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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
Results First Received: November 15, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Prostate Cancer
Interventions: Drug: bicalutamide
Drug: goserelin acetate
Other: clinical observation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Combined Androgen Deprivation (CAD) Patients receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily for 7 months.
Continuous Hormonal Therapy Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
Intermittent Hormonal Therapy Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. 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 (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).

Participant Flow for 2 periods

Period 1:   Induction
    Combined Androgen Deprivation (CAD)   Continuous Hormonal Therapy   Intermittent Hormonal Therapy
STARTED   3040   0   0 
Eligible   2950   0   0 
Eligible and Began Protocol Therapy   2950   0   0 
COMPLETED   1697   0   0 
NOT COMPLETED   1343   0   0 
Adverse Event                44                0                0 
Refusal unrelated to adverse event                50                0                0 
Progression/relapse                274                0                0 
Death                62                0                0 
not specified                823                0                0 
not eligible                90                0                0 

Period 2:   Consolidation and Randomization
    Combined Androgen Deprivation (CAD)   Continuous Hormonal Therapy   Intermittent Hormonal Therapy
STARTED   0   867 [1]   882 [1] 
Eligible   0   765   770 
Assessable for Toxicity [2]   0   732   702 
COMPLETED   0   29   22 
NOT COMPLETED   0   838   860 
Adverse Event                0                36                14 
Refusal unrelated to adverse event                0                53                75 
Progression/relapse                0                295                298 
Death                0                38                48 
not specified                0                314                313 
not eligible                0                102                112 
[1] After induction,patients with stable or declining PSA (≤ 4.0 ng/mL) were eligible for randomization
[2] Patients with no AE evaluations, received wrong protocol arm, or received non-protocol trt excluded



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized and eligible patients (After induction, Patients with stable or declining PSA levels of 4.0 ng per milliliter or lower at months 6 and 7 were eligible for randomization).

Reporting Groups
  Description
Continuous Hormonal Therapy Patients continue to receive goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily until progression of disease
Intermittent Hormonal Therapy Patients are cycled between observation periods and Combined Androgen Deprivation (CAD) periods based on PSA results. 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 (goserelin 3.6 mg subcutaneously once a month and oral bicalutamide 50 mg once daily ). Patients whose PSA normalizes after 8 cycles of CAD treatment return to observation. Patients whose PSA does not normalize after 8 cycles of CAD treatment continue CAD therapy until progression (1 cycle of CAD treatment = 7 months with 8 injections. There are 2 injections in the first month on Days 1 and 29).
Total Total of all reporting groups

Baseline Measures
   Continuous Hormonal Therapy   Intermittent Hormonal Therapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 765   770   1535 
Age 
[Units: Years]
Median (Full Range)
 70 
 (39 to 92) 
 70 
 (39 to 97) 
 70 
 (39 to 97) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      765 100.0%      770 100.0%      1535 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      17   2.2%      23   3.0%      40   2.6% 
Not Hispanic or Latino      571  74.6%      564  73.2%      1135  73.9% 
Unknown or Not Reported      177  23.1%      183  23.8%      360  23.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      2   0.3%      4   0.5%      6   0.4% 
Asian      5   0.7%      8   1.0%      13   0.8% 
Native Hawaiian or Other Pacific Islander      2   0.3%      0   0.0%      2   0.1% 
Black or African American      93  12.2%      94  12.2%      187  12.2% 
White      507  66.3%      519  67.4%      1026  66.8% 
More than one race      2   0.3%      1   0.1%      3   0.2% 
Unknown or Not Reported      154  20.1%      144  18.7%      298  19.4% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: Up to 15 years ]

2.  Primary:   Physical Functioning as Measured by the SF-36   [ Time Frame: 3 months ]

3.  Primary:   Emotional Functioning as Measured by the SF-36 Mental Health Inventory   [ Time Frame: 3 months ]

4.  Primary:   Erectile Dysfunction   [ Time Frame: 3 months ]

5.  Primary:   High Libido   [ Time Frame: 3 months ]

6.  Primary:   Vitality   [ Time Frame: 3 months ]

7.  Other Pre-specified:   Global Perception of Quality of Life   [ Time Frame: 15 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Social Functioning   [ Time Frame: 15 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Other Pre-specified:   Role Functioning   [ Time Frame: 15 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Other Pre-specified:   General Symptoms   [ Time Frame: 15 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


Publications of Results:
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.

Other Publications:
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