Prostate Cancer Clinical Trial
Official title:
Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III
RATIONALE: Testosterone can stimulate the growth of prostate cancer cells. Hormone therapy
may be effective treatment for prostate cancer. It is not yet known which regimen of hormone
therapy is most effective for stage IV prostate cancer.
PURPOSE: This randomized phase III trial is studying two different regimens of hormone
therapy and comparing how well they work in treating men with stage IV prostate cancer.
OBJECTIVES:
Primary
- Compare the survival of patients with metastatic stage IV prostate cancer responsive to
combined androgen-deprivation therapy (CAD) treated with intermittent vs continuous
CAD.
- Compare the effects of these treatment regimens on impotence, libido, and
vitality/fatigue as well as the physical and emotional well-being of these patients.
Secondary
- Compare general symptoms, role functioning, global perception of quality of life, and
social functioning of patients treated with these regimens.
- Assess prostate-specific antigen (PSA) levels after continuous CAD administered before
randomization and evaluate PSA changes throughout randomized treatment of these
patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to SWOG
performance status (0-1 vs 2), severity of disease (minimal vs extensive), and prior
hormonal therapy (neoadjuvant hormonal therapy vs finasteride vs neither).
- Induction therapy: Patients receive combined androgen-deprivation (CAD) therapy
comprising goserelin subcutaneously once a month and oral bicalutamide once daily for 8
courses (7 months).
- Consolidation therapy: Patients are randomized to 1 of 2 consolidation regimens.
- Arm I (continuous CAD therapy): Patients continue CAD therapy as in induction
therapy. Treatment continues in the absence of disease progression.
- Arm II (intermittent CAD therapy): Patients undergo observation in the absence of
rising prostate-specific antigen (PSA) or clinical symptoms of progressive
disease. Patients with rising PSA or progressive disease begin CAD therapy as in
induction therapy. Patients whose PSA normalizes after 8 courses return to
observation. Patients whose PSA does not normalize after 8 courses continue CAD
therapy.
Quality of life is assessed before induction therapy, at 3 months (before consolidation
therapy), and then at 9 and 15 months.
Patients are followed every 6-12 months for at least 10 years.
PROJECTED ACCRUAL: Approximately 1,500 patients will be accrued for this study.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
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