It's important to read the description of each test. Some are pre-biopsy while some are post-biopsy. They are specific and not all of them are suitable for all diagnoses. For more information about a specific test, it's best to reach out directly to the testing company.
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Opko Health released the 4KScore Test, a tool designed to help doctors and their patients better predict the presence of high-grade cancer before deciding whether to undergo prostate biopsy. The test measures the blood plasma levels of four different kallikrein proteins derived from the prostate: total PSA, free PSA, intact PSA, and human kallikrein 2 (hK2). These biomarkers are then combined with a patient’s age, DRE status, and prior biopsy results, using a proprietary formula, to calculate the probability of a Gleason score of 7 or higher prostate cancer.The 4Kscore Test is for any man concerned about his risk for high-grade, aggressive prostate cancer, and is especially useful when considering a prostate biopsy. The 4Kscore test provides information that a man and his Urologist can use to make an informed, shared decision about whether or not to perform a prostate biopsy.
Confirm MDx is a test that works on the DNA level to help doctors identify undetected prostate cancer. The test is capable of uncovering abnormalities in DNA that are associated with prostate cancer and that are not identifiable using the standard microscopic methods used for prostate biopsies.
According to the manufacturer of the test, MDxHealth, this approach is best for men who have had a negative prostate biopsy within the past two years. Use of the test can:
- Rule out men without prostate cancer and prevent them from undergoing unnecessary biopsies and additional screenings
- Rule in men at high risk for prostate cancer who had a false-negative biopsy result but are harboring cancer and would therefore benefit from having another biopsy
Based on the results of an April 2016 report in Prostate, use of ConfirmMDx can help identify men at high risk for aggressive prostate cancer for whom a repeat biopsy would be beneficial and also result in fewer unnecessary repeat biopsies. Your doctor can use the remaining tissue samples from your previous biopsy to perform this test.
The Decipher® prostate cancer test allows clinicians to evaluate the activity of genes in a prostate cancer tumor so they can determine the development and progression of the disease. A tissue sample is harvested during radical prostatectomy for the test. Decipher measures the expression levels of nearly two dozen RNA biomarkers that are associated with aggressive prostate cancer. Experts can use this information to calculate the probability of cancer metastasis within five years of undergoing radical prostatectomy.
ExoDx Prostate (IntelliScore), available now, is a non-invasive urine test that accurately predicts the aggressiveness of prostate cancer.
- Detects three important genetic biomarkers that can identify aggressive prostate cancer.
- Non-invasive test that does not require a digital rectal exam.
- Provides physicians with an easy-to-read score that corresponds to the Gleason Score. The Gleason Score is the measure used to grade cancer cells in biopsied tissue.
- Shown to accurately identify the presence of aggressive prostate cancer in a large, multi-center trial.
The total PSA test and free PSA test are often ordered together. This is because the free PSA test measures how much PSA is unbound, and this result is best understood by comparing it with how much total PSA is in the bloodstream.
Free PSA is measured as the proportion of free PSA to total PSA. Below is a table outlining the likelihood of finding prostate cancer based on the percentage of free PSA in men with a total PSA between 4ng/mL and 10 ng/mL, according to the Journal of American Medical Association.
|Percentage of free PSA||Probability of prostate cancer|
|Greater than 25%||8%|
In 2013, the Mi-Prostate Score (MiPS) test became commercially available to men throughout the United States through the University of Michigan MLabs. This test scans urine samples for two markers (rather than one, as does the PCA3 test) that are specific to prostate cancer:
- An RNA fragment from the PCA3 gene, which is overactive in 95 percent of prostate cancer cases; and
- RNA that is produced only when two genes (TMPRSS2 and ERG) bind abnormally. This marker is especially specific for prostate cancer
These two markers, plus PSA blood levels, are combined to create one score, which is an improvement over the standard PSA blood test because it provides men and their doctors with a personalized assessment of risk for prostate cancer. Use of the MPS could therefore help save tens of thousands of men from undergoing unnecessary prostate biopsies.
The Oncotype DX Prostate Cancer Test (Genomic Health) looks at the activity of specific genes in a man’s prostate tumor and provides information that can help men and their doctors identify the aggressiveness of the cancer. This biopsy-based genetic test is designed for men who have been recently told they have early-stage prostate cancer.
When to have the test - If you have been recently diagnosed with low-risk prostate cancer or have yet to decide on a management option, your biopsy tissue may be used to provide additional information about the aggressiveness of your tumor, which may help you choose the right treatment plan. See if you could be eligible.
What’s needed to perform the test - The Oncotype DX GPS test uses a tissue sample from a biopsy performed within the last three years. So, if you’ve had a recent biopsy, no additional procedure is needed. The test can predict the aggressiveness and biology of the prostate cancer without additional tests or having to remove the tumor by analyzing a very small sample of the tumor tissue.
This test for patients with metastatic, castration-resistant prostate cancer (mCRPC). It’s designed to learn whether you have a specific genetic mutation known as AR-V7. Not all mCRPC patients respond to androgen receptor (AR)-targeted therapies, like abiraterone and enzalutamide. When AR-targeted therapy fails, acquired resistance could be the cause.
The only predictive and prognostic test for men with mCRPC, the AR-V7 Nucleus Detect test:
- Accurately identifies patients who will not benefit from AR-targeted therapies.
- Is predictive of improved overall survival with taxanes versus AR-targeted therapies.
PCA3 is an acronym for Prostate CAncer gene 3. Prostate cells have PCA3 genes that are responsible for making this prostate cancer-specific protein. Prostate cancer cells produce higher levels of PCA3 than do healthy cells, and when the level of PCA3 protein is high, it leaks into the urine, where it can be measured. Unlike the PSA test, PCA3 is not affected by benign prostatic hyperplasia (enlarged prostate) or other noncancerous prostate conditions.
To take the PCA3 test, you must first have a digital rectal examination (DRE), which stimulates the PCA3 to enter the urine. Then you must immediately provide a urine sample. It takes 1 to 2 weeks for the results of the PCA3 test. For diagnostic purposes, the higher the PCA3 score, the more likely a man has prostate cancer. When the PCA3 score is used to help with treatment, the higher the score, the more aggressive the prostate cancer is likely to be.
The Prostate Health Index (phi; by Beckman Coulter Inc.) is a blood test designed to help doctors decide whether they should recommend a repeat prostate biopsy for their patients. The test, which was approved in 2012 by the FDA, measures the level of [-2]proPSA, which is a type of free PSA found in higher levels in the tissue and blood of men who have prostate cancer.
Prolaris® is a genetic test that can help you and your doctor better predict the aggressiveness of localized prostate cancer when used along with your Gleason score and PSA levels. This test, developed by Myriad Genetics, uses a tissue sample from a prostate biopsy to measure how fast your prostate cancer cells are dividing; that is, how aggressive the cancer is. Prolaris can help doctors predict a patient’s risk of disease progression within ten years. The test is expensive (about $3,400) and not always covered by insurance.For men who have just been diagnosed with prostate cancer, Prolaris may be helpful in identifying who could be candidates for active surveillance. If you have already undergone surgery for prostate cancer, Prolaris testing could be the ticket for assistance in identifying the chances of disease recurrence.
Prostarix™ (Metabolon; released 2013) is a urine test that measures certain biomarkers (i.e., alanine, glycine, glutamate, and sarcosine) used for early detection of prostate cancer. Alanine is an energy source, glycine is a precursor of sarcosine and is important for rate of cell proliferation, glutamate is essential for tumor growth, and sarcosine is a marker of prostate cancer progression.
A tissue-based panel, this test examines two major mechanisms of prostate carcinogenesis: ERG gene fusion/translocation and the loss of the PTEN tumor suppressor gene. By examining these two markers, ProstaVysion is able to provide a molecular analysis of prostate cancer aggressiveness and long-term patient prognosis. The ProstaVysion Score summarizes patient results with information present in published medical literature for a projected outcome of prostate cancer. These results are beneficial to physicians for guiding patient treatment
The Prostate Core Mitomic Test (MDNA Life Sciences) is based on mitochondrial DNA science. Basically, this simple lab test is capable of identifying the presence of malignant prostate cells by detecting molecular changes in tissue that appears to be normal. This highly sensitive test is suggested for men who have had a prostate biopsy that yielded inconclusive or negative results and who also have elevated PSA, rising PSA, irregular findings on DRE, atypical small acinar proliferation, or high-grade prostatic intraepithelial neoplasia (high PIN). Rather than undergo a second biopsy, men can request this test, which involves using their existing prostate biopsy tissue to look for malignant cells. Research shows that use of this test is able to accurately identify true negative results with 92 percent accuracy.
Prostate-specific antigen, or PSA, is a protein produced by normal, as well as malignant, cells of the prostate gland. The PSA test measures the level of PSA in a man’s blood. For this test, a blood sample is sent to a laboratory for analysis. The results are usually reported as nanograms of PSA per milliliter (ng/mL) of blood.
The blood level of PSA is often elevated in men with prostate cancer, and the PSA test was originally approved by the FDA in 1986 to monitor the progression of prostate cancer in men who had already been diagnosed with the disease. In 1994, the FDA approved the use of the PSA test in conjunction with a digital rectal exam (DRE) to test asymptomatic men for prostate cancer. Men who report prostate symptoms often undergo PSA testing (along with a DRE) to help doctors determine the nature of the problem.
PSA testing has a number of limitations. It is known to have a high rate of false positives. It is not uncommon for a man to have prostate cancer when his PSA is below the limits that indicate there might be cancer. About 75 percent of men who have an elevated PSA do not have cancer; normal PSA ranges were established primarily on white males, though PSA levels may vary depending on a man’s ethnicity; there can also be changes in PSA levels if they’re tested by a different lab or technicians use different testing methods.
Warning: In addition to prostate cancer, a number of benign (not cancerous) conditions can cause a man’s PSA level to rise. The most frequent benign prostate conditions that cause an elevation in PSA level are prostatitis (inflammation of the prostate) and benign prostatic hyperplasia (BPH) (enlargement of the prostate). There is no evidence that prostatitis or BPH leads to prostate cancer, but it is possible for a man to have one or both of these conditions and to develop prostate cancer as well.
Select MDx measures biomarkers that help a physician determine if a patient is at higher or lower risk for prostate cancer and which men can safely avoid biopsy.
A non-invasive urine test (“liquid biopsy”), SelectMDx measures the expression of two mRNA cancer-related biomarkers (HOXC6 and DLX1).1 The test provides binary results that, when combined with the patient’s clinical risk factors, help the physician determine whether:
- The patient may benefit from a biopsy and early prostate detection, or
- The patient can avoid a biopsy and return to routine screening