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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
227
Up to 24 courses of therapy
Up to 24 courses of therapy
Kyoto University Hospital
Kyoto, Kyoto, Japan
Time to treatment failure (TTF)
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.
Time frame: 6 years
Time to first skeletal-related events (SRE)
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.
Time frame: 6 years
Overall survival
The interval from the date of randomization to death for any reason.
Time frame: 6 years
Extent of disease on bone scan (EOD)
Ransition of EOD bone scan grade at randomization, 12, 24, 36 months after the therapy.
Time frame: Baseline, Month 12, 24 and 36
Pain scale
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.
Time frame: Baseline, Month 12, 24 and 36
FACES pain-rating scale
Ransition of FACES pain-rating scale at randomization, 12, 24, 36 months after the therapy.
Time frame: Baseline, Month 12, 24 and 36
Adverse events
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.
Time frame: Month 6, 12, 18, 24 and 30
QOL (SF-36)
Rantision of QOL health survey scale durintg protocol treatment.
Time frame: Month 6, 12, 18, 24, 30 and 36
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