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Trial Title:
Radiomics of Treatment-naive Prostate Cancer Patients on Multiparametric MRI for Risk Stratification and Treatment Outcomes Predictions
NCT ID:
NCT06126172
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Prostate cancer
Multiparametric MRI
Radiomics
Risk stratification
Recurrence
Prediction
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Multiparametric magnetic resonance imaging (mpMRI)
Description:
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.
Arm group label:
Multiparametric magnetic resonance imaging
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.
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.
Criteria for eligibility:
Criteria:
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:
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.
Gender:
Male
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Li-Jen Wang
Address:
City:
Taoyuan
Zip:
333
Country:
Taiwan
Start date:
February 15, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Chang Gung Memorial Hospital
Agency class:
Other
Source:
Chang Gung Memorial Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06126172
