Phase II study of zoledronic acid concomitant with androgen deprivation therapy for patients with treatment-naive bone-metastatic prostate cancer
Phase 2
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000007548
- Lead Sponsor
- Kinki University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 52
Inclusion Criteria
Not provided
Exclusion Criteria
Symptomatic central nervous system metastases. Coagulation disorders. Infection requiring intravenous antibiotics. Radiologically proved interstitial pneumonitis. Clinically significant cardiovascular disease. Pleural or pericardial effusion Dental problem requiring invasive treatment. History of bisphosphonate. History of another malignancy within the preceding 5 years.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Skeleton-related event-free survival at 24 month after the introduction of treatment
- Secondary Outcome Measures
Name Time Method Progression-free survival, time to first SRE, overall survival, decrease of the extent of bone diseases, improvement of pain, and safety