Prostate Assessment using Comparative Interventions – Fast MRI and Image-fusion for Cancer (PACIFIC)

One of the main methods to diagnose prostate cancer is a special type of Magnetic Resonance Imaging (MRI) scan called a multi-parametric MRI (mpMRI) scan, which helps doctors see if there is any cancer inside the prostate and how quickly the cancer is likely to grow. The procedure involves an injection of a dye called gadolinium through a small plastic tube into a vein in of the arm. This helps to show up the body’s organs more clearly. The mpMRI scan takes 40 minutes and costs £350 to £450. Administration of gadolinium requires further medical supervision due to the risk of anaphylactic shock. 

One arm of the new trial will look at the effectiveness of using Bi-parametric MRI (bpMRI), a shorter type of MRI scan that uses the same device to image the prostate to detect signs of cancer.  Instead of 40 minutes, it takes 15 minutes and does not involve a gadolinium injection and costs £200. 

Primary objective - randomisation 1

To determine whether biparametric MRI (bpMRI) could be recommended as an alternative to multiparametric MRI (mpMRI) for the detection of clinically significant prostate cancers in patients at risk.

Men who have a suspicious MRI are referred for a biopsy, which involves using thin needles to take small samples of tissue from the prostate. This is then looked at under a microscope to check for cancer.  The current method relies on a doctor’s judgement to guide where to place the biopsy needle. This could mean that cancers are missed as samples may be taken from an area that does not contain the cancer.

The second part of the trial will use image fusion technology, which merges MRI and ultrasound images of the prostate to help identify the target area for biopsy. The technology is able to guide the biopsy needle to within two-three millimetres accuracy. Experts think that this technology might be more accurate at detecting prostate cancer than traditional methods but no large studies have previously been carried out to confirm this.

Primary objective - randomisation 2

To determine whether image-fusion targeted biopsy is better than visual-registration (cognitive) targeted biopsy at detecting clinically significant prostate cancers in patients requiring prostate biopsy due to a suspicious MRI.