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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002651
First Posted: January 27, 2003
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
November 1, 1999
January 27, 2003
November 15, 2016
April 17, 2017
April 17, 2017
May 1995
June 2013   (Final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00002651 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
  • 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 ]
Not Provided
 
SWOG-9346, Hormone Therapy in Treating Men With Stage IV Prostate Cancer
Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer, Phase III

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostate Cancer
  • 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.
  • 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.
    Interventions:
    • Drug: bicalutamide
    • Drug: goserelin acetate
  • 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.
    Interventions:
    • Drug: bicalutamide
    • Drug: goserelin acetate
    • Other: clinical observation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3040
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
Belgium,   Italy,   Malta,   Netherlands,   Slovakia,   South Africa,   Switzerland,   Turkey,   United Kingdom,   United States
 
NCT00002651
CDR0000064184
SWOG-9346
CAN-NCIC-PR8
CALGB-9594
ECOG-S9346
EORTC-30985
CAN-NCIC-JPR8
INT-0162
Yes
Not Provided
Not Provided
Southwest Oncology Group
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
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
Southwest Oncology Group
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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