Novel MRI Assessment of Prostate Cancer (VALIDATE-PRO)
Research type
Research Study
Full title
Determination of diagnostic and prognostic VALue, bIological correlates, Diagnostic And TEechnical performance of novel metabolic and microstructural MRI in PROstate cancer (VALIDATE-PRO)
IRAS ID
264330
Contact name
Shonit Punwani
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2020/01/73, UCL Data Protection Registration
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
For 50 years the diagnosis of prostate cancer has been with Prostate Specific Antigen (PSA) blood testing and prostate biopsy. However, this approach resulted in over-diagnosis, over-treatment and missed clinical important cancers. Multi-parametric MRI (mp-MRI) has provided a solution to some of these issues and the National Institute for health and Care Excellence has advocated the use of mp-MRI before biopsy in men with a suspicion for prostate cancer.
However, important challenge challenges remain and the current way we pick up and assess prostate cancer can be improved. mp-MRI can miss significant cancer in around 11% of cases, 30% of positive MRI scans turn out not to have significant cancer at biopsy. Lastly, 34% of mp-MRI lesions are scored as in-determinant which sometimes makes decisions for further investigation and treatment unclear.
There are also difficulties predicting patients who will have progression of their disease or those who will not suffer harm from their cancer. Therefore the development of non-invasive tests and markers that can tell apart aggressive and non-aggressive disease would be extremely useful in deciding what treatment approach suits individual patients.
This study will investigate the use of three different novel MRI methods; Vascular, extracellular and restricted diffusion for cytometry in tumours (VERDICT), Luminal Imaging (LI) and hyperpolarised [1-13C]-pyruvate MRI (HYP-MRI). These scans help us to look at the microstructure as well as the metabolism of prostate tissue and may offer ways to better differentiate aggressive vs non-aggressive disease. These scans will be performed in men with prostate cancer suitable for active surveillance at baseline and 1 year later to assess for prognostic indicators for progression in early prostate cancer.HYP-MRI will also be performed in men undergoing radical prostatectomy for validation of image findings and pathology. Whilst some men will have repeat scanning to asses for the repeatability of these techniques.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
20/EE/0134
Date of REC Opinion
28 Jul 2020
REC opinion
Further Information Favourable Opinion