Status:
COMPLETED
Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
SWOG Cancer Research Network
Conditions:
Metastatic Cancer
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatm...
Detailed Description
Zoledronic acid decreases the risk of skeletal related events in men with prostate cancer metastatic to bone and disease progression after primary hormonal therapy. This study is designed to evaluate...
Eligibility Criteria
Inclusion
- Histologic Documentation: Histologic documentation of prostate adenocarcinoma. Patients with small cell, neuroendocrine, or transitional cell carcinomas are not eligible.
- Staging: At least one bone metastasis by radiographic imaging (bone scan, magnetic resonance imaging, computed tomography, or plain radiographs). Indeterminate lesions should be confirmed by a second imaging method. Imaging to document bone metastases is to be completed either within 12 weeks before registration or within 12 weeks before initiating androgen deprivation therapy for bone metastases.
- Hormone Therapy
- While on this study, patients must receive androgen deprivation therapy (ADT) for treatment of prostate cancer. Androgen deprivation therapy may have begun prior to enrollment on this study; however patients must have initiated ADT ≤ 6 months prior to enrollment.
- Androgen deprivation therapy is defined as bilateral orchiectomy or gonadotropin- releasing hormone (GnRH) agonist with or without an antiandrogen.
- Patients treated with intermittent androgen deprivation therapy are not eligible except for patients concurrently enrolled in SWOG-9346/INT-0162/CALGB 9594, Phase III Study of Intermittent Androgen Deprivation in Patients with Stage D2 Prostate Cancer.
- Prior Treatment:
- Hormone therapy at any point prior to 6 months before enrollment is prohibited. This includes any of the following treatments:
- orchiectomy,
- GnRH agonist (e. g., leuprolide, goserelin, triptorelin),
- estrogen therapy,
- antiandrogen (e. g., bicalutamide, flutamide, nilutamide), or
- any other therapy known to lower testosterone level or inhibit testosterone effect.
- Prior neoadjuvant and/or adjuvant hormone therapy is allowed provided that the duration of hormone therapy was six months or less and the hormone therapy was discontinued more than 6 months prior to study entry.
- No prior treatment with a bisphosphonate
- No prior treatment with denosumab
- No prior treatment with radiopharmaceuticals
- ≥ 4 weeks since completion of prior radiation therapy with at least one bone metastasis present that has NOT been radiated.
- ECOG (CTC) performance status 0-2
- Age: ≥ 18 years
- Required Initial Laboratory Data:
- Calculated Creatinine Clearance ≥ 30 mL/min
- Corrected serum calcium ≥ 8.0 mg/dL (2.00 mmol/L) and \<11.6 mg/dL (2.90 mmol/L)
Exclusion
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
645 Patients enrolled
Trial Details
Trial ID
NCT00079001
Start Date
January 1 2004
End Date
October 1 2014
Last Update
May 12 2020
Active Locations (241)
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1
Providence Cancer Center at Providence Hospital
Mobile, Alabama, United States, 36608
2
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72903
3
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
4
Veterans Affairs Medical Center - Loma Linda (Pettis)
Loma Linda, California, United States, 92357