What are Prostate Cancer Biomarkers?
Biomarkers are measurable aspects of the body that can give information about a disease. In prostate cancer, biomarkers are genes or proteins in the cancer cells. These genes and proteins give information about how the cancer may grow. Biomarker testing is one way to help you and your doctor make treatment decisions.
Most biomarker tests are done on the small pieces of prostate tissue collected during a biopsy. Some can also be done on tissue from a prostate that has been removed during surgery.
These tests may help estimate:
- How fast-growing (aggressive) your cancer is
- How likely your cancer is to spread outside the prostate
- How likely your cancer is to come back after treatment
- If active surveillance (watching and waiting) may be an option
- If additional treatment may be helpful
A biomarker test is one tool your doctor can use. It does not replace the information from your PSA, biopsy, physical exam, imaging tests, or other standard tests. Instead, it may give extra information to help you and your doctor decide how best to manage your cancer.
Not every biomarker test is recommended for every person with prostate cancer. Your doctor can help you decide if one of these tests is right for you.
Decipher Genomic Classifier
Decipher is a genomic test that looks at the activity of certain genes in your prostate cancer tissue. It gives information about how likely your cancer is to grow fast, spread, or come back after treatment.
The test can be done on tissue from a prostate biopsy or on tissue from a prostate removed during surgery (radical prostatectomy).
For some men with Gleason 3+3 (low-risk) or Gleason 3+4 (favorable‑intermediate-risk) prostate cancer, Decipher may help you and your doctor decide between active surveillance and treatment sooner.
Decipher may also be useful after surgery. It can help estimate:
- If you may benefit from radiation therapy after surgery
- The risk that cancer may spread outside the prostate if your PSA begins to rise after surgery (biochemical recurrence)
- The risk that cancer may spread to other parts of the body in 5-10 years after surgery, especially in men whose cancer is higher-risk
The results are considered along with your other test results and clinical information when making treatment decisions.
ArteraAI Prostate Test
The ArteraAI Prostate Test uses artificial intelligence (AI) to analyze digital images of prostate biopsy tissue along with information such as your PSA level and Gleason score.
The test can give information about how your cancer is likely to grow, and if you might benefit from certain treatments.
For example, the test may help:
- Estimate your long-term risks, including if the cancer may spread or cause serious problems
- Determine if adding short-term androgen deprivation therapy (ADT) (also called hormone therapy) to radiation therapy is likely to be helpful
- Support decisions about active surveillance in some men with low-risk or favorable-intermediate-risk prostate cancer
- Estimate the risk that the cancer may spread after surgery if PSA levels start to rise, and see if adding ADT therapy to radiation may be helpful
ConfirmMDx
ConfirmMDx is used when a prostate biopsy does not find cancer, but your doctor still has concerns that cancer may be present.
The test looks for chemical “tags” around DNA. These are called epigenetic changes. These changes can suggest there may be cancer cells somewhere in the prostate, even if cancer cells were not found in the biopsy samples.
Because a biopsy samples only small areas of the prostate, it is possible for cancer to be missed. ConfirmMDx may help your doctor decide if you should have another biopsy.
Prolaris
Polaris is a genomic test that looks at genes involved in how quickly prostate cancer cells grow and divide. The test gives a Prolaris Score, which tells your doctor how fast-growing (aggressive) your cancer may be.
Prolaris can help when deciding if active surveillance is an option, or if you need treatment such as surgery or radiation.
Genomic Prostate Score (GPS)
The Genomic Prostate Score (GPS) analyzes the activity of certain genes in prostate cancer cells. The test used to be called Oncotype DX Prostate.
The test is done on prostate biopsy tissue and gives a score from 0 to 100. The score can show if your cancer may be more low- or high-risk than it appears based on the biopsy. The GPS may help when deciding between active surveillance and treatment.
ProMark
ProMark is a test for men whose biopsy shows Gleason 3+3 or 3+4 prostate cancer. The test measures certain proteins in prostate cancer cells. It gives a score between 0 and 1. This score helps estimate how aggressive the cancer is. It can help predict if more-aggressive cancer would be found in the prostate after it’s removed.
Biomarker Tests at a Glance
| Biomarker | When to Consider this Biomarker? |
|---|---|
| Decipher Genomic Classifier | For men with intermediate-risk prostate cancer see how likely their cancer is to spread, and whether it is safer to choose active surveillance or move ahead with stronger treatment. |
| ArteraAI Prostate Test | For men with intermediate-risk prostate cancer to estimate long-term outlook and whether adding hormone therapy to radiation is likely to help. |
| ConfirmMDx | For men whose first biopsy did not show cancer, but there is still concern, to help decide if another biopsy is needed. |
| Prolaris | For men with low or favorable-intermediate risk prostate cancer to understand their long-term risk and decide between monitoring and treatment. |
| Genomic Prostate Score (GPS) test | For men with low- or favorable-intermediate risk prostate cancer to predict whether more aggressive cancer might be found at surgery and to better define risk. |
| ProMark | For men with low- or favorable-intermediate risk prostate cancer to use protein markers in the tumor to help decide whether active surveillance is a good option. |
Other Types of Testing
Other biomarkers and genetic tests may be useful in certain cases.
Examples include:
- PTEN loss testing. PTEN is a gene that helps control cell growth. Loss of PTEN is linked with more aggressive prostate cancer. Testing for PTEN loss may help your doctor decide if you are a candidate for capivasertib + abiraterone acetate + ADT if you have metastatic hormone sensitive prostate cancer (mHSPC).
- Germline testing. Germline testing looks for genetic changes that you were born with and are in cells throughout your body. It is usually done with a blood or saliva sample. It can help doctors choose targeted treatments for advanced prostate cancer. Germline testing can also give information that may be important for your male family members. This is because some inherited gene changes can increase the risk of prostate cancer in a family.
- Somatic testing. Somatic testing looks for genetic changes in the cancer cells themselves. Somatic testing can help doctors choose targeted treatments, especially for men with advanced prostate cancer.
Other tests are also being studied, including tests that look at gene activity in prostate cancer cells, or look at combinations of inherited genetic changes. These tests may become useful in the future, but are not yet part of routine care.
Deciding If You Should Have a Biomarker Test
A biomarker test is most useful when the results could change what you and your doctor decide to do. Your doctor can help you decide if the information it gives is likely to be useful in your situation.
For example, a test might give information that helps you decide between active surveillance and treatment. Another test might help your doctor decide if follow-up treatment could be helpful after surgery.
Not all of these tests are available in every hospital or clinic. Insurance coverage can vary, and you may have to pay out-of-pocket costs.
Before having a biomarker test, you can ask your doctor:
- Will this test give information that you don't already have?
- Could the results change my treatment or monitoring plan?
- How reliable is the test?
- Is this test recommended for someone with my type and risk level of prostate cancer?
- Will my insurance cover the test?
- Will I have any out-of-pocket costs?
Testing is One Tool
Biomarker testing is just one part of making a prostate cancer treatment decision. Your PSA, biopsy results, cancer grade and stage, imaging results, overall health, and personal preferences are all important. Your doctor can help put all of this information together to choose the approach that is right for you.
What Is Prostate Cancer Genomic Testing?
Genomic testing has become an important part of customizing prostate cancer treatment. It can help men with high-risk prostate cancer have a more effective treatment so they can reduce their risk of dying of prostate cancer.
Genomic testing looks at your overall DNA, and genes just in the cancer tissue. This is done to learn more about the cancer. It may help your doctor understand how fast-growing (aggressive) the cancer is. This can help them decide which treatments are more likely to work.
There are two types of genomic testing:
- Germline testing. This looks at the genes you were born with. These genes are found in almost every cell in your body and are inherited from your parents.
- Somatic testing. This looks at genetic changes that are just in the cancer cells.
These tests can give different types of information, so your doctor may recommend one or both.
Genomic testing is a type of biomarker testing for prostate cancer. You can learn more about biomarker testing in Understanding Prostate Cancer Biomarker Testing.
What Does Genomic Testing Tell My Doctor?
Genomic testing can help your doctor better understand the nature of your prostate cancer. Depending on the type of test, it may give information that helps answer questions such as:
- How fast-growing (aggressive) is the cancer likely to be?
- Is the cancer more likely to spread?
- How likely is the cancer to come back after treatment?
- Are there treatments that may work well for this cancer?
Genomic testing is just one tool that a doctor can use. The results are considered along with other information, such as your PSA level, biopsy results, cancer stage, overall health, and previous treatments.
Understanding Germline Testing
Germline testing looks for genetic changes that you were born with. Because these genetic changes are found in every cell of your body, the test can be done with a blood or saliva sample.
Some inherited genetic changes can increase a person’s risk of prostate cancer. Some may also affect how aggressive the cancer is.
It’s important to know that finding an inherited genetic change may have implications for your family’s risks. Your doctor or a genetic counselor can explain what your test results may mean for you and your relatives.
Understanding Somatic Testing
Somatic testing looks for genetic changes just inside the prostate cancer cells. Somatic testing can give information about the genetic features of your cancer. This may help your doctor decide which treatments will work best for you.
The test is most often done with a sample of cancer tissue taken during a prostate biopsy. If the cancer has spread to lymph nodes, bone, liver, or lung, tissue from any of those may also be tested. There is also an FDA-approved somatic test for blood called the FoundationOne Liquid CDX test that looks at more than 300 genes.
Who Should Consider Genomic Testing?
Not every person with prostate cancer needs genomic testing. The National Comprehensive Cancer Network (NCCN) recommends genomic testing for men with any of these:
- A family history of prostate cancer
- High- or very-high-risk localized prostate cancer
- Locally advanced prostate cancer
- Metastatic prostate cancer
- Ashkenazi Jewish ancestry
- Intraductal or cribriform (very aggressive) prostate cancer cells
How Can Genomic Testing Help Treatment?
The most important benefit of genomic testing is that it may help doctors customize your treatment. There are some examples below.
If You Have Prostate Cancer Surgery…
If you have surgery to remove your prostate, genomic testing may help doctors better understand your risk of the cancer returning. This may help guide decisions about using early follow-up treatment, such as radiation therapy or hormone therapy.
If You Have Advanced Prostate Cancer…
Genomic testing can be important for men with prostate cancer that has spread outside the prostate gland (advanced). This is because certain gene changes may make the cancer more likely to respond to specific treatments.
For example, some prostate cancers have changes in the genes BRCA1 and BRCA2. These genes normally help repair damaged DNA. Changes in these genes are known for their link to breast and ovarian cancer. In men with prostate cancer, they are linked to aggressive prostate cancer.
For some men with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1 or BRCA2 gene changes, medicines called PARP inhibitors may be a treatment option.
Genomic testing can also look for microsatellite instability-high (MSI-high) gene changes. MSI-high prostate cancer is a rare subtype of prostate cancer. It occurs in 3% or less of prostate cancers. For men with mCRPC cancer and MSI-high gene changes, the immunotherapy medicine pembrolizumab may be a treatment option.
Should I Have Genomic Testing?
Genomic testing can give important information about prostate cancer, but it is not needed for every person with prostate cancer.
If you have high-risk localized prostate cancer, advanced prostate cancer, or other features that may make genomic testing useful, talk with your cancer doctor about genomic testing.
You can ask:
- Would genomic testing give useful information about my prostate cancer?
- Should I have germline testing, somatic testing, or both?
- Could the results change my treatment options?
- Could the results have implications for my family members?
- Should I meet with a genetic counselor?
Genomic testing is an important tool for customized prostate cancer care. If you think you may benefit from genomic testing, ask your doctor about it.
Magnetic resonance imaging (MRI) is a type of imaging, or way to take pictures of the inside of the body. It creates images with a magnetic field and computer-generated radio waves. The MRI machine is a large tube-shaped structure that you lie inside. For prostate cancer imaging, the machine will take pictures of your pelvis (lower abdomen), including your prostate gland.
Why would I get a prostate MRI?
There are several reasons why your doctor may order an MRI to help them with staging and planning treatment for your prostate cancer.
When Considering Prostate Biopsy After an Elevated PSA
If your PSA blood test (a screening test for prostate cancer) is elevated or high, your urologist may order a prostate MRI before considering a prostate biopsy (to see if you have prostate cancer). There are several large clinical studies that show that men who have an elevated PSA and receive an MRI before getting a biopsy benefit in at least two ways.
First, some men may have such a good result from their MRI that a biopsy is not needed right away. However, a “normal” MRI does not guarantee there is no prostate cancer. So, you should still talk with your urologist about whether or not you need a prostate biopsy.
Second, the MRI provides a “map of the prostate” to guide a urologist to perform targeted biopsies of those areas most likely to have prostate cancer. As a result, these studies have shown that clinically significant prostate cancer (that which requires treatment) is more likely to be found in men who have an MRI before biopsy.
During Active Surveillance for Low-Grade/Low Volume Prostate Cancer
There are many protocols that doctors may follow when patients are on active surveillance. However, nearly all modern protocols use prostate MRI at some point in the active surveillance journey. Patients that are being considered for active surveillance most often have an MRI soon after their first biopsy. This is done to see if there are areas in the prostate that should be targeted at the time of the second, or confirmation, biopsy. For men that have been on active surveillance, most doctors will perform an MRI every one to two years to make sure there are no changes in how the prostate looks on MRI.
Local Staging for High-Risk Prostate Cancer
Prior to local therapy (i.e., surgery or radiotherapy) for high-risk prostate cancer, your doctor may order an MRI to get a better look at the anatomy of the prostate. The MRI will also help your doctor see the areas around the prostate, such as any enlarged lymph nodes (which is a common location for prostate cancer to spread).
Specifically, for patients who will have surgery, a prostate MRI may allow your urologist to see if prostate cancer is close to the prostate capsule (the wall of the prostate gland). This information can help your urologist to plan how much nerve-sparing can or should be done for each side of the prostate gland during the operation. Your urologist can be better prepared to do the cancer operation and provide you with the best chance to return to your normal life as much as possible.
What does a prostate MRI involve?
During an MRI, you will lie on the narrow bed of the MRI machine while it moves in and out of the MRI tube. This process takes about 30 minutes. In most cases, you will receive contrast dye through an I.V. during the scan.
Some men are claustrophobic (afraid of small spaces) and may find being in the MRI “tube” hard to tolerate. If you are claustrophobic, you should mention this to your doctor. They may prescribe a light sedative or a medication (i.e., Valium) to help ease the anxiety of the MRI.
Before the MRI you must remove any clothing with snaps or zippers. You likely will be asked to wear a hospital gown in the MRI scanner. Additionally, you should take off any jewelry or metal, including hearing aids.
There are several absolute contraindications (i.e., reasons why you should NOT have an MRI) to receiving an MRI. These include having a cardiac implantable electronic device (CIED) such as a pacemaker, an implantable cardioverter defibrillator (ICDs), and cardiac resynchronization therapy (CRT) device. Patients who have one of these devices are at risk of device malfunction (not working right), device heating/movement, and possible irregular heartbeat (arrhythmia) during an MRI.
If you have an elevated or high PSA test, an MRI may help your urologist to check to see if and where cancer may be in your prostate. The results of the MRI will help your urologist plan the next steps of your prostate cancer journey, and guide you and your loved ones in shared decision-making.