UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011990 |
|---|---|
| Receipt number | 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 16:09:45 |
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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
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
kazu@gunma-u.ac.jp
Sponsor or person
Institute
Department of Urology, Gunma University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012049
