Additive effect of zoledronic acid on hormone-sensitive prostate cancer patients with bone metastasis treated by hormonal therapy: a prospective, multicenter study
- Conditions
- Prostate cancer
- Registration Number
- JPRN-UMIN000010765
- Lead Sponsor
- Department of Urology, Saitama Medical Center, Saitama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 100
Not provided
Patients 1) do not meet the inclusion criteria. 2) have an allergy to bisphosphonates including zoledronic acid. 3) required an urgent radiation therapy for bone metastasis based on symptoms described below: unmanageable pain, spinal cord paralysis, etc. 4) have a treatment history with a bisphosphonate (excluding bisphosphonates taken orally). 5) have an uncontrollable pleural or pericardial effusion. 6) have a brain metastasis with symptoms. 7) have a heavy infection. 8) under or planned an invasive dental treatment. 9) have an interstitial pneumonitis or pulmonary fibrosis. 10) have an active cancer except prostate cancer: cancer free duration <= 3 years. 11) have a myocardial infarction within 6 months. 12) have severe complications: cardiovascular disease, hepatic dysfunction, or coagulation disorders, etc. 13) have mental disorders or neurological symptoms. 14) disqualified by a doctor in charge.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to progression
- Secondary Outcome Measures
Name Time Method 1) SRE rate 2) Time to the first SRE 3) PSA response 4) Changes in ALP, BAP, serum NTx, TRAP-5b 5) Adverse effects 6) Changes in bone scan index 7) Changes in bone mineral density