UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031347 |
|---|---|
| Receipt number | R000035785 |
| Scientific Title | The effect of Enzalutamide and Radium-233 chloride for castration-resistant prostate cancer patients with bone metastasis |
| Date of disclosure of the study information | 2018/02/17 |
| Last modified on | 2018/07/06 08:57:54 |
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Basic information
Public title
The effect of Enzalutamide and Radium-233 chloride for castration-resistant prostate cancer patients with bone metastasis
Acronym
The effect of Enzalutamide and Radium-223 chloride for CRPC patients with bone metastasis
Scientific Title
The effect of Enzalutamide and Radium-233 chloride for castration-resistant prostate cancer patients with bone metastasis
Scientific Title:Acronym
The effect of Enzalutamide and Radium-223 chloride for CRPC patients with bone metastasis
Region
| Japan |
Condition
Condition
castration-resistant prostate cancer patients with bone metastasis
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of Enzalutamide and Radium-223 chloride for CRPC patients with bone metastasis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To elucidate the effect of Enzalutamide and Radium-223 chloride for CRPC patients with bone metastasis
Key secondary outcomes
Time to PSA failure, Time to SSE, Safty.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of Radium-233 chloride
Interventions/Control_2
Administration of Radium-233 chloride and Enzalutamide
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
The case of castration-resistant prostate cancer patients with bone metastasis
Key exclusion criteria
The case of Distant metastasis other than bone metastasis or visceral metastasis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryoichi Shiroki |
Organization
Fujita Health University Hospital
Division name
Department of Urology
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
TEL
0562-93-2382
rshiroki@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoshi Takahara |
Organization
Fujita Health University Hospital
Division name
Department of Urology
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-city, Aichi, Japan
TEL
0562-93-9257
Homepage URL
takahara@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
藤田保健衛生大学病院（愛知県）/Fujita Health University Hospital(Aichi)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 17 | Day |
Last modified on
| 2018 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035785
