Abstract
Men with high serum prostate specific antigen usually undergo transrectal ultrasound-guided prostate biopsy (TRUS-biopsy). TRUS-biopsy can cause side-effects including bleeding, pain, and infection. Multi-parametric magnetic resonance imaging (MP-MRI) used as a triage test might allow men to avoid unnecessary TRUS-biopsy and improve diagnostic accuracy. We did this multicentre, paired-cohort, confirmatory study to test diagnostic accuracy of MP-MRI and TRUS-biopsy against a reference test (template prostate mapping biopsy [TPM-biopsy]). Men with prostate-specific antigen concentrations up to 15 ng/mL, with no previous biopsy, underwent 1·5 Tesla MP-MRI followed by both TRUS-biopsy and TPM-biopsy. The conduct and reporting of each test was done blind to other test results. Clinically significant cancer was defined as Gleason score ≥4 + 3 or a maximum cancer core length 6 mm or longer. This study is registered on ClinicalTrials.gov, NCT01292291. Between May 17, 2012, and November 9, 2015, we enrolled 740 men, 576 of whom underwent 1·5 Tesla MP-MRI followed by both TRUS-biopsy and TPM-biopsy. On TPM-biopsy, 408 (71%) of 576 men had cancer with 230 (40%) of 576 patients clinically significant. For clinically significant cancer, MP-MRI was more sensitive (93%, 95% CI 88-96%) than TRUS-biopsy (48%, 42-55%; p<0·0001) and less specific (41%, 36-46% for MP-MRI vs 96%, 94-98% for TRUS-biopsy; p<0·0001). 44 (5·9%) of 740 patients reported serious adverse events, including 8 cases of sepsis. Using MP-MRI to triage men might allow 27% of patients avoid a primary biopsy and diagnosis of 5% fewer clinically insignificant cancers. 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. MP-MRI, used as a triage test before first prostate biopsy, could reduce unnecessary biopsies by a quarter. MP-MRI can also reduce over-diagnosis of clinically insignificant prostate cancer and improve detection of clinically significant cancer. PROMIS is funded by the UK Government Department of Health, National Institute of Health Research-Health Technology Assessment Programme, (Project number 09/22/67). This project is also supported and partly funded by UCLH/UCL Biomedical Research Centre and The Royal Marsden and Institute for Cancer Research Biomedical Research Centre and is coordinated by the Medical Research Council Clinical Trials Unit (MRC CTU) at UCL. It is sponsored by University College London (UCL).
Highlights
The diagnosis of prostate cancer differs from that in other solid organ cancers where imaging is used to identify those patients who require a biopsy
The prostate cancer diagnostic pathway offers transrectal ultrasoundguided biopsy (TRUS-biopsy) in men who present with an elevated serum prostate specific antigen (PSA)
We aimed to investigate whether Multi-Parametric Magnetic Resonance Imaging (MP-MRI) could discriminate between men with and without clinically significant prostate cancer based on template prostate mapping biopsy (TPM-biopsy) as a reference test
Summary
The diagnosis of prostate cancer differs from that in other solid organ cancers where imaging is used to identify those patients who require a biopsy. The prostate cancer diagnostic pathway offers transrectal ultrasoundguided biopsy (TRUS-biopsy) in men who present with an elevated serum prostate specific antigen (PSA). Many men without cancer undergo unnecessary biopsies, clinically insignificant cancers are often detected and clinically significant cancers are sometimes missed.[1,2] TRUS-biopsy carries significant morbidity and can cause life-threatening sepsis.[3]. A pathway with imaging as a triage test to decide which men with an elevated PSA go on to biopsy might both reduce unnecessary biopsy and improve diagnostic accuracy. Multi-Parametric Magnetic Resonance Imaging (MP-MRI) provides information on not just tissue anatomy and tissue characteristics such as prostate volume, cellularity, and vascularity. There is some evidence that MP-MRI tends to detect higher risk disease and systematically overlooks low-risk disease,[4,5] which makes it attractive as a potential triage test.[6,7]
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