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    Almost twice as sensitive as TRUS-biopsy for detecting aggressive prostate cancer

    • Kristin Jenkins, Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco, Reviewer, and Dorothy Caputo, MA, BSN, RN, Nurse Planner, have disclosed that they have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity.The staff of Projects In Knowledge®, Inc. and the staff of MedPage Today have no relevant financial relationships or conflicts of interest with commercial interests related directly or indirectly to this educational activity.

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    One in four men presenting with elevated prostate-specific antigen (PSA) may be able to safely avoid prostate biopsy if they have triage testing with multi-parametric magnetic resonance imaging (MP-MRI) first, researchers said.

    The use of MP-MRI might also improve the detection of clinically significant cancer compared with transrectal ultrasound-guided prostate biopsy (TRUS-biopsy) and reduce over-diagnosis of clinically insignificant prostate cancer, the multicenter, paired-cohort, confirmatory PROMIS (PROstate MR Imaging Study) showed.

    For clinically significant cancer, the study demonstrated that MP-MRI was more sensitive than TRUS-biopsy (93% versus 48%) and less specific (41% versus 96%; P<0·0001), with a negative predictive value of 89% versus 74%; P<0·0001), Hashim U. Ahmed, MD, PhD, of University College London Medical School in the U.K., and colleagues reported.

    “Using MP-MRI to triage men might allow 27% of patients to avoid a primary biopsy and diagnosis of 5% fewer clinically insignificant cancers,” the researchers wrote online in The Lancet.

    “If subsequent TRUS-biopsies were directed by MP-MRI findings, up to 18% more cases of clinically significant cancer might be detected compared with the standard pathway of TRUS-biopsy for all.”

    Using the scan to guide the biopsy would also result in “fewer and better biopsies being taken.”

    The high negative predictive value is “reassuring,” Ahmed and colleagues said, since a negative MP-MRI result “implies a high probability of no clinically significant cancer.” However, they emphasized, patients should be monitored after their MP-MRI scan.

    Previous results from the Prostate Testing for Cancer and Treatment (ProtecT) trial have highlighted the problems facing men who present with an elevated serum PSA, the researchers pointed out.

    At a median of 10 years of follow-up, the landmark trial showed that there were no cancer-specific survival differences in men randomly assigned to have active monitoring, radical prostatectomy, or radical radiotherapy, although there was reduced time to metastases with treatment.

    “Over three-quarters of men in ProtecT had low-risk disease, exemplifying the problem of over-diagnosis from a TRUS-biopsy in all strategy and the need to avoid biopsy in such men whilst improving detection of cancer that requires treatment,” Ahmed and colleagues said.

    In PROMIS, transperineal template prostate mapping biopsies (TPM-biopsies) were used as the reference standard to test the diagnostic accuracy of MP-MRI and TRUS-biopsy. “TPM-biopsies can be applied to men at risk and are highly accurate, since the prostate is sampled every 5 mm.”

    Between May 17, 2012, and November 9, 2015, a total of 740 biopsy-naïve men were enrolled at 11 centers. Of this group, 576 men with PSA concentrations up to 15 ng/mL underwent 1·5 Tesla MP-MRI followed by both TRUS-biopsy and TPM-biopsy blinded to other test results.

    Clinically significant cancer was defined as having a Gleason score ≥4 + 3 or a maximum cancer core length of 6 mm or longer.

    Cancer was detected on TPM-biopsy in 408 of the 576 men (71%) and clinically significant cancer was detected in 230 (40%). A total of 174 men with low-grade disease were classified as having significant disease on the basis of core length.

    An analysis of the cost-effectiveness of the PROMIS data is underway, the researchers said, and they plan to follow up with central cancer and mortality registries to document the long-term outcomes of participants.

    Limitations of the study, the researchers noted, include the use of a 5 mm sampling frame of the entire prostate — exclusion of large prostates “might result in a decrease in the proportion of true negatives.”

    Asked for his perspective, Christopher Anderson, MD, of New York-Presbyterian/Columbia University Medical Center, in New York City, who was not involved with the study, said via email: “These data do support using MRI in biopsy-naïve men to eliminate unnecessary biopsies and find more aggressive cancer. Since the purpose of prostate cancer screening is to identify patients who have potentially aggressive disease, these findings show that MRI may be able to substantially improve our ability to identify these men.”

    The limitation of MRI in the study was the high rate of false-positive tests, but the high negative predictive value was “a major benefit,” he added.

    In patients with a negative MRI, very few had significant cancer, a finding that could “support the avoidance of biopsy for those with a ‘normal’ MRI.”

    Anderson explained that MRI provides superior soft-tissue resolution compared with other imaging techniques, and takes advantage of differences between normal and cancerous prostate tissue to identify cancers.

    One of the study’s main caveats, however, is the quality of MRI interpretation — i.e., normal versus abnormal — and the experience of the radiologist. “The results are not necessarily externally valid to all practice settings,” he said.

    In addition, the routine use of 3T machines, which can perform targeted biopsies of abnormal lesions and provide superior imaging to 1.5T machines, are already offering improved diagnostic accuracy, Anderson pointed out. “It is possible that with newer technology and more experienced radiologists, our ability to accurately risk-stratify patients using MRI will improve.”

    He said that although many insurers do cover MRIs for men with elevated PSAs, particularly those who have had a prior negative biopsy, as more data emerges about the utility of MRI in this setting, “I would anticipate that it is more likely to be covered.”

    PROMIS was funded by the U.K. Government Department of Health, National Institute of Health Research-Health Technology Assessment Programme, University College London Biomedical Research Centre, and The Royal Marsden and the Institute for Cancer Research Biomedical Research Centre.

    Ahmed reported relationships with Sonacare Medical, Sophiris, and Trod Medical. Some of the other co-authors reported relationships with Nuada Medical Ltd., Steba Biotech, GSK, Sanofi Aventis, Astellas, Sonacare, Angiodynamics, Sonacare Inc, Sophiris Inc., and Trod Medical, and one of the coathors is clinical director for the prostate care division of Nuada.

    • Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner

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