Hormone Therapy in Treating Men With Stage IV Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Southwest Oncology Group
Collaborators:
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
European Organisation for Research and Treatment of Cancer - EORTC
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002651
First received: November 1, 1999
Last updated: October 23, 2012
Last verified: April 2009
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Purpose
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 acetate Other: clinical observation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Treatment-specific symptoms as measured on the four-item Medical Outcomes Study Short Form-36 (SF-36) and Vitality scale [ Designated as safety issue: No ]
- Physical functioning as measured by the SF-36 [ Designated as safety issue: No ]
- Emotional functioning as measured by the SF-36 Mental Health Inventory [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Symptoms as assessed by the Symptom Distress Scale [ Designated as safety issue: No ]
- Role functioning as assessed by the Role Functioning Scale SF-20 [ Designated as safety issue: No ]
- Social functioning as assessed by the General Health Survey SF-20 [ Designated as safety issue: No ]
- Global quality of life (QOL) and health-related QOL [ Designated as safety issue: No ]
- Comorbidity, social support, and demographic variables [ Designated as safety issue: No ]
| Estimated Enrollment: | 1512 |
| Study Start Date: | May 1995 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002651
Locations
| Canada, Alberta | |
| Tom Baker Cancer Centre - Calgary | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Contact: Bryan Donnelly 403-259-2676 | |
| Cross Cancer Institute at University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Peter Venner 780-432-8757 | |
| Canada, British Columbia | |
| University of British Columbia | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: S. Larry Goldenberg 604-875-4111 | |
| Canada, Nova Scotia | |
| Nova Scotia Cancer Centre | Recruiting |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Contact: Derek Wilke 902-473-6022 | |
| Canada, Ontario | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Recruiting |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Contact: Aamer Mahmud 613-544-2631 | |
| London Regional Cancer Program at London Health Sciences Centre | Recruiting |
| London, Ontario, Canada, N6A 4L6 | |
| Contact: Joseph Chin 519-685-8451 | |
| Ottawa Hospital Regional Cancer Centre - General Campus | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Libni Eapen 613-737-7700 | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Juanita Crook 416-946-4501 | |
| Odette Cancer Centre at Sunnybrook | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Laurence Klotz 416-480-4673 | |
| Canada, Quebec | |
| McGill Cancer Centre at McGill University | Recruiting |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Contact: Raghu Rajan 514-934-1934 | |
| Hopital Notre-Dame du CHUM | Recruiting |
| Montreal, Quebec, Canada, H2L 4M1 | |
| Contact: Fred Saad 514-890-8000 | |
| Centre Hospitalier Universitaire de Quebec | Recruiting |
| Quebec City, Quebec, Canada, G1R 2J6 | |
| Contact: Louis Lacombe 418-691-5O50 | |
| CHUS-Hopital Fleurimont | Recruiting |
| Sherbrooke, Quebec, Canada, J1H 5N4 | |
| Contact: Abdenour Nabid 819-346-1110 | |
| Canada, Saskatchewan | |
| Saskatoon Cancer Centre at the University of Saskatchewan | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Contact: Donald B. Gardiner 306-655-2743 | |
Sponsors and Collaborators
Southwest Oncology Group
NCIC Clinical Trials Group
Cancer and Leukemia Group B
Eastern Cooperative Oncology Group
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
| 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 |
| Investigator: | Atif Akdas, MD | Marmara University Hospital |
More Information
Additional Information:
Publications:
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.
Hussain M, Tangen CM, Higano CS, et al.: Improved overall survival (OS) of patients (pts) with new metastatic prostate cancer (pca): better efficacy or stage migration? Data from SWOG: S9346 and 8894. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-30, 2010.
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.
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.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Laurence H. Baker, Southwest Oncology Group - Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT00002651 History of Changes |
| Other Study ID Numbers: | CDR0000064184, SWOG-9346, CAN-NCIC-PR8, CALGB-9594, ECOG-S9346, EORTC-30985, CAN-NCIC-JPR8, INT-0162 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 23, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Goserelin Bicalutamide |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Androgen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013