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

NCT06612047 | Recruiting DMC

• 1 other identifier: 2024-ky399
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; prostate biospy; Biparametric Magnetic Resonance; Prostate Imaging-Reporting and Data System; Diagnosis

Outcome Measures

Primary Outcomes (1)

• Compare the diagnostic efficacy of 5.0TbpMRI and 3.0TbpMRI for prostate cancer.

  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.

  through study completion, an average of 1 month

Secondary Outcomes (2)

• Evaluation of the reliability (repeatability) of the diagnostic test.

  through study completion, an average of 1 month

• 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

Study Arms (1)

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.

Procedure: Prostate biopsy

Interventions

Prostate biopsy PROCEDURE

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study mainly screened patients who need to complete mainly included serum PSA test, digital rectal examination, and 3.0TbpMRI and with indications of prostate biopsy. An informed consent conversation was conducted with the patient. After the patient fully understood the content of the study and signed the informed consent form, the researcher guided and arranged the 5.0TbpMRI examination throughout the process. All patients should complete the prostate biopsy according to the routine diagnosis and treatment process. The pathological diagnosis results of the prostate biopsy are the diagnostic gold standard of this study. The accuracy of 3.0TbpMRI and 5.0TbpMRI in preoperative prostate cancer tumor staging based on the final pathological results of radical prostatectomy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Department of Urology, The First Affiliated Hospital of USTC

Hefei, Anhui, 230001, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Xiao, M.D.

  The First Affiliated Hospital of USTC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changming Wang, M.D.

CONTACT

15840256553; wcmurologist@mail.ustc.edu.cn

Jun Xiao, M.D.

CONTACT

13956934087; anhuiurology@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief Physician

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 25, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

CN (1)