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A Phase III, Multicenter, Randomized, Controlled Study of Maximum Androgen Blockade With vs. Without Zoledronic Acid in Prostatic Cancer Patients With Metastatic Bone Disease


Phase 3
20 Years
N/A
Open (Enrolling)
Male
Metastatic Cancer, Prostate Cancer

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Trial Information

A Phase III, Multicenter, Randomized, Controlled Study of Maximum Androgen Blockade With vs. Without Zoledronic Acid in Prostatic Cancer Patients With Metastatic Bone Disease


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Time to treatment failure

Safety Issue:

No

Principal Investigator

Osamu Ogawa, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kyoto University

Authority:

United States: Federal Government

Study ID:

CDR0000595493

NCT ID:

NCT00685646

Start Date:

May 2008

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Prostate Cancer
  • bone metastases
  • stage IV prostate cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Prostatic Neoplasms

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