UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of clinical efficacy of Enzalutamide and its predictive factors in CRPC patients
Acronym	Efficacy of Enzalutamide in CRPC patients
Scientific Title	Investigation of clinical efficacy of Enzalutamide and its predictive factors in CRPC patients
Scientific Title:Acronym	Efficacy of Enzalutamide in CRPC patients
Region	Japan

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

Objectives
Narrative objectives1	To investigate the clinical efficacy of Enzalutamide and its predictive factors on disease progression after the administration of bicalutamide
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SMAC, CBC, serum PSA, cytokines, androgens, Lipid metabolism. Bone markers, QoL assessment PSA-PFS
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	Treatment with Enzalutamide
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	95 years-old >=
Gender	Male
Key inclusion criteria	1)CRPC patients undergoing ADT with GnRH antagonists,agonist or bilateral orchiectomy 2) Testosterone levels of less than 50 ng/dL 3) 25% increase in PSA from nadir (and by 2 ng/mL) which is confirmed 4 weeks later 4) ECOG PS 0-2 5) Signed written informed consent
Key exclusion criteria	1) Severe cardiac function disorders, hepatic function disorders, renal function disorders, infectious disease or hematopoietic disorders 2) Hypersensitivity to study medication 3) History of seizure or any condition that may predispose to seizure 4) Age <20 years 5) History of treatment with Enzalutamide, Abiraterone or chemotherapy 6) Patients whom the investigator judges inappropriate for the study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Mototsugu Oya
Organization	Keio University School of Medicine
Division name	Department of Urology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL	03-5363-3825
Email	moto-oya@z3.keio.jp

Public contact
Name of contact person	1st name Middle name Last name Takeo Kosaka
Organization	Keio University School of Medicine
Division name	Department of Urology
Zip code
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan.
TEL	03-5363-3825
Homepage URL
Email	takemduro@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Astellas Pharmaceutical Co. Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2014 Year 12 Month 23 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	Completed
Date of protocol fixation	2014 Year 12 Month 05 Day
Date of IRB	2014 Year 07 Month 25 Day
Anticipated trial start date	2014 Year 12 Month 22 Day
Last follow-up date	2020 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 12 Month 18 Day
Last modified on	2020 Year 11 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018599