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Diagnostic Efficacy Comparison Between 3T and 5T MRI in Targeted Prostate Biopsy: A Prospective, Randomized Controlled Clinical Trial

Diagnostic Efficacy Comparison Between 3T and 5T MRI in Targeted Prostate Biopsy: A Prospective, Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107888
Enrollment
Unknown
Registered
2025-08-20
Start date
2025-08-20
Completion date
Unknown
Last updated
2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Interventions

3T MRI:Participants underwent 3.0T multiparametric prostate MRI, including sequences such as T2WI, DWI, and ADC. Imaging results will be independently interpreted and scored by two experienced radiolo
5T MRI:Participants underwent 5.0T multiparametric prostate MRI, including sequences such as T2WI, DWI, and ADC. Imaging results will be independently interpreted and scored by two experienced radiolo

Sponsors

Zhongda Hospital. Southeast University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients with elevated PSA (4-20 ng/mL), or those with suspicious prostate lesions indicated by digital rectal examination/ultrasound; 2. No history of prostate biopsy; 3. Planned to undergo MRI examination and transperineal targeted biopsy.

Exclusion criteria

Exclusion criteria: 1. Patients with a confirmed diagnosis of prostate cancer; 2. Contraindications to biopsy (such as acute prostatitis, coagulation dysfunction, etc.); 3. Patients unable to cooperate with MRI examination.

Design outcomes

Primary

MeasureTime frame
Positive rate of targeted biopsy;Detection rate of clinically significant prostate cancer;MRI image quality score;

Secondary

MeasureTime frame
Consistency between PIRADS Score and Pathological Results ;Number of Positive Biopsy Cores and Tumor Proportion;Lesion Detection Ability in Different Prostate Regions;Inter-Observer Agreement in Imaging Scoring;Comparison of Detection Rates Between Targeted Biopsy and Systematic Biopsy;

Countries

China

Contacts

Public ContactBin Xu

Zhongda Hospital, Southeast University

zhongdacq452@126.com+86 180 1294 9196

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026