Prostate cancer (PCa) is the most common cancer in men. In most cases, PCa does not cause any symptoms. Only a minority of cancers will progress rapidly and are potentially lethal. These need to be detected before they have spread out of the prostate. Prostate biopsy is invasive but the only way to diagnose PCa. Currently prostate specific antigen (PSA) measurement and digital rectal examination (DRE) are used to determine the need for a biopsy. Until today, only a PSA value below the age-specific reference value (of 2.5-6.5 ng/mL) can rule out the need for biopsy. Therefore, to find all the rapidly progressing cancers, the physicians need to recommend prostate biopsies in many men. This has two unwanted consequences. Firstly, prostate biopsy may cause pain, bleeding and infection. Secondly, and more importantly, performing many biopsies may unveil many "indolent" cancers and lead to unnecessary treatment.

Prostate CAncer gene 3 (PCA3) is a new gene-based test carried out on a urine sample. PCA3 is highly specific to PCa and, therefore, in contrast to PSA, not increased by conditions such as benign enlargement or inflammation of the prostate. If you are concerned about PCa because of an elevated PSA or are feeling insecure about a previously performed (negative) biopsy, the PCA3 urine test can provide additional information that may help you and your doctor to decide whether a (new) biopsy is really needed.

This test is now becoming routinely available in European countries like Belgium, France, Germany, The Netherlands and the United Kingdom, where different laboratories are certified to perform this test. No PCA3 test has been cleared or approved by the U.S. Food and Drug Administration (FDA). However, several laboratories in the U.S. are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing.