An observational study in Prostate Cancer, sponsored by The Leeds Teaching Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2019-02-28.
Sponsored by The Leeds Teaching Hospitals NHS Trust · Observational
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men who have a diagnosis of prostate cancer on their prostate biopsy.
Exclusion Criteria:
Prolaris test outcome received via report.
Results of the test received.
Time frame: 30-60mins
Treatment counselling
Feedback of the results of the prolaris test. Consultant Urologist will see each participant in clinic after receipt of the Prolaris test report. They will explain the results to the patient and the patient will have the opportunity to ask any questions that they may have. The patient will then be able to decide on their treatment option.
Time frame: 30-60mins
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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The Leeds Teaching Hospitals NHS Trust