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While not appropriate for every prostate cancer patient, genomic testing can provide a man and his care team with valuable information at various stages of disease management specific to whether the cancer is likely to be aggressive or indolent, thereby helping him to make an informed decision on how to best address his prostate cancer.
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Because every prostate cancer is different, treatment should not be “one size fits all.” Genomics provides unique information about the nature of a man’s individual prostate cancer that can’t be found in other clinical measures such as a PSA level and Gleason score.
Over the past several years, a number of genomic tests have been developed and they are described in the tables below. Presently, there is no “best” test because adequate comparisons have not been performed. Each one has advantages and disadvantages so it is important to understand their strengths and weaknesses in order to have an informed discussion with your physician about whether one of these tests is right for you. Men should be aware that genomic testing is not an exact science. It cannot tell any individual what will happen to them. Rather it only can provide the odds or chances that something will occur. For example, a test may show that a newly diagnosed cancer has a 10-15% chance it will progress over the next 10 years. This means that there is an 85-90% chance it will not progress. Some men may feel that they like those odds and will decide to treat it conservatively and consider active surveillance, while others may feel that even a 10-15% chance of progression is too great and therefore they will decide to treat it aggressively with surgery or radiation. There is no right answer about what someone should do; rather genomic test results are one additional factor to consider when making a decision.
Genetics looks at specific genes responsible for inherited traits, such as hair or eye color or the risk for certain cancers. The study of genetics in prostate cancer is important because family predisposition may be responsible for five to 10 percent of all prostate cancers. A family history increases a man’s risk for prostate cancer by 60 percent.1 And the presence of the BRCA gene can be a high-risk indicator for prostate cancer in men as it is for breast cancer in women.2
Genomics looks at how certain sets of genes interact and function, including their role in specific diseases. In the case of prostate cancer, a genomic test can help predict the aggressiveness of the tumor, enabling the patient to select the most appropriate course of care.
In an effort to establish the risk level for a man’s prostate cancer, doctors have traditionally used prostate cancer characteristics such as PSA level, Gleason score, and tumor stage to estimate the aggressiveness of the disease and help guide treatment decisions. While these characteristics are helpful, they cannot fully determine the risk level of the cancer. The additional information provided by genomic testing can provide greater confidence in the development of a personalized treatment plan.
The Following Genomic Tests Help Determine if an Initial or Repeat Biopsy is Needed (Click on Test Name Link for More Info):
|4K Score||Blood test that measures 4 markers that can be used in combination with DRE and PSA results||Can help determine if a man has a high risk for developing an aggressive prostate cancer over the next 20 years and if so, a biopsy should be performed. If the risk is low, then no biopsy may be needed. The test does not provide an absolute yes or no. Rather, it provides a probability of having a high- or low-risk cancer.||Currently only Medicare pays for this test, if bill is turned in to insurance, GENPATH will help with appeals (4 times), give patient CPT code for insurance, cost to insurance is $595, cost for self pay is $395|
|PHI (Prostate Health Index)||Blood test that combines the PSA test, freePSA and Pro2PSA test||Can help determine the odds that a patient will have prostate cancer on a biopsy. If the odds are high, a patient may want a biopsy but if the odds are low, he may choose to postpone a biopsy.||Any doctor can order this test, but insurance questions would need to be answered by the doctor’s office|
|Progensa PCA3||Urine collected after a digital rectal exam (DRE) is analyzed to determine a PCA3 score||Can help determine if a biopsy is necessary by providing a score that indicates the probability of finding prostate cancer in a biopsy; and can help men on active surveillance determine if prostate cancer is progressing. Currently, test is not sufficiently reliable to use in place of PSA test.||No financial assistance, but patient should speak with his doctor|
|ConfirmMDx||Test performed on tissue from a negative prostate biopsy to determine the odds that an aggressive cancer is present and whether a repeat biopsy should be performed.||Helps identify patients at increased risk for aggressive disease, thereby aiding in the selection of men for repeat prostate biopsy.||Test is too new to determine a trend regarding insurance coverage|
|SelectMDx||Urine test that helps identify those patients who may benefit from a prostate biopsy and early prostate detection versus routine screening||Helps identify patients at increased risk for prostate cancer, aiding in the selection of men for prostate biopsy||NA|
Genomic Tests to Consider When Choosing a Treatment (Click on Test Name Link for More Info):
|4K Score||Blood test that measures 4 markers that can be used in combination with DRE and PSA results||Can help determine the odds that a man will develop metastatic disease in the next 20 years so it helps in trying to determine if treatment is necessary or active surveillance is appropriate.||Currently only Medicare pays for this test, if bill is turned in to insurance, GENPATH will help with appeals (4 times), give patient CPT code for insurance, cost to insurance is $595, cost for self pay is $395|
|Decipher||Measurement of the expression levels of 22 RNA biomarkers involved in multiple biological pathways across the genome that are associated with aggressive prostate cancer||Test predicts the probability of developing metastases 5 years after surgery, which can help a person decide about additional therapy.||Covered in most cases by insurance, financial assistance if requested, patient can call (888) 792-1601 – option 3|
CLICK HERE for additional information.
|Assay that analyzes prostate cancer gene activity to predict disease aggressiveness for patients with clinically low-risk prostate cancer (very low, low or intermediate NCCN-risk) prostate cancer||Generates a Genomic Prostate Score (GPS) to indicate the likelihood of favorable pathology (low-grade [3+3, 3+4], organ-confined disease) It provides a value between 0-100; the higher the number, the greater the odds of having an aggressive cancer.||Medicare covers this test for eligible patients, insurance coverage varies, assistance is available, contact the Genomic Access Program at 866-ONCOTYPE or visit this webpage|
Oncotype DX AR-V7 Nucleus Detect test
CLICK HERE for additional information.
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|This liquid biopsy test offers a predictive biomarker that seeks to improve patient outcomes by identifying men who are positive for AR-V7. The test is a single blood draw with a binary result. It is recommended for men who: have metastatic castrate-resistant prostate cancer (mCRPC), are considering androgen receptor (AR) targeted therapies, and/or have undergone AR therapies unsuccessfully and are considering other options.||The test detects a splice variant of androgen receptor protein (AR-V7) in the nucleus of tumor cells. Results help determine whether a patient might be resistant to androgen receptor signaling inhibitor (ARSI) therapies and might instead benefit more by choosing another therapy, such as chemotherapy.||Medicare covers this test for eligible patients, and private insurance coverage varies. Check with your insurance provider. Genomic Health will help file insurance claims and work with any insurance rejection. They will also help to set up payment plans. For questions, contact Genomic Health at 888-662-6897 or at firstname.lastname@example.org.|
|ProMark||Tissue analysis of gene-expression||Predicts the odds between 0-100% that a Gleason 3+3 or 3+4 cancer will behave aggressively.||ProMark has specialists that will help with questions related to billing and with financial assistance for those with costs not covered by insurance, call ProMark Patient Assistance Program at (877) 743-3338 or visit this webpage|
|Prolaris||Prolaris is a measure of how fast the cells in the prostate cancer tumor are dividing. It provides additional information beyond the Gleason score about the likelihood the cancer will behave aggressively.||Measures the aggressiveness of the prostate cancer||Only covered by Medicare Part B, they do offer financial assistance, call (855) 469-7765|
|PTEN||Performed in a man with a biopsy showing Gleason Scores 3+3 and 3+4 to predict the odds of having aggressive disease||PTEN/TMPRSS2:ERG molecular testing can help predict prostate cancer aggressiveness||NA|
|ConfirmMDx||Test performed on tissue from initial prostate biopsy to determine the odds that cancer is present and another biopsy should be performed.||Helps identify patients at increased risk for aggressive disease, thereby aiding in the selection of men for repeat prostate biopsy.||Test is too new to determine a trend regarding insurance coverage|
|SelectMDx||Urine test that helps identify those patients who are likely to have prostate cancer that requires treatment rather than low-risk disease that would be appropriate for active surveillance||Helps identify patients at increased risk for aggressive disease, thereby aiding in the selection of men for prostate biopsy||NA|
Genomic Tests That Analyze Tissue from the Prostate After Surgery (Prostatectomy)(Click on Test Name Link for More Info):
If you have already been treated with surgery (radical prostatectomy) for your prostate cancer, genomic testing can help to predict if your cancer is likely to come back, or recur, helping you, your doctor and care team to decide if additional treatment is necessary. In this case, the genomic test is performed on either biopsy tissue or a tissue sample taken from your surgical procedure. It is important to talk to your doctor to find out if you are a candidate for a genomic test.
|Decipher||Measurement of the expression levels of 22 RNA biomarkers involved in multiple biological pathways across the genome that are associated with aggressive prostate cancer||Test predicts the probability of metastasis after surgery and provides an independent assessment of tumor aggressiveness; information distinct from that provided by Gleason score or PSA||Covered in most cases by insurance, financial assistance if requested, patient can call (888) 792-1601 – option 3|
CLICK HERE for additional information.
|Assay that analyzes prostate cancer gene activity to predict disease aggressiveness for patients with clinically low-risk prostate cancer (very low, low or intermediate NCCN-risk) prostate cancer||Generates a Genomic Prostate Score (GPS) to indicate the likelihood of metastases and death within 10 years of a radical prostatectomy.||Medicare covers this test for eligible patients, insurance coverage varies, assistance is available, contact the Genomic Access Program at 866-ONCOTYPE or visit this webpage|
|Prolaris||Prolaris is a measure of how fast the cells in the prostate cancer tumor are dividing to generate an accurate assessment for cancer aggressiveness||Measures how fast cancer cells are dividing, or the aggressiveness of the prostate cancer; may help to determine the likelihood of recurrence; 10-year mortality||Only covered by Medicare Part B, they do offer financial assistance, call (855) 469-7765|
There is no perfect approach for imaging with a biopsy; it’s evolving. While a multiparametric MRI can potentially identify areas of the prostate that appear to be cancerous, it is not able to detect all cancerous tissue that may be present, which can potentially be detected with the more common TRUS (transrectal ultrasound) guided biopsy. Typically, the initial biopsy is a TRUS biopsy. The multiparametric MRI may be used after an initial treatment with a rise in PSA to detect tissue that looks cancerous thereby avoiding multiple biopsies. As more data are accumulated, the optimal approach to biopsy may change.
Unlike some diseases with a diagnosis that leads to a few treatment options, a diagnosis of prostate cancer requires a man and his care team to understand a multitude of tests and the implication of the test results, along with the option of active surveillance or a multitude of treatment options, and the potential side effects associated with each type of treatment.
In addition, there’s confusion and controversy over the test that’s used to diagnose prostate cancer. The prostate-specific antigen (PSA)–based screening for prostate cancer is currently only recommended by the U.S. Preventive Services Task Force (USPSTF) for men who are between 55 and 69 years of age, with the recognition that the decision on whether or not to have a PSA test should be specific to each individual and an informed decision following a conversation between a man and his physician. Much of the debate over the PSA test stems from the prevalence of over-treating the disease in the past.
Of course a man diagnosed with prostate cancer wants to avoid over-treatment and the resulting side effects that often include erectile dysfunction and incontinence. Conversely, he needs to know when his condition mandates a treatment rather than having the option of considering active surveillance.
Questions about genomic testing to ask your doctor:
To start or join an online discussion about genomic testing, join the Us TOO Prostate Cancer Support Group and Discussion Community on Inspire at: https://www.inspire.com/groups/us-too-prostate-cancer/
For more information on prostate cancer treatment options, CLICK HERE.
For more information on side effects related to treatment, CLICK HERE.
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