What is Prostate Cancer?

Prostate cancer is cancer that occurs in the prostate – a small walnut shaped gland in men below the bladder and in front of the rectum, which produces the seminal fluid that nourishes and carries the sperm. Prostate cancer is the second most common cancer in men worldwide, and the incidence, morbidity, and mortality rates vary among men by race and ethnicity in the U.S. Regardless of your race or ethnicity, if you have an elevated prostate-specific antigen (PSA) value, you may be at risk for prostate cancer.


Early detection is key. When detected early, there is nearly a 99% survival rate compared to men with advanced disease. Usually, prostate cancer grows slowly and is initially confined to the prostate gland and will not cause harm while some prostate cancers grow and spread quickly and need aggressive treatment.

What Detection Options Exist?

While PSA is commonly used as a screening tool, the PSA test cannot tell which prostate cancers can be safely left alone and which need aggressive treatment. It is therefore important to understand the difference between aggressive or clinically insignificant prostate cancer.

The gold standard for detecting Prostate Cancer is achieved by performing a prostate biopsy: an outpatient procedure that takes 15-30 minutes. While reasonably well tolerated in most men, about 40% of prostate biopsies can be associated with discomfort and complications, such as bleeding, infection, urinary incontinence, and sexual dysfunction.

It is established that 70-80% of prostate biopsies show no cancer or clinically insignificant slow growing cancers. Men diagnosed with prostate cancer can find out by taking a simple, non-invasive urine test that will tell them their risk (low vs. high) of having aggressive clinically significant prostate cancer. Learn about the EPI-CE Test

Prostate cancer PSA screening

The EPI-CE Test is Different

The EPI-CE Test is different in that the biomarkers that are analyzed are cancer-specific and the results indicate a patient’s risk for having aggressive prostate cancer. The EPI-CE test is based on the well-established ExoDx Prostate test which has successfully operated from the ExosomeDx CLIA facility in the U.S. since 2016.  The U.S. EPI test was validated in two separate studies with 1,022 men to determine its reliability. To date, the U.S. EPI test has provided guidance to over 60,000 men, based in the US, in their decision to proceed with a prostate biopsy.

What is the difference between slow-growing and aggressive prostate cancer?

There is a big difference between slow-growing (clinically insignificant or indolent) and aggressive (clinically significant) prostate cancer. The PSA Test has no way of differentiating these two types of prostate cancer.

  • Slow-growing prostate cancer can be present in the body and never give rise to symptoms or lead to death during an individual’s lifetime
  • Aggressive prostate cancer may grow quickly and can metastasize and spread to other parts of the body. These aggressive prostate cancers, if caught early can potentially save lives.

The result of the EPI-CE test can help a man understand his risk of having an aggressive prostate cancer.

How Many Biopsies Are Performed Each Year in the European Union?

More than 1 million initial diagnostic prostate biopsies are performed annually in the European Union. Only about 25 percent of men who have a prostate biopsy due to an elevated PSA level have aggressive prostate cancer. The remaining 75 percent have low-grade disease that may remain slow-growing or are found to not have cancer at all (benign). Serious complications associated with the prostate biopsy, including infection and hospitalization, are concerns that should be discussed with the doctor.


Despite the high prevalence of low-risk disease, approximately 50 percent of men are still treated with surgery or radiation at diagnosis. Aggressive treatment is often associated with significant, often long-term complications including impotence and incontinence.