UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035857 |
|---|---|
| Receipt number | R000040835 |
| Scientific Title | Early treatment effect and prognosis measurement of bone metastasis in prostate cancer patients by using whole-body diffusion-weighted imaging. |
| Date of disclosure of the study information | 2019/02/12 |
| Last modified on | 2021/08/15 10:26:02 |
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Basic information
Public title
Early treatment effect and prognosis measurement of bone metastasis in prostate cancer patients by using whole-body diffusion-weighted imaging.
Acronym
Bone metastasis evaluation in prostate cancer patients by using whole-body diffusion-weighted imaging.
Scientific Title
Early treatment effect and prognosis measurement of bone metastasis in prostate cancer patients by using whole-body diffusion-weighted imaging.
Scientific Title:Acronym
Bone metastasis evaluation in prostate cancer patients by using whole-body diffusion-weighted imaging.
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the early treatment effect and prognosis of bone metastasis in prostate cancer patients by using whole-body diffusion-weighted imaging.
We further evaluate the relationships among BD score, Circulating tumor cell (CTC), cell free DNA, quantitative value of conventional imaging technique, and clinical information in this study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of BD score 12 weeks after treatment
Key secondary outcomes
Prediction of recurrence at the time of treatment-effect judgment
Evaluation of the relationships among BD score, CTC, cell free DNA, quantitative value of conventional imaging technique, and clinical information
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
Prostate cancer patients before or under hormonal therapy or chemotherapy who agreed written informed consent for participating in this study.
Key exclusion criteria
1) Under 20 years old
2) The person who has internal implantation material to operate electrically or magnetically such as heart pacemaker
3) History of claustrophobia
4) The person who are regarded as inadequate for this study by a responsibility researcher
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Jinzaki |
Organization
Keio University, School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
1608582
Address
35, Shinanomachi, Shinjuku-Ku, Tokyo
TEL
03-3353-1211
jinzaki@rad.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Okuda |
Organization
Keio University, School of Medicine
Division name
Department of Diagnostic Radiology
Zip code
1608582
Address
35, Shinanomachi, Shinjuku-Ku, Tokyo
TEL
03-3353-1211
Homepage URL
http://rad.med.keio.ac.jp/
okuda@rad.med.keio.ac.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University, School of Mrdicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
0353633837
okuda@rad.med.keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
To evaluate improvement of BD score 12 weeks after treatment and prediction of recurrence at the time of treatment-effect judgment.
Management information
Registered date
| 2019 | Year | 02 | Month | 12 | Day |
Last modified on
| 2021 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040835
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/02/19 | DWIBS-IRB.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
