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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009079
Receipt No. R000010645
Scientific Title The effect of luteinizing hormone-releasing hormone antagonist in the progression prostate cancer with initial luteinizing hormone-releasing hormone agonist
Date of disclosure of the study information 2012/11/01
Last modified on 2014/05/28

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Basic information
Public title The effect of luteinizing hormone-releasing hormone antagonist in the progression prostate cancer with initial luteinizing hormone-releasing hormone agonist
Acronym PC-antagonist
Scientific Title The effect of luteinizing hormone-releasing hormone antagonist in the progression prostate cancer with initial luteinizing hormone-releasing hormone agonist
Scientific Title:Acronym PC-antagonist
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effect of luteinizing hormone-releasing hormone antagonist, in the prostate cancer with prostate specific antigen biochemical treated with initial luteinizing hormone-releasing hormone agonist, especially associated with testosterone level 20ng/dl.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes PSA response after three months with luteinizing hormone-releasing hormone agonist
Key secondary outcomes

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 luteinizing hormone-releasing hormone agonist
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

Not applicable
Age-upper limit
85 years-old >=
Gender Male
Key inclusion criteria 25% elevation from PSA nadir and 2.0ng/ml
Serum testosterone >20ng/dl
WHO performance status 0 or 1
WBC over 3000/mm3
Pl t over 100,000/mm3
Hgb over 8.0g/mm3
Ccr over 50ml/m
Bil less than 2.0mg/dl
GOT(AST) less than 2.5xnormal range
GPT(ALT) less than 2.5x normal range
Key exclusion criteria Active infection
Fever elevation >38 celsius
Exclusion decided by physician
Target sample size 32

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Norihito Soga
Organization Aichi cancer center hospital
Division name urology
Zip code
Address 1-1Kanokodenn, Chikusa, Nagoya
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization M-CURE
Division name urology
Zip code
Address
TEL
Homepage URL
Email n-soga@aichi-cc.jp

Sponsor
Institute M-CURE
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2012 Year 11 Month 01 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 Enrolling by invitation
Date of protocol fixation
2012 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 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
2012 Year 10 Month 10 Day
Last modified on
2014 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010645

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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