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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041830
Receipt No. 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

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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
Email 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
Email urology@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047753

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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