UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000240 |
|---|---|
| Receipt number | R000000302 |
| Scientific Title | A multi-center trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in stage C,D prostate cancer patients |
| Date of disclosure of the study information | 2005/09/20 |
| Last modified on | 2011/06/04 17:22:51 |
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Basic information
Public title
A multi-center trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in stage C,D prostate cancer patients
Acronym
A trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in prostate cancer patients
Scientific Title
A multi-center trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in stage C,D prostate cancer patients
Scientific Title:Acronym
A trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in prostate cancer patients
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A randomized study whether the green tea extract (GTE) delay time to hormone refractory in patients treated with hormonal therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to hormone refractory
Key secondary outcomes
Survival time (disease specific survival, overall survival) and adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Taking GTE tablet with hormonal therapy
Interventions/Control_2
hormonal therapy alone
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
a) clinical stage C or D
b) any age
c) performance status 0-3
d) both of beginning hormonal therapy (fresh cases)and under hormonal theprapy(under treatment cases)are included
e) The PSA value of under treatment cases were normalized (less than 4 ng/ml) within 6 months after hormonal therapy, and the PSA value was stable.
f) The PSA value before hormonal therapy was out of normal range. The measurement of PSA value is decided as Tandem-R. The value with other measurement is converted into Tandem-R.
g) The treatment before hormonal therapy is not unrelated.
h) Acquired informed consent with writing
Key exclusion criteria
a) Patients who have active double cancer.
b) Patients who have digestive tract ulcer and a critical liver, kidney, and heart disease.
c) Patients who experienced palpitation and heartburn with coffee or tea.
d) Patients who have abnormality in a blood cells or biochemical examination of blood classified into two or more grade of NCI toxicity criteria
e) Patients considered not to have a six months prognosis.
f) Patients who are judged to be unsuitable for the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Akaza |
Organization
The University of Tsukuba Graduate Schools
Division name
Department of Urology, Institute of Clinical Medicine
Zip code
Address
1-1-1 Ten-nodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-853-3223
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoto Miyanaga |
Organization
The University of Tsukuba Graduate Schools
Division name
Department of Urology, Institute of Clinical Medicine
Zip code
Address
1-1-1 Ten-nodai, Tsukuba, Ibaraki 305-8575, Japan
TEL
029-853-3223
Homepage URL
nao-miya@md.tsukuba.ac.jp
Sponsor or person
Institute
The University of Tsukuba Graduate Schools
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tsukuba prostate cancer prevention study group
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
| 2005 | Year | 09 | Month | 20 | 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
Completed
Date of protocol fixation
| 2000 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2000 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 20 | Day |
Last modified on
| 2011 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000302
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