FAQ

  • What is a normal PSA value?

    Prostate-specific antigen (PSA) is a protein that is produced by both normal and cancer cells of the prostate. Your blood naturally contains small amounts of PSA.

    The ‘normal’ PSA level remains a matter of debate and no clear cut-offs have been identified. Indeed, PSA levels may vary over time in the same man and may increase with age and benign diseases. Although the identification of cut-offs for PSA values is debated, the following limits have been proposed based on large studies assessing the role of PSA-based screening for early detection of prostate cancer:

    • PSA levels less than 4 ng/mL are generally considered normal. However, some studies suggest that a PSA  less than 1.5 ng/mL should be regarded as normal. But in both cases the PSA level should be evaluated together with the results of the digital rectal examination (DRE), age, comorbidities, concomitant medications and symptoms.
    • PSA levels between 4 and 10 ng/mL are seen as suspicious but are in the ‘grey zone’. Men with a PSA level between 4 and 10 ng/mL have about a 1 in 4 chance of having prostate cancer.
    • PSA levels above 10.0 ng/mL are considered elevated. If the PSA is more than 10 ng/mL, the chance of having prostate cancer is over 50%. However, PSA values can increase above the cut-off of 10 ng/ml even in patients with benign conditions such as acute prostatitis.

     

    Of note, not all doctors use the same PSA cut-off point to decide if further tests, such as a biopsy, MRI or biomarker, are needed. Other risk factors, such as your age, the outcome of the digital rectal examination (DRE), race and family history are important in this decision.

    In addition, an elevated PSA level may not only be caused by prostate cancer. Other non-cancerous conditions such as benign enlargement of the prostate (BPH), inflammation and infection of the prostate can also increase the PSA level.

    Read more about your options when you have an elevated PSA.

  • When should I use the SelectMDx test?

    When you are concerned about having prostate cancer based on a PSA test, the SelectMDx test for prostate cancer provides you with more information. The SelectMDx test combines your clinical information with the measurement of two genes in your urine. In this way, it provides you and your physician with an estimate of your chances of having aggressive prostate cancer found upon biopsy.

    Furthermore, SelectMDx testing can also aid you and your physician in determining the need for redoing a prostate biopsy if:

    • you already underwent a prostate biopsy and cancer cells were not discovered in the collected tissue
    • your PSA keeps rising
    • you are concerned that the performed biopsy missed prostate tissue with cancer cells

     

    A SelectMDx test should only be done when your PSA has been determined less than 6 months ago.

    If you had a prostate biopsy or a transurethral resection of the prostate (TURP), you have to wait 3 months before the SelectMDx test can be done as it may influence the serum PSA levels.

    Your physician has to interpret the results with caution when you take 5α-reductase inhibitors such as finasteride or dutasteride, or when you have a urinary tract infection.

    If you are already diagnosed with prostate cancer, you are not eligible for using the SelectMDx test.

     

    Read more about your options when you have an elevated PSA.

  • Where can I find a urologist that performs the SelectMDx test?

    A list of urologists that perform the SelectMDx test can be found here.

    However, any urologist can perform the SelectMDx test. It is an urine-based test and there are no special skills required for performing the test. This means that you can ask the urologist of your choice to perform the SelectMDx test.

    Download the patient brochure to take with you to your urologist.

    You urologist can request a free test

    Your urologist can find more information here.

  • How much does the SelectMDx test cost?

    SelectMDx for prostate cancer is a non-invasive urine test. It measures the amount of two genes in urine that are associated with aggressive prostate cancer. This is combined with clinical information to assess the risk of having aggressive prostate cancer.

    The SelectMDx test costs between 250 and 290 euro (excl. VAT) depending on the local circumstances of your country. As the SelectMDx test is new, it may not yet be covered by your health insurances. It will depend on your country and the type of health insurance. You can contact your health insurance for more information.

     

    Read more about the available options in case of an elevated PSA.

  • How does the SelectMDx test work?

    SelectMDx for prostate cancer is a non-invasive urine test. It measures the amount of two genes that are associated with aggressive prostate cancer in urine. This is combined with clinical information to assess a man’s risk of having aggressive prostate cancer.

    The SelectMDx test provides more information if one is concerned about his risk for prostate cancer. It allows for discrimination between prostate cancer and ‘benign’ prostate conditions such as prostatitis and an enlargement of the prostate (benign prostatic hyperplasia (BPH), adenoma). On top of that, the SelectMDx test can also discriminate aggressive prostate cancer from insignificant disease.

    In clinical practice, the physician performs a digital rectal examination (DRE), as part of the normal diagnostic work-up: the physician gently inserts a gloved, lubricated finger into the rectum. After this exam, the patient is asked to urinate in a special device to collect the urine sample.

    The sample is sent to the lab for analysis. After about 7 days the physician receives the report. This report indicates the patient’s probability of having prostate cancer, and most importantly, aggressive prostate cancer, according to the SelectMDx test.  

     

    Read more about the available options in case of an elevated PSA.

  • What do the results of the SelectMDx test mean?

    SelectMDx for prostate cancer is a non-invasive urine test. It measures the amount of two genes that are associated with aggressive prostate cancer in urine. This is combined with clinical information to assess a man’s risk of having aggressive prostate cancer.

    The SelectMDx report provides an individualised likelihood that prostate cancer will be found when performing a prostate biopsy. There are two scenarios:

    • Very low risk of prostate cancer: the possibility of cancer cells being present upon a biopsy is very low. This allows you and your physician to make the informed choice about delaying or avoiding a prostate biopsy.
    • Risk of prostate cancer: The risk score for having prostate cancer, especially the likelihood for aggressive prostate cancer detected upon prostate biopsy is very important for determining next steps. You and your physician can make the informed choice to undergo or delay a prostate biopsy.

     

    As with any test, aggressive prostate cancer may be present in men even if you have a very low risk outcome. For the SelectMDx test, this chance is only 2%.

     

    Read more about the available options in case of an elevated PSA.

  • How accurate is a PSA test in diagnosing prostate cancer?

    One of the limitations of the PSA test is that PSA is not specific to prostate cancer. The PSA level can also be increased due to several other non-cancerous conditions such as benign enlargement of the prostate (BPH), inflammation, and infection of the prostate. Thus, a PSA test cannot discriminate between ‘benign’ prostate conditions and prostate cancer.

    Another concern is that PSA cannot discriminate between more aggressive, clinically significant prostate cancer from one that is less likely to cause harm, i.e. clinically insignificant cancer. As a result many men are diagnosed with clinically insignificant cancer who may in turn be unnecessarily treated.

    Diagnostic biomarker tests can overcome these limitations of PSA. They are specific to prostate cancer and more importantly the new biomarker tests (e.g. SelectMDx) can discriminate between aggressive and indolent cancer.

    SelectMDx is a new biomarker test that determines the risk of finding aggressive prostate cancer on biopsy. If the test is negative, you can be 98% sure that you do not have aggressive prostate cancer and can avoid an unnecessary biopsy.

    Read more about your options when you have an elevated PSA

    Download the patient brochure

  • How does a prostate biopsy work?

    During a prostate biopsy, the doctor takes small pieces of tissue from different areas of your prostate using a thin needle. There are two types of prostate biopsy:

    • Transrectal biopsy: guided by ultrasound, a needle is inserted into the prostate under local anaesthesia through the wall of the rectum. This is the most commonly used method.
    prostate biopsy
    • Transperineal biopsy: guided by ultrasound, a needle is inserted through the area of skin between the testicles and the rectum.

     

    Prostate biopsies can also be performed utilizing information from MRI, which provides more detailed images of the prostate than is possible with ultrasound only. The MRI-guided biopsy and the MRI/ultrasound fusion-guided biopsy are typically more accurate than a random biopsy and can be performed with a transrectal approach or a transperineal approach.

    The tissue is observed under a microscope to see if any cancer cells are present. If the answer is yes, it is important to determine how aggressive the cancer is. This is indicated by the biopsy or ISUP grade group which ranges from 1 to 5. The higher this score, the more aggressive the cancer is.

    Read more about your options when you have an elevated PSA.

  • What are the risks of a prostate biopsy?

    A prostate biopsy may be uncomfortable and painful. The degree of pain and discomfort varies from patient to patient. While some men experience only moderate pain, other men may find a biopsy very painful. Some men continue to have pain in their rectum for some time after the biopsy.
    Other risks associated with a prostate biopsy include:

    • Rectal bleeding and blood in your stools is common and is caused by bleeding at the biopsy site. Blood in your stools may persist for about 2 weeks.
    • Blood in your urine is also common and may persist for about 2 weeks.
    • Blood in your semen. It's common to notice red or rust colouring in your semen after a prostate biopsy caused by blood in the semen. This may persist for a few weeks after the biopsy.
    • Difficulty urinating. In some men, prostate biopsy can cause difficulty urinating after the procedure. Sometimes a temporary urinary catheter must be inserted.
    • Infection. Men who have a prostate biopsy can develop an infection of the urinary tract or prostate that requires treatment with antibiotics and sometimes hospitalisation.

    Read more about your options when you have an elevated PSA

  • Should I discuss referral for an imaging procedure such as magnetic resonance imaging (MRI) or the conduct of a diagnostic biomarker test?

    Imaging (such as MRI) and biomarkers (such as SelectMDx) give different information about your prostate, which is often complementary. Imaging provides an anatomical picture of your prostate, while biomarkers provide biological information of your prostate cells.

    An MRI procedure is non-invasive, safe and covered by most health insurance because it is already available for several years. Unfortunately, not all clinical centres have MRI machines available so travel time can be long. In addition, waiting lists are often long and not all persons are fit to undergo an MRI procedure. For example if you have non-MRI compatible implants, allergies to the contrast agent, or claustrophobia. Also, the interpretation of MRI images requires specialists (uro-radiologists) with real expertise in this domain. An MRI image may still leave you with a certain risk of having aggressive prostate cancer [1].

    SelectMDx is a biomarker-based urine test that combines the expression levels of two genes in a urine sample with traditional clinical risk factors of an individual patient to determine the likelihood of finding (aggressive) prostate cancer upon biopsy. This test has a 2% risk of missing aggressive prostate cancer (negative predictive value, NPV 98%). This means that if the test is negative, you can be 98% sure that you do not have aggressive prostate cancer and can thus avoid an unnecessary biopsy.

    There is also the possibility of using biomarkers such as SelectMDx and MRI in sequence. The SelectMDx test can first be performed to determine the likelihood of having prostate cancer. If the likelihood is high, there is a high risk of having prostate cancer but the exact location is not known. This is where MRI can help: it can determine where the suspicious lesions are located and help in guiding the biopsy. The biopsy should be performed to determine the aggressiveness of the cancer and determine the appropriate treatment.

    If the SelectMDx is demonstrating a very low risk for aggressive prostate cancer, you can rule out with 98% certainty that there are aggressive prostate cancer cells present in the prostate. This will allow you and your physician to make the most informed choice about undergoing, delaying, or avoiding a prostate biopsy.  

     

    Read more about your options when you have an elevated PSA.

     

    1. Moldovan PC, Van den Broeck T, Sylvester R, et al. What Is the Negative Predictive Value of Multiparametric Magnetic Resonance Imaging in Excluding Prostate Cancer at Biopsy? A Systematic Review and Meta-analysis from the European Association of Urology Prostate Cancer Guidelines Panel. Eur Urol 2017;72:250-66

Ask your question to the editorial board

If you have any more questions regarding the use of biomarker tests in the diagnosis of prostate cancer, that haven’t been addressed, feel free to ask them to the editorial board using the form below and we’ll get back to you as soon as we can!

Please note that answers to questions about your personal medical situation should not be regarded as a second opinion. Your treating physician/urologist should always be consulted.

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