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In the PROMIS study, 576 patients with suspected prostate cancer underwent MP-MRI, with the report locked and blinded, followed by a standard transrectal ultrasonography-guided (TRUS)-biopsy
plus template mapping (TPM)-biopsy testing. TRUS–TPM-biopsy sampling was used as the 'gold-standard' reference diagnostic test, as performing radical prostatectomy in all patients was, of
course, ethically unacceptable.
The sensitivity of MP-MRI for the detection of 'clinically significant' prostate cancer (Gleason score ≥4 + 3, or cancer core length ≥6 mm) was found to be almost double that of TRUS biopsy
(93% versus 48%). The false-positive rate, however, was 49% for MP-MRI, necessitating follow-up biopsy sampling to confirm suspicious findings. Nevertheless, MP-MRI triage for subsequent
TRUS-biopsy testing was estimated to enable the detection of 18% of the clinically significant cancers that would have been missed had primary TRUS-biopsy been used in all patients.
Moreover, the authors estimated that MP-MRI triage could have avoided TRUS-biopsy testing for 27% of the men and reduced the overdiagnosis of clinically insignificant cancer by 5%. Of note,
the false-negative rate with MP-MRI was not insubstantial at 11%, but was 26% with TRUS biopsy as the primary test.
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