February 4, 2021
Multidisciplinary research group demonstrates that using MRI and targeted biopsies can avoid unnecessary prostate biopsies in a third of men and reduce the diagnosis of insignificant cancers
Determining whether a patient with prostate cancer requires aggressive therapy or active surveillance is a challenge. Current tests can detect early signs of prostate cancer, but these tests can lead to many unnecessary and painful biopsies for patients whose disease never becomes aggressive.
In an OICR-funded Phase III clinical trial, researchers have found that using Magnetic Resonance Imaging (MRI) and MRI-guided biopsies as needed, can reduce the number of unnecessary prostate biopsies and the diagnosis of insignificant cancers. The study results were recently published in JAMA Oncology.
The study, called the Prostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures (PRECISE), included 453 participants at cancer centres across Canada who were assigned to either the current standard of care – a systematic transrectal ultrasound-guided (TRUS) biopsy – or a new method – MRI with MRI-guided biopsy as needed.
The study demonstrated that using MRI and MRI-targeted biopsies caught clinically significant cancers as effectively as conventional TRUS biopsies, but reduced the rate of men undergoing biopsy by almost 40 per cent. The MRI method also halved the number of unnecessary diagnoses of slow growing, clinically insignificant cancers. Additionally, those who did have biopsies in the MRI arm had significantly fewer samples taken relative to those in the TRUS biopsy arm, meaning fewer needles and less pain and discomfort for patients.
These clinical data show the revolutionary impact of the use of prostate MRI in cancer diagnosis and surveillance.
“Approximately one in eight men will be diagnosed with prostate cancer in their lifetime,” says the study’s lead statistician and OICR Investigator, Dr. Greg Pond, who is also an Associate Professor at McMaster University and Senior Biostatistician at the Ontario Clinical Oncology Group. “These clinical data show the revolutionary impact of the use of prostate MRI in cancer diagnosis and surveillance.”
“Using our current standard methods, we recognize that we are overdiagnosing some prostate cancers, leading to unnecessary biopsies and treatments,” says co-lead of the study, Dr. Masoom Haider, Head of the Radiomics and Machine Learning Research Lab at the Lunenfeld-Tanenbaum Research Institute, Professor at the University of Toronto, and OICR Clinician Scientist. “Through PRECISE, we’ve demonstrated that using MRI and MRI-targeted biopsies as an alternative to standard biopsies, can effectively detect clinically significant cancers, but avoid overdiagnosing clinically insignificant cancers. This means reducing the number of needles or eliminating biopsy altogether if a patient doesn’t need it. For our health system, this alternative may present an opportunity to use our resources more effectively.”
Haider has played a leading role in integrating the PRECISE findings into Cancer Care Ontario (CCO) guidelines for prostate cancer management. The study’s findings influenced CCO’s Prostate MRI Guideline 27-2 and will be implemented this year, meaning more prostate cancer patients across Ontario may be spared unnecessary biopsies and treatment thanks to MRI and MRI-targeted biopsies.
February 4, 2021
Phase III clinical trial of men with a clinical suspicion of prostate cancer finds MRI with targeted biopsies to be more accurate at diagnosis and less intrusive than current standard
Toronto – (February 4, 2021) The results of a Phase III randomized clinical trial have shown that when it comes to detecting clinically significant prostate cancer, Magnetic Resonance Imaging (MRI) with targeted biopsies (MRI-TBx) matches the current standard and brings a multitude of advantages. The PRostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures (PRECISE)study will help to make prostate cancer diagnosis more accurate and less invasive.
PRECISE included 453 participants at Canadian academic cancer centres who were either assigned to receive MRI imaging followed by MRI-TBx of suspicious areas (identified by MRI), or the current standard of care of a systematic 12-core transrectal ultrasound-guided (TRUS) biopsy (TRUS-Bx).
- MRI with targeted biopsy found five per cent more clinically significant prostate cancers compared to those receiving systematic TRUS-Bx biopsies, conclusively demonstrating the method can at least match the performance of the current standard of care.
- Compared to standard TRUS-Bx, the MRI-TBx were found to be better in identifying clinically significant cancers.
- More than a third of patients in the MRI arm of the trial avoided biopsies altogether following negative imaging results. Those individuals received a follow-up MRI in two years’ time.
- Those who did have biopsies in the MRI arm had significantly fewer samples taken when compared to systematic TRUS-Bx, resulting in less pain and discomfort for patients. Moreover, the MRI arm had a decreased adverse event profile, including less hematuria (blood in the urine) and incontinence.
- There is a major unmet need for a test that identifies clinically significant prostate cancer while avoiding overdiagnosing clinically insignificant cancers. Use of MRI reduced the unnecessary diagnosis of slow growing, clinically insignificant prostate cancers by 55 per cent.
These findings show decisively that MRI together with targeted biopsies offer patients a less invasive procedure, the chance to avoid a biopsy all together and can help avoid the over-treatment of clinically insignificant prostate cancer – all while detecting a higher rate of clinically significant cancers.
“My colleagues and I are thrilled about these results that show, without a doubt, that imaging and targeted biopsies are the future of prostate cancer diagnosis. We can catch more of the cancers we should be treating, avoid unnecessary treatment at the same time and improve the quality of life for our patients.” says Dr. Laurence Klotz, Chair of Prostate Cancer Research at Sunnybrook Health Sciences Centre and lead author of the study. “We thank the study participants and our funders for their support and look forward to continuing our efforts to have this technology used more widely.”
“The study’s findings have influenced Ontario Health-Cancer Care Ontario’s upcoming, updated Prostate MRI Guidelines, which will be released this year,” says Dr. Masoom Haider, co-lead of the study and Professor of Medical Imaging at the University of Toronto, and Clinician Scientist with the Ontario Institute for Cancer Research (OICR). “I am pleased to see our research produce results that will make a real difference in how prostate cancer is diagnosed and improve the lives of patients.”
“I congratulate Dr. Klotz and the PRECISE team on this truly impactful research which will change clinical care and make a difference for men with prostate cancer,” says Dr. Christine Williams, Deputy Director and Head, Clinical Translation, OICR. “It is a great example of how, with our partners, we are moving research innovations to the clinic to improve the lives of patients and treat cancer with improved precision.”
“These practice-changing results will have a significant and positive impact on the roughly 64 Canadians who are diagnosed with prostate cancer every day. Thanks to the efforts of Dr. Klotz and his team, people will need to undergo fewer biopsies and for some of them, they will be spared from unnecessary biopsies and treatments altogether,” says Dr. Stuart Edmonds, Executive Vice President, Mission, Research and Advocacy at the Canadian Cancer Society. “We are proud to support this research, which will help people with prostate cancer live longer, fuller lives.”
“At Movember, we are honoured to play a role in funding cutting-edge research like the PRECISE study, ultimately helping to provide more positive outcomes for men living with or beyond a prostate cancer diagnosis,” says Todd Minerson, Country Director for Movember Canada.
PRECISE was funded by the Canadian Cancer Society with funds provided by Movember and by the Ontario Institute for Cancer Research.
About the Ontario Institute for Cancer Research
OICR is a collaborative, not-for-profit research institute funded by the Government of Ontario. We conduct and enable high-impact translational cancer research to accelerate the development of discoveries for patients around the world while maximizing the economic benefit of this research for the people of Ontario. For more information visit http://www.oicr.on.ca.
About the Canadian Cancer Society
The Canadian Cancer Society (CCS) is the only national charity that supports Canadians with all cancers in communities across the country. No other organization does what we do; we are the voice for Canadians who care about cancer. We fund groundbreaking research, provide a support system for all those affected by cancer and shape health policies to prevent cancer and support those living with the disease.
Help us make a difference. Call 1-888-939-3333 or visit cancer.ca today.
Movember is the leading charity changing the face of men’s health on a global scale, focusing on mental health and suicide prevention, prostate cancer and testicular cancer. The charity raises funds to deliver innovative, breakthrough research and support programs that enable men to live happier, healthier and longer lives. Committed to disrupting the status quo, millions have joined the movement, helping fund over 1,250 projects around the world. In addition to tackling key health issues faced by men, Movember is working to encourage men to stay healthy in all areas of their life, with a focus on men staying socially connected, and becoming more open to discussing their health and significant moments in their lives. The charity’s vision is to have an everlasting impact on the face of men’s health. To donate or learn more, please visit Movember.com.
November 24, 2020
As records are becoming more accessible and patients are becoming more engaged with their health data, who will make it all make sense?
Cancer patients are becoming increasingly involved with their care decisions and care systems are increasingly providing patients access to their test results, health data and relevant reports. These reports, however, can be dense, technical and confusing, leading to more questions than answers for patients and their caregivers. Dr. Nathan Perlis at the Princess Margaret Cancer Centre is dedicated to bridging this gap between patients and their health information.
“Traditional radiology and pathology reports were designed for a specific reason, to communicate results between experts in the field, from physician to physician,” says Perlis, Staff Urologist in the Department of Surgical Oncology at the Princess Margaret Cancer Centre and Assistant Professor at the University of Toronto. “We can’t expect that traditional forms will communicate information effectively with patients and caregivers. Our team recognized the need to design new documents to convey the most relevant information for patients in an easy-to-understand way.”
Perlis and collaborators – including OICR and Sinai Health’s Dr. Masoom Haider, UHN’s Healthcare Human Factors team and a group of patient partners – decided to address a key report used in making prostate cancer treatment decisions – the prostate magnetic resonance imaging (MRI) radiology report.
“Unlike a blood pressure measurement or a fever, prostate MRI results are difficult to interpret,” says Perlis. “This can cause unnecessary anxiety and confusion and barriers between patients and their care team. Our new patient-centred design addresses these concerns, providing a steppingstone for further discussion between patients and their clinicians.”
The team recently published their patient-centred radiology report design, coined PACERR, in the Canadian Urological Association Journal. Their design includes key elements including diagrams, a legend and a glossary to help make the MRI results more understandable. All elements of the form – including the format, layout and the language – were developed and evaluated in partnership with patients and caregivers. The group is now evaluating the form in a clinical trial.
In parallel, the group has recognized a key barrier to implementing these forms in practice. Creating these forms would significantly add to the reporting burden on radiologists. Perlis and collaborators have now set out to create a software package that can read a traditional standard report and automatically complete a tailored patient-centred report. As they develop this software, they hope to apply their learnings to other types of reports across different cancer types.
“Patient-centred communication tools are necessary for shared decision-making,” say Perlis. “We can imagine a future where patients are truly enabled and engaged in their health decisions and this work is a purposeful step toward that goal.”
This research was funded in part by OICR’s Investigator Awards Program.