The Challenge of Prostate Cancer

Although PSA screening is part of standard of care, its benefits have caused debate in recent years. The ExoDx Prostate test allows for greater confidence to identify high grade prostate cancer (GS7 and above) in patients.



Prostate cancer doctor and patient PSA

Prostate Cancer

Prostate cancer is the most common non-skin cancer in men with close to $12 billion spent annually on the treatment of prostate cancer. Approximately 500,000 biopsies are performed each year on men, many of which are potentially unnecessary.  It has been acknowledged, the clinical challenges in prostate cancer are many and depend on the disease category at patient presentation. It is helpful to view prostate cancer in a series of distinct clinical categories as these categories will define not only the appropriate treatments, but also the current clinical challenges. 

Although prostate specific antigen (PSA) screening for prostate cancer has been a standard of care (SOC) for many years, its benefits have caused debate recently. The United States Preventive Services Task Force (USPSTF) changed its guidelines in 2018 advising men 55-69 years to make an informed choice and discuss with their doctor whether PSA screening is right for them, while recommending against screening for men over 70 years of age. This change in guidance came about after a review of published data of 1.9 million men on the use of PSA testing to screen for cancer based on the potential harms and benefits for PSA screening.

Limitations of PSA might include:

• Low sensitivity and specificity for prostate cancer 

• PSA levels can be increased by benign prostatic hyperplasia (BPH) and prostatic inflammation or lower urinary tract infection 

• When PSA results are in the “gray zone”, other factors such as age, family history, ethnicity and digital rectal examination (DRE) factor into the shared decision-making discussion regarding prostate biopsy 

• PSA cannot distinguish high grade from low grade cancer and is not prostate cancer specific 

The right patient at the right time for biopsy

Importantly the increased detection of prostate cancer has led to over-treatment of indolent clinically insignificant prostate cancer and performance of large numbers of negative biopsies. The ExoDx Prostate Test utilized as a biomarker risk stratification is emerging as an important aspect of clinical practice and utility in the shared decision-making discussion on biopsy.

Challenges of prostate cancer

When there is uncertainty about proceeding with a biopsy, The ExoDx Prostate Test may be a solution. Clinical studies show The ExoDx Test can distinguish high grade prostate cancer vs. low grade prostate cancer, help avoid 27% of biopsies in patients with PSA levels in the gray zone (2-10 ng/mL), improve compliance for biopsy decision, and improve area under the curve (AUC) . ExoDx results can be part of your best practices to send the right patient to the right intervention at the right time. 

The ExoDx Prostate test is intended to enhance the lack of differentiation currently missing from the PSA Test.

As urologists know, there are many limitations of the PSA test, the biggest one is in using the PSA Test to indicate whether a patient may have aggressive prostate cancer (defined as Grade Group 2 or higher) when the results are slightly above two and below 10.  In this “gray zone”, there is a difference in opinion among clinicians, research institutions and even clinical guidelines on what PSA level warrants proceeding with a prostate biopsy.  While PSA testing is routine and part of standard of care (SOC), the USPSTF guidance against PSA testing and conflicting outcomes of 2 clinical trials for PSA screening have created uncertainty in the use of the PSA test alone as a decision tree for proceeding with a prostate biopsy. 


The ExoDx Prostate Test is clear.  It is designed to alleviate the clinical uncertainty that currently exists by providing a standardized approach for assessing a patient’s risk for aggressive prostate cancer.  The results of the test can help urologists and their patients feel confident in the decision to proceed with a biopsy or not.

The 2019 NCCN Guidelines include the EPI Test for early detection in men for both initial and repeat biopsy. See the guidelines.

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