A large international study conducted in collaboration with the University of Birmingham has found that an MRI scan and targeted prostate biopsies are significantly better at making a positive prostate cancer diagnosis than standard biopsies.
The PRECISION trial randomly allocated 500 men with suspected prostate cancer from 35 international centres. The trial found that using MRI to perform prostate biopsies lead to more of the harmful prostate cancers, and fewer harmless cancers being diagnosed, than the standard way of performing biopsies.
Researchers, led by University College London, found the MRI approach can also reduce the number of men undergoing biopsy by 28%, as men who do not present with abnormal areas in the prostate may be able to avoid biopsy altogether. This is particularly important as over one million men in Europe undergo biopsy every year and biopsies can be uncomfortable, costly, and carry a risk of infection.
Currently men who have suspected prostate cancer typically undergo a standard biopsy test called a TRUS (TRansrectal UltraSound guided prostate biopsy). However, TRUS biopsy has been known to have limitations and can both miss harmful cancers, and also diagnose harmless cancers that don't need to be identified.
PRECISION is the first international multi-centre randomised trial to show the benefits of using MRI at the start of the prostate cancer diagnosis process.
The University of Birmingham’s Test Evaluation Research Group assisted in the design of the PRECISION trial and completed the analysis of the results.
Professor Jon Deeks, Head of the Test Evaluation Research Group and Deputy Director of the Institute of Applied Health Research at the University of Birmingham, said: “Assessing which of two different medical tests is best for patients is challenging.
“Good medical tests must not miss patients who have disease, and should identify patients early in their disease. This is so patients can be given the treatment they need, and get treated before disease becomes more serious.
“But the same tests may also wrongly suggest other patients need treatment, or refer them for unnecessary further investigations which are uncomfortable, expensive and inevitably create anxiety.
“Medical tests can harm as well as help, and it is essential to properly evaluate the good and bad ways that they impact on patients when deciding which tests should be used.”
Chief Investigator, Dr Veeru Kasivisvanathan, from the UCL Surgery and Interventional Science, funded by a National Institute for Health Research (NIHR) Doctoral Fellowship, presented the results of the PRECISION Trial at the 33rd European Association of Urology Congress, Copenhagen, with simultaneous publication in the New England Journal of Medicine.
Dr Kasivisvanathan said: “In men who need to have investigation for prostate cancer for the first time, PRECISION shows that using an MRI to identify suspected cancer in the prostate and performing a prostate biopsy targeted to the MRI information, leads to more cancers being diagnosed than the standard way that we have been performing prostate biopsy for the last 25 years.”
Dr Caroline Moore, Reader in Urology at UCL and senior author of the study commented: “We compared standard prostate biopsy to the use of MRI, offering targeted biopsies to only those men who had a suspicious MRI.
“The MRI pathway detected more harmful cancers that needed treatment, and it reduced overdiagnosis of harmless cancers, even though fewer men had a biopsy in the MRI arm.”
Professor Mark Emberton of University College London commented: “This study was the first to allow men to avoid a biopsy. If high quality MRI can be achieved across Europe, then over a quarter of the one million men who currently undergo a biopsy could safely avoid it.”
The PRECISION trial was funded by The National Institute for Health Research (NIHR) and the European Association of Urology (EAU) Research Foundation.
For more information please contact Emma McKinney, Communications Manager (Health Sciences), University of Birmingham, call +44 (0)121 414 6681. Alternatively, contact the Press Office out of hours on +44 (0)7789 921165.
- The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 5,000 international students from over 150 countries.
- The Test Evaluation Research Group at the University of Birmingham has expertise in designing studies to evaluate medical tests. They support teams, both nationally and internationally, who are planning and completing studies that compare medical tests. They also coordinate the work of the international Cochrane Collaboration in summarising the worldwide evidence of the properties of different medical tests, and support groups such as the World Health Organisation who are assessing which tests should be provided and used in different patient groups.
- Professor Jon Deeks received support for this trial from the NIHR Birmingham Biomedical Research Centre.
PRECISION trial - what did they do?
Researchers from 23 centres randomly allocated 500 men to be examined either with a standard 10-12 core TRUS biopsy, or with an initial MRI scan followed by a targeted biopsy if the MRI showed an abnormality. The main aim was to assess what proportion of men were diagnosed with clinically significant prostate cancer (defined as a Gleason Grade of ≥3+4) which is harmful cancer that is desirable to find. It also aimed to assess the proportion of men who were diagnosed with clinically insignificant cancer (Gleason Grade 3+3) which is desirable to avoid as it doesn’t benefit from treatment.
What were the results?
The researchers found that 71 (28%) of the 252 men in the MRI arm of the study avoided the need for a subsequent biopsy. Of those who needed a biopsy, the researchers detected clinically significant cancer in 95 (38%) of the 252 men, compared with 64 (26%) of the 248 men who received only the TRUS biopsy.
Prostate cancer statistics
Prostate cancer is the most common male cancer, with around 400,000 new cases every year in Europe. In the UK, there are over 46,000 new cases of prostate cancer every year, leading to more than 11,000 deaths4. 2015 figures show that for the first time there were more prostate cancer deaths than breast cancer deaths in the UK.
- The 35 organisations and institutions involved in this research were:
- University College London
- University College London Hospitals NHS Foundation Trust
- Helsinki University
- Helsinki University Hospital
- Centro de Urologia CDU, Argentina
- Sapienza University, Italy
- Mayo Clinic, Rochester, MN, USA
- MRC Oulu and University of Oulu
- Oulu University Hospital, Finland
- San Raffaele Hospital, Italy
- Martini Klinik, Germany
- London North West Healthcare NHS Trust
- Hampshire Hospitals NHS Foundation Trust
- Erasmus University Medical Center, the Netherlands
- University of Chicago, USA
- Whittington Health NHS Trust, UK
- CHU Lille, France
- Jewish General Hospital, Canada
- Ghent University Hospital, Belgium
- Princess Alexandra Hospital NHS Trust, UK
- University Hospital Bern, Switzerland
- Bordeaux Pellegrin University Hospital, France
- Royal Free London NHS Foundation Trust, UK
- Radboudumc, the Netherlands
- University Hospital Essen, Germany
- University Hospital Heidelberg, Germany
- Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, France
- Weill Cornell Medicine New York-Presbyterian Hospital, USA
- Hospices Civils de Lyon of the Hôpital Edouard Herriot, France
- Sunnybrook Health Sciences Centre, Canada
- New York University Langone Medical Center, USA
- National Institutes of Health, Bethesda, USA
- University Southern California Institute of Urology, Keck School of Medicine, USA
- University College London Surgical and Interventional Trials Unit, UK
- Institute of Applied Health Research and the National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University of Birmingham
- The National Institute for Health Research (NIHR): improving the health and wealth of the nation through research. Established by the Department of Health and Social Care, the NIHR:
- funds high quality research to improve health
- trains and supports health researchers
- provides world-class research facilities
- works with the life sciences industry and charities to benefit all
- involves patients and the public at every step.