Prostatectomy Clinical Trials

Clinical trials related to Prostatectomy Procedure

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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: Male
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Hospital
RECRUITING
Beijing
The First Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Zhejiang Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of Nanjing Medical University (Jiangsu Province Hospital)
RECRUITING
Nanjing
Henan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University
COMPLETED
Zhengzhou
Contact Information
Primary
Dan Wu, PhD
danwu.bme@zju.edu.cn
+86 571 87951385
Time Frame
Start Date: 2020-09-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 2000
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Zhejiang University, The First Affiliated Hospital of Dalian Medical University, Jiangsu Provincial People's Hospital, Henan Cancer Hospital, Zhejiang Hospital, Beijing Hospital
Leads: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov