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

This study has been completed.
Sponsor:
Collaborator:
Kyoto University, Graduate School of Medicine
Information provided by (Responsible Party):
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00685646
First received: May 22, 2008
Last updated: October 15, 2015
Last verified: October 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Time to treatment failure (TTF) [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    The interval from the date of randomization to the earliest date on which prostate-specific antigen (PSA) progression, clinical progression, first skeletal-related events (SRE), death, or cessation of protocol treatment for any reason occurred.


Secondary Outcome Measures:
  • Time to first skeletal-related events (SRE) [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    The interval from the date of randomization to the earliest date of the first SRE or death for any reason. But exlude tha another SRE existing case on the same region as of the randomization.

  • Overall survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
    The interval from the date of randomization to death for any reason.

  • Extent of disease on bone scan (EOD) [ Time Frame: Baseline, Month 12, 24 and 36 ] [ Designated as safety issue: No ]
    Ransition of EOD bone scan grade at randomization, 12, 24, 36 months after the therapy.

  • Pain scale [ Time Frame: Baseline, Month 12, 24 and 36 ] [ Designated as safety issue: No ]
    Ransition of with/without narcotic drug usage at randomization, 12, 24, 36 months after the therapy and if the case of without usage, ransition of rest pain scale.

  • FACES pain-rating scale [ Time Frame: Baseline, Month 12, 24 and 36 ] [ Designated as safety issue: No ]
    Ransition of FACES pain-rating scale at randomization, 12, 24, 36 months after the therapy.

  • Adverse events [ Time Frame: Month 6, 12, 18, 24 and 30 ] [ Designated as safety issue: No ]
    Adverse events from date of starting protocol treatment until 28 days after date of finishing the treatment are evaluated according to Japanese version of the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0) by Translational Research Informatics Center.

  • QOL (SF-36) [ Time Frame: Month 6, 12, 18, 24, 30 and 36 ] [ Designated as safety issue: No ]
    Rantision of QOL health survey scale durintg protocol treatment.


Enrollment: 227
Study Start Date: May 2008
Study Completion Date: January 2014
Primary Completion Date: January 2014 (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

Inclusion Criteria:

  • Patients with definitive diagnosis of prostatic cancer by histopathological diagnosis or cytology
  • Androgen blockade therapy-, systemic chemotherapy-, bisphosphonates-naïve prostatic cancer patients
  • Patients who are sensitive to androgen blockade therapy
  • Patients with bone metastasis on bone scan (EOD ≥ 1)
  • Patients who have Eastern Cooperative Oncology Group performance status (ECOG: 0-2)
  • Patients who have prostate-specific antigen performance status (PSA ≧30 ng/mL)
  • Patients who demonstrate appropriate bone marrow, hepatic and renal functions in laboratory tests within four weeks before the registration.

    • 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
    • Aspartate aminotransferase (AST) Levels ≤ 90 IU/L
    • Alanine aminotransferase (ALT) Levels ≤ 100 IU/L
    • Patients who agreed to participate in this clinical study in writing after receiving sufficient explanation

Exclusion criteria:

  • Patients with poorly-controlled dental caries
  • Patients with double cancer that requires treatment
  • Patients who are using following steroid drugs (except for topical ointment)
  • Patients with poorly-controlled hypertension or cardiovascular disease
  • Patients with active infectious diseases or HIV or hepatitis virus infections
  • Other patients whose 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
Translational Research Informatics Center, Kobe, Hyogo, Japan
Kyoto University, Graduate School of Medicine
Investigators
Principal Investigator: Osamu Ogawa, MD, Ph.D. Kyoto University, Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier: NCT00685646     History of Changes
Other Study ID Numbers: TRIGU0705  KYUH-TRIGU0705 
Study First Received: May 22, 2008
Last Updated: October 15, 2015
Health Authority: Japan: Translational Research Informatics Center Institutional Review Board

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
bone metastases
stage IV prostate cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Prostatic Diseases
Urogenital Neoplasms
Androgen Antagonists
Androgens
Diphosphonates
Zoledronic acid
Bone Density Conservation Agents
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 10, 2016