Castration resistant prostate cancer
Conditions
Interventions
All patients will be treated with zoledronic acid (dosage according to calculated creatinine clearance before first administration of zoledronic acid) administered as a 15-minute infusion every 4 week
Sponsors
Teikyo University, School of Medicine Department of Urology
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Histologically proven carcinoma of the prostate with evidence of at least one cancer related bone lesion with castration resistant prostate cancer (2 or more consecutive rising PSA values determined in 2 or more weeks interval). 2) No changes in antitumoral treatment planned through the course of study. 3) Prior surgery, chemotherapy and radiotherapy of metastases (including therapeutic radioisotopes such as strontium 89) is allowed. At least 2 months must have elapsed after completion of surgery, chemotherapy and radiotherapy. 4) Patients with presence of CTCs 5) Performance status ECOG 0-2 6) Laboratory requirements: a) hepatic function: total bilirubin less than 2,5 times the upper-normal limit of the institution, b) AST, ALT less than 2,5 times the upper-normal limit of the institution. c) Renal function: creatinine clearance more than 30 ml/min Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula: CrCl= [140-age (years)] x weight (kg) } [72 x serum creatinine (mg/dL)] 7) Life expectancy more than 6 months 8) Signed informed consent prior to trial entry
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with decreased CTCs at 12 weeks after first infusion of zoledronic acid | — |
Secondary
| Measure | Time frame |
|---|---|
| *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 ) | — |
Countries
Japan
Contacts
Public ContactHisamitsu Ide, M.D.
Teikyo University, School of Medicine Department of Urology
Outcome results
None listed