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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016783
Receipt No. R000019471
Scientific Title Study of treatment starategy for patients with castration resistsnt prostate cancer using new hormonal agents before chemotherapy
Date of disclosure of the study information 2015/04/01
Last modified on 2018/09/12

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Basic information
Public title Study of treatment starategy for patients with castration resistsnt prostate cancer using new hormonal agents before chemotherapy
Acronym Starategy for pre-chemo CRPC
Scientific Title Study of treatment starategy for patients with castration resistsnt prostate cancer using new hormonal agents before chemotherapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Mitsuzuka Koji
Organization Tohoku University School of Medicine
Division name Urology
Zip code
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
1st name
Middle name
Last name Mitsuzuka Koji
Organization Tohoku University School of Medicine
Division name Urology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2015 Year 04 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019471

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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