Hormone Therapy in Treating Men With Stage IV Prostate Cancer
Recruitment status was: Recruiting
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.
Drug: goserelin acetate
Other: clinical observation
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III|
- Treatment-specific symptoms as measured on the four-item Medical Outcomes Study Short Form-36 (SF-36) and Vitality scale
- Physical functioning as measured by the SF-36
- Emotional functioning as measured by the SF-36 Mental Health Inventory
- Symptoms as assessed by the Symptom Distress Scale
- Role functioning as assessed by the Role Functioning Scale SF-20
- Social functioning as assessed by the General Health Survey SF-20
- Global quality of life (QOL) and health-related QOL
- Comorbidity, social support, and demographic variables
|Study Start Date:||May 1995|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Active Comparator: Consolidation arm I
Patients continue CAD therapy comprising goserelin subcutaneously once a month and oral bicalutamide once daily. Treatment continues in the absence of disease progression.
Given orallyDrug: goserelin acetate
Experimental: Consolidation arm II
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 consolidation arm I. Patients whose PSA normalizes after 8 courses return to observation. Patients whose PSA does not normalize after 8 courses continue CAD therapy.
Given orallyDrug: goserelin acetate
Given subcutaneouslyOther: clinical observation
Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002651
|Tom Baker Cancer Centre - Calgary|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute at University of Alberta|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Canada, Nova Scotia|
|Nova Scotia Cancer Centre|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Cancer Centre of Southeastern Ontario at Kingston General Hospital|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program at London Health Sciences Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Hospital Regional Cancer Centre - General Campus|
|Ottawa, Ontario, Canada, K1H 8L6|
|Odette Cancer Centre at Sunnybrook|
|Toronto, Ontario, Canada, M4N 3M5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Hopital Notre-Dame du CHUM|
|Montreal, Quebec, Canada, H2L 4M1|
|McGill Cancer Centre at McGill University|
|Montreal, Quebec, Canada, H2W 1S6|
|Centre Hospitalier Universitaire de Quebec|
|Quebec City, Quebec, Canada, G1R 2J6|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Saskatoon Cancer Centre at the University of Saskatchewan|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Study Chair:||Maha Hadi A. Hussain, MD||University of Michigan Cancer Center|
|Study Chair:||Bryan J. Donnelly, MD, FRCSC, MSC||Tom Baker Cancer Centre - Calgary|
|Study Chair:||Eric J. Small, MD||University of California, San Francisco|
|Study Chair:||George Wilding, MD||University of Wisconsin, Madison|
|OverallOfficial:||Atif Akdas, MD||Marmara University Hospital|