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SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
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 (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00002651
First received: November 1, 1999
Last updated: March 3, 2017
Last verified: March 2017
  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
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

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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 ]

Enrollment: 3040
Study Start Date: May 1995
Study Completion Date: June 2013
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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002651

Locations
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
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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
Study Chair: Atif Akdas, MD Marmara University Hospital
  More Information

Publications:
Hussain M, Tangen CM, Higano CS, et al.: Intermittent (IAD) versus continuous androgen deprivation (CAD) in hormone sensitive metastatic prostate cancer (HSM1PC) patients (pts): results of S9346 (INT-0162), an international phase III trial. [Abstract] J Clin Oncol 30 (Suppl 15): A-4, 2012.
Moinpour C, Berry DL, Ely B, et al.: Preliminary quality-of-life outcomes for SWOG-9346: Intermittent androgen deprivation in patients with hormone-sensitive metastatic prostate cancer (HSM1PC)—phase III. [Abstract] J Clin Oncol 30 (Suppl 15): A-4571, 2012.
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Southwest Oncology Group
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
Results First Received: November 15, 2016
Last Updated: March 3, 2017

Keywords provided by Southwest Oncology Group:
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
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2017