Prostate Cancer Clinical Trial
Official title:
Prolaris Enhanced Risk Stratification - an ecONomic and clinicAL Evaluation
One in 8 men will be diagnosed with prostate cancer during their lifetime. The majority of
men diagnosed with prostate cancer have early stage disease, which can be managed in a
variety of ways, ranging from monitoring to international treatment. However is it not always
clear which treatment option is best.
All men with newly diagnosed localised prostate cancer are assigned a disease risk category
(low/intermediate/high risk). This is based on clinical findings and prostate biopsy results,
but these factors are limited in their ability to distinguish between aggressive and indolent
prostate cancers. The current risk grouping can make it difficult to plan appropriate
treatment tailored and personalised to the individual patient.
There is evidence reporting overtreatment of localised prostate cancer in the UK. However,
many patients with aggressive disease are wrongly assigned a low risk categorisation and are
recommended surveillance when better suited to more interventional treatment.
Myriad Genetics have developed a test, called Prolaris which measures how fast cells in a
prostate cancer are dividing to assess its aggressiveness. The Prolaris test is performed on
routine prostate biopsy tissue, so patients are not subjected to any additional invasive
investigations.
In this study, led by Leeds Teaching Hospitals NHS Trust, the aim is find out if the
Prolaris® test score helps patients with newly diagnosed prostate cancer and their clinical
team make better informed treatment choices that are tailored to the individual patient.
The aim to achieve a Prolaris risk score for 100 patients and determine the impact it has on
treatment decision making. The research team will look at how the test fits into routine
clinical practice, investigate the clinician and patient views and understanding on the test
report and assess the quality of life of patients in the different risk and treatment groups.
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