SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00002651 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
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Prostate Cancer | Drug: bicalutamide Drug: goserelin acetate Other: clinical observation | Phase 3 |
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).
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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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 3040 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III |
Study Start Date : | May 1995 |
Actual Primary Completion Date : | June 2013 |
Actual Study Completion Date : | June 2013 |

Arm | Intervention/treatment |
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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.
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Drug: bicalutamide
Given orally Drug: goserelin acetate Given subcutaneously |
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.
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Drug: bicalutamide
Given orally Drug: goserelin acetate Given subcutaneously Other: clinical observation Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease. |
- Overall Survival [ Time Frame: Up to 15 years ]Non-inferiority test to determine if intermittent combined androgen deprivation (CAD) overall survival is not substantially worse than continuous CAD overall survival. Specifically, the trial is designed for a one-sided test of the hypothesis that the hazard ratio of intermittent CAD to continuous CAD is 1.2. The assumptions used to compute the trial size are an overall type I error rate of 0.05 and a type II error of 0.10 (power = 0.9).
- Physical Functioning as Measured by the SF-36 [ Time Frame: 3 months ]This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months
- Emotional Functioning as Measured by the SF-36 Mental Health Inventory [ Time Frame: 3 months ]This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. Change from Baseline in SF-36 Score at 3 Months
- Erectile Dysfunction [ Time Frame: 3 months ]This outcome was assessed by having patients report whether they had erectile dysfunction (a score of 1) or no erectile dysfunction (a score of 0). This analysis looks at change from Baseline to 3 Months.
- High Libido [ Time Frame: 3 months ]This outcome was assessed by having patients report whether their interest in sexual activities was very high, high, or moderate (a score of 1) or low or very low (a score of 0). This outcome measure is reporting a change from baseline in the percentage of participants with High Libido at 3 months. "High Libido" is defined as very high, high or moderate interest in sexual activities.
- Vitality [ Time Frame: 3 months ]This outcome was scored on a scale of 0 to 100, with higher scores indicating better functioning. This analysis looks at mean change from Baseline score to 3 Months.
- Global Perception of Quality of Life [ Time Frame: 15 months ]
- Social Functioning [ Time Frame: 15 months ]Mean of the change in social functioning from randomization
- Role Functioning [ Time Frame: 15 months ]Mean of the change in role functioning from randomization
- General Symptoms [ Time Frame: 15 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed adenocarcinoma of the prostate
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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])
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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
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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
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002651
Canada, Alberta | |
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 | |
Canada, Ontario | |
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 | |
Canada, Quebec | |
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 | |
CHUS-Hopital Fleurimont | |
Sherbrooke, Quebec, Canada, J1H 5N4 | |
Canada, Saskatchewan | |
Saskatoon Cancer Centre at the University of Saskatchewan | |
Saskatoon, Saskatchewan, Canada, S7N 4H4 |
Study Chair: | Maha Hadi A. Hussain, MD | University of Michigan Rogel 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 | |
Study Chair: | Atif Akdas, MD | Marmara University Hospital |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Southwest Oncology Group |
ClinicalTrials.gov Identifier: | NCT00002651 |
Other Study ID Numbers: |
CDR0000064184 SWOG-9346 CAN-NCIC-PR8 CALGB-9594 ECOG-S9346 EORTC-30985 CAN-NCIC-JPR8 INT-0162 |
First Posted: | January 27, 2003 Key Record Dates |
Results First Posted: | April 17, 2017 |
Last Update Posted: | April 17, 2017 |
Last Verified: | March 2017 |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Goserelin |
Bicalutamide Antineoplastic Agents, Hormonal Antineoplastic Agents Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |