NCT05903781

Brief Summary

This study aims to assess the value of ultra-fast MRI sequences in the assessment of prostate cancer, compared to the full multiparametric/biparametric protocol as the clinical standard.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
536

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

June 26, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

1.7 years

First QC Date

May 31, 2023

Last Update Submit

May 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Diagnostic accuracy of ultrafast bpMRI of the prostate

    Diagnostic accuracy of ultrafast bpMRI of the prostate

    1.5 years

Interventions

Prostate MRIDIAGNOSTIC_TEST

MRI of the prostate

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ca. 300 men with suspected prostate cancer

You may qualify if:

  • Patients who undergo clinically indicated MR imaging of the prostate
  • Informed consent as documented by signature (Informed Consent Form)
  • Patients ≥18 years of age

You may not qualify if:

  • Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc. of the participant
  • Previous enrolment into the current study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Patients with non-MRI compatible metallic or electronic implants, devices or metallic foreign bodies (cardiac pacemaker, shrapnel, cochlea implants, neurostimulator, or other non-MRI compatible implants).
  • Patients with known hypersensitivity reactions to MRI contrast agents will undergo the examination without application of a contrast agent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 15, 2023

Study Start

June 26, 2023

Primary Completion

February 18, 2025

Study Completion

February 18, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations