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Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00363311
First received: August 11, 2006
Last updated: March 15, 2012
Last verified: June 2011
Results First Received: March 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Neoplasms, Prostate
Prostate Cancer
Interventions: Drug: Dutasteride
Drug: Matching 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
A completed participant is defined as one who completed the 36-month treatment phase of the study and the 4-month safety follow-up phase.

Reporting Groups
  Description
Matching Placebo 0.5 mg Once Daily Matching placebo 0.5 milligrams (mg) administered orally once daily for 156 weeks
Dutasteride 0.5 mg Once Daily Dutasteride 0.5 mg administered orally once daily for 156 weeks

Participant Flow:   Overall Study
    Matching Placebo 0.5 mg Once Daily     Dutasteride 0.5 mg Once Daily  
STARTED     155     147  
COMPLETED     79     102  
NOT COMPLETED     76     45  
Adverse Event                 6                 4  
Lost to Follow-up                 3                 0  
Protocol Violation                 1                 2  
Withdrawal by Subject                 12                 6  
Physician Decision                 1                 1  
Sponsor Terminated Study                 2                 2  
Disease Progression                 46                 26  
Non-Compliance                 1                 1  
Participant Refused Biopsy                 1                 0  
Prostate Volume/PSA Doubled                 1                 0  
Participant Opted for Treatment                 1                 0  
Participant Moved to Another Country                 1                 0  
Participant Withdrew Waiting for Surgery                 0                 1  
Withdrawn per Instructions of Monitor                 0                 1  
Participant Moved to Louisiana                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Matching Placebo 0.5 mg Once Daily Matching placebo 0.5 mg administered orally once daily for 156 weeks
Dutasteride 0.5 mg Once Daily Dutasteride 0.5 mg administered orally once daily for 156 weeks
Total Total of all reporting groups

Baseline Measures
    Matching Placebo 0.5 mg Once Daily     Dutasteride 0.5 mg Once Daily     Total  
Number of Participants  
[units: participants]
  155     147     302  
Age  
[units: Years]
Mean ± Standard Deviation
  65.0  ± 7.56     65.1  ± 7.13     65.0  ± 7.34  
Gender  
[units: Participants]
     
Female     0     0     0  
Male     155     147     302  
Race/Ethnicity, Customized  
[units: participants]
     
White     141     132     273  
African American     12     8     20  
Asian     1     4     5  
American Indian or Alaskan Native     0     1     1  
Native Hawaiian or Other Pacific Islander     1     1     2  
White and American Indian/Alaskan Native     0     1     1  



  Outcome Measures
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1.  Primary:   Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression   [ Time Frame: Year 1.5 and Overall (Years 0-3) ]

2.  Secondary:   Number of Participants With Therapeutic Progression   [ Time Frame: Year 1.5 and Overall (Years 0-3) ]

3.  Secondary:   Number of Participants With Pathologic Progression   [ Time Frame: Year 1.5 and Overall (Years 0-3) ]

4.  Secondary:   Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis   [ Time Frame: Baseline to Month 18 ]

5.  Secondary:   Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy   [ Time Frame: Years 0-3 ]

6.  Secondary:   Number of Cancer-positive Cores in a 12-core Biopsy   [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ]

7.  Secondary:   Change From Baseline in the Number of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3   [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ]

8.  Secondary:   Mean Percentage of Cancer-positive Cores in a 12-core Biopsy   [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ]

9.  Secondary:   Change From Baseline in the Percentage of Cancer-positive Cores in a 12-core Biopsy at Years 1.5, 3, and 0-3   [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ]

10.  Secondary:   Cumulative Length of Cancer Tumor Core   [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ]

11.  Secondary:   Change From Baseline in the Cumulative Length of Cancer Tumor Core at Years 1.5, 3, and 0-3   [ Time Frame: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy) ]

12.  Secondary:   Number of Participants With the Indicated Change From Baseline in Gleason Score (GS) on Repeat Biopsy at Year 1.5   [ Time Frame: Year 1.5 ]

13.  Secondary:   Number of Participants With the Indicated Change From Baseline in Gleason Score on Repeat Biopsy at Years 0-3   [ Time Frame: Years 0-3 (Final Biopsy) ]

14.  Secondary:   Number of Participants With the Indicated Total Gleason Score   [ Time Frame: Years 0-3 (Final Biopsy) ]

15.  Secondary:   Number of Biopsies With the Indicated Clinical Tumor Stage at Baseline   [ Time Frame: Baseline ]

16.  Secondary:   Number of Post-baseline Biopsies With the Indicated Change From Baseline in Clinical Stage   [ Time Frame: Months 0-18 ]

17.  Secondary:   Prostate Volume (PV) LOCF   [ Time Frame: Baseline and Years 1.5 and 3 ]

18.  Secondary:   Change From Baseline in Prostate Volume at Years 1.5 and 3   [ Time Frame: Baseline and Years 1.5 and 3 ]

19.  Secondary:   Percent Change From Baseline in Prostate Volume at Years 1.5 and 3   [ Time Frame: Baseline and Years 1.5 and 3 ]

20.  Secondary:   Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)   [ Time Frame: Baseline and Month 3, 6, 12, 18, and 36 ]

21.  Secondary:   Change From Baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF   [ Time Frame: Baseline and Months 3, 6, 12, 18, and 36 ]

22.  Secondary:   Total MAX-PC Anxiety Subscale Score Related to PSA Testing   [ Time Frame: Baseline and Months 3, 6, 12, 18, and 36 ]

23.  Secondary:   Change From Baseline in MAX-PC Anxiety Subscale Score Related to PSA Testing (LOCF)   [ Time Frame: Baseline and Months 3, 6, 12, 18, and 36 ]

24.  Secondary:   Total MAX-PC Fear of Recurrence Subscale Score   [ Time Frame: Baseline and Months 3, 6, 12, 18, and 36 ]

25.  Secondary:   Change From Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)   [ Time Frame: Baseline and Months 3, 6, 12, 18, and 36 ]

26.  Secondary:   Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score   [ Time Frame: Baseline and Months 18 and 36 ]

27.  Secondary:   Change From Baseline in Total FACT-P Score (LOCF)   [ Time Frame: Baseline and Months 18 and 36 ]

28.  Secondary:   Percent Change From Baseline in Total FACT-P Score (LOCF)   [ Time Frame: Baseline and Months 18 and 36 ]

29.  Secondary:   Change From Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)   [ Time Frame: Baseline and Months 18 and 36 ]

30.  Secondary:   Change From Baseline in FACT-P Social Well-Being Subscale Score (LOCF)   [ Time Frame: Baseline and Months 18 and 36 ]


  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 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.


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: NCT00363311     History of Changes
Other Study ID Numbers: AVO105948
Study First Received: August 11, 2006
Results First Received: March 31, 2011
Last Updated: March 15, 2012
Health Authority: United States: Food and Drug Administration