Overview

Zoledronate in Preventing Skeletal (Bone)-Related Events in Men Who Are Receiving Androgen Deprivation Therapy For Prostate Cancer and Bone Metastases

Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborators:
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Novartis Pharmaceuticals
Southwest Oncology Group
Treatments:
Androgens
Ascorbic Acid
Calcium
Calcium, Dietary
Deslorelin
Diphosphonates
Ergocalciferols
Estrogens, Conjugated (USP)
Methyltestosterone
Vitamin D
Vitamins
Zoledronic Acid
Criteria
1. Histologic Documentation: Histologic documentation of prostate adenocarcinoma.
Patients with small cell, neuroendocrine, or transitional cell carcinomas are not
eligible.

2. 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.

3. 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.

4. 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.

5. ECOG (CTC) performance status 0-2

6. Age: ≥ 18 years

7. 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)