Here’s welcome news for men of a certain age: new findings support a less aggressive approach to screening for suspected prostate cancer.
An approach using MRI of the prostate followed by targeted biopsy (TB) in men with imaging that suggests high risk of the case is the usual method of using transrectal ultrasound (TRUS) – biopsy 12-core systemic.
The results come from the randomized level 3 PRECISION test, and were published online at Oncology JAMA.
“What the lawsuit has shown is that by adopting an image-first strategy, you could reduce the number of patients requiring a biopsy by about 40% and more cancers. important detection (35% vs. 30%) and reduced group 1 diagnosis of cancers we do not want to detect by more than one individual, “said lead author Laurence Klotz, CM, MD, of the Sunnybrook Center for Health Sciences in Toronto, Canada , in an interview with Medscape Medical News.
These results are from PRECISE test support and slightly better than results from the European-based PRECISION test.
That European trial had “already provided strong evidence for MRI and targeted biopsy,” notes Olivier Rouvière, MD, PhD, of the University of Lyon, Lyon, France, writing an editorial chois. But he argues that it is worth doubling the lawsuit, because “it should not be forgotten that science, testing the strength of influence and the factors that influence it, is as important as show this effect in the first place. “
The results of both tests suggest that, instead of completely replacing the TRUS biopsy, MRI results could be used to guide patients to the appropriate diagnostic pathway, Rouvière says.
“It may just be using MRI findings to determine which patients should have a biopsy,” he said. “Most likely, MRI findings will be used in conjunction with biomarkers. other such as PSA concentration to select, among patients with advanced MRI findings, those requiring targeted biopsy (and those who can safely avoid it), and among patients with negative MRI Results, those who may still be eligible for a systematic biopsy, “he writes.
Information on PRECISE Decisions
The Canadian PRECISE study was developed as a noninferiority test in coordination with the European PRECISION study, but the Canadian version had several additional features: It added risk-based eligibility, systematic follow-up of all patients for 2 years, next full MRI report. untreated patients, study of fluid and tissue-based biomarkers in the group, and economic study.
PRECISE was performed in five Canadian academic health science centers from January 2017 through November 2019. A total of 453 biopsy-naive men with clinical suspicion of prostate cancer who were referred for prostate biopsy were registered . Of this group, 421 were valuable for each protocol.
The researchers defined clinical suspicion as an ≥5% chance of a stage 2 group or larger prostate cancer. Patients were also asked for prostate specific antigen (PSA) levels of 20 ng / mL or less and without contraindication to MRI.
Patients were randomly assigned MRI through MRI-targeted biopsy only if injured with a Prostate Imaging and Data System (PI-RADS) score of 3 or more was identified, but was excluded. -all males in the other branch of the test under a TRUS-led 12-heart Biopsy system.
The MRI method identified cancers that were clinically more important. Stage 2 or higher tumors were detected in 79 (35%) of 227 men assigned to MRI-TB, vs. 67 (30%) of 225 men who underwent a TRUS biopsy.
MRI also reduced the need for biopsy, allowing many men to avoid the risks associated with pain, discomfort and infection. Of 221 men randomly assigned to the MRI group, 83 (37%) had a negative MRI result and avoided biopsy. In contrast, everyone in the TRUS group had a biopsy.
In addition, MRI was associated with a significant reduction in the diagnosis of clinically small International Society of Urological Pathology (ISUP) stage 1 cancers (10% with MRI-TB vs 22% with TRUS) . Early detection of such cancers, under conventional protocols, often leads to unnecessary treatments or invasive procedures with major side effects.
These results led the researchers to conclude that an MRI strategy followed by an MRI-led biopsy only in men at risk of prostate cancer “offers significant benefits over biopsy original system. “
The MRI strategy “leads to consistent detection rates of clinically significant prostate cancer… while avoiding biopsy in more than a third of men and reducing the diagnosis of clinically unimportant cancer , “the researchers point out.
The researchers acknowledged that the performance of the target MRI biopsy varied between centers, with differences in both advanced MRI rates and target biopsy outcome.
“This difference occurred despite the fact that all MRIs were reviewed, and biopsies performed, by experienced radiologists or urologists. This reinforces the need for quality control measures to allow MRI to be performed. widely used, “they write.
What now?
Klotz noted that an important addition to PRECISE is the planned follow-up of untreated patients on study.
“We know MRI isn’t perfect, so what happens to the boys who avoid the biopsy? What is the risk of missing something? So the only way to know is that that is with long – term follow – up on the patients, “he said Medscape.
In addition to repeated MRI at 2 years, the investigators plan to follow these patients for up to 8 years.
“But definitely, compared to the traditional strategy of systemic biopsy, this looks a lot better,” Klotz said.
In his editorial, Rouvière said the interregional variability seen in the study is “like a warning to the MRI pathway.”
“Given that the partner institutions were familiar with high-level tertiary institutions, inter-regional variability appears to be much higher among less experienced institutions,” he wrote. the diagnostic pathway, continuing education and quality assurance programs are going to be big questions in the future, not only for MRI definition of the prostate, but also for targeted biopsy, which has a learning curve even with regenerative systems. -magnetic positioning and ultrasound fusion, and even for systematic biopsy. “
PRECISE was funded by the Ontario Institute for Cancer Research and Prostate Cancer Canada. Klotz and Rouvi there were no material financial relationships.
JAMA Oncol. Published online February 4, 2021. Abstract, Editorial
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