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RecruitingNCT07552285Updated Apr 27, 2026

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

An observational study in Prostate Cancer and Prostate Cancer (Diagnosis), sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to male participants aged 20 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by The First Affiliated Hospital of Soochow University · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
20 Years to 90 Years
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer
  • Prostate Cancer (Diagnosis)
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In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's planned enrollment of 300 is above the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
Male
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.

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
4 Months
Patient registry
Yes

Groups and cohorts

  • 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

  • Otherobservational 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.

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What researchers measure

Primary outcomes

  1. Microstructure parameters related to the OGSE sequence

    Time frame: Within one week after the MRI scan

  2. CEST sequence-related numerical values

    Time frame: Within one week after the MRI scan

  3. MAGIC sequence-related numerical values

    Time frame: Within one week after the MRI scan

  4. IVIM sequence-related numerical values

    Time frame: Within one week after the MRI scan

Secondary outcomes

  1. Regular sequence-related numerical values

    Time frame: Within one week after the MRI scan

07

Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07552285
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Apr 27, 2026
Start date
May 1, 2025
Primary completion
May 1, 2027 (estimated)
Completion
Jun 1, 2027 (estimated)
Last update
Apr 27, 2026

Study contacts

Qian Zhang
Contact
zhangqian0194@163.com
+86 15137562688

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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