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Abstract
Background: The optimal diagnostic pathway for prostate cancer (PCa) is evolving, requiring further evaluation in a randomized controlled trial.
Purpose: To assess the diagnostic accuracy of prebiopsy multiparametric MRI in the identification of clinically significant PCa (csPCa) using radical prostatectomy (RP) specimens as the reference standard, and to test the diagnostic accuracy of combined US and MRI fusion-targeted biopsy with systematic biopsies.
Materials and Methods: In a prospective randomized controlled trial including university hospitals, men with suspected PCa were recruited between January 2015 and August 2020 to assess the diagnostic accuracy of multiparametric MRI before biopsy in detection of csPCa at biopsy and RP histopathologic structure (primary outcome). Men with lesions suspicious for cancer (Prostate Imaging and Reporting Data System [PI-RADS] ≥3) at multiparametric MRI were first randomized to either systematic random prostate biopsies alone (control group) or US and MRI fusion-targeted biopsies with systematic random prostate biopsies (intervention group) at a one-to-one ratio to compare the diagnostic accuracy of systematic random versus combined fusion with systematic random biopsies (secondary outcome). A subset of recruited participants (n = 89) underwent RP and histologic sectioning.
Results: There were 582 participants who were eligible to undergo multiparametric MRI (mean age, 65 years ± 6 [SD]). In total, 413 had a PI-RADS score of at least 3 and were randomized into either the intervention group (207 of 413; 50.1%) or control group (206 of 413; 49.9%). The csPCa detection rate in the intervention group was higher, with an adjusted odds ratio of 1.79 (95% CI: 1.14, 2.79; P = .01). A subgroup of 89 men underwent RP (21.5%; 89 of 413). Multiparametric MRI helped correctly identify 131 of 182 csPCa foci in 89 men (sensitivity, 72%; 95% CI: 65, 78). The specificity, positive predictive value, and negative predictive value were 71% (91 of 128), 78% (131 of 168), and 64% (91 of 142), respectively.
Conclusion: Prebiopsy multiparametric MRI was accurate in the depiction of clinically significant PCa. Combining US and MRI fusion-targeted biopsies with systematic biopsies helped detect more clinically significant lesions than did systematic biopsies alone.
Clinical trial registration no. NCT02745496
Original language | English |
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Article number | e221428 |
Number of pages | 9 |
Journal | Radiology |
Volume | 308 |
Issue number | 1 |
Early online date | 25 Jul 2023 |
DOIs | |
Publication status | Published - Jul 2023 |
Keywords
- Male
- Humans
- Aged
- Magnetic Resonance Imaging
- Prospective Studies
- Prostatic Neoplasms
- Image-Guided Biopsy
- Multiparametric Magnetic Resonance Imaging
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging
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Dive into the research topics of 'Multicenter randomized trial assessing MRI and image-guided biopsy for suspected prostate cancer: The MULTIPROS study'. Together they form a unique fingerprint.Projects
- 1 Finished
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Multiparametric MRI for Disease Characterisation and Guided Biopsy of the Prostate in Men Suspected of having Prostate Cancer (Joint with NHS Grampian)
Bidaut, L. (Investigator), Donnan, P. (Investigator), Doull, R. (Investigator), Gandy, S. (Investigator), Lang, S. (Investigator), Nabi, G. (Investigator) & Vinnicombe, S. (Investigator)
1/07/14 → 31/12/20
Project: Research