UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014702 |
|---|---|
| Receipt number | R000017089 |
| Scientific Title | Clinical study of enzalutamide on castration resistant prostate cancer |
| Date of disclosure of the study information | 2014/07/31 |
| Last modified on | 2019/03/18 16:08:31 |
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Basic information
Public title
Clinical study of enzalutamide on castration resistant prostate cancer
Acronym
Enzalumide on CRPC
Scientific Title
Clinical study of enzalutamide on castration resistant prostate cancer
Scientific Title:Acronym
Enzalumide on CRPC
Region
| Japan |
Condition
Condition
Castration resistant prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Clinical evaluation of enzalutamide on castration prostate cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PSA response rate, 50% and 90%
Key secondary outcomes
Overall survival rate, radiographical progression free survival rate, progression free survival rate, QOL evaluation, serum levels of hormones and prognosis
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
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
| Not applicable |
Gender
Male
Key inclusion criteria
1 male, age >= 20 years old
2 hitologically proven prostate cancer
3 castrated state
4 castration resistant prostate cancer
5 PS 0 -2
6 radiographical metastasis site at diagnosis or teatment periods
7 obtain by written consent
Key exclusion criteria
1 Epileptic state patients
2 Brain damage, apoplexy, brain metastatis, active epidural metastatis of cranium
3 Hypersensitivity to enzalutamide or its component
4 Severe liver dysfunction
5 Impropriate state judged by charged doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | kazuhiro |
| Middle name | |
| Last name | Suzuki |
Organization
CRPC-TRG: castration resistant prostate cancer treatment research group
Division name
Department of Urology, Gunma University Graduate School of Medicine
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi, 371-8511, Gunma, Japan
TEL
027-220-8303
kazu@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Koike |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Urology
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi, 371-8511, Gunma, Japan
TEL
207-220-8303
Homepage URL
hkoike@gunma-u.ac.jlp
Sponsor or person
Institute
CRPC-TRG: castration resistant prostate cancer treatment research group
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharmaceutical Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of gunma university hosipital
Address
3-39-22 showa-machi,maebashi, gunma
Tel
027-220-8740
gunmaciru-office@umin.ac.jp
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
| 2014 | Year | 07 | Month | 31 | 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
104
Results
Total 104 patients were enrolled with age of 53 to 88 years. PSA responses over 50% and 90% were 62.5% and 25.0%. Response duration of 50% response was 7.0 month. Median overall survival was 133.3 weeks with median. Prognostic factor affecing to overall survival was docetaxel treatment history, hemoglobin levels.
Results date posted
| 2019 | Year | 03 | Month | 18 | Day |
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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 27 | Day |
Date of closure to data entry
| 2019 | Year | 02 | Month | 27 | Day |
Date trial data considered complete
| 2019 | Year | 02 | Month | 27 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 29 | Day |
Last modified on
| 2019 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017089
| Research Plan | |
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| Registered date | File name |
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