UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018634 |
|---|---|
| Receipt number | R000021564 |
| Scientific Title | Exploration of Predictive factors for response to Enzaltamide in bone metastasis of Prostate cancer |
| Date of disclosure of the study information | 2015/08/10 |
| Last modified on | 2019/04/26 10:16:11 |
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Basic information
Public title
Exploration of Predictive factors for response to Enzaltamide in bone metastasis of Prostate cancer
Acronym
EPEP study
Scientific Title
Exploration of Predictive factors for response to Enzaltamide in bone metastasis of Prostate cancer
Scientific Title:Acronym
EPEP study
Region
| Japan |
Condition
Condition
Bone metastasis of prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploring predictive factors for response to Enzaltamide in bone metastasis of prostate cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
BSI responder rate
3 months, 6 months, reccurence point
Key secondary outcomes
Response rate of 50 percent of PSA
PFS, OS
QOL SF-8, EPIC, FACT-P, I-PSS ,QOL score for urination
OS
Time to chemotherapy
Expression of micro RNA in blood
CTC and character change of androgen receptor
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
| Not applicable |
Gender
Male
Key inclusion criteria
1. 20 years old or more
2. Diagnosed as prostate cancer by histological examination and also have 2 or more bone metastasis by CRPC.
3. Testosterone < 50ng/dL
4. Progression on the image or PSA relapse
5. 2 months or more has passed from operation for metastasis or radiation therapy.
6. PS of ECOG; 0-2
7. Liver and renal function are adequate
8. Life expectancy is more than 6 months
Key exclusion criteria
1. Patients treated by chemotherapy
2. Patients judged to be inappropriate to perform this study by investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shgeo |
| Middle name | |
| Last name | Horie |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Urology
Zip code
1128421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
shorie@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Haruna |
| Middle name | |
| Last name | Haruna |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Urology
Zip code
1138421
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
harunase@juntendo.ac.jp
Sponsor or person
Institute
Department of Urology, Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Urology, Teikyo University school of medicine
Juntendo University Urayasu hospital
National Cancer Center Research Institute
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center of GCP, Juntendo university hospital
Address
3-1-3, Hongo, Bunko-ku, Tokyo, Japan
Tel
03-3813-3111
kenkyu5858@juntendo.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
順天堂大学医学部附属順天堂医院（東京都）、順天堂大学医学部附属浦安病院（千葉）、帝京大学医学部附属病院（東京都）、順天堂大学医学部附属練馬病院（東京都）、順天堂大学医学部附属江東高齢者医療センター（東京都）、順天堂大学医学部附属静岡病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 10 | Day |
Last modified on
| 2019 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021564
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| Registered date | File name |
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