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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000240 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Prostate cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | The University of Tsukuba Graduate Schools |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000302 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |