Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III
bicalutamide
+ goserelin acetate
+ bicalutamide
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: May 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.3040 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the prostate Metastatic stage IV (stage D2) Any number of bone metastases by bone scan allowed Unequivocal visceral organ metastases (liver, brain, or lung) allowed No suspected second primary tumors unless metastases are histologically confirmed, including special stains (e.g., prostate specific antigen [PSA] and prostatic alkaline phosphatase [PAP]) For entry into late induction therapy: No more than 1 month from the beginning of antiandrogen therapy to the beginning of luteinizing hormone-releasing hormone (LHRH) agonist therapy No more than 6 months since initiation of current combined androgen-deprivation therapy (LHRH agonist and antiandrogen) The effectiveness of the current depot LHRH agonist would not extend beyond 8 months after initiation of combined androgen therapy PSA at least 5 ng/mL No acute spinal cord compression PATIENT CHARACTERISTICS: Age: Adult Performance status: SWOG 0-2 Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Recovered from any major infection No active medical illness that would preclude study or limit survival No other malignancy within the past 5 years except: Adequately treated basal cell or squamous cell skin cancer Adequately treated carcinoma in situ of the bladder Adequately treated other superficial cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biological response modifier therapy Chemotherapy: No concurrent chemotherapy Endocrine therapy: See Disease Characteristics More than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of no more than 4 months Single or combination therapy allowed More than 1 year since prior finasteride for prostate cancer for a duration of no more than 9 months (less than 6 months for benign prostatic hypertrophy) Prior or concurrent megestrol for hot flashes allowed No other concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy other than palliation of painful bone metastases Surgery: No prior bilateral orchiectomy Recovered from any prior major surgery
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 14 locations
Tom Baker Cancer Centre - Calgary
Calgary, CanadaOpen Tom Baker Cancer Centre - Calgary in Google MapsCross Cancer Institute at University of Alberta
Edmonton, CanadaUniversity of British Columbia
Vancouver, CanadaNova Scotia Cancer Centre
Halifax, Canada