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

NCT07552285 | Recruiting

• 1 other identifier: 2025465
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial aims to explore the diagnostic efficacy and grading of prostate cancer by a novel MRI sequences such as MAGiC，OGSE,CEST,IVIM,etc.The main question it aims to answer is: Can the novel non-contrast multiparametric MRI imaging improve the accuracy of diagnosis and grading of prostate cancer? For patients with clinical suspicion of prostate cancer, both conventional and new sequences magnetic resonance scans are conducted, with surgical or biopsy pathological results serving as the gold standard.

Conditions

Prostate Cancer; Prostate Cancer (Diagnosis)

Outcome Measures

Primary Outcomes (4)

• Microstructure parameters related to the OGSE sequence

  Within one week after the MRI scan

• CEST sequence-related numerical values

  Within one week after the MRI scan

• MAGIC sequence-related numerical values

  Within one week after the MRI scan

• IVIM sequence-related numerical values

  Within one week after the MRI scan

Secondary Outcomes (1)

• Regular sequence-related numerical values

  Within one week after the MRI scan

Study Arms (5)

the categorie is GG1 according to the ISUP grading standard

Other: observational study

the categorie is GG2 according to the ISUP grading standard

Other: observational study

the categorie is GG3 according to the ISUP grading standard

Other: observational study

the categorie is GG4 according to the ISUP grading standard

Other: observational study

the categorie is GG5 according to the ISUP grading standard

Other: observational study

Interventions

observational study OTHER

The researchers will conduct observations, collect data and conduct follow-ups on the participants, but will not actively alter their treatment or health conditions.

the categorie is GG1 according to the ISUP grading standard; the categorie is GG2 according to the ISUP grading standard; the categorie is GG3 according to the ISUP grading standard; the categorie is GG4 according to the ISUP grading standard; the categorie is GG5 according to the ISUP grading standard

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical suspicion of prostate cancer, those who have a serum tPSA level greater than 4.0 ng/ml during outpatient examination, and patients with clinical manifestations of frequent urination, urgent urination and incomplete urination.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Interventions

Observation

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Qian Zhang

CONTACT

+86 15137562688; zhangqian0194@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 27, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)