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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018634
Receipt No. 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

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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
Email 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
Email harunase@juntendo.ac.jp

Sponsor
Institute Department of Urology, Juntendo University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021564

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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