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Clinical trial Recruiting at 5 sites Observational Men only

Time-dependent diffusion MRI for prostate cancer microstructural imaging

Official title: Development of MR Microstructural Imaging Markers for Prostate Cancer Diagnosis and Investigation of the Associated Molecular Mechanisms

Run by First Affiliated Hospital of Zhejiang University · NCT07249281 · Data updated 2026-11-12

The team will test whether time-dependent diffusion MRI can help doctors more accurately diagnose prostate cancer in men who are suspected of having the disease.

Quick facts

Study typeObservational
SexMen only
Enrollment2000 (estimated)
SponsorFirst Affiliated Hospital of Zhejiang University
Academic / other
Drugs / interventionschemotherapy, radiation
Locations6 sites (Beijing, Beijing Municipality and 5 other locations)
StatusRecruiting
StartedSeptember 1, 2020
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedNovember 25, 2025
Trial IDNCT07249281 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men with clinical suspicion of prostate cancer (for example elevated PSA or abnormal digital rectal exam) who are scheduled for prostate MRI and willing to undergo biopsy or prostatectomy are ideal candidates.

Probably not a fit

Patients with prior prostate cancer treatment, contraindications to MRI, severe comorbidities, or poor image quality are unlikely to receive benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center diagnostic cohort in which men with suspected prostate cancer undergo standardized 3T multiparametric MRI that includes time-dependent diffusion MRI (TDDMRI) sequences. Quantitative microstructural parameters such as apparent cell size and cellularity will be derived from TDDMRI and compared directly with conventional mpMRI measures. Imaging findings will be validated against whole-slide histopathology from biopsy or prostatectomy, and harmonized imaging protocols across sites will support reproducibility. The investigators will develop and test diagnostic models that combine multiple imaging features to improve presurgical diagnosis across participating centers.

Why it matters

Potential benefit: If successful, TDDMRI-derived markers could improve detection of clinically significant prostate cancer and help reduce unnecessary procedures or misclassification.

How similar studies have gone: Early single-center and technical studies suggest TDDMRI can estimate tissue microstructure, but large multi-center validation for clinical diagnostic use is still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Clinical suspicion of prostate cancer (elevated PSA, abnormal digital rectal examination, or other clinical indication).
* Undergoing prostate MRI including TDDMRI as part of diagnostic evaluation. Able and willing to provide written informed consent.

Exclusion Criteria:

* Contraindications to MRI (e.g., pacemaker, ferromagnetic implants, severe claustrophobia).
* Prior treatment for prostate cancer (surgery, radiation, hormonal therapy, chemotherapy).
* Severe comorbid conditions precluding MRI or biopsy.
* Inability to provide informed consent.
* Poor image quality due to motion or technical artifacts (assessed at imaging QC).

Where it's running

  • Beijing Hospital
    Beijing, Beijing Municipality, China     Recruiting
  • The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
    Nanjing, Jiangsu, China     Recruiting
  • The First Affiliated Hospital of Dalian Medical University
    Dalian, Liaoning, China     Recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang, China     Recruiting
  • Zhejiang Hospital
    Hangzhou, Zhejiang, China     Recruiting
  • Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University
    Zhengzhou, Henan, China     Completed

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.