Diagnostic accuracy of multi‑parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study

Rákkutatás · Prostate cancer

MP‑MRI triage before prostate biopsy reduces unnecessary biopsies by 27 % and improves detection of clinically significant prostate cancers.

BACKGROUND: Men with high prostate‑specific antigen (PSA) levels usually undergo transrectal ultrasound‑guided prostate biopsy (TRUS‑biopsy), which can cause bleeding, pain, and infection. Multi‑parametric magnetic resonance imaging (MP‑MRI) may serve as a triage test to reduce unnecessary biopsies and improve diagnostic accuracy. METHODS: In this multicentre, paired‑cohort, confirmatory study, 740 men with PSA concentrations up to 15 ng/mL and no prior biopsy underwent 1.5 T MP‑MRI followed by both TRUS‑biopsy and template prostate mapping biopsy (TPM). Clinically significant cancer was defined as Gleason score ≥6 + 3 or a maximum cancer core length ≥6 mm. RESULTS: 576 men underwent all procedures. Clinically significant cancer was present in 230 men (40 %). MP‑MRI had sensitivity 93 % (95 % CI 88–96) versus 48 % (42–55) for TRUS‑biopsy (p < 0.0001) and specificity 41 % (36–46) versus 96 % (94–98) for TRUS‑biopsy (p < 0.0001). Serious adverse events occurred in 5 % of patients, including 8 cases of sepsis. CONCLUSION: MP‑MRI triage before first biopsy may reduce unnecessary biopsies by 27 % and improve detection of clinically significant cancers, thereby limiting overdiagnosis of indolent disease.

MP‑MRI as a triage tool can reduce unnecessary biopsies, improve detection of clinically significant prostate cancers, and limit overdiagnosis of indolent disease, improving patient experience and health‑care resource utilization.

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