Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III
- Compare the survival of patients with metastatic stage IV prostate cancer responsive to
combined androgen-deprivation therapy (CAD) treated with intermittent vs continuous
- 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.
- 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
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
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
Treatment-specific symptoms as measured on the four-item Medical Outcomes Study Short Form-36 (SF-36) and Vitality scale
Maha Hadi A. Hussain, MD
University of Michigan Cancer Center