The PSA test cannot differentiate between prostate cancer and non-cancerous (benign) conditions, such as benign prostatic hyperplasia (BPH). Men who receive a PSA level above 1.5 ng/ML should discuss additional biomarker testing with their healthcare providers prior to considering a prostate biopsy.

Prostate cancer biomarkers (PCMs) are molecules found in blood, tissue, or body fluids. PCMs are revolutionary new, non-invasive diagnostic tests that may help your healthcare provider decide if your prostate cancer is in fact low risk, if something more aggressive may be lurking in your prostate, or if there are hot spots in the prostate that may need to be re-evaluated upon biopsy. PCMs also can help you and your healthcare provider determine the most appropriate treatment for your cancer.

There are many factors that will make one prostate cancer marker test better suited for individual cases. Many times, individuals who have never had a biopsy or had low to intermediate grade prostate cancer (Gleason 3+3=6 or 3+4=7) diagnosed on a biopsy are well suited for blood or urine prostate cancer markers, whereas individuals who have persistently negative biopsies or a biopsy of intermediate to high grade cancer may benefit from tissue prostate cancer markers. Use this interactive questionnaire to see what tests may be right for you.  Once you’ve completed the questionnaire, discuss the results with your healthcare provider. Also be sure to check out our Patient Journey section that may help you decide which test is right for you.

Although there are many factors that contribute to your healthcare provider’s decision to conduct a prostate biopsy, there are several urinary and blood based PCMs that may help guide you and your physician through the decision of conducting a prostate biopsy. These include:

• Select mdx
• 4K
• Prostate health index (phi)
• ExoDx

Genetic tests also may be worth considering if you have a family history of prostate cancer, breast cancer, ovarian cancer or colorectal cancer. These genetic tests are recommended for men who are determined through genetic counseling to be at potential risk for hereditary cancer:

• Myriad myRisk
• ProstateNext
• Ambry Score

If you have a negative or atypical biopsy and are wanting more insights about prostate cancer risk, you might consider the tissue-based PCM test:

• Confirm mdx

If your prostate biopsy has a Gleason Score of less than or equal to 7 or if your prostate biopsy has a Gleason Score greater than 7 and you have not yet undergone treatment (surgery or radiation), you and your healthcare provider might consider these tissue-based PCM tests: 

• Decipher Biopsy
• Prolaris 
• Oncotype DX GPS 

If your prostate biopsy has a Gleason Score greater than 7 and you have already undergone treatment, please see Waypoint 4 for additional PCM tests to consider.

If you are in the active surveillance stage and wondering about getting more insights into your prostate cancer, these tissue-based tests can be performed on the prostate biopsy you previously had. Results can give you peace of mind or inform your next move.

• Prolaris
• GPS
• Decipher Prostate Biopsy

If you have not had a biopsy and are in the watchful waiting stage based on your initial PSA, DRE, or other tests, consider the PCMs and genetic tests highlighted in Waypoint 1 of the prostate cancer journey.

If you have had a prostatectomy and are at risk of your cancer spreading or recurring, the following PCMs could be helpful:

• Decipher RP

If your physician has recommended radiation to treat your prostate cancer, the following tests can help inform your treatment plan. Or, if you have had radiation and underwent another biopsy, these tissue-based tests could help you and your healthcare provider assess whether you may need additional treatment down the line. However, many radiation oncologists may want to wait until your PSA rises +2ng/ml above the lowest point after your radiation to see if further biopsies or treatment are necessary.

• Decipher Biopsy
• Oncotype DX GPS
• Prolaris

A medicine that targets a specific receptor present in some prostate cancers is used to treat qualifying patients with late-stage cancer. This PCM test can help determine if you are a candidate for androgen receptor (AR) targeted therapies.

• OncotypeDx ARV7

The 4Kscore® Test is appropriate for the following men:

• Men 45-54 years old and total PSA ≥2 ng/mL and/or abnormal DRE
• Men 55-75 years old and total PSA ≥3 ng/mL and/or abnormal DRE
• Men ≥76 years old and total PSA ≥4 ng/mL and/or abnormal DRE

The 4Kscore measures 4 kallikreins (proteins) in the blood: Total PSA, FreePSA, Intact PSA and hK2. These results are combined with clinical information into an algorithm to determine a score that reflects the risk of having prostate cancer. See a 4Kscore sample result report and learn more about interpreting them.

It’s important for you to talk to your healthcare provider about any test results. In general, the 4Kscore results include a range for probability of prostate cancer risk:

• Low risk: 1%-7.5%
• Intermediate risk: 7.5%-20%
• High risk: 20%->90%

The 4KScore also calculates a probability of not developing distant metastases within the next 10 years. See a sample of a 4Kscore result report and learn more about how to interpret these results.

Good candidates for the FDA-approved blood test, Prostate Health Index (phi), are men with abnormal digital rectal exam (DRE), a PSA between 2-10 ng/ml, a low risk (Gleason 3+3=6) prostate biopsy, or men with a previously negative prostate biopsy.

While you should always consult with your physician when reviewing any test results, in general, the Beckman Coulter phi range for probability of prostate cancer risk upon biopsy are:

• phi between 0-26.9: 9.8% risk
• phi between 27-35.9: 16.8% risk
• phi between 36-54.9: 33.3% risk
• phi greater than 55: 50.1% risk

See sample phi test results and learn more about how to interpret the test report.

Men 50 and older, men with a low risk (Gleason 3+3=6) prostate biopsy, and men with a previously negative prostate biopsy may benefit from the non-invasive, urine-based ExoDx test.

The ExoDx test analyzes exosomal RNA from a non-invasive urine sample for three biomarkers known to be expressed in men with high-grade prostate cancer: ERG, PCA3 and SPDEF. You should consult your physician or healthcare provider when reviewing the results of your ExoDx test.

The ExoDx Score is returned as above or below 15.6, which is the test’s cutoff for high grade prostate cancer.

• If below 15.6, there is a decreased likelihood of greater than or equal to Gleason 7 prostate cancer on biopsy.
• If above 15.6, there is an increased likelihood of greater than or equal to Gleason 7 prostate cancer on biopsy.

See a sample ExoDx test result report and learn more about how to interpret these scores.

Men with an abnormal PSA or DRE may be good candidates for the non-invasive Select mdx test, which can help determine whether or not a prostate biopsy is necessary.

Select mdx is a reverse transcriptase polymerase chain reaction (RT-PCR) assay that measures the urinary mRNA levels of HOXC6 and DLX1 biomarkers. Higher levels of HOXC6 and DLX1 are associated with an increased risk for clinically significant prostate cancer.

Your Select mdx results should be reviewed with your physician. Generally, test results for Select mdx are presented in a binary fashion.

• Very low risk: You have a less than a 5% chance of having a Gleason ≥ 3+4=7 prostate cancer detected on biopsy
• Relative percent risk: This result demonstrates two risk categories:
  • Percent risk of you having any cancer on prostate biopsy.
  • Percent risk of you having clinically significant prostate cancer (greater than or equal to Gleason 7) on a prostate biopsy.

See a sample Select mdx result report and learn more about how to interpret these results.

Men may be a candidate for the Myriad Genetics MyRisk test if they:

• have a personal history of any of the following: male breast cancer; metastatic prostate cancer; pancreatic, colon or rectal cancer
• have a family history of any of the following: breast cancer under age 50; ovarian, metastatic prostate, pancreatic cancers; colon, rectal or uterine cancer under age 50

To help determine if genetic testing is appropriate, healthcare providers will refer patients to a genetic counselor who helps determine their risk of hereditary cancer and whether testing is right for them and their family.

The Myriad Genetics MyRisk genetic test uses a saliva sample to analyze 48 genes. The test identifies elevated risk for 11 hereditary cancers. Test results for MyRisk are presented in the following fashion:

• Positive Result: A genetic mutation was found in one or more genes tested, putting the patient at increased risk for cancer.
• Elevated Result: No genetic mutation was found, but the patient is at elevated risk of cancer based on family history, personal risk factors or additional genetic markers.
• Negative Result: No genetic mutation was found in the genes tested. Risk for cancer depends on personal or family history.
• Variant of uncertain significance: A change in a gene was identified, but it is not yet known if this change is associated with increased cancer risk.

Patients’ healthcare providers or genetic counselors will review the results with the patients, answer any questions and recommend next steps. See a sample Myriad Genetics MyRisk test report and learn more about interpreting this report.

Men with a personal and/or family history of any of the following may benefit from the ProstateNext genetic test:

• early-onset (<50) of prostate cancer
• metastatic prostate cancer at any age
• more than 1 person in their family with prostate, pancreatic, breast or ovarian cancers
• multiple primary cancers in one person (e.g. prostate and male breast cancer)
• personal history of prostate cancer and more than 1 family member* with breast cancer (<50 years of age) and/or invasive ovarian cancer
• personal history of prostate cancer and >2 family members* with breast, pancreatic or prostate cancer

*on the same side of the family

The ProstateNext test analyzes a blood or saliva sample to provide a full gene sequencing and looks for the deletion/duplication of 14 genes (including BRCA1 and BRCA2).

Test results for ProstateNext are presented in the following fashion (please note that you should always consult with your healthcare provider when reviewing test results):

• Positive: A mutation was found in at least one of your genes tested. Your risk of developing prostate cancer may be at increased risk compared to others.
• Negative: No mutations were found in any of your genes tested.
• Variant of unknown significance (VUS): At least one genetic change was found, but it is not clear if this may lead to an increased risk of cancer.

See a sample ProstateNext test result report and learn more about how to interpret them.

Men of Northern European ancestry with a personal and/or family history of any of the following conditions should talk to their healthcare providers about adding the Ambry Score as a supplementary test with other genetic testing:

• early-onset (<50) or metastatic prostate cancer
• more than 1 person in your immediate family with prostate, pancreatic, breast or ovarian cancers
• no personal or family history of a mutation in a prostate cancer susceptibility gene, including ATM, BRCA1, BRCA2, CHEK2, EPCAM, HOXB13, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, RAD51D, TP53

The Ambry Score is known as a polygenic risk score (PRS), which means it can evaluate the genetic variants you inherited at birth, coupled with your age and ethnicity, to determine your individual risk of having developed or eventually developing prostate cancer. The Ambry Score is used in combination with other tests, such as ProstateNext.

The Ambry Score analyzes 72 single nucleotide polymorphisms (SNPs). A SNP is an error that exists in your DNA, or genetic code. SNPs are typically inherited from your parents and are unique to each person. Research has shown these 72 SNPs are associated with prostate cancer risk.

Test results for Ambry Score are presented in the following fashion:

• Unaffected males (no current prostate cancer diagnosis):
  • Average remaining lifetime risk of developing prostate cancer (0-10.2%)
  • Above average remaining lifetime risk of developing prostate cancer (>10.2%)
• Affected males (current prostate cancer diagnosis):
  • Average PRS Score (≤ 1)
  • Above average PRS Score (>1)

A PRS Score of above 1 suggests that your cancer may have occurred as a result of an error related to the 72 SNPs, as well as other factors, associated with prostate cancer development. A PRS Score of less than or equal to 1 suggests that your cancer likely did not occur as a result of an error related to the 72 SNPs associated with prostate cancer development.

Results from the Ambry Score, along with other personal risk factors and PCMs, can be used by you and your healthcare provider to develop a customized monitoring or treatment plan specific to your risk profile. See a sample Ambry Score report and learn more about how to interpret them.

Men with a cancer-negative (HGPIN, ASAP, atypia) prostate biopsy may benefit from insights provided by the Confirm mdx test. Confirm mdx can be used immediately after biopsy to confirm negative results, determine a patient’s risk for clinically significant prostate cancer and to help inform the patient’s prostate cancer risk management plan or need for rebiopsy/MRI.

Confirm mdx detects the presence of hypermethylation (which is when certain molecules bind to areas of the genetic code, also known as the DNA) of three cancer specific genes: APC, RASSF1, and GSTP1. A positive test indicates you are at increased risk for clinically significant prostate cancer, your clinical risk factors need to be monitored more closely, or you may be a candidate for a re-biopsy. Results of the Confirm mdx test may also help you and your healthcare provider determine which area(s) of the prostate may be “hot spots” for prostate cancer, subsequently targeting these zone(s) of suspicion at the time of repeat biopsy.

While you should always discuss the results of your Confirm mdx test with your healthcare provider first, in general, test results are presented as negative or positive:

• Negative for hypermethylation: You have a  ≤ 4% risk of having clinically significant prostate cancer.
• Positive for hypermethylation: You are at increased risk and should be monitored more closely or a re-biopsy/MRI should be considered.
  • This result demonstrates three risk categories:
    • Overall risk of finding prostate cancer upon repeat biopsy.
    • Percent risk of having low-grade cancer upon repeat prostate biopsy.
    • Percent risk of having clinically significant prostate cancer (greater than or equal to Gleason 7) upon repeat prostate biopsy.

See a sample Confirm MDx results report and learn more about interpreting it.

Men who have a PSA < 20 ng/ml, have low or intermediate grade(Gleason 3+3=6 or 3+4=7) prostate cancer diagnosed via biopsy, and who have not received definitive therapy for their prostate cancer could benefit from the GPS test.

The Genomic Prostate Score test results determine if a patient may be a candidate for interventional therapy or if active surveillance could be appropriate. The test predicts prostate cancer specific metastasis (spread outside the prostate), mortality (death caused by prostate cancer) and risk of harboring adverse pathology.  GPS results are provided as a Genomic Prostate Score (GPS) between 0 and 100. This score can provide information about the:

• Likelihood of freedom from high grade and/or non- organ-confined disease.
• Risk of prostate cancer death within 10 years (0-100%)
• Risk of prostate cancer metastasis within 10 years (0-100%)
• Risk of adverse pathology (>4+3 or pT3+) elsewhere in the prostate

See a sample GPS result report and learn more about interpreting these results.

Men who have a PSA score of less than or equal to 20 ng/ml and have organ confined, less than or equal to Gleason score of 4+3=7 prostate cancer found on biopsy could benefit from the Decipher genomic testing. However, the Decipher Biopsy test may be appropriate for any man post-biopsy regardless of his PSA, Gleason score, or the stage of his cancer to help him and his healthcare provider make a more informed decision about next steps.

The Decipher Biopsy test analyzes 22 RNA biomarkers associated with metastatic progression including: cell cycle progression, immune system activity/response, androgen signaling, metabolism and cancer blood vessel formation potential. Patients should always discuss the results of their test with their physician. In general, results of the Decipher Biopsy test are presented as follows:

• Overall genomic cancer risk
  • Low, intermediate or high risk
• Risk of harboring high-grade disease (0-100%) if you had prostate removal surgery
• Risk of metastasis within 5 years (0-100%)
• Risk of prostate cancer death within 10 years (0-100%)

See a sample Decipher Biopsy test report and learn more about how to read the results.

The Decipher Radical Prostatectomy (RP) test is a tissue-based prostate cancer marker (PCM) that helps high-risk patients and their healthcare providers understand if they may need additional treatment following radical prostatectomy.

The Decipher RP test analyzes 22 RNA biomarkers associated with metastatic progression including: cell cycle progression, immune system activity/response, androgen signaling, metabolism and cancer blood vessel formation potential. In general, results of the Decipher RP test are presented as follows:

• Low risk: 0-.45
• Average risk: .45-.60
• High risk: .60-1.0

The test also reports on the following for each risk category:

• Risk of metastasis within 5 years (0- 100%)
• Risk of prostate cancer death within 10 years (0-100%)

See a sample Decipher RP result report and learn more about interpreting these results. Patients  should always discuss the results of their test with their physician.

Prolaris is a tissue-based prostate cancer marker (PCM) that helps patients and their healthcare providers understand if they may need definitive therapy or if they may be eligible for active surveillance protocol.

Testing with Prolaris is recommended before deciding on prostate cancer treatment options. Any untreated patient diagnosed with localized prostate cancer is a candidate for Prolaris testing, including those who are:

• Newly diagnosed
• Currently on active surveillance

In addition, Prolaris can help make an informed decision about whether or not adding hormone therapy (ADT) may be effective.

The Prolaris Prostate Cancer Prognostic Test analyzes positive cancer tissue from a previous prostate biopsy. The genetic test evaluates a patient’s National Comprehensive Cancer Network (NCCN) risk category as compared to the results of 46-gene expressions, including cell cycle progression genes selected based upon correlation with a patient’s prostate tumor cell proliferation. The Prolaris molecular score measures cell proliferation, not including clinical variables. The score falls between 0 and 10, with 0 being the least aggressive and 10 being the most. The Prolaris Score combined with clinical variables show the 10-year risk of prostate cancer specific mortality on active surveillance (0-100%) and 10-year metastasis risk with definitive treatment (0-100%). See a sample Prolaris test result and learn more about how to interpret these results.

Patients who have mCRPC (metastatic castration-resistant prostate cancer) may consider the AR-V7 test to determine if they will NOT respond to androgen receptor (AR) targeted therapies, such as abiraterone and enzalutamide, and should consider chemotherapy instead.

While patients should always discuss the results of their prostate cancer test with their healthcare provider, in general, a negative test result for the AR-V7 test means they are NOT resistant to androgen-receptor targeted therapy and could consider the treatment. If their test is positive, it means they are resistant to androgen-receptor targeted therapy and may not benefit from this targeted hormonal therapy. If that is the case, the patient and their healthcare provider may consider other treatments such as taxane chemotherapy. See a sample ARV-7 test and learn more about how to interpret the results.