We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer (TAPS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00298155
First Posted: March 1, 2006
Last Update Posted: May 8, 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:
GlaxoSmithKline
AstraZeneca
Information provided by (Responsible Party):
Bruce Montgomery, University of Washington
Results First Submitted: March 26, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cancer
Prostate Neoplasms
Interventions: Drug: goserelin with dutasteride
Drug: goserelin with bicalutamide and dutasteride
Drug: goserelin with bicalutamide and dutasteride and ketoconazole

  Participant Flow
  Hide Participant Flow

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
Group 1

Goserelin + dutasteride

goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week.

Group 2

Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks

goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd.

Group 3

Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks

goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg).


Participant Flow:   Overall Study
    Group 1   Group 2   Group 3
STARTED   12   10   13 
COMPLETED   12   10   13 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
  Hide Baseline Characteristics

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
Group 1

Goserelin + dutasteride

goserelin with dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd; continue bicalutamide for one more week.

Group 2

Bicalutamide for one week, begin goserelin plus dutasteride, continue bicalutamide for the full 12 weeks

goserelin with bicalutamide and dutasteride: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot) and begin dutasteride 3.5 mg qd.

Group 3

Begin bicalutamide for one week, goserelin injection; begin dutasteride, ketoconazole (and replacement hydrocortisone), continue bicalutamide for the full 12 weeks

goserelin with bicalutamide and dutasteride and ketoconazole: Bicalutamide 50 mg qd for one week, inject goserelin 10.8 mg (3-month depot), begin dutasteride 3.5 mg qd and ketoconazole 200 mg tid (with hydrocortisone 30 mg).

Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Group 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   10   13   35 
Age 
[Units: Years]
Median (Full Range)
 62 
 (41 to 82) 
 66 
 (41 to 82) 
 60 
 (41 to 82) 
 64 
 (41 to 82) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      12 100.0%      10 100.0%      13 100.0%      35 100.0% 
Region of Enrollment 
[Units: Participants]
       
United States   12   10   13   35 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Primary Endpoint of the Study is to Evaluate the Effect of Different Combinations of Anti-androgen Medicines on Androgen Levels in the Prostate Tissue   [ Time Frame: post-treatment ]

2.  Secondary:   To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT, T, Dehydroepiandrosterone (DHEA) and Androstenedione   [ Time Frame: post-treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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: Dr. Bruce Montgomery
Organization: University of Washington
phone: 206-598-0860
e-mail: rbmontgo@uw.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bruce Montgomery, University of Washington
ClinicalTrials.gov Identifier: NCT00298155     History of Changes
Other Study ID Numbers: 28741
FHCRC-05026 ( Other Identifier: Cancer Consortium IRB )
05-8538-V 01 ( Other Identifier: U. of Washington IRB (old application number) )
28741-A ( Other Identifier: U. of Washington IRB (application number); dual review )
01253 ( Other Identifier: VA Puget Sound Health Care System IRB (current) )
First Submitted: February 27, 2006
First Posted: March 1, 2006
Results First Submitted: March 26, 2017
Results First Posted: May 8, 2017
Last Update Posted: May 8, 2017