PCA3 urine tests have shown to improve the specificity in prostate cancer diagnosis, and have the potential to reduce the number of unnecessary prostate biopsies and to predict repeat biopsy outcomes. PCA3 is one of the most prostate cancer specific markers available to date.

Although the routine use of serum PSA testing has undoubtedly increased prostate cancer detection, one of its main drawbacks has been its lack of specificity, which results, later, in a high negative biopsy rate. Consequently, a large population of men with chronically elevated serum PSA and one or more negative biopsies has emerged.

Hence the understanding that more accurate tests are needed to help identify which patients are at high risk of developing prostate cancer, and for whom repeat prostate biopsies are mandatory. Quantification of PCA3 mRNA levels in urine was found to help predict the outcome of prostate biopsies. PCA3 is the first RNA-based molecular diagnostic assay and probably the best adjunct to serum PSA for predicting biopsy outcomes. New research methods will continue to emerge, in an attempt to realise an, as yet, unmet need for markers that differentiate indolent from aggressive cancers, to better inform treatment decisions.

It would seem that there are five indications where PCA3 assay can be considered and applied, based on scientific evidence in clinical practice*. The PCA3 assay might be used to guide biopsy decisions in:

• men with an elevated serum total PSA level and one or more previous negative biopsies;
• men with a normal tPSA level and a family history of prostate cancer;
• men with an elevated tPSA level (2.5-10 ng/mL) and no previous biopsy;
• men with an elevated tPSA level and a concomitant urinary condition;
• men diagnosed with prostate cancer, the PCA3 assay could aid in the decision of whether active therapy is needed or active surveillance is appropriate.

For further information about PCA3, or to order Gen-Probe PCA3 Urine Specimen Transport Tubes please contact Annette Wilkinson on 020 7307 7373 or by email  

*BJU Int. 2010 Feb 1;105(4):452-5.

PCA3 Score As the PCA3 score increases the likelihood for positive biopsy increases. As the PCA3 score decreases, the likelihood for a positive biopsy decreases.  The greatest diagnostic utility occurs at a cut-off of 35.   • Highly specific to Prostate Cancer • Non-invasive • Improves diagnosis of Prostate Cancer • Helps reduce the number of unnecessary biopsies