Prostate Imaging using MRI +/- contrast Enhancement (PRIME)
Research type
Research Study
Full title
A study assessing whether bi-parametric MRI is non-inferior to multi-parametric MRI in the diagnosis of clinically significant prostate cancer
IRAS ID
282789
Contact name
Veeru Kasivisvanathan
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Z6364106/2020/09/60 health research , Data Protection Number
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
The standard way of diagnosing prostate cancer is to carry out a multiparametric prostate MRI scan and prostate biopsy. This type of MRI scan normally involves an injection of contrast into one of your veins.
Another type of MRI scan (biparametric) can be performed that does not require contrast, and therefore does not require the insertion of a cannula. We currently do not know for certain whether using this type of MRI will allow us to detect the same, more or less prostate cancer than if we use the standard (multiparametric) type of MRI. Current evidence supports the idea that using biparametric MRI may detect a similar amount of cancer to when it is not used but one advantage is it may allow a man to have a scan without contrast.
The main purpose of this study is to assess if biparametric MRI can provide similar information to multiparametric MRI. You will undergo a multiparametric MRI with a contrast injection, which is the typical method used for investigating the prostate for the presence of cancer. The doctor reviewing your scan will be asked to review the MRI scan in a particular order so that they can tell whether the additional information given by the contrast injection helps identifies prostate cancer.
If there is a suspicious area in the prostate on the MRI, a few biopsies can be directed at where the suspicious area is thought to be, also using an ultrasound probe in the back passage. If there is no suspicious area on the MRI and if you at low risk of harbouring cancer, which occurs in about 30% of men, then no biopsy will be taken at all.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
21/WM/0091
Date of REC Opinion
27 May 2021
REC opinion
Further Information Favourable Opinion