UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015161 |
|---|---|
| Receipt number | R000011173 |
| Scientific Title | Randomized comparative study of immediate CAB (combined androgen blockade) therapy and differed CAB therapy for stage B to D2 prostate cancer |
| Date of disclosure of the study information | 2014/09/15 |
| Last modified on | 2014/09/15 11:17:02 |
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Basic information
Public title
Randomized comparative study of immediate CAB (combined androgen blockade) therapy and differed CAB therapy for stage B to D2 prostate cancer
Acronym
Randomized comparative study of immediate CAB (combined androgen blockade) therapy and differed CAB therapy for prostate cancer
Scientific Title
Randomized comparative study of immediate CAB (combined androgen blockade) therapy and differed CAB therapy for stage B to D2 prostate cancer
Scientific Title:Acronym
Randomized comparative study of immediate CAB (combined androgen blockade) therapy and differed CAB therapy for prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison of time to CRPC and number of the patients who will be diagnosed CRPC (castration resistant prostate cancer) between the immediate CAB therapy and differed CAB therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival, (time to progression (CRPC))
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
immediate MAB (CAB) therapy
patients receive LH-RH agonist and bicaltamide from the biginning of endocrine therapy
Interventions/Control_2
differed MAB (CAB) therapy
patients receive LH-RH agonist only from the biginning of endocrine therapy, and added bicaltamide after progression
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) pathologically confirmed prostate cancer
2) Patients who want to receive endocrine therapy
3) age from 20 years old, no upper limits
4) PS 0-1
Key exclusion criteria
1) high ALP> x2.5 WNL
2)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidefumi Kinoshita |
Organization
Kansai Medical University
Division name
Department of Urology and Andrology
Zip code
Address
Shin-machi 2-3-1, Hirakata, Osaka 573-1191, Japan
TEL
072-804-0101
kinoshih@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidefumi Kinoshita |
Organization
Kansai Medical University
Division name
Department of Urology and Andrology
Zip code
Address
Shin-machi 2-3-1, Hirakata, Osaka 573-1191, Japan
TEL
072-804-0101
Homepage URL
kinoshih@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical 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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2007 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 21 | 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
| 2014 | Year | 09 | Month | 15 | Day |
Last modified on
| 2014 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011173
