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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011990
Receipt No. R000012049
Scientific Title Endocrinological profiles in patients with prostate cancer treated with LHRH antagonist
Date of disclosure of the study information 2013/10/08
Last modified on 2017/10/12

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Basic information
Public title Endocrinological profiles in patients with prostate cancer treated with LHRH antagonist
Acronym Endocrinological profiles of LHRH antagonist
Scientific Title Endocrinological profiles in patients with prostate cancer treated with LHRH antagonist
Scientific Title:Acronym Endocrinological profiles of LHRH antagonist
Region
Japan

Condition
Condition Prostate Cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is aimed to study the changes of endocrinological parameters in patients with prostate cancer treated with LHRH antagonist, Degarelix.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of serum sex and peptide hormones.
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 LHRH antagonist, degarelix
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

Not applicable
Gender Male
Key inclusion criteria Patients with prostate cancer treated with LHRH antagonist, Degarelix
Key exclusion criteria 1. Patients treated with concomitant anti-androgens.
2. Patients treated with concomitant medicines that affect serum sex hormone levels.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Suzuki
Organization Gunma University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8300
Email kazu@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhiro Suzuki
Organization Gunma University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 3-39-22 Showa-machi, Maebashi, Gunma, Japan
TEL 027-220-8300
Homepage URL
Email kazu@gunma-u.ac.jp

Sponsor
Institute Department of Urology, Gunma University Graduate School of Medicine
Institute
Department

Funding Source
Organization Astellas Pharmaceutical. Co. Ltd
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 10 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5575925/
Number of participants that the trial has enrolled
Results Degarelix reduced serum testosterone levels soon after the first administration. It also reduced serum adrenal androgen levels.
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
2012 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 05 Day
Last follow-up date
2015 Year 04 Month 30 Day
Date of closure to data entry
2015 Year 07 Month 30 Day
Date trial data considered complete
2015 Year 08 Month 30 Day
Date analysis concluded
2015 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 08 Day
Last modified on
2017 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012049

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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