UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of treatment starategy for patients with castration resistsnt prostate cancer using new hormonal agents before chemotherapy
Title of the study (Brief title)	Starategy for pre-chemo CRPC
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To know impact of new hormonal agents (Enzalutamide and abiraterone) in patients with castration resistant prostate cancer before chemotherapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	PSA resopnse
Key secondary outcomes	QOL Duration before chemotherapy Skeletal related event Survival

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	85 years-old >=
Gender	Male
Key inclusion criteria	1. Pathologicalyconfirmation of prostate cancer 2. Castration resistant prostate cancer 3. Next treatment: Enzalutamide or abiraterone 4. No chemotherapy 5. No steroids 6. Performance status 0-1
Key exclusion criteria	1. Other malignancies 2. Prior chemotherapy (excluding estramuscin) 3. Steroids 4. Severe visceral dysfunction 5. Other clinical trial 6. Prior enzalutamide or abiraterone
Target sample size	200

Research contact person
Name of lead principal investigator	Mitsuzuka Koji
Organization	Tohoku University School of Medicine
Division name	Urology
Address	1-1 Seiryo-machi,Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL	022-717-7278
Email	yarai@uro.med.tohoku.ac.jp

Public contact
Name of contact person	Mitsuzuka Koji
Organization	Tohoku University School of Medicine
Division name	Urology
Address	1-1 Seiryo-machi,Aoba-ku, Sendai, Miyagi 980-8574, Japan
TEL	022-717-7278
Homepage URL
Email	mitsuzuka@uro.med.tohoku.ac.jp

Sponsor
Institute	Department of urology, Tohoku University School of Medicine
Institute
Department

Funding Source
Organization	Astellas
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Clinical ressearch, Innovation and Education Center, Tohoku University Hospital
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	弘前大学（青森県）、秋田大学（秋田県）、宮城県立がんセンター（宮城県）、むつ総合病院（青森県）、青森県立中央病院（青森県）、青森労災病院（青森県）、八戸市民病院（青森県）、秋田赤十字病院（秋田県）、市立秋田総合病院（秋田県）、大館市立病院（秋田県）、岩手県立磐井病院（岩手県）、栗原中央病院（宮城県）、気仙沼市立病院（宮城県）、大崎市民病院（宮城県）、仙台医療センター（宮城県）、宮城県立がんセンター（宮城県）、仙台市立病院（宮城県）、柳生クリニック（宮城県）、東北公済病院（宮城県）、泉中央病院（宮城県）、仙塩利府病院（宮城県）、山形県立中央病院（宮城県）、白河厚生総合病院（福島県）、総合磐城共立病院（福島県）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 09 Month 30 Day
Date trial data considered complete	2020 Year 09 Month 30 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective observation study Efficiency of each drugs Setquential effiiency among the drugs

Management information
Registered date	2015 Year 03 Month 11 Day
Last modified on	2018 Year 09 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019471