Androgen Blockade Therapy With or Without Zoledronic Acid in Treating Patients With Prostate Cancer and Bone Metastases
This study is ongoing, but not recruiting participants.
Sponsor:
Kyoto University
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00685646
First received: May 22, 2008
Last updated: May 27, 2011
Last verified: July 2009
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Purpose
RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen blockade therapy may lessen the amount of androgens made by the body. Zoledronic acid may help relieve some of the symptoms caused by bone metastasis. It is not yet known whether androgen-blockade therapy is more effective with or without zoledronic acid in treating patients with prostate cancer that has spread to the bone.
PURPOSE: This randomized phase III trial is studying androgen-blockade therapy given together with zoledronic acid to see how well it works compared with androgen-blockade therapy alone in treating patients with prostate cancer and bone metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer Prostate Cancer |
Drug: antiandrogen therapy Drug: zoledronic acid |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Phase III, Multicenter, Randomized, Controlled Study of Maximum Androgen Blockade With vs. Without Zoledronic Acid in Prostatic Cancer Patients With Metastatic Bone Disease |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Time to treatment failure [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to first skeletal-related events [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Extent of disease on bone scan [ Designated as safety issue: No ]
- Pain scale [ Designated as safety issue: No ]
- FACES pain-rating scale [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses.
|
Drug: antiandrogen therapy
Up to 24 courses of therapy
Drug: zoledronic acid
Up to 24 courses of therapy
|
|
Active Comparator: Arm II
Patients receive maximum androgen-blockade therapy for up to 24 courses.
|
Drug: antiandrogen therapy
Up to 24 courses of therapy
|
Detailed Description:
OBJECTIVES:
- Evaluate the time to treatment failure in prostatic cancer patients with metastatic bone disease receiving maximum androgen-blockade therapy with vs without zoledronic acid.
- Evaluate the time to first skeletal-related events in these patients.
- Evaluate the overall survival of these patients.
- Evaluate the extent of disease on bone scan in these patients.
- Evaluate the pain scale and FACES pain-rating scale in these patients.
- Evaluate the safety of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive maximum androgen-blockade therapy and zoledronic acid for up to 24 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive maximum androgen-blockade therapy for up to 24 courses in the absence of disease progression or unacceptable toxicity.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed prostate cancer
- Must have metastatic bone disease (bone metastases present on bone scan, extent of disease [EOD] ≥ 1)
- Must be sensitive to androgen-blockade therapy
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-1
- Leukocyte count ≥ 3,000/μL
- Hemoglobin ≥ 9.0 g/dL
- Platelet count ≥ 7.5 × 10^4/μL
- Serum creatine level ≤ 3.0 mg/dL
- 8.5 mg/dL ≤ corrected serum level of calcium ≤ 11.5 mg/dL
- Total bilirubin ≤ 1.8 mg/dL
- ALT ≤ 90 IU/L
- AST ≤ 100 IU/L
Exclusion criteria:
- Poorly controlled dental caries
- Another cancer that requires treatment
- Poorly controlled hypertension or cardiovascular disease
- Active infectious diseases, HIV, or hepatitis virus infections
- Participation in the present study is considered inappropriate by a Principal Investigator or Clinical Investigator
PRIOR CONCURRENT THERAPY:
- No prior androgen-blockade therapy
- No prior or other concurrent anticancer therapy
- No prior or concurrent immunologic adjuvant therapy
- No prior or concurrent steroid drugs (except ointment)
- No other prior or concurrent bisphosphonates (excluding zoledronic acid)
- No prior systemic chemotherapy
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00685646 History of Changes |
| Other Study ID Numbers: | CDR0000595493, KYUH-TRIGU0705 |
| Study First Received: | May 22, 2008 |
| Last Updated: | May 27, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
bone metastases stage IV prostate cancer |
Additional relevant MeSH terms:
|
Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Prostatic Neoplasms Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |
Androgen Antagonists Androgens Zoledronic acid Diphosphonates Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Hormones Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 19, 2013