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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Jeremy
Clark
Jeremy.clark@uea.ac.uk
Paul
Jackson
paul.r.jackson@uea.ac.uk
Dr
Jeremy
Clark
Jeremy.clark@uea.ac.uk
Malignant neoplasms of male genital organs
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Cancer is present in the prostates of around half of all men over 60, however only a very small proportion of these men will die of prostate cancer. There is therefore a need to determine which men have cancer that needs treating and which does not require treatment. The progression of prostate cancer is highly heterogeneous, with risk assessment at the time of diagnosis considered as a critical step in the management of this disease. Sampling issues associated with needle biopsy of the prostate have prompted the development of non-invasive urine tests for aggressive disease which examine prostate-derived material harvested in urine.
We are proposing the use of urine to detect aggressive prostate cancer. The prostate constantly produces secretions which naturally flow into the urine. These secretions carry cancer markers and are flushed out of the body on urination. We can collect these markers from urine and examine them for the presence of prostate cancer as well as determining how aggressive the cancer is.
Our hypothesis is that urine expression signatures obtained from urine can be used to predict clinical outcome in prostate cancer patients adding clinical benefit in pre-biopsy patients and helping triage active surveillance (AS) patients into groups with high and low risk of progression. We also hypothesis that use of home-sample collection from the first urination of the day without a DRE can substitute for post-DRE collection at the clinic (confirmed in a pilot study).
Using a cohort of 537 samples taken from 503 patients we have developed a test called PUR (Prostate Urine Risk), based on NanoString assessment of RNA expression levels in urine extracellular vesicles (EVs), that allows the probability of membership of each D'Amico risk group to be assessed prior to needle biopsy. The test was developed in a Training Cohort (n=359) and confirmed in a Test Cohort (n=178).
PUR signatures that have shown efficacy in predicting prostate cancer biopsy results. A particularly effective application of the PUR test was in predicting failure in Active Surveillance (AS) patients. In a pilot study of 87 AS men, PUR could dichotomise the men into those that would progress up to 5 years later with a Hazard ratio >8. There is nothing currently in the clinic that can do this. In AS patients PUR still had predictive value after MRI monitoring was considered. In the proposed study we will (i) validate the use of urine collected by the patient at home from their first urination of the day, (ii) test a simplified method of harvesting EV RNA and (iii) confirm the observations in our initial studies of the predictive value of PUR, including prognosis within AS cohorts. The study will involve the collection of urine from patients, from 8 UK NHS hospitals, 3 EU sites and 1 Canadian. The PUR test was developed as part of the Movember GAP1 Biomarker Initiative. This study is designed to provide information that will progress the future implementation of the PUR test in the clinic as an aid in shared decision making between patients and clinicians.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Observational type: Validation of outcome measures;
You can take part if:
You may not be able to take part if:
Male patient post-prostate cancer treatment such as radical surgery or radiotherapy Patients who are unable to consent for any reason will be excluded.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Paul
Jackson
paul.r.jackson@uea.ac.uk
Dr
Jeremy
Clark
Jeremy.clark@uea.ac.uk
Dr
Jeremy
Clark
Jeremy.clark@uea.ac.uk
The study is sponsored by University of East Anglia and funded by PROSTATE CANCER UK .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
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for Trial ID: CPMS 47442
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