Efficacy of intermittent versus continuous endocrine therapy on localized and non-palpable prostate cancer: a multi-center randomized controlled trial
Phase 3
Recruiting
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000008843
- Lead Sponsor
- Chiba Prostate Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 600
Inclusion Criteria
Not provided
Exclusion Criteria
<Pre-registration> 1) Active malignancy in other organs 2) Serum testosterone under 100 ng/dL or 1 ng/mL 3) Under continuous oral administration of 5-alpha reductase inhibitor or steroids 4) Diagnosed with osteoporosis and under oral treatment 5) Other reasons for being inadequate case judged by the attending doctor <Registration> While 6-months introduction treatment, 1) escape from criteria of prohibited treatments and drugs 2) intake of bicaltamide less than 50% 3) escape from criteria of amount and intervals of LH-RH agonists
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival
- Secondary Outcome Measures
Name Time Method 1. Disease-specific survival 2. Progression-free survival 3. Adverse events a) Skeltal-related event: fracture, osteoporosis b) Acute coronary syndrome, acute myocardial infarction c) Stroke d) Disorder of laboratory data: Hb, T-Cho, TG, Glucose, HbA1c(NGSP)