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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000014702
Receipt No. R000017089
Scientific Title Clinical study of enzalutamide on castration resistant prostate cancer
Date of disclosure of the study information 2014/07/31
Last modified on 2019/03/18

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Basic information
Public title Clinical study of enzalutamide on castration resistant prostate cancer
Acronym Enzalumide on CRPC
Scientific Title Clinical study of enzalutamide on castration resistant prostate cancer
Scientific Title:Acronym Enzalumide on CRPC
Region
Japan

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

Objectives
Narrative objectives1 Clinical evaluation of enzalutamide on castration prostate cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PSA response rate, 50% and 90%
Key secondary outcomes Overall survival rate, radiographical progression free survival rate, progression free survival rate, QOL evaluation, serum levels of hormones and prognosis

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
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 male, age >= 20 years old
2 hitologically proven prostate cancer
3 castrated state
4 castration resistant prostate cancer
5 PS 0 -2
6 radiographical metastasis site at diagnosis or teatment periods
7 obtain by written consent
Key exclusion criteria 1 Epileptic state patients
2 Brain damage, apoplexy, brain metastatis, active epidural metastatis of cranium
3 Hypersensitivity to enzalutamide or its component
4 Severe liver dysfunction
5 Impropriate state judged by charged doctor
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name kazuhiro
Middle name
Last name Suzuki
Organization CRPC-TRG: castration resistant prostate cancer treatment research group
Division name Department of Urology, Gunma University Graduate School of Medicine
Zip code 3718511
Address 3-39-22 Showa-machi, Maebashi, 371-8511, Gunma, Japan
TEL 027-220-8303
Email kazu@gunma-u.ac.jp

Public contact
1st name of contact person
1st name Hidekazu
Middle name
Last name Koike
Organization Gunma University Graduate School of Medicine
Division name Department of Urology
Zip code 3718511
Address 3-39-22 Showa-machi, Maebashi, 371-8511, Gunma, Japan
TEL 207-220-8303
Homepage URL
Email hkoike@gunma-u.ac.jlp

Sponsor
Institute CRPC-TRG: castration resistant prostate cancer treatment research group
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 IRB of gunma university hosipital
Address 3-39-22 showa-machi,maebashi, gunma
Tel 027-220-8740
Email gunmaciru-office@umin.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

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 31 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 104
Results
Total 104 patients were enrolled with age of 53 to 88 years. PSA responses over 50% and 90% were 62.5% and 25.0%. Response duration of 50% response was 7.0 month. Median overall survival was 133.3 weeks with median. Prognostic factor affecing to overall survival was docetaxel treatment history, hemoglobin levels.
Results date posted
2019 Year 03 Month 18 Day
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
2014 Year 06 Month 25 Day
Date of IRB
2014 Year 06 Month 25 Day
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
2019 Year 02 Month 27 Day
Date of closure to data entry
2019 Year 02 Month 27 Day
Date trial data considered complete
2019 Year 02 Month 27 Day
Date analysis concluded
2019 Year 02 Month 27 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 29 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017089

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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