Prolaris Enhanced Risk Stratification - an ecONomic and clinicAL Evaluation (PERSONAL)

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: William Cross, MRCS; Phone Number: 0113 243 3144; Email: williamcross@nhs.net

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • Recruiting
      • St James's University Hospitals NHS Trust
      • Contact: William Cross, MRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Men who have a diagnosis of prostate cancer on their prostate biopsy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolaris test outcome received via report.	Results of the test received.	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.	30-60mins

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Anticipated): October 30, 2020
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 28, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: UR17/104867

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No