Zoledronate in Preventing Skeletal (Bone)-Related Events in Patients Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | January 2004 |
| Contact: | Lillian Pliner, MD |
| Email: | plinerlf@umdnj.edu |
| Phone: | 9739726257 |
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
This research study is being done to find out if giving zoledronic acid before the cancer
spreads to the bone is better or worse than standard treatment. The study will also compare
the effects (good and bad) of early treatment with zoledronic acid compared to standard
treatment.
In this study Group A will receive zoledronic acid and Group B will receive placebo (salt
and water). The placebo contains no medication and is used to compare the effects of early
treatment with zoledronic acid to no early treatment with zoledronic acid in a fair way. It
is used so that neither you nor your doctor will know what you are receiving.
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
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