UMIN-CTR Clinical Trial

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