ClinicalTrials.gg
RecruitingNCT06482489Low-PRISMUpdated Oct 30, 2026

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

An observational study in Prostate Cancer, sponsored by University of Lausanne Hospitals. Recruiting at 1 site in Switzerland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by University of Lausanne Hospitals · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 2 years later.
Updated Oct 30, 2026Primary completion movedStudy completion moved+2 moreGo to Updates ↓

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
74
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 136 studies in Prostatic Neoplasms with a site in Switzerland — 40 open to participants now, 58 under way, 20 of them phase 3. Prostatic Neoplasms · Switzerland.

Planned enrollment
19th of 28
74 · median 219
Started
2024
with 9 others
Observational
28 of 136
9 open now
Primary completion
2027-05
later than 22 of 57 live
Registered
109th of 136
by date

Among the 136 studies in Prostatic Neoplasms with a site in Switzerland, this one is the 19th largest by planned enrollment of the 28 observational ones that give a count, is one of 10 that started in 2024, is one of 28 observational ones, reaches primary completion later than 22 of the 57 other live ones, and was the 109th registered.

Prostatic Neoplasms

7,047 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

40 of the 136 studies in Prostatic Neoplasms with a site in Switzerland are open now. Recruiting first, the newest first:

34 more — sign in →

All 40 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 18 Years and older · male.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 136 studies in Prostatic Neoplasms with a site in Switzerland, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Prostate Cancer

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

WP1: 0.55T MRI Protocol Development

  • Individuals with a history of prostate cancer
  • MR 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
74 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy volunteers for protocol optimization

    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.

    Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).

  • Study of 0.55T Prostate MRI in Adult Men with Metal Implants.

    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).

    Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).

  • Evaluation of 0.55T Prostate MRI in Adult Men with Suspicious Lesions.

    The third phase includes 31 patients whose 3T MRIs detected lesions classified as PI-RADS 4/5 and who are scheduled for targeted prostate biopsy.

    Device: Siemens Magnetom Free.Max 0.55T (Siemens Healthineers, Erlangen, Germany).

Interventions

  • DeviceSiemens 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Assess the overall quality of prostate MR images obtained with 0.55T compared to 3T MRI in patients with suspected prostate cancer, using metrics of SNR, CNR and the PI-QUAL scaling score. Evaluate the diagnostic accuracy of 0.55T MRI in detecting prostate suspicious lesions using the PI-RADS grading score, with the results of a targeted prostate biopsy as the reference.

    Time frame: 9 months

Secondary outcomes

  1. Protocol optimization on healthy volunteers

    Assess image quality at 3T MRI and optimize the trade-off between quality and scan time.

    Time frame: 1 month

  2. Image quality on patients with metal implants

    Compare 0.55T and 3T MRI image quality in patients with implants and suspected prostate cancer, assessing PI-QUAL scaling.

    Time frame: 9 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 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. PubMed 33570542 ↗

Individual participant data

Plan to share: Yes — eCRF on RedCap Software

Supporting information: Study protocol, Informed consent form

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for May 2027, 30 months after the start.

Of 542 non-industry observational studies under Prostatic Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 162. This study's planned 30 months is below that.

Counting every sponsor, half of 651 studies reached it within 60 months; a quarter within 29 and three quarters within 141.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion May 2025 → May 2027 and completion Jul 2025 → May 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 25, 2024
First posted
Jul 1, 2024
StartActual
Nov 1, 2024
Primary completionEst.
May 31, 2027was May 2025
CompletionEst.
May 31, 2027was Jul 2025
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed
Show site
  • Lausanne University Hospital · Lausanne, Switzerland
Show 1 removed
  • Lausanne University Hospital · Lausanne, Switzerland
Oct 30, 2026
Primary completion
May 31, 2025→May 31, 2027
Oct 30, 2026
Study completion
Jul 31, 2025→May 31, 2027
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    1 site added, 1 site removed
    Show site
    • Lausanne University Hospital · Lausanne, Switzerland
    Show 1 removed
    • Lausanne University Hospital · Lausanne, Switzerland
    Primary completion May 31, 2025→May 31, 2027
    Study completion Jul 31, 2025→May 31, 2027
    + 2 other changes: verification date and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06482489
Responsible party
Naik Vietti Violi (Principal-Investigator, Executive Physician of Diagnostic And Interventional Radiology Department, University of Lausanne Hospitals) — Principal investigator
First posted
Jul 1, 2024
Start date
Nov 1, 2024
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Naïk Vietti-Violi, Dre
Contact
Naik-Vietti-Violi@chuv.ch
0795560240 ext. +41
Gorun Ilanjian, Dr
Contact
Gorun.Ilanjian@chuv.ch
0795560232 ext. +41
Ileana Jelescu, Prof
study chair · University of Lausanne Hospitals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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