UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011379 |
|---|---|
| Receipt number | R000013327 |
| Scientific Title | Examination about safety and the effectiveness when we switched from a GnRH antagonist to a GnRH agonist at the time of prostate cancer hormonal therapy introduction |
| Date of disclosure of the study information | 2013/08/06 |
| Last modified on | 2013/08/05 16:36:06 |
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Basic information
Public title
Examination about safety and the effectiveness when we switched from a GnRH antagonist to a GnRH agonist at the time of prostate cancer hormonal therapy introduction
Acronym
Clinical trial when I switched from a GnGH antagonist to a GnRH agonist at the time of prostate cancer hormonal therapy introduction
Scientific Title
Examination about safety and the effectiveness when we switched from a GnRH antagonist to a GnRH agonist at the time of prostate cancer hormonal therapy introduction
Scientific Title:Acronym
Clinical trial when I switched from a GnGH antagonist to a GnRH agonist at the time of prostate cancer hormonal therapy introduction
Region
| Japan |
Condition
Condition
Prostate Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
At the time of introduction of hormonal therapy prostate cancer, even if we switch from a GnRH antagonist to a GnRH agonist, to examine the safety and efficacy of PSA, testosterone and et all values measured after the switch
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in LH and testosterone level after switch the GnRH agonist
Key secondary outcomes
Changes in LH, testosterone, PSA. FSH level after administration of the GnRH antagonist
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male
Key inclusion criteria
1.The patient pathologically
diagnosed as a prostatic cancer
2.The first patient to receive an hormonal therapy
Key exclusion criteria
1.The patient who has the condition by metastasis
2.Gleason Score8over
3.Prostate volume 50cc over
4.The patient who judged that a doctor
in charge was unsuitable
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki Yanishi |
Organization
Kansai Medical University
Division name
Urology
Zip code
Address
2-3-1 Sinmachi Hirakata city
TEL
072-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaaki Yanishi |
Organization
Kansai Medical University
Division name
Urology
Zip code
Address
2-3-1 Sinmachi Hirakata city
TEL
072-804-0101
Homepage URL
masaaki.yanishi@gmail.com
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
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 | 06 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 04 | Month | 30 | Day |
Other
Other related information
Changes in LH and testosterone level after switch the GnRH agonist
Management information
Registered date
| 2013 | Year | 08 | Month | 05 | Day |
Last modified on
| 2013 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013327
