Value of Ultra-fast Prostate MRI in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Value of Ultra-fast Biparametric MRI in the Assessment of Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05903781
• Other study ID #: Ultra- Fast Prostate MRI
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: November 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 1, 2025
• Est. primary completion date: January 1, 2025
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who undergo clinically indicated MR imaging of the prostate

• Informed consent as documented by signature (Informed Consent Form)

• Patients =18 years of age

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Prostate MRI
MRI of the prostate

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of ultrafast bpMRI of the prostate	Diagnostic accuracy of ultrafast bpMRI of the prostate	1.5 years