MARKERS AND TESTS
Prostate cancer markers are making an impact on the world of prostate cancer by helping to individualize patient care in the early detection, diagnosis and treatment choices for prostate cancer.
Through advanced science researchers from many different institutions and companies have developed a variety of tests that look at each person’s genes or biomarkers and help to determine individual risk for having prostate cancer, the need for biopsies or repeat biopsies and often the best course of treatment.
Screening and Early Detection
Who to Biopsy
Who to Treat
Who Would Benefit From Additional Testing
Ongoing Testing
Genetic Testing
Markers & Tests for Early Detection of Prostate Cancer
PSA
Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. The PSA test measures the level of PSA in a man’s blood. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate cancer or other prostate disorders.
SelectMDx
Helps identify patients at increased risk for aggressive disease, thereby aiding in the selection of men for prostate biopsy who have never had biopsy. It is performed on post-DRE urine to measure the genes DLX1 and HOXC6 using KLK3 as the reference point.
phi
This is a combination of 3 blood tests, tPSA, fPSA and proPSA tests, to develop a score. It is approved by the FDA and used in men with PSA values of 4-10ng/ml. The optimal PHI cutoff score is 24 and can predict aggressive prostate cancer. It was studied that the use of PHI helped determine the need for biopsies. It is an option both before and after the biopsy.
4Kscore
The 4Kscore Test is a blood test that provides a patient-specific probability for finding a aggressive (Gleason score 7 or higher) prostate cancer upon biopsy. The information can be used by the Urologist to have an informed discussion with the patient about whether or not to have a prostate biopsy. The 4Kscore Test measures four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, digital rectal exam, and prior biopsy results(if available). However, no optimal cutoff threshold is known.
ERG Protein Tissue Marker
Development of an ERG protein assays to be utilized on prostate cancer biopsy tissue is also underway. Presence of the ERG protein in tissue helps to identify patients who have prostate cancer. Additionally, the presence of ERG in high grade PIN (pre-cancerous lesion) is indicative of a patient more likely to be diagnosed with cancer upon the next biopsy.
ExoDX Prostate (intelliscore)
this test evaluates 3 biomarkers using urine sample, PCA3, ERG to predict the aggressiveness of the prostate cancer. It is used in patients who have no prior biopsy with a PSA value of 2-10ng/mL aged >50years.
IsoPSA
This is a blood test that is used to detect PSA in different forms. This is done before biopsy or in patients with negative biopsy results with higher risk of developing aggressive prostate cancer.
MyProstateScore
This test measures the total blood PSA, PCA3 and the TMPRSS2:ERG found in urine to determine the risk of developing aggressive prostate cancer
Markers & Tests for Determining Who to Repeat Biopsy
ConfirmMDx
For men with an initial negative biopsy, independently published clinical studies have shown that the ConfirmMDx test is the most significant, independent predictor of patient outcome relative to other available clinical factors such as age, PSA and DRE results.
4Kscore
The 4Kscore Test is a blood test that provides a patient-specific probability for finding an aggressive (Gleason score 7 or higher) prostate cancer upon biopsy. The information can be used by the Urologist to have an informed discussion with the patient about whether or not to have a prostate biopsy. The 4Kscore Test measures four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, digital rectal exam, and prior biopsy results(if available). However, no optimal cutoff threshold is known.
Markers & Tests for Determining Who to Treat for Prostate Cancer
Oncotype DX
The Oncotype DX Prostate Cancer Assay harnesses the power of genomics to provide a more precise and accurate assessment of risk based on individual tumor biology.
Prolaris
Prolaris is a measure of how fast a prostate cancer tumor is growing. Biopsy tissue samples can be used to determine a patient’s personal Prolaris Score. Studies have shown that Prolaris provides an accurate assessment of cancer aggressiveness.
P10
Most studies have found that PTEN loss is a powerful predictor of which prostate tumors are likely to recur or metastasize,” says urologic pathologist Tamara Lotan, M.D.
ProMark
On September 10, 2013, Metamark announced positive results from a large clinical validation study of ProMarkTM, its biopsy-based prostate cancer prognostic test. The study met its primary endpoint demonstrating that ProMarkTM, evaluated in standard formalin-fixed, paraffin-embedded prostate tissue, can differentiate indolent from aggressive disease.
Markers & Tests for Determining Who Would Benefit from Additional Treatment
Prolaris
Prolaris is a measure of how fast a prostate cancer tumor is growing. Biopsy tissue samples can be used to determine a patient’s personal Prolaris Score. Studies have shown that Prolaris provides an accurate assessment of cancer aggressiveness.
Decipher
The Decipher 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.
Markers & Tests for Ongoing Testing
PSA
Prostate-specific antigen, or PSA, is a protein produced by cells of the prostate gland. The PSA test measures the level of PSA in a man’s blood. PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate cancer or other prostate disorders.
Testosterone
In men, testosterone plays a key role in the development of male reproductive tissues such as the testis and prostate as well as promoting secondary sexual characteristics such as increased muscle, bone mass, and the growth of body hair.
Circulating Tumor Cells
Circulating tumor cells (CTCs) are cells that have shed into the vasculature from a primary tumor and circulate in the bloodstream. CTCs thus constitute seeds for subsequent growth of additional tumors (metastasis) in vital distant organs, triggering a mechanism that is responsible for the vast majority of cancer-related deaths.
Markers & Tests for Genetic Testing
Genetic Testing
Genetic counseling before and after genetic testing is very important. Genetic testing plays an important role in identifying who is at risk for certain disease, who is at risk for more aggressive disease and often genetic testing can play a critical role in determining the best and most effective treatment options. In prostate cancer specifically, identifying genetic mutations of inherited prostate cancer has implications for a man’s risk of prostate cancer, the risk of more aggressive disease and to personalize treatment options. Additionally, there may be an impact on families, if certain gene mutations are found it may be important that family members are also tested.