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Trial record 56 of 278 for:    prostate cancer AND localized | ( Map: United States )

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

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.
 
ClinicalTrials.gov Identifier: NCT00298155
Recruitment Status : Completed
First Posted : March 1, 2006
Results First Posted : May 8, 2017
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
GlaxoSmithKline
AstraZeneca
Information provided by (Responsible Party):
Bruce Montgomery, University of Washington

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
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description

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.

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.

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).

Period Title: Overall Study
Started 12 10 13
Completed 12 10 13
Not Completed 0 0 0
Arm/Group Title Group 1 Group 2 Group 3 Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 12 10 13 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants 10 participants 13 participants 35 participants
62
(41 to 82)
66
(41 to 82)
60
(41 to 82)
64
(41 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 10 participants 13 participants 35 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 10 participants 13 participants 35 participants
12 10 13 35
1.Primary Outcome
Title Prostate Tissue DHT
Hide Description Tissue dihydrotesterone (DHT)
Time Frame After 12 weeks of neoadjuvant androgen deprivation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description:

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.

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.

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).

Overall Number of Participants Analyzed 12 10 13
Mean (Standard Deviation)
Unit of Measure: ng/g
0.03  (0.01) 0.06  (0.06) 0.03  (0.02)
2.Secondary Outcome
Title To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT
Hide Description Serum DHT
Time Frame After 12 weeks of neoadjuvant androgen deprivation
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with clinically localized prostate cancer treated for 3 months with the treatments in Groups 1-3
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description:

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.

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.

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).

Overall Number of Participants Analyzed 12 10 13
Mean (Standard Deviation)
Unit of Measure: ng/dL
4.2  (3.4) 3.6  (2.0) 5.7  (4.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 Group 2 Group 3
Hide Arm/Group Description

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.

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.

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).

All-Cause Mortality
Group 1 Group 2 Group 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/10 (0.00%)      0/13 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 Group 2 Group 3
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/12 (100.00%)      10/10 (100.00%)      13/13 (100.00%)    
General disorders       
Fatigue *  5/12 (41.67%)  5 6/10 (60.00%)  6 8/13 (61.54%)  8
Vascular disorders       
hot flushes *  12/12 (100.00%)  12 10/10 (100.00%)  10 13/13 (100.00%)  13
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Dr. Bruce Montgomery
Organization: University of Washington
Phone: 206-598-0860
EMail: rbmontgo@uw.edu
Layout table for additonal information
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: August 9, 2018