Clinical trial · Observational
Accurate Prostate Cancer Following Using Low-Field MRI (Low-PRISM)
Comparing Prostate Cancer Screening Between Standardized 3T MRI Screening Protocol and Low-Field MRI in a Prospective Study
NCT06482489CI-TRIAL-00088053Low-PRISMrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany). | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Healthy volunteers for protocol optimization
- description
- The commencement of the study involves the formulation of the 0.55T MRI protocol. For this purpose, a cohort of 23 male volunteers will undergo a 0.55T MRI. The objective is to achieve the same spatial resolution and coverage as observed at 3T.
- interventionNames
- Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
- label
- Study of 0.55T Prostate MRI in Adult Men with Metal Implants.
- description
- The second phase of the research will be carried out to compare the MRI image quality between 0.55T and 3T MRI. The study will involve 20 adult men, who on 3T prostate MRI, have DWI reported as sub-diagnostic (PI-QUAL \< 3) due to the presence of metallic implant(s).
- interventionNames
- Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).
- label
- Evaluation of 0.55T Prostate MRI in Adult Men with Suspicious Lesions.
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDMottet 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. PMID 33172724
- BACKGROUNDBarentsz 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
- BACKGROUNDTurkbey 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
- BACKGROUNDKaranasios 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
- BACKGROUNDGiganti 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
- BACKGROUNDEldred-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.