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

Recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Prostate biopsy

• Registration Number: NCT06612047
• Lead Sponsor: Anhui Provincial Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2024-09-21
• Study First Submitted QC: 2024-09-21
• Study First Posted: 2024-09-25
• Study Start: 2024-10-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

1. The patient has at least one indication for prostate biopsy (Chinese expert consensus on prostate biopsy (2022 edition) );
2. The primary prostate cancer has no other cancer history;
3. The 3.0TbpMRI examination was completed, and the images were clear and accessible;
4. The 5.0TbpMRI examination was further completed, and the images were clear and accessible;
5. The patient fully understands the relevant content of the study and voluntarily signs the informed consent.

Exclusion Criteria

1. The patient has contraindications to MRI examination, such as metal plates and heart stents in the body;
2. The patient does not have an indication for prostate biopsy or refuses biopsy;
3. The patient has contraindications to prostate biopsy;
4. 3.0T MRI considers that the patient has multiple lymph node or bone metastases;
5. The patient has undergone other prostatic surgery in the past;
6. The patient is unable to cooperate, has communication barriers, or refuses to sign the informed consent form.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with clinical suspicion of prostate cancer undergo 5.0T and 3.0T bpMRI	Prostate biopsy	All enrolled patients need to undergo 5.0TbpMRI and 3.0TbpMRI (within one month). The magnetic resonance imaging sequences mainly include T1WI, multi-plane T2WI and multi-b-value DWI images.

Primary Outcome Measures

Name	Time	Method
Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer.	through study completion, an average of 1 month	Definitions: csPCa, Gleason score ≥ 3+4， ISUP grade ≥ 2; agPCa, Gleason score ≥ 3+3， ISUP grade ≥ 1.; Evaluation indexes: ROC curves and AUC value (95%CI) , Sensetivity, Specificity, Positive predictive value and negative predictive value.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the reliability (repeatability) of the diagnostic test.	through study completion, an average of 1 month	The inter-reader agreement was evaluated using Cohen's kappa analysis (Cohen's kappa coefficeint, P-value and 95%CI)
Comparative analysis of the accuracy of 5.0TbpMRI and 3.0TbpMRI in determining the stage of prostate cancer	through study completion, an average of 2 months	Accuracy of prostate capsule invasion, seminal vesicle invasion and pelvic lymph node metastasis.

Trial Locations

Locations (1)

Department of Urology, The First Affiliated Hospital of USTC; 🇨🇳 Hefei, Anhui, China