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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011506
Receipt No. 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

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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
Email 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
Email nozawa06@med.kindai.ac.jp

Sponsor
Institute South-Kinki Prostate Cancer Study Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013462

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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