Exploiting Image-based Risk Stratification in Early Prostate Cancer to Discriminate Progressors from non-Progressors (RECONCILE)
What is the purpose of this study?
Prostate cancer is the most common cancer in men. At the moment we do not fully understand how prostate cancer develops, why some prostate cancers grow and others do not, and which cancers are better served with early treatment or active surveillance.
A large proportion of prostate cancer patients diagnosed with Gleason 7 intermediate risk disease represent a challenge in risk-stratification and treatment planning. Such disease is eligible for active surveillance as a standard of care management option. Many do not progress during surveillance or with local treatment alone, but the risk of progression remains.
RECONCILE will address this risk by using radiological progression, the first significant and identifiable progression event, to identify cancers that progress and are therefore considered to be clinically important. This will allow us to derive baseline molecular, biological and radiological characteristics associated with cancers that progress. We will use this information to develop a new baseline risk stratification model.
In order to achieve this, we will follow a population of patients with localised Gleason 7 disease from baseline multiparametric magnetic resonance imaging (mpMRI), targeted biopsy, biological and genomic testing to repeat tests at one year. These two time points are necessary to compare data and identify important changes over time. Markers which are associated with cancers that grow more quickly and more slowly will be identified.
Why is this research being done?
As reported in U.K. National Guidelines that were updated in 2019, current evidence does not show a difference in the number of deaths from prostate cancer among people managed with active surveillance, prostatectomy or radical radiotherapy during 10 years of follow up. The information gathered within RECONCILE will enable us to predict more accurately how prostate cancers behave. This means that in the future we will be able to offer bespoke treatment for prostate cancer based upon how likely, and how quickly, it is to grow. Patients with prostate cancer which is not likely to progress will therefore be spared the side effects associated with biopsy and invasive treatments, whereas those with cancer that is likely to grow and progress will be offered treatment at an earlier stage.
What are the benefits of taking part in the study?
The side effect profile of radical treatment, either surgery or radiotherapy for prostate cancer, is well recognised and associated with a significant risk of urinary incontinence, erectile dysfunction and bowel function alteration. This led to the wide uptake of active surveillance as a management option for very low grade, low volume prostate cancer.
RECONCILE’s aim of risk re-stratification at diagnosis will ensure that we can more accurately identify progressors and non-progressors, therefore ensuring that optimal management options are offered to each group by minimising risks associated with unnecessary intervention.
Who is being included in the study?
The RECONCILE team aims to recruit 60 participants from a single NHS centre, University College London, who chose active surveillance as a standard of care option for biopsy proven prostate cancer Gleason 7 concordant with a mpMRI lesion. RECONCILE is running alongside the ReIMAGINE study which is currently recruiting at our centre. ReIMAGINE requires donation of prostate biopsy tissue, urine and blood in a population undergoing targeted biopsy of prostatic lesions observed on mpMRI. ReIMAGINE patients may also be eligible for RECONCILE.
What is the status of the study?
The RECONCILE study is currently in the set-up phase and is not yet open for recruitment.
Who is carrying out the study?
The study is being conducted by University College London, who is the sponsor of the research. The study is funded by J P Moulton Charitable Foundation.
If I have any questions, who can I contact?
If you have any questions, please contact your hospital medical team. You can also contact us by email at dsis.reconcile@ucl.ac.uk
For more information, see the RECONCILE study record on ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04340245