UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016175 |
|---|---|
| Receipt number | R000018776 |
| Scientific Title | Sarcopenia following maximal androgen suppression in men with prostate cancer |
| Date of disclosure of the study information | 2015/01/15 |
| Last modified on | 2015/01/10 11:22:28 |
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Basic information
Public title
Sarcopenia following maximal androgen suppression in men with prostate cancer
Acronym
Sarcopenia following maximal androgen suppression in men with prostate cancer
Scientific Title
Sarcopenia following maximal androgen suppression in men with prostate cancer
Scientific Title:Acronym
Sarcopenia following maximal androgen suppression in men with prostate cancer
Region
| Japan |
Condition
Condition
prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We evaluated the relationship between reduced muscle mass, strength and function, and maximal androgen blockade therapy in men with prostate cancer.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The change of muscle mass, strength and function in temporal observation
Key secondary outcomes
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
| 85 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Patient with prostate cancer defined by pathological examination
2.untreated patientin prostate cancer
Key exclusion criteria
1.prostate cancer patient without any metastasis
2. Patient with a severe renal or liver function disorder
3. Patient with double cancer
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyama Matsuyama |
Organization
Yamaguchi University
Division name
Department of urology
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2275
hidde@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naohito Isoyama |
Organization
Yamaguchi University
Division name
Department of urology
Zip code
Address
1-1-1 Minamikogushi, Ube, Yamaguchi, Japan
TEL
0836-22-2275
Homepage URL
uroiso21@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Department of urology, Gradeate school of medicine, Yamaguchi University
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 01 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective case control study
Management information
Registered date
| 2015 | Year | 01 | Month | 10 | Day |
Last modified on
| 2015 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018776
