UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of docetaxel, estramustine and carboplatin chemotherapy on castration-resistant prostate cancer
Title of the study (Brief title)	DEC
Region	Japan

Condition
Condition	CRPC
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To exam the efficacy of DEC on CRPC
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	survival, QOL
Key secondary outcomes

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	Chemotherapy
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	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male
Key inclusion criteria	1 Male 2 Older tha 18 3 Patients agree with this study
Key exclusion criteria	1 Patients who can not visit our hospitall 2 History of allergy on DEC agents 3 Patiens whom the doctor don't think appropriate
Target sample size	100

Research contact person
Name of lead principal investigator	Masahiro Sumura
Organization	Shimane University
Division name	Urology
Address	Enya 89-1, Izumo, Shimane
TEL	0853202256
Email	sumura@med.shimane-u.ac.jp

Public contact
Name of contact person	Masahiro Sumura
Organization	Shimane University
Division name	Urology
Address	Enya 89-1, Izumo, Shimane
TEL	0853202256
Homepage URL
Email	sumura@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

Funding Source
Organization	Shimane University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 05 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 06 Month 28 Day
Anticipated trial start date	2013 Year 06 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 04 Month 25 Day
Last modified on	2017 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031088