Trial Outcomes & Findings for Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer (NCT NCT00298155)
NCT ID: NCT00298155
Last Updated: 2018-08-09
Results Overview
Tissue dihydrotesterone (DHT)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
After 12 weeks of neoadjuvant androgen deprivation
Results posted on
2018-08-09
Participant Flow
Participant milestones
| Measure |
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
13
|
|
Overall Study
COMPLETED
|
12
|
10
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Maximal Suppression of the Androgen Axis in Clinically Localized Prostate Cancer
Baseline characteristics by cohort
| Measure |
Group 1
n=12 Participants
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
n=10 Participants
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
n=13 Participants
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
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62 years
n=99 Participants
|
66 years
n=107 Participants
|
60 years
n=206 Participants
|
64 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
35 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
10 participants
n=107 Participants
|
13 participants
n=206 Participants
|
35 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: After 12 weeks of neoadjuvant androgen deprivationTissue dihydrotesterone (DHT)
Outcome measures
| Measure |
Group 1
n=12 Participants
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
n=10 Participants
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
n=13 Participants
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).
|
|---|---|---|---|
|
Prostate Tissue DHT
|
0.03 ng/g
Standard Deviation 0.01
|
0.06 ng/g
Standard Deviation 0.06
|
0.03 ng/g
Standard Deviation 0.02
|
SECONDARY outcome
Timeframe: After 12 weeks of neoadjuvant androgen deprivationPopulation: Patients with clinically localized prostate cancer treated for 3 months with the treatments in Groups 1-3
Serum DHT
Outcome measures
| Measure |
Group 1
n=12 Participants
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
n=10 Participants
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
n=13 Participants
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).
|
|---|---|---|---|
|
To Determine the Effects of Different Modes of Androgen Deprivation on Serum DHT
|
4.2 ng/dL
Standard Deviation 3.4
|
3.6 ng/dL
Standard Deviation 2.0
|
5.7 ng/dL
Standard Deviation 4.9
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=12 participants at risk
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
n=10 participants at risk
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
n=13 participants at risk
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).
|
|---|---|---|---|
|
Vascular disorders
hot flushes
|
100.0%
12/12 • Number of events 12
|
100.0%
10/10 • Number of events 10
|
100.0%
13/13 • Number of events 13
|
|
General disorders
Fatigue
|
41.7%
5/12 • Number of events 5
|
60.0%
6/10 • Number of events 6
|
61.5%
8/13 • Number of events 8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place