Overview

Proclarix is an innovative blood-based test designed to assess the risk of clinically significant prostate cancer (csPCa) in men with suspected prostate cancer. The test combines several biomarkers, including thrombospondin-1 (THBS1), cathepsin D (CTSD), total PSA (prostate-specific antigen), and percent free-PSA, alongside patient age, to provide a comprehensive risk score. This score aids in identifying patients who are most likely to benefit from further diagnostic procedures, such as multiparametric magnetic resonance imaging (mpMRI) and prostate biopsies.



Purpose and Clinical Utility

Proclarix is particularly useful for men with serum PSA levels between 2 and 10 ng/mL, prostate volume of 35 mL or more, and a normal digital rectal examination (DRE). By calculating the risk of csPCa, Proclarix helps clinicians make informed decisions about whether to recommend further testing with mpMRI or biopsies. This is especially important in reducing unnecessary procedures, which can lead to overtreatment and the associated risks.


How the Test Works

The Proclarix test utilizes a scoring system that ranges from 0% to 100%, reflecting the likelihood of clinically significant prostate cancer. The score is derived from a combination of specific biomarkers measured in the blood. These biomarkers were identified through advanced proteomics research and have been shown to be involved in the development and progression of prostate cancer.

Benefits of Using Proclarix

Improved Selection for mpMRI and Biopsies

Proclarix has been shown to reduce the number of unnecessary mpMRIs and biopsies by accurately identifying patients with a low risk of csPCa. This helps to avoid the potential harms associated with overdiagnosis and overtreatment of insignificant prostate cancer (iPCa).

High Sensitivity

The Proclarix test is highly sensitive, particularly at the recommended 10% risk threshold. This sensitivity ensures that the majority of significant prostate cancers are detected, while minimizing the number of false positives.

Integration into Clinical Practice

Proclarix can be easily integrated into current diagnostic pathways. When combined with PSA levels and DRE results, it provides a powerful tool for determining the necessity of further testing.

Evidence

Studies have demonstrated that Proclarix is effective in distinguishing between clinically significant and insignificant prostate cancers. For instance, Proclarix has shown a median score of 21.3% in men with benign biopsy results compared to 39.6% in men with prostate cancer. 

Furthermore, the test has been validated in various clinical settings, confirming its utility in different patient populations, including those outside the initial development criteria (e.g., PSA outside the 2-10 ng/mL range or prostate volume less than 35 mL).


Get your Proclarix test

Proclarix represents a significant advancement in the early detection and management of prostate cancer. By providing a more accurate risk assessment, it enables better decision-making, reduces unnecessary procedures, and ultimately improves patient outcomes.


Download the article for more information

The Efficacy of Proclarix to Select Appropriate Candidates for Magnetic Resonance Imaging and Derived Prostate Biopsies in Men with Suspected Prostate Cancer