UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of Enzalutamide and Radium-233 chloride for castration-resistant prostate cancer patients with bone metastasis
Title of the study (Brief title)	The effect of Enzalutamide and Radium-223 chloride for CRPC patients with bone metastasis
Region	Japan

Condition
Condition	castration-resistant prostate cancer patients with bone metastasis
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the effect of Enzalutamide and Radium-223 chloride for CRPC patients with bone metastasis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To elucidate the effect of Enzalutamide and Radium-223 chloride for CRPC patients with bone metastasis
Key secondary outcomes	Time to PSA failure, Time to SSE, Safty.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of Radium-233 chloride
Interventions/Control_2	Administration of Radium-233 chloride and Enzalutamide
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	The case of castration-resistant prostate cancer patients with bone metastasis
Key exclusion criteria	The case of Distant metastasis other than bone metastasis or visceral metastasis
Target sample size	30

Research contact person
Name of lead principal investigator	Ryoichi Shiroki
Organization	Fujita Health University Hospital
Division name	Department of Urology
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
TEL	0562-93-2382
Email	rshiroki@fujita-hu.ac.jp

Public contact
Name of contact person	Kiyoshi Takahara
Organization	Fujita Health University Hospital
Division name	Department of Urology
Address	1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
TEL	0562-93-9257
Homepage URL
Email	takahara@fujita-hu.ac.jp

Sponsor
Institute	Fujita Health University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	藤田保健衛生大学病院（愛知県）/Fujita Health University Hospital(Aichi)

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 17 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 02 Month 14 Day
Anticipated trial start date	2018 Year 02 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 17 Day
Last modified on	2018 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035785