Clinical trial NCT03851211: Prolaris Enhanced Risk Stratification - an ecONomic and clinicAL Evaluation
Official title: Prolaris Enhanced Risk Stratification - an ecONomic and clinicAL Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men who have a diagnosis of prostate cancer on their prostate biopsy.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* Clinical suspicion of prostate cancer
* 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:

* Men with locally advanced, clinical node positive or metastatic disease
* Patients who lack capacity to consent to study participation
* Non-adenocarcinoma prostate cancer histology

Primary outcomes:
measure: Prolaris test outcome received via report.
timeFrame: 30-60mins
measure: Treatment counselling
timeFrame: 30-60mins
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: St James's University Hospitals NHS Trust
state: West Yorkshire
Study officials:
References: