UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy and safety of enzalutamide for castrate-resistant prostate cancer patient showing disease progression after or during chemotherapy including docetaxel.
Title of the study (Brief title)	The efficacy and safety of enzalutamide on castrate-resistant prostate cancer after docetaxel treatment.
Region	Japan

Condition
Condition	Castrate-resistant prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To study the efficacy and safety of enzalutamide for castrate-resistant prostate cancer showing disease progression during or after chemotherapy including docetaxel.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PSA response rate
Key secondary outcomes	duration of PSA response Overall Survival QOL (FACT-P) Adverse Events

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 administration
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	Not applicable
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	1) histologically diagnosed as prostate cancer. 2) on-going androgen-deprivation therapy by either GnRH analogue or surgical castration. 3) judged as progressive disease after chemotherapy including docetaxel with concomitant medical castration or after surgical castration.
Key exclusion criteria	1) contraindication for enzalutamide 2) history of seizure (including febrile seizure), loss of consciousness. 3) symptom of temporal brain ischemia or warning sign of seizure within a year 4) judged as inappropriate by the investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	Yoshiaki Kawano
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Urology
Address	1-1-1 Honjo, Chuo-ku, Kumamoto
TEL	096-373-5240
Email	urology@kumamoto-u.ac.jp

Public contact
Name of contact person	Yoshiaki Kawano
Organization	Faculty of Life Sciences, Kumamoto University
Division name	Department of Urology
Address	1-1-1 Honjo, Chuo-ku, Kumamoto
TEL	096-373-5240
Homepage URL
Email	urology@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

Funding Source
Organization	Kumamoto 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	2016 Year 08 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 07 Month 07 Day
Anticipated trial start date	2014 Year 07 Month 07 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	2015/09/30 Principal Invstigator has been changed as below: Masatoshi Eto -> Yoshiaki Kawano

Management information
Registered date	2016 Year 08 Month 15 Day
Last modified on	2016 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027193