UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046470 |
|---|---|
| Receipt number | R000053022 |
| Scientific Title | A study to elucidate the clinical factors of contrast-enhanced MRI in prostate cancer clinical practice |
| Date of disclosure of the study information | 2021/12/24 |
| Last modified on | 2025/01/06 15:02:04 |
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Basic information
Public title
A study to elucidate the clinical factors of contrast-enhanced MRI in prostate cancer clinical practice
Acronym
Is contrast-enhanced MRI necessary for prostate cancer?
Scientific Title
A study to elucidate the clinical factors of contrast-enhanced MRI in prostate cancer clinical practice
Scientific Title:Acronym
Is contrast-enhanced MRI necessary for prostate cancer?
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the clinical significance of dynamic contrast-enhanced MRI in multiparametric MRI by analyzing the relationship between the contrast enhancement and histopathological factors, treatment evaluation, prediction of treatment effect, predicting prognosis after treatment and the impact of dynamic contrast-enhanced MRI on practical clinical reading in patients with prostate cancer diagnosed by multiparametric MRI, MRI-guided biopsy or total prostatectomy due to elevated PSA levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
To evaluate the correlation between clinicopathological and contrast enhancement, treatment evaluation, prediction of treatment effect and predicting prognosis after treatment by dynamic contrast-enhanced MRI.
Key secondary outcomes
To evaluate the impact of dynamic contrast-enhanced MRI on practical clinical reading.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1. Patients who performed mpMRI (T2WI, DWI, DCE-MRI) due to elevated PSA levels.
2. MRI-US fusion biopsy proven prostate cancer(PI-RADS version 2.1 category 3 or more or likert scale category 3 or more)
Key exclusion criteria
1. Patients who lack of imaging quality
Investigator judged ineligible as a subject
2. Unevaluable of PI-RADS category due to lack of T2WI or DWI or DCE-MRI
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tsutomu |
| Middle name | |
| Last name | Tamada |
Organization
Kawasaki Medical School
Division name
Department of Radiology
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama, Japan
TEL
+81-86-462-1111
ttamada@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Tsutomu |
| Middle name | |
| Last name | Tamada |
Organization
Kawasaki Medical School
Division name
Department of Radiology
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama, Japan
TEL
+81-86-462-1111
Homepage URL
ttamada@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Radiology,
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama, Japan
Tel
086-464-1076
kmsrec@med.kawasaki-m.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
DOI: 10.1007/s12672-024-01668-9
Publication of results
Unpublished
Result
URL related to results and publications
DOI: 10.1007/s12672-024-01668-9
Number of participants that the trial has enrolled
231
Results
The PI-RADS category, qualitative enhancement effect, and tumor size were significantly lower in GS=3+3 lesions than in GS3+4 or higher lesions. The proportion of pattern 1 enhancement was significantly higher in GS=3+3 lesions than in GS3+4 or higher lesions.
In TZ PI-RADS category 3 lesions, the frequency of pattern 2 and 3 contrast patterns was significantly higher in GS=3+4 or more lesions than in GS=3+3 lesions.
Results date posted
| 2025 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Male patients with a increase in PSA levels or suspected　prostate cancer who underwent a 3.0T prostate multiparametric MRI examination and were diagnosed with prostate cancer histopathologically.
Participant flow
Eligible for inclusion in the study were 419 consecutive male patients with elevated PSA levels or suspected PC who underwent 3.0T prostate multiparametric MRI, including T2-weighted imaging, DWI, and DCE-MRI as well as MRGB of lesions suggestive of PC between October 2019 and March 2023. Of the 419 patients, 188 were excluded for the following reasons: diagnosis of benign prostatic condition by MRGB (n = 174); previous therapy including radiation therapy, radical prostatectomy, or bacillus Calmette-Guerin (BCG) administration for bladder cancer (n = 13); and prostatic neuroendocrine tumor (n = 1). After applying these exclusion criteria, 231 patients were included in this study. This study was approved by the ethics committee of our facility, and patient consent was obtained using the opt-out method.
Adverse events
None
Outcome measures
PSA
PI-RADS v2.1 assessment category
DCE-MRI: qualitative enhancement effect (QCE), contrast enhancement ratio (CER), and contrast enhancement pattern (CEP). CEP: Type 1, delayed enhancement with a gradual increase in SI over time; type 2, early enhancement followed by plateau; and type 3, early enhancement followed by wash-out.
DWI: ADCmean and ADC0-10
Tumor size
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 12 | Month | 24 | Day |
Last modified on
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053022
