Clinical trial NCT06482489: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 74
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators initiate the study by establishing a specialized Low-Field MRI protocol. 23 healthy volunteers participate in this phase undergoing a 0.55T MRI to refine imaging sequences for prostate cancer screening. The objective is to optimize these sequences ensuring diagnostic quality on par with the standard 3T MRI, comparing technical settings such as SNR and CNR from healthy volunteers and the retrospective 3T prostate MRI cohort.

In WP2, 0.55T MRI exam will be performed on 20 patients who had a previous 3T MRI with a sub-diagnostic prostate MRI, using metrics of SNR, CNR, DWI and the PI-QUAL scaling score due to metallic implants.

In WP3, 31 eligible and enrolled patients who have a PI-RADS 4 or 5 lesion detected during a clinical 3T MRI exam with scheduled targeted prostate biopsy will undergo an additional MRI exam at 0.55T (before the biopsy).

Brief summary: 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.

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

Primary outcomes:
measure: 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.
timeFrame: 9 months
Secondary outcomes:
measure: Protocol optimization on healthy volunteers
timeFrame: 1 month
measure: Image quality on patients with metal implants
timeFrame: 9 months
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
affiliation: University of Lausanne Hospitals
name: Ileana Jelescu, Prof
role: STUDY_CHAIR
References:
citation: 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 1: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2021 Feb;79(2):243-262. doi: 10.1016/j.eururo.2020.09.042. Epub 2020 Nov 7.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.