UMIN-CTR Clinical Trial

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
Last 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
1st 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