safety test in luteoli
Phase 1
Recruiting
- Conditions
- prostate cancer patients
- Registration Number
- JPRN-jRCTs041210142
- Lead Sponsor
- aiki-Ito Aya
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 5
Inclusion Criteria
1)newly diagnosed, or recurrence after radical treatment but slowly progression in PSA in low risk patients
2)initial PSA < 10ng/mL, and cT2, orrecurrence after radical treatment but slowly progressed 0.05ng/mL per year in PSA
3)patients with informed consent in this research
4) male patients older than 20
5)patients with less than ECOG PS 1
Exclusion Criteria
patients in dementia
patients with severe infection
patients with hepatic dysfunction
patients with renal disorders
patients who was recognized as inadequate in this test by doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method incidence and severity in adverse events
- Secondary Outcome Measures
Name Time Method PSA or UA response from baseline