Radiomics of Treatment-naive Prostate Cancer Patients on Multiparametric MRI for Risk Stratification and Treatment Outcomes Predictions

NCT06126172 | Active Not Recruiting

• 1 other identifier: 202002364B0
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate cancers (PCA) are a heterogeneous group which include indolent tumors that has no clinical significance to very aggressive cancer that could result in morbidities and mortality. Thus, an accurate risk stratification at the time of PCA diagnosis is crucial. The histological examination of PCA biopsy specimens could not accurately predict the final tumor aggressiveness shown on radical prostatectomy specimens because of heterogeneous distributions of the most malignant tumor cells. Prostate multiparametric magnetic resonance imaging (mpMRI) has been generally accepted to be the best imaging modality for detecting and localizing prostate cancers themselves. Furthermore, the rapid development of radiomics provide comprehensive quantitative information of all tumor data which could be used for risk stratification and prognosis prediction. Thus, this study plans to enroll 200 eligible patients who undergo prostate mpMRI first, followed by radical prostatectomy for prostate cancers. We use radiomics extracted from prostate mpMRI for risk stratification patients of histological aggressiveness as well as to predict very early recurrence of PCA patients within 6 months after radical prostatectomy.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Multiparametric MRI; Radiomics; Risk stratification; Recurrence; Prediction

Outcome Measures

Primary Outcomes (3)

• MR characteristics assessment-T2WI

  T2-weighted images (T2WI)

  1.5 year

• MR characteristics assessment- DWI

  Axial diffusion weighted images (DWI)

  1.5 year

• MR characteristics assessment- ADC

  Apparent diffusion coefficient maps (ADC)

  1.5 year

Study Arms (1)

Multiparametric magnetic resonance imaging

EXPERIMENTAL

Detecting and localizing prostate cancers. The radiomics provide comprehensive quantitative information of all tumor data which could be used for risk stratification and prognosis prediction.

Diagnostic Test: Multiparametric magnetic resonance imaging (mpMRI)

Interventions

Multiparametric magnetic resonance imaging (mpMRI) DIAGNOSTIC_TEST

Detecting and localizing prostate cancers and using radiomics extracted from prostate mpMRI for risk stratification patients of histological aggressiveness as well as to predict very early recurrence of PCA patients within 6 months after radical prostatectomy.

Multiparametric magnetic resonance imaging

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 20 years old.
• Suspected or confirmed prostate cancer.
• Undergoing prostate mpMRI before clinical treatment.
• Normal renal function(i.e.: estimated GFR ≧60).
• No allergy history to gadolinium based contrast agent.
• Agree to participate this study and sign informed consent.

You may not qualify if:

• mpMRI photography not completed.
• mpMRI images are damaged or poor in quality and cannot be interpreted.
• Without pathological examination confirmed prostate cancer.
• Patient withdraw informed consent.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Li-Jen Wang

Taoyuan District, Taiwan, 333, Taiwan

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Recurrence

Interventions

Multiparametric Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Li-Jen Wang, M.D., M.P.H.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Imaging Department Director

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 13, 2023
• Study Start: February 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)