A multicenter, open-label trial to evaluate the effects of zoledronic acid on circulating tumor cells in patients with castration resistant prostate cancer (CRPC) with bone metastasis.
- Conditions
- Castration resistant prostate cancer
- Registration Number
- JPRN-UMIN000006736
- Lead Sponsor
- Teikyo University, School of Medicine Department of Urology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Male
- Target Recruitment
- 20
Not provided
1) Prior treatment with bisphosphonates within 6 months before study start, and during treatment with zoledronic acid 2) Prior treatment with antiresorptive agent (e.g. RANK ligand inhibitor) 3) Patients with proven brain metastases 4) History of diseases with influence on bone metabolism such as Paget's disease and primary hyperparathyroidism 5) Patients with need of treatment for osteoporosis (defined according to DXA, lumber spine BMD T-Score less than 2.5). 6) Patients with NYHA III or IV, cardiac failure, clinically relevant pathologic findings in ECG 7) Patients with clinically significant ascites 8) Known hypersensitivity to zoledronic acid or other bisphosphonates 9) Corrected (adjusted for serum albumin) serum calcium concentration < 8.0 mg/dl) or more than 12.0 mg/dl 10) Prior malignancy except basal cell or squamous cell skin cancer or any other cancer from which the patient has been disease-free for more than 5 yrs. 11) Current active dental problems including infection of the teeth or jawbone 12) Recent (within 6 weeks) or planned dental or jaw surgery (e.g.. extraction, implants) 13) Any change in therapy within the last 2 months (Chemotherapy, change in hormonal therapy) 14) Known history or present abuse of alcohol or drugs 15) Use of other investigational drugs at the time of enrollment, or within 30 days before enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with decreased CTCs at 12 weeks after first infusion of zoledronic acid
- Secondary Outcome Measures
Name Time Method *Relationship between PSA and course of CTCs *Proportion of patients with stable or decreased CTCs at 12 weeks *Proportion of patients with stable CTCs at 12 weeks *Analysis of patients based on baseline CTCs (Proportion of patients with stable or decreased CTCs at 12 weeks in a subgroup of patients with >5 CTCs at baseline vs proportion of patients with stable or decreased CTCs below 5 CTCs at baseline) *Analysis of patients based on baseline CTCs (Proportion of patients with decreased CTCs at 12 weeks in a subgroup of patients with >5 CTCs at baseline vs proportion of patients with decreased CTCs below 5 CTCs at baseline) *Time until decrease of CTCs *Safety and Tolerability (adverse events, serious adverse events )