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

NCT ID: NCT06612047

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2026-12-31

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with clinical suspicion of prostate cancer undergo 5.0T and 3.0T bpMRI

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.

Prostate biopsy

Intervention Type: PROCEDURE

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

Interventions

Prostate biopsy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

XiaoJun

Professor, Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jun Xiao, M.D.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of USTC

Locations

Department of Urology, The First Affiliated Hospital of USTC

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Changming Wang, M.D.

Role: CONTACT

wcmurologist@mail.ustc.edu.cn

15840256553

Jun Xiao, M.D.

Role: CONTACT

anhuiurology@126.com

13956934087

Facility Contacts

Changming Wang, M.D.

Role: primary

anhui930602wcm@126.com

+8615840256553

Other Identifiers

2024-ky399

Identifier Type: -

Identifier Source: org_study_id