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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Prostate Cancer (Diagnosis)
• Intervention / Treatment: Other: observational study

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Qian Zhang; Phone Number: +86 15137562688; Email: zhangqian0194@163.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Gang Chen; Phone Number: +86 0512 67972861; Email: E-mail:sdfyec@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
the categorie is GG1 according to the ISUP grading standard	Other: observational study; 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 GG2 according to the ISUP grading standard	Other: observational study; 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 GG3 according to the ISUP grading standard	Other: observational study; 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 GG4 according to the ISUP grading standard	Other: observational study; 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 GG5 according to the ISUP grading standard	Other: observational study; The researchers will conduct observations, collect data and conduct follow-ups on the participants, but will not actively alter their treatment or health conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Regular sequence-related numerical values	Within one week after the MRI scan

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 11, 2026
• First Submitted That Met QC Criteria: April 20, 2026
• First Posted (Actual): April 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Pathological Conditions, Signs and Symptoms; Prostatic Neoplasms; Disease; Investigative Techniques; Methods; Observation
• Other Study ID Numbers: 2025465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No