Prolaris Enhanced Risk Stratification - an ecONomic and clinicAL Evaluation
NCT ID: NCT03851211
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-02-21
2020-10-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Able to provide informed written consent
* No contraindication to prostate biopsy
* Newly diagnosed treatment-naive patient with histologically proven localised adenocarcinoma of the prostate
* Low or intermediate D'Amico risk prostate cancer
* Sufficient quantity and quality of tissue remains from biopsy to perform genomic testing
* No contraindication to radical treatment if diagnosed with localised prostate cancer
* Estimated life expectancy \>10 years
Exclusion Criteria
* Patients who lack capacity to consent to study participation
* Non-adenocarcinoma prostate cancer histology
18 Years
100 Years
MALE
No
Sponsors
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The Leeds Teaching Hospitals NHS Trust
OTHER
Responsible Party
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Locations
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St James's University Hospitals NHS Trust
Leeds, West Yorkshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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William Cross, MRCS
Role: primary
Other Identifiers
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UR17/104867
Identifier Type: -
Identifier Source: org_study_id