NCT06612047

Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer

Comparison of 5.0T and 3.0T Biparametric Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer: A Prospective, Single Center and Paired-design Diagnostic Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to compare 5.0T and 3.0T biparametric magnetic resonance imaging in the diagnosis of prostate cancer. The main aims of this study are: * Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer. Preliminarily evaluate the value of 5.0TbpMRI in diagnosing prostate cancer. * Compare and analyze the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the T stage of prostate cancer. Preliminary evaluation of the value of 5.0TbpMRI in determining the tumor stage of prostate cancer. The data of participants was collected prospectively.

Detailed description

The methods currently recommended by the guidelines for early diagnosis of prostate cancer mainly include rectal examination, serum prostate-specific antigen detection, transrectal prostate ultrasound, and multi-parameter magnetic resonance imaging. However, these methods lack sufficient specificity for the diagnosis of prostate cancer. Therefore, prostate biopsy is still the gold standard for the diagnosis of prostate cancer. mpMRI has good accuracy in detecting clinically significant prostate cancer, but mpMRI is difficult to identify lesions with a tumor diameter of less than 5 mm, and false positive results may occur for benign diseases such as prostatitis. The magnetic field strength of mpMRI magnetic resonance scanners commonly used in clinical practice is mostly 1.5T or 3.0T. The application of 3.0T magnetic resonance allows patients to no longer accept the use of rectal coils and makes the examination images clearer, making it the most commonly used magnetic field strength for mpMRI. The main problems of 3.0T prostate magnetic resonance examinations are low specificity (false positive results) and insufficient accuracy in determining tumor staging. At present, there is no research and exploration on the use of 5.0T magnetic resonance in the diagnosis of prostate cancer in the world. This study intends to analyze and compare the differences between 5.0TbpMRI and 3.0TbpMRI in the diagnosis of prostate cancer through a prospective, paired-design diagnostic trial, and try to explore whether 5.0TbpMRI can improve the limitations of 3.0TbpMRI in the diagnosis of prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	Prostate biopsy	All patients were required to underwent transperineal prostate biopsy (Systemetic + Targeted) and have corresponding pathological diagnosis results.

Timeline

• Start date: 2024-10-08
• Primary completion: 2026-09-30
• Completion: 2026-12-31
• First posted: 2024-09-25
• Last updated: 2025-02-11

Locations

1 site across 1 country: China