Phase 3
N=645
Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases
Metastatic Cancer · Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00079001 ↗Enrolled (actual)
645
Serious AEs
19.6%
Results posted
Oct 2014
Primary outcome: Primary: Time to First Skeletal Related Event — 31.9; 28.8 months — p=0.385
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- zoledronic acid (Drug); placebo (Other); androgen deprivation therapy (Drug); GnRH agonist (Drug); Calcium supplement (Dietary_supplement); Vitamin D (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Skeletal Related Event |
31.9; 28.8 | 0.385 |
| SECONDARY Overall Survival |
37.9; 36.0 | 0.29 |
| SECONDARY Progression-free Survival |
10.6; 9.2 | 0.22 |
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 treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.
PURPOSE: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases.
Eligibility Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00079001). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.