A Randomized Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men With Prostate Cancer Metastatic to Bone
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- No small cell, neuroendocrine, or transitional cell carcinomas
- At least 1 bone metastasis by bone scan, MRI, CT scan, or plain radiographs
- Indeterminate lesions should be confirmed by a second imaging method
- At least 1 bone metastasis with no prior irradiation
- Concurrent androgen deprivation therapy required, defined as any of the following:
- Bilateral orchiectomy
- Gonadotropin-releasing hormone (GnRH) agonist with or without an antiandrogen
PATIENT CHARACTERISTICS:
AGE
- 18 and over PERFORMANCE STATUS
- ECOG 0-2 LIFE EXPECTANCY
- Not specified HEMATOPOIETIC
- Not specified HEPATIC
- Not specified RENAL
- Creatinine clearance ≥ 30 mL/min
- Corrected calcium ≥ 8.0 mg/dL and < 11.6 mg/dL OTHER
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
BIOLOGIC THERAPY
- Concurrent standard biologic response modifiers allowed during open-label therapy
only CHEMOTHERAPY
- Concurrent standard cytotoxic chemotherapy allowed during open-label therapy only
ENDOCRINE THERAPY
- See Disease Characteristics
- Prior neoadjuvant and/or adjuvant hormonal therapy allowed provided duration of
therapy was no more than 6 months AND therapy was discontinued more than 6 months
before study entry
- No more than 6 months since initiation of any of the following hormonal therapies:
- Orchiectomy
- GnRH agonist (e.g., leuprolide, goserelin, or triptorelin)
- Estrogen therapy
- Antiandrogens (e.g., bicalutamide, flutamide, or nilutamide)
- Any other therapy known to lower testosterone levels or inhibit testosterone
effect
- No intermittent androgen deprivation therapy except for patients concurrently
enrolled on SWOG-9346
- Concurrent palliative corticosteroids allowed during open-label therapy only
- Concurrent standard hormonal agents allowed during open-label therapy only
RADIOTHERAPY
- See Disease Characteristics
- No prior radiopharmaceuticals
- At least 4 weeks since prior radiotherapy
- Concurrent standard radiotherapy to extraskeletal and/or skeletal tumor sites allowed
during open-label therapy only SURGERY
- See Disease Characteristics OTHER
- No prior bisphosphonates
- No other concurrent agents expected to alter osteoclast activity (e.g., calcitonin,
mithramycin, gallium nitrate, or any other bisphosphonate)
- Concurrent daily supplemental elemental calcium (500 mg) and a multivitamin
containing cholecalciferol (Vitamin D) (400 IU) OR a combination tablet containing
both recommended
- Concurrent standard marketed antineoplastic therapies allowed during open-label
therapy only