UMIN-CTR Clinical Trial

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
Email

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
Email	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
Email

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
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

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