PCA3 Test – For Patients

Prostate cancer has been at the forefront of DiagnoCure’s R&D projects since the Company first in-licensed PCA3 in 2000. PCA3 is a genetic marker believed to be more accurate for the diagnosis of prostate cancer than the currently used diagnostic test, PSA (prostate specific antigen).

Why a new diagnostic test for prostate cancer?

  • Unlike PSA, the PCA3 result is not elevated when a man suffers from a disease that increases the size of his prostate gland such as benign prostatic hyperplasia or BPH.

    The prevalent prostate cancer diagnostic routine today starts with an annual PSA test and digital rectal examination (DRE) for men over age 50. As men age, close to 90% of them will develop a condition known as BPH (benign prostatic hyperplasia), in which their prostate gland increases in size. But this does not necessarily mean that they have cancer. Data from numerous studies have shown that PSA values increase in men with BPH and this creates a dilemma for these men and their physicians, who rightly ask: “Do I really have cancer?” Unlike PSA, research studies suggest that the PCA3 score does not increase with the size of the prostate gland.
  • PCA3 may be more accurate than PSA to help identify the likelihood of prostate cancer

    Today, the standard of care after the finding of an elevated PSA (over 4ng/ml) or a suspicious DRE is a prostate biopsy where from 6 to 24 16-gauge needles are inserted transrectally into the prostate gland to extract tissue for pathology analysis. For up to 70% of men with an elevated PSA, no cancer is found in the biopsy samples. These men are left to wonder if the elevated PSA was due to BPH or if the biopsy missed cancer. They also cannot depend on PSA testing to detect the development of prostate cancer in the future. As a result of testing men with PSA over the past 15 years, as many as 20 million men alive today face this dilemma, with all the anxiety that such a situation may cause. Preliminary data shows that PCA3 may be more specific for prostate cancer than PSA, thus decreasing the likelihood of false positive results.

Scientists and healthcare practitioners are starting to recognize the potential benefits of the PCA3 marker in the diagnosis of prostate cancer.  More than 50 scientific reviewed have been published to date.  Just in 2010, PCA3 was shown to be clinically useful to predict the outcome of a repeat or an initial prostate biopsy.  In one European study, PCA3 could have reduced the number of prostate biopsies by 40% while missing only 5% of the aggressive cancers at the initial diagnosis.

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