UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041830 |
|---|---|
| Receipt number | R000047753 |
| Scientific Title | Examination for patients with bone metastatic Castration resistant prostate cancer to predict Overall survival and Treatment efficacy by bone Scan index Use study |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/09/17 20:19:19 |
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Basic information
Public title
Examination for patients with bone metastatic Castration resistant prostate cancer to predict Overall survival and Treatment efficacy by bone Scan index Use study
Acronym
COTSU study
Scientific Title
Examination for patients with bone metastatic Castration resistant prostate cancer to predict Overall survival and Treatment efficacy by bone Scan index Use study
Scientific Title:Acronym
COTSU study
Region
| Japan |
Condition
Condition
Castration resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Examination of VSBONE BSI index utility as a predictive factor for prognosis in patients with bone matastatic castration-resistant prostate cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between VSBONE BSI index and progression-free survival
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male
Key inclusion criteria
Patients with bone metastatic castration-resistant prostate cancer
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shunta |
| Middle name | |
| Last name | Hori |
Organization
Nara Medical University
Division name
Urology
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara
TEL
0744223051
urology@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunta |
| Middle name | |
| Last name | Hori |
Organization
Nara Medical University
Division name
Urology
Zip code
634
Address
840 Shijo-cho, Kashihara, Nara
TEL
634-8522
Homepage URL
urology@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara
Tel
0744223051
urology@naramed-u.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
| 2020 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 09 | Month | 17 | Day |
Last modified on
| 2020 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047753
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
