PROMIS - Prostate MRI Imaging Study: Evaluation of Multi-Parametric Magnetic Imaging in the Diagnosis and Characterisation of Prostate Cancer
Can MRI improve the diagnosis of prostate cancer?
What is 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 will test the value of Multi Parametric Magnetic Resonance Imaging (MP-MRI) for men who have been recommended to have a prostate biopsy. It will investigate whether MP-MRI can 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 involves all men attending for 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 participate in PROMIS will have biopsies. This is called the Combined Biopsy Procedure (CBP). The CBP will be performed under general or spinal anaesthetic and includes both a template prostate mapping (TPM) biopsy and a TRUS biopsy. TPM is a more accurate biopsy which is not usually offered to patients at present. It involves taking biopsies from the whole prostate. TPM is included so that we can 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 will be assessed independently.
Overall, we hope this will improve the future accuracy of prostate cancer diagnoses and the subsequent management and treatment of patients.
Who is included?
Men currently advised to have a prostate biopsy
When is it taking place?
PROMIS began recruitment in March 2012 and will continue until 2015.
Where is it taking place?
PROMIS is divided into a pilot phase and a main phase. The pilot phase was run in two centres and the main phase will be conducted at approximately 6-9 UK centres in total (including the original pilot centres)
The following centres have been pre-selected:
-University College London Hospital NHS Foundation Trust (original pilot centre)
-North Hampshire Hospitals NHS Trust (original pilot centre)
-Imperial College Healthcare NHS Trust
-Royal Marsden NHS Foundation Trust
-North West London Hospitals NHS Trust
-Brighton and Sussex University Hospitals NHS Foundation Trust
Who is funding 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.
|Type of study:||Non-randomised trial|
|Status:||Open to recruitment|
|Study start date:||2012|
|Study end date:||2015|
|Registrations achieved:||148, as of October 2013|
|Also included in this study:||Health Economics|
Quality of life outcomes
NHS Information Centre flagging
|Chief investigator:||Professor Mark Emberton|
|Sponsor:||University College London|
|Inclusion criteria:||1. Men at risk of prostate cancer who have been advised to have a prostate biopsy |
2. Serum PSA =/<15ng/ml within previous 3 months
3. Suspected stage = T2 on rectal examination (organ confined)
4. Fit for general/spinal anaesthesia
5. Fit to undergo all protocol procedures including a transrectal ultrasound
6. Signed informed consent
|Exclusion criteria:||1. Previous history of prostate biopsy, prostate surgery or treatment for prostate cancer (interventions for benign prostatic hyperplasia/bladder outflow obstruction is acceptable)|
2. Evidence of a urinary tract infection or history of acute prostatitis within the last 3 months
3. Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR =50)
4. Any other medical condition precluding procedures described in the protocol
5. Previous history of hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
6. Treated using 5-alpha-reductase inhibitors at time of registration or during the prior 6 months
|Method of randomisation:||No randomisation. Registration only as all participants will have all 3 tests. |
To access the urinary infection/sepsis SOP for the PROMIS study, please click here
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