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Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) National Cancer Institute of Canada Cancer and Leukemia Group B Eastern Cooperative Oncology Group European Organization for Research and Treatment of Cancer |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002651 |
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 | Intervention | Phase |
Prostate Cancer |
Drug: bicalutamide Drug: goserelin Procedure: observation |
Phase III |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Goserelin Bicalutamide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III |
Estimated Enrollment: | 1500 |
Study Start Date: | May 1995 |
Arms | Assigned Interventions |
Consolidation arm I: Active Comparator
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
Given subcutaneously
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Consolidation arm II: Experimental
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
Given subcutaneously
Procedure: observation
Patients undergo observation in the absence of rising prostate-specific antigen (PSA) or clinical symptoms of progressive disease.
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OBJECTIVES:
Primary
Secondary
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).
Consolidation therapy: Patients are randomized to 1 of 2 consolidation regimens.
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 months.
PROJECTED ACCRUAL: Approximately 1,500 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Metastatic stage IV (stage D2)
For entry into late induction therapy:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Hematopoietic:
Hepatic:
Renal:
Other:
No other malignancy within the past 5 years except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
More than 1 year since any prior neoadjuvant or adjuvant hormonal therapy for a duration of no more than 4 months
Radiotherapy:
Surgery:
Show 37 Study Locations |
Southwest Oncology Group |
National Cancer Institute (NCI) |
National Cancer Institute of Canada |
Cancer and Leukemia Group B |
Eastern Cooperative Oncology Group |
European Organization for Research and Treatment of Cancer |
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 | UCSF Helen Diller Family Comprehensive Cancer Center |
Study Chair: | George Wilding, MD | University of Wisconsin, Madison |
Investigator: | Atif Akdas, MD | Marmara University Hospital |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Hussain M, Tangen CM, Higano C, Schelhammer PF, Faulkner J, Crawford ED, Wilding G, Akdas A, Small EJ, Donnelly B, MacVicar G, Raghavan D; Southwest Oncology Group Trial 9346 (INT-0162). Absolute prostate-specific antigen value after androgen deprivation is a strong independent predictor of survival in new metastatic prostate cancer: data from Southwest Oncology Group Trial 9346 (INT-0162). J Clin Oncol. 2006 Aug 20;24(24):3984-90.
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Hussain M, Tangen CM, Schellhammer PF, et al.: Absolute PSA value after androgen deprivation (AD) is a strong independent predictor of survival in new metastatic (D2) prostate cancer (PCa): data from Southwest Oncology Group trial 9346 (INT-0162). [Abstract] J Clin Oncol 24 (Suppl 18): A-4517, 2006.
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Tangen CM, Hussain M, Wilding G, et al.: Determinants of prostate specific antigen (PSA) normalization in prostate cancer (PCa) patients (pts) treated with androgen deprivation (AD) on Southwest Oncology Group (SWOG) study 9346 (INT-0162). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-1591, 2003.
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Goldman B, Hussain M, Tangen C, et al.: Prostate-specific antigen progression (PSA-P) as a predictor of overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-165, 2008.
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Hussain MH, Goldman B, Tangen CM, et al.: Use of prostate-specific antigen progression (PSA-P) to predict overall survival (OS) in patients (pts) with metastatic prostate cancer (PC): data from S9346 and S9916. [Abstract] J Clin Oncol 26 (Suppl 15): A-5015, 2008.
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Study ID Numbers: | CDR0000064184, SWOG-9346, CAN-NCIC-PR8, CALGB-9594, ECOG-S9346, EORTC-30985, CAN-NCIC-JPR8, INT-0162 |
First Received: | November 1, 1999 |
Last Updated: | September 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00002651 |
Health Authority: | United States: Federal Government |
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