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 |
A multi-center trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in stage C,D prostate cancer patients
A trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in prostate cancer patients
A multi-center trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in stage C,D prostate cancer patients
A trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in prostate cancer patients
Japan |
Prostate cancer
Urology |
Malignancy
NO
A randomized study whether the green tea extract (GTE) delay time to hormone refractory in patients treated with hormonal therapy.
Efficacy
Time to hormone refractory
Survival time (disease specific survival, overall survival) and adverse event
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
YES
YES
Institution is considered as adjustment factor in dynamic allocation.
NO
Central registration
2
Treatment
Food |
Taking GTE tablet with hormonal therapy
hormonal therapy alone
Not applicable |
Not applicable |
Male
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
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.
200
1st name | |
Middle name | |
Last name | Hideyuki Akaza |
The University of Tsukuba Graduate Schools
Department of Urology, Institute of Clinical Medicine
1-1-1 Ten-nodai, Tsukuba, Ibaraki 305-8575, Japan
029-853-3223
1st name | |
Middle name | |
Last name | Naoto Miyanaga |
The University of Tsukuba Graduate Schools
Department of Urology, Institute of Clinical Medicine
1-1-1 Ten-nodai, Tsukuba, Ibaraki 305-8575, Japan
029-853-3223
nao-miya@md.tsukuba.ac.jp
The University of Tsukuba Graduate Schools
None
Self funding
Tsukuba prostate cancer prevention study group
NO
2005 | Year | 09 | Month | 20 | Day |
Unpublished
Completed
2000 | Year | 05 | Month | 17 | Day |
2000 | Year | 07 | Month | 01 | Day |
2008 | Year | 08 | Month | 01 | Day |
2009 | Year | 03 | Month | 01 | Day |
2005 | Year | 09 | Month | 20 | Day |
2011 | Year | 06 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000302