Prostate Cancer
Conditions
Keywords
Prostate cancer, molecular staging, antitumor potential
Brief summary
The objective of this study is to assess the effect Of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer
Interventions
DRUGZoledronic acid
Sponsors
University of Athens
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Prostate cancer * Radical prostatectomy or external beam irradiation therapy within 6 months before study entry. * No bone metastases according to bone scan
Exclusion criteria
* Metastatic prostate cancer * Hormone ablation therapy for more than 3 months before/after radical prostatectomy and external beam irradiation therapy * Treatment with bisphosphonates or other drugs known to affect the skeleton within the past year. Other protocol-defined inclusion /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the activity of one year treatment with zoledronic acid | 12 mos |
Secondary
| Measure | Time frame |
|---|---|
| Three-year disease free survival | 3 years |
| Change in bone mineral density at 12, 24 and 36 months versus baseline | 12, 24 and 36 months |
| Changes in bone resorption markers at 12, 24 and 36 months versus baseline | 12, 24 and 36 months |
| Safety and tolerability through abnormal values and AE reporting | upto 36 mos |
Countries
Greece
Outcome results
None listed