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Home » EU Health, Health, Prostate Cancer

Identifying patients with early prostate cancer

Submitted by on 28 Sep 2015 – 09:07

As newly diagnosed men can have either aggressive or indolent tumors, Dr Colin R W Hayward, European Medical Director, Myriad Genetics says There is a clear need to further personalize initial management approaches for men diagnosed with early prostate cancer

Working towards an EU-wide telehealthThere is no question that prostate cancer is a leading cause of death in men in Europe – there are ~ 400,000 newly diagnosed cases in every year with over 90,000 deaths annually.The increasing use of prostate-specific antigen (PSA) testing has potentially resulted in an increase in prostate cancer diagnoses. However, it is clear that newly diagnosed men can have either aggressive or indolent tumors. Current clinical and pathologic features are limited in their ability to distinguish between the two.

Despite the risk of treatment-related complications and the fact that many prostate cancers do not cause death even when initial management is conservative, the choice for many men and their physicians will be definitive treatment (such as radical prostatectomy, radiation therapy, androgen deprivation therapy, or some combination thereof). These treatments are associated with significant morbidity and reduced quality of life for patients undergoing these therapies.

A recent study from 5 European countries (Germany, Italy, Spain, Switzerland and UK) showed that even in patients with low-risk disease, radical therapy was considered in 80% of patients. herefore, there is a clear need to further personalize initial management approaches for those men diagnosed with early prostate cancer.

The Prolaris Test
Given this current state of clinical uncertainty, Myriad Genetics developed Prolaris, a novel
prognostic test that directly measures tumor biology in order to accurately stratify patients with localized prostate cancer according to disease aggressiveness. The test combines the RNA expression levels of 31 genes involved in cell cycle progression and 15 housekeeping genes to generate a Prolaris Score. Prolaris has been proven in a number of published validation studies to be the most powerful variable for predicting long-term oncological outcomes, including 10-year prostate cancer progression and 10-year disease-specific mortality.

Studies assessed not just its prognostic performance, but also its superiority to existing clinico-pathologic variables. Results from these cohorts demonstrate that, within each clinical risk group (D’Amico or AUA) – low, intermediate, and high – Prolaris provides further stratification of the risk of prostate cancer death for individual patients.

Clinical Impact of Prolaris on Patient Care
Since Prolaris gives greater insight into the indolence or aggressiveness of the cancer, its results are directly impactful for clinical management. In many cases, Prolaris results predict a low-risk cancer, and more physicians and patients respond to this information by electing to avoid unnecessary invasive interventions.

In some cases, where less aggressive therapy was planned based upon clinical features, Prolaris identifies a more aggressive cancer, where interventions have more potential benefit for the patient. In a pivotal clinical utility study, physicians used the more accurate risk stratification provided by Prolaris to change their treatment plan in 65% of cases. Overall, there was a 50% reduction in recommendations for surgical intervention and a 29% reduction in recommendations for radiation treatment.

Conversely, physicians increased their use of interventional treatment in 23% of cases as warranted by the Prolaris Score. The findings of this prospective study are very similar to those previously obtained in a retrospective study. Together, these results provide convincing evidence that the use of Prolaris addresses a previously unmet need in clinical decision making. The pattern of prostate cancer aggressiveness seen above is very similar to that seen in the EMPATHY-P study where the levels of aggression of prostate cancer of European men was assessed using Prolaris. In this study 51.6% of patients tested with Prolaris had a more or less aggressive cancer than would be expected using clinical criteria alone.In recent health economic analyses of the clinical utility studies, the use of Prolaris has been shown to be dominant – i.e. cost saving for healthcare systems – by reducing the number of unnecessary interventions.

In summary, Prolaris has been shown in multivariate analysis, to be the most predictive variable for predicting risk of prostate cancer progression defined by 10-yr mortality in a biopsy cohort. Prolaris can be used allowed for personalized risk stratification independent of Gleason score or PSA, identifying low-risk patients who are good candidates for active surveillance and high-risk patients who may require more aggressive treatment

References:
EUCAN database accessed July2015. http://eco.iarc.fr/eucan/CancerOne.aspx?Cancer=29&Gender=1
Welch HG et al. Prostate cancer diagnosis and treatment after the introduction of prostate-specific antigen screening: 1986–2005. J Natl Cancer Inst. 2009
Carter HB et al. Early detection of prostate cancer: AUA Guideline. J Urol. 2013
Cooperberg MR et al. Multiinstitutional validation of the UCSF cancer of the prostate risk assessment for prediction of recurrence after radical prostatectomy. Cancer. 2006
EMPATHY-P study. Myriad data on file 2015.
Cuzick J et al. Transatlantic Prostate Group. Prognostic value of an RNA expression signature derived from cell cycle proliferation genes in patients with prostate cancer: a retrospective study. Lancet Oncol. 2011
Cuzick J et al. Transatlantic Prostate Group. Prognostic value of a cell cycle progression signature for prostate cancer death in a conservatively managed needle biopsy cohort. Br J Cancer. 2012
Cooperberg MR et al. Validation of a cell-cycle progression gene panel to improve risk stratification in a contemporary prostatectomy cohort. J Clin Oncol. 2013
Freedland SJ et al. Prognostic Utility of Cell Cycle Progression Score in Men With Prostate Cancer After Primary External Beam Radiation Therapy. Int J Radiat Oncol Biol Phys. 2013
Bishoff JT et al. Prognostic utility of the CCP score generated from biopsy in men treated with prostatectomy. J Urol. 2014 [Epub ahead of print]
Crawford ED et al. Cell cycle progression score and treatment decisions in prostate cancer: Results from an ongoing registry. Curr Med Res Opin. 2014
Shore N et al. Clinical utility of a biopsy-based cell cycle gene expression assay in localized prostate cancer. Curr Med Res Opin. 2013