UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011506 |
|---|---|
| Receipt number | R000013462 |
| Scientific Title | A randomized phase II study of degarelix combined with anti-androgen for prostate cancer |
| Date of disclosure of the study information | 2013/08/17 |
| Last modified on | 2015/05/13 16:53:33 |
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Basic information
Public title
A randomized phase II study of degarelix combined with anti-androgen for prostate cancer
Acronym
Degarelix with anti-androgen for prostate cancer
Scientific Title
A randomized phase II study of degarelix combined with anti-androgen for prostate cancer
Scientific Title:Acronym
Degarelix with anti-androgen for prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine the benefit of degarelix/bicalutamide versus degarelix monotherapy in patients with prostate cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum level of prostate specific antigen at Day 28.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
Degarelix
Interventions/Control_2
Degarelix + bicalutamide
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
Histologically proven prostate adenocarcinoma.
Patients indicated for androgen deprivation therapy.
Key exclusion criteria
Previous or present endocrine therapy for prostate cancer.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotsugu Uemura |
Organization
Kinki University Faculry of Medicine
Division name
Urology
Zip code
Address
377-2, Ohno-higashi, Osaka-sayama
TEL
0723660221
huemura@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Nozawa |
Organization
Kinki University Faculry of Medicine
Division name
Urology
Zip code
Address
377-2, Ohno-higashi, Osaka-sayama
TEL
0723660221
Homepage URL
nozawa06@med.kindai.ac.jp
Sponsor or person
Institute
South-Kinki Prostate Cancer Study Group
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
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
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
| 2013 | Year | 08 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 13 | Day |
Date trial data considered complete
| 2015 | Year | 05 | Month | 13 | Day |
Date analysis concluded
| 2015 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 17 | Day |
Last modified on
| 2015 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013462
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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