Spots Global Cancer Trial Database for SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer
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Trial Identification
Brief Title: SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer
Official Title: Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III
Study ID: NCT00002651
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Tom Baker Cancer Centre - Calgary, Calgary, Alberta, Canada
Cross Cancer Institute at University of Alberta, Edmonton, Alberta, Canada
University of British Columbia, Vancouver, British Columbia, Canada
Nova Scotia Cancer Centre, Halifax, Nova Scotia, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, Ontario, Canada
London Regional Cancer Program at London Health Sciences Centre, London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre - General Campus, Ottawa, Ontario, Canada
Odette Cancer Centre at Sunnybrook, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Hopital Notre-Dame du CHUM, Montreal, Quebec, Canada
McGill Cancer Centre at McGill University, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec, Quebec City, Quebec, Canada
CHUS-Hopital Fleurimont, Sherbrooke, Quebec, Canada
Saskatoon Cancer Centre at the University of Saskatchewan, Saskatoon, Saskatchewan, Canada
Contact Details
Name: Maha Hadi A. Hussain, MD
Affiliation: University of Michigan Rogel Cancer Center
Role: STUDY_CHAIR
Name: Bryan J. Donnelly, MD, FRCSC, MSC
Affiliation: Tom Baker Cancer Centre - Calgary
Role: STUDY_CHAIR
Name: Eric J. Small, MD
Affiliation: University of California, San Francisco
Role: STUDY_CHAIR
Name: George Wilding, MD
Affiliation: University of Wisconsin, Madison
Role: STUDY_CHAIR
Name: Atif Akdas, MD
Affiliation: Marmara University Hospital
Role: STUDY_CHAIR
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