A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men With Prostate Cancer Receiving Long-Term Androgen Deprivation
18 Years
N/A
Male
Osteoporosis, Prostate Cancer
Trial Information
A Phase III Randomized Study of Zolendronate Bisphosphonate Therapy for the Prevention of Bone Loss in Men With Prostate Cancer Receiving Long-Term Androgen Deprivation
OBJECTIVES:
- Compare bone loss in patients receiving long-term androgen deprivation therapy for
stage III or IV prostate cancer when treated with supportive care with vs without
zoledronate.
- Compare the percentage change in lumbar spine and hip bone density in patients treated
with these regimens.
- Compare markers of bone formation and resorption in patients treated with these
regimens.
- Compare the incidence of skeletal events (pathologic and non-pathologic bone fractures,
spinal cord compression, surgery to bone, and radiotherapy to bone) in patients treated
with these regimens.
- Compare the incidence of new or progressive bone metastatic disease in patients treated
with these regimens.
- Compare the survival rate of patients treated with these regimens.
OUTLINE: Patients are stratified according to race (black vs other). Patients are randomized
to 1 of 2 treatment arms.
- Arm I: Patients receive zoledronate IV over 15 minutes on day 1 and oral calcium
gluconate and oral cholecalciferol daily. Courses repeat every 3 months for 12 months
in the absence of toxicity.
- Arm II: Patients receive oral calcium gluconate and oral cholecalciferol as in arm I.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 72 patients (36 per treatment arm) will be accrued for this
study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed prostate cancer
- Stage III or IV disease
- Received at least 3 months of prior androgen deprivation therapy (no maximum
amount/time) by either surgical or medical castration
- Medical castration may be by intermittent or continuous androgen suppression via
single- or combined-drug androgen blockade
- Continued concurrent androgen deprivation therapy required throughout study
participation
- No bone metastases by baseline bone scan
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 1 year
Hematopoietic
- Not specified
Hepatic
- Bilirubin less than 3 times upper limit of normal (ULN)
- AST and ALT less than 3 times ULN
- No chronic liver disease
Renal
- Creatinine no greater than 2.0 mg/dL
Other
- Fertile patients must use effective contraception
- No Paget's disease
- No Cushing's disease
- No hyperthyroidism
- No hyperprolactinemia
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Prior chemotherapy for prostate cancer allowed
Endocrine therapy
- See Disease Characteristics
- More than 12 months since prior suppressive doses of thyroxine or calcitonin
- More than 6 months since prior corticosteroids
- Concurrent corticosteroids allowed (after enrollment on study)
Radiotherapy
- Prior radiotherapy for prostate cancer allowed
Surgery
- See Disease Characteristics
Other
- More than 12 months since prior bisphosphonate therapy (oral or IV)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Bone density change as measured by dual-energy x-ray absorptiometry from baseline to 13 months
Outcome Description:
To assess bone density change as measured by dual-energy x-ray absorptiometry
Outcome Time Frame:
Bone scan taken at baseline and month 13
Safety Issue:
No
Principal Investigator
Charles L. Bennett, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
NU 02U1
NCT ID:
NCT00058188
Start Date:
March 2003
Completion Date:
December 2015
Related Keywords:
- Osteoporosis
- Prostate Cancer
- osteoporosis
- stage III prostate cancer
- stage IV prostate cancer
- Osteoporosis
- Prostatic Neoplasms
Name | Location |
|---|---|
| Veterans Affairs Medical Center - Lakeside Chicago | Chicago, Illinois 60611 |
| Northwestern University | Chicago, Illinois 60611 |
| John H. Stroger Hospital of Cook County | Chicago, Illinois 60612 |
