Inclusion criteria, exclusion criteria and study summary
Every year, 150,000 patients at risk of prostate cancer (PCa) are referred to hospital. Guidelines have recently recommended patients have a multi-parametric MRI (mMRI) before biopsy so those with a negative mpMRI can avoid an invasive biopsy. This is because a negative mpMRI means there is a low chance of there being important prostate cancer. In patients with a suspicious mpMRI, targeted biopsies improve detection of important PCa. We want to further improve this new pathway. First, mpMRI takes 40-minutes due to injection of a dye called gadolinium. This requires medical supervision due to risk of allergic reactions. Many hospitals do not have enough scanner time or expert radiologists to look at all the images. A 15-minute biparametric MRI (bpMRI), without gadolinium, which is less costly might be as accurate as mpMRI. Second, once a patient needs a biopsy the doctor has to estimate where to target the biopsy needle using live ultrasound. This so-called visual-registration targeting requires expertise which is not readily available everywhere. New image-fusion technology overlays MR images onto ultrasound images to guide the biopsy needle better. We want to test if a bpMRI, compared to mpMRI, is as accurate in diagnosing important PCa. We also want to test whether image-fusion is better than visual-registration biopsies. We want to answer both questions in one trial. Patients who need a prostate MRI and agree to participate will first be randomised to mpMRI or bpMRI. If the mpMRI or bpMRI is suspicious, patients will then be randomised to visual-registration or image-fusion targeted biopsy. We will look at the number of patients biopsied, and the numbers diagnosed with important and unimportant PCa. We also want to assess value for money in the NHS.
