UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016783 |
|---|---|
| Receipt number | 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 12:17:42 |
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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
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
mitsuzuka@uro.med.tohoku.ac.jp
Sponsor or person
Institute
Department of urology, Tohoku University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019471
