Using new non-contrast MRI sequences to improve diagnosis and grading of prostate cancer

The Enhancement of Diagnostic and Grading Efficacy of Prostate Cancer by New MRI Sequences: A Prospective Observational Study Based on New MRI Sequences in a Single Center

This project tries new non-contrast MRI scans to see if they improve diagnosis and grading for men with suspected prostate cancer and elevated PSA.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 20 Years to 90 Years
• Sex: Male
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07552285 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center observational effort that performs both conventional multiparametric MRI and novel non-contrast MRI sequences (for example MAGiC, OGSE, CEST, IVIM) on patients with clinical suspicion of prostate cancer. Imaging results from the new sequences will be compared to conventional MRI findings and to surgical or biopsy pathology as the gold standard. The goal is to determine whether adding these sequences improves detection accuracy and tumor grading without using contrast. Eligibility focuses on patients with elevated total PSA and no prior prostate cancer treatment or contraindications to MRI.

Who should consider this trial

Good fit: Ideal candidates are men with clinical suspicion of prostate cancer and elevated total PSA who have not had prior prostate cancer treatment and have no contraindications to MRI.

Not a fit: Patients who have already been treated for prostate cancer, have a history of other malignant tumors, have undergone radical prostatectomy, or cannot undergo MRI are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the approach could improve noninvasive accuracy for detecting and grading prostate cancer and potentially reduce unnecessary biopsies.

How similar studies have performed: Advanced MRI techniques such as IVIM, CEST, and quantitative mapping have shown promising but mixed results in previous research, and combining multiple novel sequences remains relatively new.

Eligibility criteria

Inclusion Criteria:

1. Patients with a high clinical suspicion of prostate cancer and elevated tPSA levels;
2. Patients with no prior history of other tumors;
3. Patients with no contraindications to MRI, including claustrophobia, presence of pacemakers, cardiac stents, or metal implants such as screws and plates.

Exclusion Criteria:

1. The patient has a history of malignant tumors and has received corresponding treatment;
2. Prior to the MRI examination, the patient has undergone treatment for prostate cancer, including endocrine therapy, radiotherapy, etc.;
3. Patients who have previously undergone radical prostatectomy for prostate cancer.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Qian Zhang

Conditions: Prostate Cancer