PERSONAL Study
Research type
Research Study
Full title
Prolaris Enhanced Risk Stratification – an ecONomic and clinicAL evaluation
IRAS ID
242067
Contact name
William Cross
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Clinicaltrials.gov Identifier
UKPR01, Myriad Genetics Funder Reference
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
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 interventional 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, we want to 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.
We aim to achieve a Prolaris risk score for 100 patients and determine the impact it has on treatment decision making. We 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.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
18/YH/0395
Date of REC Opinion
30 Nov 2018
REC opinion
Further Information Favourable Opinion