UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023627 |
|---|---|
| Receipt number | R000027193 |
| Scientific Title | The efficacy and safety of enzalutamide for castrate-resistant prostate cancer patient showing disease progression after or during chemotherapy including docetaxel. |
| Date of disclosure of the study information | 2016/08/16 |
| Last modified on | 2016/08/15 00:34:33 |
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Basic information
Public title
The efficacy and safety of enzalutamide for castrate-resistant prostate cancer patient showing disease progression after or during chemotherapy including docetaxel.
Acronym
The efficacy and safety of enzalutamide on castrate-resistant prostate cancer after docetaxel treatment.
Scientific Title
The efficacy and safety of enzalutamide for castrate-resistant prostate cancer patient showing disease progression after or during chemotherapy including docetaxel.
Scientific Title:Acronym
The efficacy and safety of enzalutamide on castrate-resistant prostate cancer after docetaxel treatment.
Region
| Japan |
Condition
Condition
Castrate-resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To study the efficacy and safety of enzalutamide for castrate-resistant prostate cancer showing disease progression during or after chemotherapy including docetaxel.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSA response rate
Key secondary outcomes
duration of PSA response
Overall Survival
QOL (FACT-P)
Adverse Events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Enzalutamide administration
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) histologically diagnosed as prostate cancer.
2) on-going androgen-deprivation therapy by either GnRH analogue or surgical castration.
3) judged as progressive disease after chemotherapy including docetaxel with concomitant medical castration or after surgical castration.
Key exclusion criteria
1) contraindication for enzalutamide
2) history of seizure (including febrile seizure), loss of consciousness.
3) symptom of temporal brain ischemia or warning sign of seizure within a year
4) judged as inappropriate by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kawano |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Urology
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5240
urology@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Kawano |
Organization
Faculty of Life Sciences, Kumamoto University
Division name
Department of Urology
Zip code
Address
1-1-1 Honjo, Chuo-ku, Kumamoto
TEL
096-373-5240
Homepage URL
urology@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
2015/09/30
Principal Invstigator has been changed as below:
Masatoshi Eto -> Yoshiaki Kawano
Management information
Registered date
| 2016 | Year | 08 | Month | 15 | Day |
Last modified on
| 2016 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027193
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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