MR Microstructural Imaging for Prostate Cancer Diagnosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
AgeNot listed
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)
Diagnostic testThe investigators will compare the diagnostic power of the proposed time-dependent diffusion MRI technique with conventional multiparameter MRI for prostate diagnosis
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Prostate Cancer Suspected Cohort1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Within 3 months after MRI and pathology confirmation.2
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.
Time frame
Within 3 months (at completion of enrollment and pathology confirmation).Secondary outcomes
1
Cross-Center Reproducibility
Agreement of TDDMRI-derived parameters across participating centers, assessed by intraclass correlation coefficient (ICC; range 0-1, higher indicates better reproducibility).
Time frame
After completion of enrollment across all centers (up to 24 months).2
Sensitivity and Specificity of TDDMRI
Sensitivity and specificity (0-100%; higher indicates better diagnostic performance) of TDDMRI-derived microstructural parameters in identifying clinically significant prostate cancer.
Time frame
Within 3 months after MRI and pathology confirmation.3
Comparison with Conventional mpMRI
Difference in diagnostic performance (AUC, sensitivity, specificity) between TDDMRI parameters and conventional mpMRI measures : apparent diffusion coefficient (ADC) and Prostate Imaging-Reporting and Data System, version 2.1 (PI-RADS v2.1; score 1-5, higher indicates a higher likelihood of csPCa).
Time frame
Within 3 months after MRI and pathology confirmation.4
Correlation with Gleason Score
Correlation between TDDMRI microstructural parameters (e.g., cellularity, cell size index) and Gleason score from pathology, using Spearman's ρ (range -1 to 1; larger magnitude indicates stronger monotonic association), with 95% confidence intervals.
Time frame
Within 3 months after MRI scanSponsors and contacts
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Zhejiang University
Lead sponsor
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
Source ClinicalTrials.gov