Prostate CancerNCT06126172
Radiomics of Treatment-naive Prostate Cancer Patients on Multiparametric MRI for Risk Stratification and Treatment Outcomes Predictions
A study testing Multiparametric magnetic resonance imaging (mpMRI) in people with Prostate Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Multiparametric magnetic resonance imaging (mpMRI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Prostate Cancer
- Being tested
- Multiparametric magnetic resonance imaging (mpMRI)
- Keywords
- Prostate cancer, Multiparametric MRI, Radiomics, Risk stratification, Recurrence, Prediction
- Medical subject headings
- Prostatic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Multiparametric magnetic resonance imaging (mpMRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR characteristics assessment-T2WI
T2-weighted images (T2WI)
Measured: 1.5 year
MR characteristics assessment- DWI
Axial diffusion weighted images (DWI)
Measured: 1.5 year
MR characteristics assessment- ADC
Apparent diffusion coefficient maps (ADC)
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start15 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Jen Wang, Chang Gung Memorial Hospital
- Investigators
- Li-Jen Wang, M.D., M.P.H., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126172
- Sponsor's protocol ID
- 202002364B0
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2023
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to make individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiomics of Treatment-naive Prostate Cancer Patients on Multiparametric MRI for Risk Stratification and Treatment Outcomes Predictions
- ClinicalTrials.gov ID
- NCT06126172
- Acronym / sponsor ID
- 202002364B0
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Multiparametric MRI, Radiomics, Risk stratification, Recurrence, Prediction
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiparametric magnetic resonance imaging | Experimental | Diagnostic Test: Multiparametric magnetic resonance imaging (mpMRI)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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiparametric 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. | Diagnostic test | Multiparametric magnetic resonance imaging |
Primary outcome
MR characteristics assessment-T2WI
Time frame: 1.5 year
T2-weighted images (T2WI)
MR characteristics assessment- DWI
Time frame: 1.5 year
Axial diffusion weighted images (DWI)
MR characteristics assessment- ADC
Time frame: 1.5 year
Apparent diffusion coefficient maps (ADC)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. Plan to make individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li-Jen Wang, M.D., M.P.H. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparametric magnetic resonance imaging (mpMRI) in people with Prostate Cancer, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MR characteristics assessment-T2WI (time frame: 1.5 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.