MRI Before Biopsy: The Global Standard Prostate Cancer Diagnosis the U.S. Has Yet to Fully Embrace
Key Insights
Pre-biopsy MRI, standard of care in Europe, Canada, Australia, and the U.K., was used in only about one-third of U.S. prostate cancer (search) cases in 2022 despite strong guideline recommendations.
The 2018 PRECISION trial and subsequent studies demonstrate that MRI before biopsy detects more clinically significant cancer while reducing overdiagnosis of low-grade disease.
Up to 70% of new U.S. prostate cancer (search) diagnoses are low-grade and require no treatment, yet as many as 50% or more of men with such disease still receive intervention.
With more than 333,000 new cases annually, prostate cancer (search) is the most frequently diagnosed cancer in the United States and by far the most common among men. It is also the least deadly: only about 4% of cases prove lethal, and the five-year survival rate stands at approximately 99%. This paradox stems largely from how the disease is diagnosed — a two-step process of PSA blood testing followed by systematic biopsy that is highly effective at detecting cancer, perhaps too effective.
Up to 70% of new prostate cancer (search) diagnoses are low-grade and require no treatment, as the risk of the disease turning deadly is negligible. Yet as many as 50% or more of men with such clinically insignificant disease get treated in the U.S., according to data from the American Urological Association (search) Quality Registry. Some providers treat essentially all patients with low-grade cancer.
A growing number of prostate cancer (search) experts argue these low-grade lesions "shouldn't even be called a cancer," said Scott Eggener, a professor of urology at the University of California, Los Angeles. The ubiquity of prostate cancer, they contend, represents an overdiagnosis problem — and it is a particularly American one.
The MRI solution: standard elsewhere, lagging at home
In the last 15 years, MRI scans of the prostate have emerged globally as the preferred test after detecting elevated PSA levels and before a potential biopsy. Between 30% and 50% of patients can avoid a biopsy entirely by undergoing an MRI, significantly reducing both the detection of clinically insignificant cancer and biopsy-related complications.
Pre-biopsy MRI is the standard of care in Europe, Canada, Australia, and the U.K. It has been included in U.S. prostate cancer (search) detection guidelines since 2020, with the National Comprehensive Cancer Network (search) strongly recommending it. The American Urological Association (search) and the American Society of Clinical Oncology (ASCO) give it a conditional recommendation, even as they acknowledge it is backed by high-level evidence.
Nonetheless, the latest available data show MRIs were used ahead of biopsies in only about a third of U.S. cases in 2022. For all other cases, systematic biopsies followed elevated PSA levels directly, even though studies — most notably the 2018 PRECISION trial — have demonstrated that more cancer is found and fewer men are diagnosed with clinically insignificant disease when an MRI precedes biopsy.
"It's one of the world's worst global scandals that the richest country in the world denies [most] of its men access to something that is proven at level one evidence and that the rest of the world has adopted," said Mark Emberton, a professor of Interventional Oncology at University College London.
Why systematic biopsies persist
Prostate biopsies carry meaningful risks. Transrectal procedures, the more common approach, carry an infection risk of up to 7%, with up to 3% risk of sepsis. Transperineal procedures carry less infection risk but are more complex and require heavier anesthesia. Systematic sampling also carries a high risk of both over-detection and under-detection: depending on needle placement, biopsies can miss the most advanced cancer cells or find low-grade cells present in at least 30% of men over 50 as part of normal aging prostate tissue.
MRI sensitivity for detecting prostate lesions now reaches up to 93%. The scan can guide a targeted biopsy of just the lesion or avoid the procedure altogether. If no lesion is detected and no other patient-specific factors suggest further testing, a biopsy is not recommended.
"Why are we using a test that is worse than tossing a coin, when there's a much better test?" Emberton said. "The MRI is twice as good — and no needles."
The targeted versus systematic biopsy debate
A key transatlantic divide persists. In the U.K. and Europe, guidelines recommend a targeted biopsy checking only tissues corresponding to MRI-visible lesions. U.S. guidelines, however, recommend performing a systematic biopsy alongside any targeted biopsy to rule out malignancy elsewhere in the prostate.
"If you look hard enough, you find most of us as we age, will harbor some cancers," said Gilbert Welch, an internist at the Center for Surgery and Public Health at Brigham and Women's Hospital. "It's not in people's best interest to look as hard as possible to see if something's wrong, because we will find things wrong."
Others see value in the combined approach. Tyler Seibert, an associate professor at the University of California, San Diego, noted: "If I'm an oncologist treating a patient, which is what I do more, I want the information from the systematic biopsy. Both of those strategies are very reasonable and appropriate and even data-driven."
Michael Ahdoot, an assistant professor of urology at Cedars-Sinai, published a landmark 2020 paper in the New England Journal of Medicine establishing the diagnostic value of pre-biopsy MRIs for the U.S., leading insurers to cover a procedure they had routinely denied. His subsequent research found that patients receiving both systematic and targeted biopsies had about 8% more clinically significant cancer detected.
Barriers to adoption
Multiple factors explain the slow U.S. uptake. Ahdoot points to a "knowledge deficit": many urologists are not comfortable ordering or interpreting prostate MRIs. "A doctor's ability to read an MRI is very heterogeneous," he said. "I would say the vast majority [of urologists] don't know how to read a prostate MRI."
Eggener adds that MRI quality in the U.S. varies dramatically, as does access, particularly in rural areas. "Access to MRI isn't so easy in certain parts of the country, and the quality of MRI pictures can be all over the map," he said.
Financial incentives also play a role. Prostate biopsies are lucrative for urologists who can perform them in their practices, and finding clinically insignificant cancers can lead to active monitoring — potentially through further biopsies. Patients, too, often push for additional testing.
Disparities are evident: uptake is especially low in rural communities, among the Medicaid population, and among Black patients.
Technological advances reshaping diagnosis
New technologies are further transforming the diagnostic landscape. The Mona Lisa robotic system (search), which combines MRI imaging with real-time ultrasound to create a three-dimensional prostate model, navigates biopsy needles with millimeter precision via a transperineal approach. The PREVENT study, involving approximately 658 patients, found zero infection cases with this approach, compared to about 1.4% with traditional transrectal biopsy.
"Our goal is not only to achieve a more accurate diagnosis," said Prof. David Margel, Director of Innovation, Research, and Risk Management at Assuta Ramat Hachayal. "We also want to make the experience safer for the patient, with less tissue trauma, less pain, and fewer complications."
Artificial intelligence integration allows real-time detection of needle deviation and automatic correction, though Margel emphasizes the technology assists rather than replaces physicians. "The technology gives the doctor better information and tools, so that they can make more precise decisions."
The road ahead
Emberton is now working on designing a trial that would test forgoing biopsy entirely, evaluating whether that changes patient outcomes. His approach — treating all MRI-visible lesions and considering invisible tumors clinically irrelevant — remains controversial among American specialists.
"Mark Emberton is one of my heroes. He is a friend and a colleague," Eggener said. "And I can give you a half a dozen reasons why I disagree with him." He notes that "every study that's out there shows that there can be meaningful cancers that aren't seen by MRIs." A recent JAMA Oncology study, however, found that only 3% of men with negative MRIs developed clinically significant prostate cancer (search) within three years of monitoring.
On one point, guidelines and experts on both sides of the Atlantic agree: "The right thing to do is to get an MRI every time," Seibert said. "Everything changes once you put a needle in the prostate," Emberton added. "If you don't have to put a needle in the prostate, you're far better off not doing it."