Prolaris Utilities

Prolaris is a prognostic genomic test for prostate cancer, developed to help healthcare professionals predict the aggressiveness of the tumor.

Prolaris is indicated for patients who have been diagnosed with prostate cancer and can help them and their doctors answer some important questions:

• Is active surveillance indicated for the patient or is other treatments necessary?
• Is prostate cancer at risk of developing?
• What are the chances of survival from prostate cancer?

Prolaris performs a direct determination of the molecular biology of the patient's prostate cancer, using the biopsy material already collected to make the histopathological diagnosis.

By measuring the expression levels of genes involved in the proliferation of tumor cells and combining them with clinical parameters such as Gleason score and PSA, Prolaris is able to accurately predict the aggressiveness of the disease.

Prolaris has been validated in large cohorts of patients in both conservative and definitive management settings. Prolaris helps to decide the best treatment option based on the specifics of the tumor under examination.

Precise analysis

Prolaris allows for precise risk stratification by combining PSA and Gleason with an independent gene expression score based on cell cycle proliferation (called “CCP”).

Prolaris is the only test with two validated cutoff values for active surveillance* and multimodal treatment** in untreated patients, respectively.

Prolaris is able to assess risk in all patients with prostate cancer, in any NCCN risk group.

* Lin, Daniel W., et al. “Identification of Men with Low-Risk Biopsy-Confirmed Prostate Cancer as Candidates for Active Surveillance.” Urologic Oncology: Seminars and Original Investigations, vol. 36, no. 6, 2018 

**Tward JD, et al. “Ability of the combined clinical cell-cycle risk score to identify patients that benefit from multi versus single modality therapy in NCCN intermediate and high-risk prostate cancer.” Journal of Clinical Oncology. Vol. 38, no. 6, 2020, pp. 346

** Tward, Jonathan D., et al. “Personalizing Localized Prostate Cancer: Validation of a Combined Clinical Cell-Cycle Risk (CCR) Score Threshold for Prognosticating Benefit from Multimodality Therapy.” Clinical Genitourinary Cancer, vol. 19, no. 4, 2021

Informed decisions

Prolaris helps you confidently prescribe active surveillance or single or multimodal therapy to patients who need it, making informed treatment decisions.

With the prognostic power of Prolaris, trusted by over five million patients worldwide, decisions for the treatment of prostate cancer are supported. In line with the recommendations of national cancer guidelines, Prolaris offers the confidence needed to make effective treatment decisions.

• Recommended by NCCN* and ASCO**
• Five million patients tested
• Multiple clinical validation studies ***

* NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Prostate Cancer. Version 2.2023 – July 17 2023. Accessed July 18 at https://www.nccn.org/professionals/physician_gls/pdf/prostate.pdf

** Eggener, Scott E., et al. “Molecular Biomarkers in Localized Prostate Cancer: ASCO Guideline.” Journal of Clinical Oncology, vol. 38, no. 13, 2020, pp. 1474–1494

*** Cuzick, J, et al. “Prognostic Value of a Cell Cycle Progression Signature for Prostate Cancer Death in a Conservatively Managed Needle Biopsy Cohort.” British Journal of Cancer, vol. 106, no. 6, 2012, pp. 1095–1099

*** Lin, Daniel W., et al. “Identification of Men with Low-Risk Biopsy-Confirmed Prostate Cancer as Candidates for Active Surveillance.” Urologic Oncology: Seminars and Original Investigations, vol. 36, no. 6, 2018

*** Eggener, Scott E., et al. “Molecular Biomarkers in Localized Prostate Cancer: ASCO Guideline.” Journal of Clinical Oncology, vol. 38, no. 13, 2020, pp. 1474–1494

***Cuzick, J, S Stone, et al. “Validation of an RNA Cell Cycle Progression Score for Predicting Death from Prostate Cancer in a Conservatively Managed Needle Biopsy Cohort.” British Journal of Cancer, vol. 113, no. 3, 2015, pp. 382–389

***Tward, Jonathan, et al. “The Clinical Cell-Cycle Risk (CCR) Score Is Associated with Metastasis after Radiation Therapy and Provides Guidance on When to Forgo Combined Androgen Deprivation Therapy with Dose-Escalated Radiation.” International Journal of Radiation Oncology*Biology*Physics, vol. 113, no. 1, 2022

***Brawer, Michael K., et al. “Development and Validation of a Mutivariate Model Combining Cell Cycle Progression Score with Capra to Predict Prostate Cancer Mortality in a Conservatively Managed Cohort.” Journal of Clinical Oncology, vol. 31, no. 6_suppl, 2013, pp. 67–67

Prolaris is Performed in Your Laboratory

● Total execution time (turn around time): 8 hours
● Active time (hands on time): 5 hours

 The Prolaris Report

The Prolaris report always provides a risk assessment for two possible scenarios: active surveillance or definitive treatment. In the example, the patient has a low risk of disease-specific mortality (1.7%) in the case of active surveillance.

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