did,is not true that an aggressive cancer is one that looks much less like a normal cell under a microscope but may in fact be slow to metastasize.
    Finally, if any of the above postulations is true , why should one in my position treat my potential cancer at all.
    Thanks for all you do.

    Reply

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