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A multi-center trial of combination therapy of hormonal therapy and Green Tea Extract (GTE) in stage C,D 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000240
Enrollment
200
Registered
2005-09-20
Start date
2000-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

Taking GTE tablet with hormonal therapy hormonal therapy alone

Sponsors

The University of Tsukuba Graduate Schools
Lead Sponsor
Tsukuba prostate cancer prevention study group
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Time to hormone refractory

Secondary

MeasureTime frame
Survival time (disease specific survival, overall survival) and adverse event

Countries

Japan

Contacts

Public ContactNaoto Miyanaga

The University of Tsukuba Graduate Schools Department of Urology, Institute of Clinical Medicine

nao-miya@md.tsukuba.ac.jp029-853-3223

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026