Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)

Official title

Comparing Prostate Cancer Screening Between Standardized 3T MRI Screening Protocol and Low-Field MRI in a Prospective Study

Overview

This study compares the effectiveness of low-field MRI (0.55T) with high-field MRI (3T) in prostate cancer screening and image quality. It consists of three phases: optimizing the low-field MRI protocol with healthy volunteers, evaluating image quality in patients with metallic artifacts (like hip prostheses), and assessing low-field MRI in patients with suspicious prostate lesions found on high-field MRI.

Detailed description

This study aims to compare the effectiveness of low-field MRI (0.55T) with traditional high-field MRI (3T) in prostate cancer screening and image quality improvement. The study is conducted in three phases: first, a pilot study with healthy volunteers to optimize the low-field MRI protocol; second, an evaluation of image quality between the two types of MRI in patients with metallic artifacts, particularly due to hip prostheses; and finally, the assessment of low-field MRI in patients with suspicious prostate lesions on high-field MRI (3T).

The goal is to find an accessible solution for prostate cancer screening while maintaining or improving image quality.

Interventions

• Device Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
  Performing low-field MRI to evaluate image quality with patients carrying metallic implants and assess the detection of suspicious prostate lesions.

Primary outcome measures

• Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of as the reference standard. [Time frame: 9 months]

Secondary outcome measures (2)

• Protocol optimization on healthy volunteers [Time frame: 1 month]
• Image quality on patients with metal implants [Time frame: 9 months]

Eligibility criteria

Inclusion criteria

Work Package1 (WP): 0.55T MRI Protocol Development

• Healthy male volunteers aged 18 and above.
• Agree to be contacted for incidental findings
• Signed informed consent

WP2: 0.55T Prostate MRI with patients with metallic implant(s)

• Adult men (≥18 y.o) with 3T MRI reported as sub-diagnostic due to metallic implants
• Signed informed Consent

WP3: 0.55T Prostate MRI with patients with suspicious lesion(s)

• Adult men (≥18 y.o)
• PI-RADS 4/5 lesions detected on 3T MRI, schedules for targeted biopsy
• Signed informed consent

Exclusion criteria

WP1: 0.55T MRI Protocol Development

• Individuals with a history of prostate cancer
• MR Contraindications as listed in the MR Safety Screening form

WP2: 0.55T Prostate MRI with patients with metallic implant(s)

• Contraindications as per MD instructions
• Any condition making the patient unsuitable for the study
• Refusal to be notified in case of incidental finding on the examination

WP3: 0.55T Prostate MRI with patients with suspicious lesion(s)

• Individuals with a history of prostate cancer.
• Contraindications as per MD instructions
• Any condition making the patient unsuitable for the study
• Refusal to be notified in case of incidental finding on the examination

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Switzerland · 1 center

• Lausanne University Hospital — Lausanne

Publications

• Mottet N, van den Bergh RCN, Briers E, Van den Broeck T, Cumberbatch MG, De Santis M, Fanti S, Fossati N, Gandaglia G, Gillessen S, Grivas N, Grummet J, Henry AM, van der Kwast TH, Lam TB, Lardas M, Liew M, Mason MD, Moris L, Oprea-Lager DE, van der Poel HG, Rouviere O, Schoots IG, Tilki D, Wiegel T, Willemse PM, Cornford P. EAU-EANM-ESTRO-ESUR-SIOG Guidelines on Prostate Cancer-2020 Update. Part PMID 33172724
• Barentsz JO, Richenberg J, Clements R, Choyke P, Verma S, Villeirs G, Rouviere O, Logager V, Futterer JJ; European Society of Urogenital Radiology. ESUR prostate MR guidelines 2012. Eur Radiol. 2012 Apr;22(4):746-57. doi: 10.1007/s00330-011-2377-y. Epub 2012 Feb 10. PMID 22322308
• Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18. PMID 30898406
• Karanasios E, Caglic I, Zawaideh JP, Barrett T. Prostate MRI quality: clinical impact of the PI-QUAL score in prostate cancer diagnostic work-up. Br J Radiol. 2022 May 1;95(1133):20211372. doi: 10.1259/bjr.20211372. Epub 2022 Feb 18. PMID 35179971
• Giganti F, Allen C, Emberton M, Moore CM, Kasivisvanathan V; PRECISION study group. Prostate Imaging Quality (PI-QUAL): A New Quality Control Scoring System for Multiparametric Magnetic Resonance Imaging of the Prostate from the PRECISION trial. Eur Urol Oncol. 2020 Oct;3(5):615-619. doi: 10.1016/j.euo.2020.06.007. Epub 2020 Jul 6. PMID 32646850
• Eldred-Evans D, Burak P, Connor MJ, Day E, Evans M, Fiorentino F, Gammon M, Hosking-Jervis F, Klimowska-Nassar N, McGuire W, Padhani AR, Prevost AT, Price D, Sokhi H, Tam H, Winkler M, Ahmed HU. Population-Based Prostate Cancer Screening With Magnetic Resonance Imaging or Ultrasonography: The IP1-PROSTAGRAM Study. JAMA Oncol. 2021 Mar 1;7(3):395-402. doi: 10.1001/jamaoncol.2020.7456. PMID 33570542

Identifiers

NCT: NCT06482489 · 2024-D0049

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗