MR Microstructural Imaging for Prostate Cancer Diagnosis

Condition(s) studied

Investigational drug(s) / intervention(s)

MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy): The investigators will compare the diagnostic power of the proposed time-dependent diffusion MRI technique with conventional multiparameter MRI for prostate diagnosis

Study 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.

Eligibility

Primary outcome measure(s)

• Diagnostic Accuracy of TDDMRI for Clinically Significant Prostate Cancer (csPCa) — Within 3 months after MRI and pathology confirmation.
  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).
• Development of Imaging-Based Diagnostic Criteria — Within 3 months (at completion of enrollment and pathology confirmation).
  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.

Trial sites (6)

More First Affiliated Hospital of Zhejiang University trials in China

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