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

A. El-Shater Bosaily, C. Parker, L. C. Brown, R. Gabe, R. G. Hindley, R. Kaplan, M. Emberton, H. U. Ahmed, on behalf of the PROMIS Group

Research output: Contribution to journalArticlepeer-review

67 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)26-40
Number of pages15
JournalContemporary Clinical Trials
Volume42
DOIs
Publication statusPublished - 1 May 2015

Keywords

  • Magnetic resonance imaging
  • Multi-parametric MRI
  • Prostate cancer
  • Template transperineal mapping biopsy
  • Transrectal ultrasound guided biopsy
  • Triage diagnostic test

Cite this