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Phase III Randomized Study of Intermittent Versus Continuous Combined Androgen-Deprivation Therapy Comprising Bicalutamide and Goserelin in Patients With Metastatic Stage IV Prostate Cancer Responsive to Such Therapy
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Published Results Related Publications Trial Contact Information Registry Information
Alternate Title
Hormone Therapy in Treating Men With Stage IV Prostate Cancer
Basic Trial Information
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Protocol IDs
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Phase III
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Treatment
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Closed
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Adult
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NCI
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SWOG-9346 SWOG-9346, CAN-NCIC-PR8, CALGB-9594, ECOG-S9346, EORTC-30985, CAN-NCIC-JPR8, INT-0162, NCT00002651, PR8
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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.
Entry 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
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
Patient Characteristics:
Age: Performance status: Hematopoietic: Hepatic: Renal: 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
Expected Enrollment 1512Approximately 1,500 patients will be accrued for this study. Outcomes Primary Outcome(s)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
Secondary Outcome(s)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
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 months. Published ResultsHussain M, Tangen CM, Higano C, et al.: 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 24 (24): 3984-90, 2006.[PUBMED Abstract] 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. 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. Related PublicationsGoldman 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. 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.
Trial Contact Information
Trial Lead Organizations Southwest Oncology Group | | | Maha Hadi Hussain, MD, Protocol chair | | Ph: 734-936-8906; 800-865-1125 |
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NCIC-Clinical Trials Group | | | Bryan Donnelly, MD, FRCSC, MSC, Protocol chair | | | |
Cancer and Leukemia Group B | | | Eric Small, MD, Protocol chair | | Ph: 415-353-7095; 800-888-8664 |
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Eastern Cooperative Oncology Group | | | George Wilding, MD, Protocol chair | | | |
European Organization for Research and Treatment of Cancer | | | Atif Akdas, MD, Study coordinator | | | |
Registry Information | | Official Title | | Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III | | Trial Start Date | | 1995-05-15 | | Trial Completion Date | | 2012-06-01 (estimated) | | Registered in ClinicalTrials.gov | | NCT00002651 | | Date Submitted to PDQ | | 1995-04-25 | | Information Last Verified | | 2008-10-28 | | NCI Grant/Contract Number | | CA32102 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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