UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013151 |
|---|---|
| Receipt number | R000015335 |
| Scientific Title | An analytical study of laboratory tests and clinical effectiveness for combination therapies using GnRH antagonist/antiandrogen and GnRH aonist/antiandrogen in prostate cancer patients. |
| Date of disclosure of the study information | 2014/02/13 |
| Last modified on | 2014/02/13 15:21:02 |
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Basic information
Public title
An analytical study of laboratory tests and clinical effectiveness for combination therapies using GnRH antagonist/antiandrogen and GnRH aonist/antiandrogen in prostate cancer patients.
Acronym
An analytical study of laboratory tests and clinical effectiveness for combination therapies using GnRH antagonist/antiandrogen and GnRH aonist/antiandrogen in prostate cancer patients.
Scientific Title
An analytical study of laboratory tests and clinical effectiveness for combination therapies using GnRH antagonist/antiandrogen and GnRH aonist/antiandrogen in prostate cancer patients.
Scientific Title:Acronym
An analytical study of laboratory tests and clinical effectiveness for combination therapies using GnRH antagonist/antiandrogen and GnRH aonist/antiandrogen in prostate cancer patients.
Region
| Japan |
Condition
Condition
Prostatic Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze/confirm the possibility of novel standard therapy by comparing the laboratory value changes at early stage after GnRH antagonist/antiandrogen combination therapy with those after GnRH agonist/antiandrogen combination in prostate cancer patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of patients whose serum PSA at day 28 are 90% or less compared to those before administration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-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 + bicalutamide
Interventions/Control_2
LHRH agonist + 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
Male patients with histologically proven prostate cancer (all stages)
Key exclusion criteria
Patient who were inappropriate for this study judged by medical doctor
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Nonomura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Organ Specific Regulation (Urology)
Zip code
Address
2-2 yamada-oka, Suita, Osaka
TEL
81668793531
nono@uro.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Motohide Uemura |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Organ Specific Regulation (Urology)
Zip code
Address
2-2 yamada-oka, Suita, Osaka
TEL
81668793531
Homepage URL
uemura@uro.med.osaka-u.ac.jp
Sponsor or person
Institute
The Supporting Center for Clinical Research and Education
Institute
Department
Personal name
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
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
| 2014 | Year | 02 | Month | 13 | 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
| 2014 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 04 | 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
| 2014 | Year | 02 | Month | 13 | Day |
Last modified on
| 2014 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015335
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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