MULTIPROS study
Research type
Research Study
Full title
Multiparametric Magnetic Resonance Imaging characterization and guided biopsy of the prostate in men suspected of having prostate cancer
IRAS ID
152473
Contact name
Ghulam Nabi
Contact email
Sponsor organisation
University of Dundee
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Research Summary
The journey to diagnosis and choice of treatment of a patient with prostate cancer (PCa) is challenging and can be circuitous. The current diagnostic pathway, based on limited accuracy of diagnostic tests, leads to a number of imprecise outcomes which includes underdetection, overdiagnosis of clinically unimportant disease, over/understaging due to post-biopsy changes and ultimately overtreament of the disease. This results in unnecessary and avoidable morbidity to the patient and cost to health service organisations. To avoid that burden, advanced imaging especially with novel magnetic resonance imaging (MRI) sequences could enable a tailored and risk stratified categorisation approach in men suspected of suffering from prostate cancer. MR imaging techniques may be able to detect and differentiate between low and high grade cancers as well as provide guidance for targeted biopsies with the help of image fusion (MRI/Ultrasound for prostate cancer). There is emerging evidence in the literature that multiparametric (MP) MRI may address these challenges and that US/MRI fusion biopsy techniques may enable targeting of suspicious areas leading to a decrease in rate of false negative biopsies.
Based on the above background, a prospective, multicentre study with subgroup randomisation into image fusion guided biopsies and routine care has been designed. It aims to answer the following questions:
1. How reliable is pre-biopsy MP-MRI in correctly predicting the grade or aggressiveness of PCa?
2. Can MRI/US image-fusion techniques allow us to reliably target suspicious areas seen on MP-MRI for biopsy?Summary of Results
Between January 2015 and August 2020, a total number of 603 consented men were recruited from three centres.
• The team have approached a total of 60 sites across Scotland and England Feedback receives from sites are: not interested, insufficient patient population and majority have no FUSION capabilities.
• The trial is registered in the ClinicalTrials.gov to comply with ethical, funder and sponsor requirements. It also provides information to potential participants and referring clinicians.
• The detection, localisation and characterisation of prostate cancer by pre-biopsy mpMRI have been thoroughly analysed to detect significant cancers and avoid over-diagnosis in most of the non-significant cases.
• MRI guided biopsy performed better in combination with systematic biopsy or alone.
• The problem of over-diagnosis of prostate cancer and subsequent overtreatment of indolent disease is well recognised and pre-biopsy mpMRI has been shown to reduce the detection of clinically insignificant cancers.
• Participants with negative mpMRI results were excluded from randomisation but they still had TRUS biopsy as the standard diagnostic procedure. Previous studies have shown a low risk of clinically significant cancer and our results concluded the same.
• There were no significant AEs recognised from the targeted biopsy procedure.REC name
East of Scotland Research Ethics Service REC 1
REC reference
14/ES/1070
Date of REC Opinion
20 Nov 2014
REC opinion
Further Information Favourable Opinion