None listed
Conditions
Interventions
Group Zoledronate Type of group
There are three treatment arms in this study: zoledronate 4 mg intravenously (in addition to the patient antineoplastic therapy)
zoledronate 8 mg intravenously (in addition to the patient antineoplastic therapy) and the patient antineoplastic therapy alone (the control placebo treatment group).
Sponsors
NOVARTIS BIOSCIENSES PERÚ S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: •Signed informed consent. •Patients 18 years of age or greater. •A histologically confírmed diagnosis of carcinoma of the prostate. •Patients must have or have had objective evidence of metastatic disease to bone. Objective evidence of metastatic bone disease is defined as múltiple foci (> 3) of increased activity on bone sean. If there are < 3 foci of increased activity on bone sean, additional radiographic or biopsy studies are required to confirm the presence of osteoblastic or osteolytic malignant bone lesions. Patients who have achieved a complete response to first-Iine hormonal therapy and their current bone sean is normal are still eligible to enroll in this study as long as bone metastases have been documented previously during the patient´s clinical course.
Exclusion criteria
Exclusion criteria: •Bone pain due to metastatic bone disease that has developed since the best response to first-line hormonal therapy for metastatic disease. •Previous or current (prior to and including Visit 2) treatment with cytotoxic chemotherapy (subsequent use of cytotoxic chemotherapy during the study is permitted). • Alteration of the first-line hormonal therapy to a second-line hormonal regimen prior to Visit 1 (subsequent alteration of the patient hormonal therapy during Visit 1 or throughout the study is not an exclusión criterio or a protocol violation). •Serum testosterone level (at Visit 1) elevated above the cástrate range (> 50 ng/ml). •Radiation therapy to bone (including radioisotopes) within 3 months prior to Visit 2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary efficacy variable is the proportion of patients with any skeletal-related event (SRE) during the first 15 months of the study and will be compared between the treatment groups using a chi-squared test. 95% confidence intervals by treatment group for the proportion of patients reporting any SRE will also be presented In addition, the primaiy efficacy variable will be summarized by the baseline prognostic factors of performance status (ECOG = 0-1 vs >1), renal function (creatinine 2.0 mg/dl), and age ( 60 years ), respectively Measure:proportion of patients with any skeletal-related event (SRE) Timepoints:The comparison of proportion of patients reporting any SRE during the first 3, 6, 9, 12, and 15 months of the study will be presented | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The ratio of the number of occurrences of any SRE, allowing one event per assessing period (3 weeks), divided by the time at risk in Phase 1 for each patient will be compared between tlie treatment groups using the Wilcoxon rank-sum test. Time at risk for each assessing period is defined as the duration fiom the start of the assessing period to the first SRE. If there is no SRE for an assessing period, the whole duration of the assessing period will be considered at risk. Time at risk for the phase 1 is the sum of time at risk of each assessing period in Phase 1 of the study. Time to the first occurrence of a SER Time from randomization to the first occurrence of any SRE will be compared between the treatment groups using survival analysis methods, including Kaplan- Meier product-limit estimates of the survival functions, and the log-rank test. Death not related to SRE will be considered as censored observations. Measure:Skeletal morbidity rate (SMR) Timepoints:For each particular type of SRE, the proportion of patients with the SRE, the SMR of the SRE, at month 3, 6, 9, 12, and 15 and the time to the first occurrence of the SRE will be similarly analyzed using the method for the respective variables with any SRE. | — |
Countries
Australia, Canada, United States
Outcome results
None listed