PROMIS — Prostate MR imaging study: A paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer

• Published in: Contemporary clinical trials Vol. 42; pp. 26 - 40
• Main Authors: El-Shater Bosaily, A, Parker, C, Brown, L.C, Gabe, R, Hindley, R.G, Kaplan, R, Emberton, M, Ahmed, H.U
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.05.2015; Elsevier
• Subjects: Cardiovascular; Cost-Benefit Analysis; Hematology, Oncology and Palliative Medicine; Humans; Image-Guided Biopsy; Magnetic resonance imaging; Magnetic Resonance Imaging - methods; Male; Multi-parametric MRI; Neoplasm Grading; Observer Variation; Prospective Studies; Prostate - pathology; Prostate cancer; Prostate-Specific Antigen; Prostatic Neoplasms - diagnosis; Prostatic Neoplasms - pathology; Research Design; Risk Factors; Template transperineal mapping biopsy; Transrectal ultrasound guided biopsy; Triage diagnostic test; Triage diagnostic test; Multi-parametric MRI; Magnetic resonance imaging; Prostate cancer; Transrectal ultrasound guided biopsy; Template transperineal mapping biopsy
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2015.02.008

Abstract Background Transrectal ultrasound-guided prostate biopsies are prone to detection errors. Multi-parametric MRI (MP-MRI) may improve the diagnostic pathway. Methods PROMIS is a prospective validating paired-cohort study that meets criteria for level 1 evidence in diagnostic test evaluation. PROMIS will investigate whether multi-parametric (MP)-MRI can discriminate between men with and without clinically-significant prostate cancer who are at risk prior to first biopsy. Up to 714 men will have MP-MRI (index), 10–12 core TRUS-biopsy (standard) and 5 mm transperineal template mapping (TPM) biopsies (reference). The conduct and reporting of each test will be blinded to the others. Results PROMIS will measure and compare sensitivity, specificity, and positive and negative predictive values of both MP-MRI and TRUS-biopsy against TPM biopsies. The MP-MRI results will be used to determine the proportion of men who could safely avoid biopsy without compromising detection of clinically-significant cancers. For the primary outcome, significant cancer on TPM is defined as Gleason grade >/= 4 + 3 and/or maximum cancer core length of ≥ 6 mm. PROMIS will also assess inter-observer variability among radiologists among other secondary outcomes. Cost-effectiveness of MP-MRI prior to biopsy will also be evaluated. Conclusions PROMIS will determine whether MP-MRI of the prostate prior to first biopsy improves the detection accuracy of clinically-significant cancer.