Prostate CancerNCT05903781
Value of Ultra-fast Prostate MRI in Prostate Cancer
An observational study of Prostate Cancer, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Prostate MRI
- How many people
- 536 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Jun 2023to 18 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: ca. 300 men with suspected prostate cancer
Who may be able to join
- Patients who undergo clinically indicated MR imaging of the prostate
- Informed consent as documented by signature (Informed Consent Form)
- Patients ≥18 years of age
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Value of Ultra-fast Biparametric MRI in the Assessment of Prostate Cancer
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.
Read the detailed description
Prostate cancer is the second most common type of cancer among men and the fifth leading cause of cancer-related deaths globally. Magnetic resonance imaging (MRI) has become an integral part of the clinical assessment of prostate cancer and is a valuable tool to identify target lesions for subsequent biopsy, perform local tumor staging, provide information on active surveillance approaches, and might also be eligible for prostate cancer screening.
To standardize the interpretation and reporting in prostate MRI, the PI-RADS (Prostate Imaging-Reporting and Data System) scoring system has been developed. PI-RADS has played a crucial role in the widespread adoption of prostate MRI among radiologists and urologists worldwide and has also become an essential part of national and international clinical guidelines. This has resulted in a notable surge in the number of prostate MRI examinations conducted in recent years, and is expected to further increase over the next years. The present PI-RADS guideline provides comprehensive technical instructions on the acquisition of prostate MRI leading to the acquisition of a multiparametric MRI (mpMRI) that typically requires around 30 minutes of scan time.
As healthcare systems around the world face increasing demand and limited resources, there is a need to identify efficient and cost-effective ways to diagnose and treat prostate cancer. Efforts have been made to reduce the duration and expenses associated with prostate MRI acquisition and interpretation, leading to a biparametric MRI (bpMRI, exclusion of contrast-enhanced sequences) with a shortened protocol compared to the conventional mpMRI. Several studies have demonstrated the high diagnostic accuracy of abbreviated prostate MRI for detecting and even staging prostate cancer in comparison to traditional full mpMRI. The accelerated protocols have therefore the potential to improve efficiency and patient comfort, to reduce healthcare costs and make this technique accessible to more men. Nevertheless, even these shortened protocols accrue a scan time of about 15-20 minutes. Recent developments in MRI technique now allow for even faster image acquisitions, but more research is necessary to fully elicit the advantages and limitations of accelerated or even ultra-fast prostate MRI protocols (scan time of < 5 min) before incorporating them into routine clinical practice.
The purpose of this study is therefore to further explore ultra-fast bpMRI compared to conventional full mpMRI of the prostate to gain valuable insights into the diagnostic performance, feasibility and clinical utility of this emerging imaging technique and consequently optimize prostate cancer management.
- Conditions
- Prostate Cancer
- Being tested
- Prostate MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate MRIDiagnostic test
MRI of the prostate
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of ultrafast bpMRI of the prostate
Diagnostic accuracy of ultrafast bpMRI of the prostate
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start26 Jun 2023
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903781
- Sponsor's protocol ID
- Ultra- Fast Prostate MRI
- Status last verified
- May 2025
- First submitted
- 31 May 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Ultra-fast Biparametric MRI in the Assessment of Prostate Cancer
- ClinicalTrials.gov ID
- NCT05903781
- Acronym / sponsor ID
- Ultra- Fast Prostate MRI
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prostate cancer is the second most common type of cancer among men and the fifth leading cause of cancer-related deaths globally. Magnetic resonance imaging (MRI) has become an integral part of the clinical assessment of prostate cancer and is a valuable tool to identify target lesions for subsequent biopsy, perform local tumor staging, provide information on active surveillance approaches, and might also be eligible for prostate cancer screening.
To standardize the interpretation and reporting in prostate MRI, the PI-RADS (Prostate Imaging-Reporting and Data System) scoring system has been developed. PI-RADS has played a crucial role in the widespread adoption of prostate MRI among radiologists and urologists worldwide and has also become an essential part of national and international clinical guidelines. This has resulted in a notable surge in the number of prostate MRI examinations conducted in recent years, and is expected to further increase over the next years. The present PI-RADS guideline provides comprehensive technical instructions on the acquisition of prostate MRI leading to the acquisition of a multiparametric MRI (mpMRI) that typically requires around 30 minutes of scan time.
As healthcare systems around the world face increasing demand and limited resources, there is a need to identify efficient and cost-effective ways to diagnose and treat prostate cancer. Efforts have been made to reduce the duration and expenses associated with prostate MRI acquisition and interpretation, leading to a biparametric MRI (bpMRI, exclusion of contrast-enhanced sequences) with a shortened protocol compared to the conventional mpMRI. Several studies have demonstrated the high diagnostic accuracy of abbreviated prostate MRI for detecting and even staging prostate cancer in comparison to traditional full mpMRI. The accelerated protocols have therefore the potential to improve efficiency and patient comfort, to reduce healthcare costs and make this technique accessible to more men. Nevertheless, even these shortened protocols accrue a scan time of about 15-20 minutes. Recent developments in MRI technique now allow for even faster image acquisitions, but more research is necessary to fully elicit the advantages and limitations of accelerated or even ultra-fast prostate MRI protocols (scan time of < 5 min) before incorporating them into routine clinical practice.
The purpose of this study is therefore to further explore ultra-fast bpMRI compared to conventional full mpMRI of the prostate to gain valuable insights into the diagnostic performance, feasibility and clinical utility of this emerging imaging technique and consequently optimize prostate cancer management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ca. 300 men with suspected prostate cancer
Key inclusion criteria (3 listed)
- Patients who undergo clinically indicated MR imaging of the prostate
- Informed consent as documented by signature (Informed Consent Form)
- Patients ≥18 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prostate MRIMRI of the prostate | Diagnostic test | – |
Primary outcome
Diagnostic accuracy of ultrafast bpMRI of the prostate
Time frame: 1.5 years
Diagnostic accuracy of ultrafast bpMRI of the prostate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of ultrafast bpMRI of the prostate (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.