PROMIS

What was this study about?

There are over 40,000 new cases of prostate cancer each year in the UK. The dramatic increase in diagnoses over the last 20 years is mainly due to serum Prostate Specific Antigen (PSA) testing in healthy men. At present, men with a raised PSA level are usually advised to have a transrectal ultrasound (TRUS) guided biopsy. Most men undergoing TRUS biopsy will not have prostate cancer and sometimes these biopsies can miss cancers or underestimate how serious they are. However, at the present moment, TRUS biopsy is the standard of care for men with a raised PSA who are advised, and agree to have, further investigations.

PROMIS tested the value of Multi Parametric Magnetic Resonance Imaging (MP-MRI) for men with a suspicion of prostate cancer who had been recommended to have a prostate biopsy. It investigated whether MP-MRI could be used (i) to advise whether or not men might safely avoid biopsy and (ii) to help us do better biopsies for men who have them.

The study involved all men attending 4 hospital visits over approximately 4 months (see also the trial schema at the bottom of the page):

1. Registration - to check eligibility and obtain consent
2. MRI scan
3. Combined Biopsy Procedure (CBP)
4. Follow up - patients find out and discuss the results of the MRI scan and biopsies with a clinician.

Men who participated in PROMIS had 2 biopsies. This was called the Combined Biopsy Procedure (CBP). The CBP was performed under general or spinal anaesthetic and included both a template prostate mapping (TPM) biopsy and a TRUS biopsy. TPM is a more accurate biopsy which is not usually offered to patients. It involves taking biopsies from the whole prostate. TPM was included so that we could compare the results of the MRI scans with a more accurate biopsy (TPM) and the current standard (TRUS). The MRI scans, TPM and TRUS biopsies were assessed independently.

A total of 740 men were registered into the study between March 2012 and October 2015 and of these, 576 underwent all 3 tests according to the trial protocol.

What difference did this study make?

The PROMIS results were published in the Lancet in January 2017.

PROMIS demonstrated the following:

1. TRUS is a poor test for the diagnosis of clinically significant prostate cancer. The sensitivity was only 48% and thus missed over half the cases.

2. mp-MRI is a highly sensitive test (93%) for the detection of clinically significant cancer and if performed prior to the biopsy, it can identify about 25% of men who might safely avoid a biopsy.

3. A subsequent cost effectiveness analysis demonstrated that performing an mp-MRI scan prior to biopsy was highly cost effective.

An imaging dataset from the PROMIS study has been curated by the National Cancer Imaging Translational Accelerator (NCITA) in partnership with the ReIMAGINE Consortium. Read more about it in this link.

Type of study

Non-randomised trial

Who funded the study?

This project is funded by the NIHR Health Technology Assessment programme (project number 09/22/67) and will be published in full in Health Technology Assessment. The views and opinions expressed therein and in any media associated with this study are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, NHS or the Department of Health.