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ARTS - AVODART After Radical Therapy For Prostate Cancer Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00558363
First received: November 13, 2007
Last updated: March 15, 2012
Last verified: December 2011
History of Changes
Results First Received: November 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Neoplasms, Prostate
Prostate Cancer After a Radical Treatment
Interventions: Drug: Avodart
Other: placebo

  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
Placebo Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Dutasteride 0.5 mg Oral dose of 0.5 mg dutasteride capsule once daily for 2 years

Participant Flow:   Overall Study
    Placebo     Dutasteride 0.5 mg  
STARTED     147     147  
COMPLETED     76     111  
NOT COMPLETED     71     36  
Physician Decision                 18                 4  
Withdrawal by Subject                 11                 4  
Adverse Event                 5                 5  
Lack of Efficacy                 2                 2  
Protocol Violation                 2                 1  
Lost to Follow-up                 0                 1  
Met Protocol-defined Stopping Criteria                 32                 16  
Randomized in Error                 1                 2  
Hospitalized; Unable to Continue                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Dutasteride 0.5 mg Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
Total Total of all reporting groups

Baseline Measures
    Placebo     Dutasteride 0.5 mg     Total  
Number of Participants  
[units: participants]
 		  147     147     294  
Age  
[units: Years]
Mean ± Standard Deviation 		  68.6  ± 6.53     69.7  ± 5.76     69.1  ± 6.17  
Gender  
[units: Participants]
 		     
Female     0     0     0  
Male     147     147     294  
Race/Ethnicity, Customized  
[units: participants]
 		     
White – Caucasian/European Heritage     145     147     292  
White – Arabic/North African Heritage     1     0     1  
Asian – Central/Soth Asian Heritage     1     0     1  



  Outcome Measures
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1.  Primary:   Time to Prostate-specific Antigen (PSA) Doubling From Baseline (in Days)   [ Time Frame: up to 28 months ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With PSA Doubling From Baseline   [ Time Frame: up to 28 months ]
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3.  Primary:   Time to PSA Doubling From Baseline (in Days) Within Year 1   [ Time Frame: up to 16 months ]
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4.  Primary:   Number of Participants With PSA Doubling From Baseline During Year 1   [ Time Frame: up to 16 months ]
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5.  Secondary:   Time to Disease Progression From Baseline (in Days)   [ Time Frame: up to 28 months ]
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6.  Secondary:   Number of Participants With Disease Progression   [ Time Frame: up to 28 months ]
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7.  Secondary:   Number of Participants Classified as Treatment Responders at Months 3, 6, 9, 12, 15, 18, 21, and 24   [ Time Frame: Months 3, 6, 9, 12, 15, 18, 21, and 24 ]
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8.  Secondary:   Time to PSA Rise From Baseline (in Days)   [ Time Frame: up to 28 months ]
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9.  Secondary:   Number of Participants With a PSA Rise From Baseline   [ Time Frame: up to 28 months ]
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10.  Secondary:   Time to PSA Progression (in Days)   [ Time Frame: up to 28 months ]
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11.  Secondary:   Number of Participants With PSA Progression   [ Time Frame: up to 28 months ]
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12.  Secondary:   Change in Total PSA From Baseline at Months 12 and 24   [ Time Frame: Baseline; Months 12 and 24 ]
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13.  Secondary:   Percent Change in Total PSA From Baseline at Months 12 and 24   [ Time Frame: Baseline; Months 12 and 24 ]
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14.  Secondary:   Change in PSA From Nadir PSA at Months 12 and 24   [ Time Frame: Baseline; Months 12 and 24 ]
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15.  Secondary:   Percent Change in PSA From Nadir PSA at Months 12 and 24   [ Time Frame: Baseline; Months 12 and 24 ]
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16.  Secondary:   Number of Participants With the Indicated Change in PSA Doubling Time (PSADT) From Baseline at Month 12, Month 24, and End-of-treatment (up to 28 Months)   [ Time Frame: Baseline; Month 12, Month 24, End-of-Treatment (up to 28 months) ]
  Show Outcome Measure 16

17.  Secondary:   Changes From Baseline in Disease-related Anxiety Measured by the Memorial Anxiety Scale for Prostate Cancer (MAX-PC)   [ Time Frame: Baseline; Months 3, 6, 12, 18, and 24 ]
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18.  Secondary:   Number of Participants With a Shift From Normal at Baseline to at Least One Abnormal Laboratory Value for Any Parameter Any Time During the Study   [ Time Frame: Baseline; up to 28 months ]
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19.  Secondary:   Number of Participants With a Threshold Laboratory Value for Any Parameter at Baseline (BL) and Any Time Post-baseline   [ Time Frame: Baseline; up to 28 months ]
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20.  Secondary:   Number of Participants With Palpable Breast Tissue (PBT) at Baseline (BL) and Any Time Post-baseline   [ Time Frame: Baseline; up to 28 months ]
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21.  Secondary:   Number of Participants With Nipple Tenderness (NT) at Baseline (BL) and Any Time Post-baseline   [ Time Frame: Baseline; up to 28 months ]
  Show Outcome Measure 21

22.  Secondary:   Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline   [ Time Frame: Baseline; up to 28 months ]
  Hide Outcome Measure 22

Measure Type Secondary
Measure Title Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline
Measure Description Participants underwent a digital rectal examination to evaluate for focal abnormality of the prostate.
Time Frame Baseline; up to 28 months  
Safety Issue Yes  

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.
ITT Population

Reporting Groups
  Description
Placebo Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
Dutasteride 0.5 mg Oral dose of 0.5 mg dutasteride capsule once daily for 2 years

Measured Values
    Placebo     Dutasteride 0.5 mg  
Number of Participants Analyzed  
[units: participants]
 		  147     147  
Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline  
[units: participants]
 		  10     8  

No statistical analysis provided for Number of Participants With a Digital Rectal Examination (DRE) Evaluation Changing From Normal/Diffusely Enlarged at Baseline to Focal Abnormality at Any Time Post-baseline



23.  Secondary:   Number of Participants With Threshold Vital Signs at Baseline and Any Time Post-baseline   [ Time Frame: Baseline; up to 28 months ]
  Show Outcome Measure 23


  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00558363     History of Changes
Other Study ID Numbers: ARI109924
Study First Received: November 13, 2007
Results First Received: November 10, 2011
Last Updated: March 15, 2012
Health Authority: Spain: Ministry of Health