Androgen Blockade Therapy With or Without Zoledronic Acid in Treating Patients With Prostate Cancer and Bone Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00685646
First received: May 22, 2008
Last updated: September 16, 2013
Last verified: July 2009
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685646

Locations
Japan
Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kyoto University
Investigators
Principal Investigator: Osamu Ogawa, MD, PhD Kyoto University
  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: September 16, 2013
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 July 24, 2014