MR Microstructural Imaging for Prostate Cancer Diagnosis

NCT07249281 | Recruiting

• 1 other identifier: [2025B] IIT.No. 0321
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 6

Brief Summary

The goal of this multi-center clinical study is to evaluate whether time-dependent diffusion MRI (TDDMRI) can provide reliable microstructural imaging markers for the diagnosis of prostate cancer. The main questions this study aims to answer are:

• Do TDDMRI-derived microstructural parameters (such as cell size and density) improve diagnostic accuracy for prostate cancer compared with conventional MRI?
• How well do the microstructural parameters correlate with whole-slide pathology findings?
• Can the investigators determine diagnostic models combining multiple features for presurgical diagnosis across multiple centers? Participants with suspected prostate cancer will undergo 3T MRI including TDDMRI. Microstructural parameters will be quantified and compared with standard multiparametric MRI. All participants will also receive prostate biopsy or prostatectomy, and imaging findings will be validated against histopathology. This study will:
• Collect TDDMRI and conventional MRI data from six hospitals.
• Derive and validate imaging markers of prostate cancer based on microstructural parameters.
• Compare diagnostic performance across centers and against pathology as the reference standard.

Conditions

Prostate Cancer; Diffusion MRI

Keywords

Prostate Cancer; Time-dependent Diffusion MRI (TDDMRI); Diagnostic Accuracy; Multi-center Study

Outcome Measures

Primary Outcomes (2)

• Diagnostic Accuracy of TDDMRI for Clinically Significant Prostate Cancer (csPCa)

  Area under the receiver operating characteristic curve (AUC, range 0-1; higher values indicate better diagnostic performance) for TDDMRI-derived microstructural parameters to detect csPCa (reference standard: histopathology; Gleason score ≥7).

  Within 3 months after MRI and pathology confirmation.

• Development of Imaging-Based Diagnostic Criteria

  Establishment of threshold values or decision rules for TDDMRI-derived microstructural parameters (e.g., cellularity, cell size index, diffusivity) to differentiate malignant from benign prostate tissue. Diagnostic cutoffs will be derived by ROC analyses and validated against histopathology.

  Within 3 months (at completion of enrollment and pathology confirmation).

Secondary Outcomes (4)

• Cross-Center Reproducibility

  After completion of enrollment across all centers (up to 24 months).

• Sensitivity and Specificity of TDDMRI

  Within 3 months after MRI and pathology confirmation.

• Comparison with Conventional mpMRI

  Within 3 months after MRI and pathology confirmation.

• Correlation with Gleason Score

  Within 3 months after MRI scan

Study Arms (1)

Prostate Cancer Suspected Cohort

Men with clinical suspicion of prostate cancer who undergo standardized MRI including time-dependent diffusion MRI (TDDMRI). Histopathological confirmation (biopsy or prostatectomy) will be obtained in a subset of participants who provide consent. Diagnostic accuracy of TDDMRI-derived microstructural markers will be evaluated against pathology when available. Participants without pathology will still contribute imaging data for exploratory analyses.

Diagnostic Test: MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)

Interventions

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy) DIAGNOSTIC_TEST

The investigators will compare the diagnostic power of the proposed time-dependent diffusion MRI technique with conventional multiparameter MRI for prostate diagnosis

Prostate Cancer Suspected Cohort

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men with clinical suspicion of prostate cancer will be recruited from six participating hospitals. Clinical suspicion may be based on elevated prostate-specific antigen (PSA) levels, abnormal digital rectal examination, or other clinical findings. All participants will undergo prostate MRI including TDDMRI. Histopathological confirmation through biopsy or prostatectomy will be obtained in a subset of participants who consent to tissue sampling. The study population will therefore include both histopathology-positive and -negative cases, enabling evaluation of diagnostic performance and development of imaging-based diagnostic criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Zhejiang University: collaborator
• Jiangsu Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Zhejiang Hospital: collaborator
• Henan Cancer Hospital: collaborator
• Beijing Hospital: collaborator

Study Sites (6)

Beijing Hospital

Beijing, Beijing Municipality, China

RECRUITING

Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

COMPLETED

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, 310000, China

RECRUITING

Zhejiang Hospital

Hangzhou, Zhejiang, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

H\&E stained histology (biopsy or whole-slide histology) of the prostate tissue for validation of the MRI microstructural features

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging; Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Image Enhancement; Photography; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Central Study Contacts

Dan Wu, PhD

CONTACT

+86 571 87951385; danwu.bme@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: November 25, 2025
• Study Start: September 1, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-08

Locations

CN (6)