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Active, not recruitingNCT06126172Updated Mar 20, 2026

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

An interventional study of Multiparametric magnetic resonance imaging (mpMRI) in Prostate Cancer, sponsored by Chang Gung Memorial Hospital. Active, not recruiting at 1 site in Taiwan. Open to male participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 8 months after the study started (first participant enrolled Feb 2022, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Not applicable
Ages
20 Years and older
Sex
Male
01

Study 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.

Read the detailed description

Prostate cancer is the 2nd most common malignancy in the world as well as the leading cancer in male population in Taiwan. The treatment selections of prostate cancer are limited by the uncertainty of its aggressiveness (i.e.: histological graded) and staging before treatment. Although prostate mpMRI has much better ability for detection and localization of prostate cancers than other imaging modalities and diagnostic tests, there is still gap for risk stratifications and treatment selection based on prostate mpMRI findings. Thus, a robust radiomics prediction models based on imaging biomarkers on prostate mpMRI with high prediction accuracy could fill the gap of misclassification of risk stratifications of prostate cancers, guides treatment selections and providing monitoring schedules for treated patients as well as early timely additional treatments (i.e.: target therapy or immunotherapy) for patients with high risk of early recurrence. Furthermore, radiomics could provide consistent information which help in decreasing interobserver and intra-observer variability of interpretating prostate cancer even in the use of PIRADS. In this way, this would save the fee of inappropriate or ineffective treatment and avoid unnecessary time and cost of monitoring low risk patients as well as improve patients' survivals and possibly life-quality as well.

02

Conditions studied

  • Prostate Cancer

Keywords

  • Prostate cancer
  • Multiparametric MRI
  • Radiomics
  • Risk stratification
  • Recurrence
  • Prediction
03

In context

Prostatic Neoplasms

6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.

This study's planned enrollment of 125 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. mpMRI photography not completed.
  2. mpMRI images are damaged or poor in quality and cannot be interpreted.
  3. Without pathological examination confirmed prostate cancer.
  4. Patient withdraw informed consent.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
125 participants (estimated)

Study arms

  • Experimental
    Multiparametric magnetic resonance imaging

    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

  • Diagnostic testMultiparametric magnetic resonance imaging (mpMRI)

    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.

06

What researchers measure

Primary outcomes

  1. MR characteristics assessment-T2WI

    T2-weighted images (T2WI)

    Time frame: 1.5 year

  2. MR characteristics assessment- DWI

    Axial diffusion weighted images (DWI)

    Time frame: 1.5 year

  3. MR characteristics assessment- ADC

    Apparent diffusion coefficient maps (ADC)

    Time frame: 1.5 year

07

Study locations

1 site
  • Li-Jen Wang
    Taoyuan, Taiwan 333, Taiwan
08

References and documents

Individual participant data

Plan to share: No — Plan to make individual participant data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06126172
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Li-Jen Wang (Medical Imaging Department Director, Chang Gung Memorial Hospital) — Principal investigator
First posted
Nov 13, 2023
Start date
Feb 15, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 20, 2026

Study contacts

Li-Jen Wang, M.D., M.P.H.
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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