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A large-scale study provides new evidence that targeted MRI ultrasound fusion prostate biopsy increases detection of high risk prostate cancers while decreasing detection of low-risk cancers. "More reliable diagnosis"
Targeted magnetic resonance imaging/ultrasound fusion prostate biopsy increases detection of high-risk prostate cancers and decreases detection of low-risk cancers compared with standard ultrasound-guided biopsy, according to new findings from a large-scale National Institutes of Health study.
The study was published in JAMA (2015; 313:390-7).
Researchers reported that 30% more high-risk prostate cancers were diagnosed with targeted fusion-guided biopsy than with standard biopsy. In addition, 17% fewer low-risk cancers were diagnosed with the fusion-guided approach.
"This study demonstrates that targeted fusion-guided biopsy could significantly enhance our ability to identify patients with high-risk prostate cancers that need more aggressive treatment," said lead author Mohummad Minhaj Siddiqui, MD, of the University of Maryland School of Medicine, Baltimore in a news release from that institution. Dr. Siddiqui was a fellow at the NIH when the study was conducted.
"With fusion technology, we now have a tool to help us differentiate high-risk cancers from low-risk ones that may require minimal or no treatment," he added. "There is a concern that we over-diagnose and over-treat low-risk cancers that are unlikely to be terminal, and this technology enables us to make a more reliable diagnosis than the current standard practice."
Dr. Siddiqui also added a note of caution: "While these findings could translate into substantial benefit to patients, this study is preliminary with regard to clinical endpoints such as recurrence of disease and prostate cancer-specific mortality," he said, noting that randomized clinical trials will be needed to determine the impact of targeted biopsy on clinical outcomes.
The study of 1,003 men was conducted at the NIH from 2007 to 2014, with Peter A. Pinto, MD, serving as the senior investigator. Participants were referred for biopsy because of elevated PSA or an abnormal digital rectal exam. They received targeted and concurrent standard biopsies.
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Researchers noted that 461 prostate cancer cases were diagnosed with targeted biopsy versus 469 cases with standard biopsy. Targeted and standard biopsies produced the same results in 69% of the cases. However, 30% more high-risk cancers were diagnosed through targeted biopsy than standard biopsy (173 vs. 122 cases) and 17% fewer low-risk cancers (213 vs. 258). Adding standard biopsy to targeted biopsy led to a 22% increase in cancer diagnoses, the vast majority of them for low-risk cancers.
Researchers also found that targeted biopsy was better able to predict whether the disease was low- or intermediate risk than standard biopsy or the two approaches combined. They were able to make that determination by comparing biopsied tissue with tissue taken from a patient's prostate after it was later removed surgically.
“Decisions to adopt new technologies such as this one that occupy a largely unregulated space ultimately rely on clinicians and payers, based on available data,” wrote Lawrence H. Schwartz, MD, of the Columbia University College of Physicians and Surgeons, New York, and Ethan Basch, MD, of the University of North Carolina, Chapel Hill, and associate editor of JAMA, in an accompanying editorial (JAMA 2015; 313:367-8.).
“Any test that can inform decision making and potentially spare patients harm is immediately appealing, even if the effect on clinical outcomes is unknown. Nonetheless, a new test should not be widely adopted in the absence of direct evidence showing benefits on quality of life, life expectancy, or ideally both. Therefore, the scientific community has the responsibility to ensure through clinical research that promising new technologies such as MR/ultrasound fusion imaging-guided biopsies bring value to patients.”
Dr. Pinto and co-author Peter L. Choyke, MD, reported holding a patent related to the MR/ultrasound fusion biopsy platform. Co-author Bradford J. Wood, MD, reported holding multiple related patents in the field.
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