Trial Outcomes & Findings for Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer (NCT NCT00668642)
NCT ID: NCT00668642
Last Updated: 2023-08-22
Results Overview
Calculation of the level of gene expression of the U19 tumor suppressor gene compared between the 2 arms at the end of "off-treatment" cycle 1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
At the end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)
Results posted on
2023-08-22
Participant Flow
20 participants enrolled and all received initial treatment with anti-androgen therapy (AAT) for planned 8 months (on-cycle 1). 7 participants progressed during this treatment, so 13 participants proceeded with randomization.
Participant milestones
| Measure |
A: Dutasteride During First Off-Cycle
Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle
Dutasteride: 0.5 mg capsule given orally on daily basis
|
B: Placebo During First Off-Cycle
Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle
Placebo: Identical placebo
|
|---|---|---|
|
First Off-cycle
STARTED
|
7
|
6
|
|
First Off-cycle
Research Biopsy
|
4
|
3
|
|
First Off-cycle
COMPLETED
|
6
|
6
|
|
First Off-cycle
NOT COMPLETED
|
1
|
0
|
|
Second AAT Treatment (On-cycle 2)
STARTED
|
6
|
6
|
|
Second AAT Treatment (On-cycle 2)
COMPLETED
|
4
|
5
|
|
Second AAT Treatment (On-cycle 2)
NOT COMPLETED
|
2
|
1
|
|
Second Off Treatment (Off-cycle 2)
STARTED
|
4
|
5
|
|
Second Off Treatment (Off-cycle 2)
Research Biopsy
|
2
|
2
|
|
Second Off Treatment (Off-cycle 2)
COMPLETED
|
4
|
5
|
|
Second Off Treatment (Off-cycle 2)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
A: Dutasteride During First Off-Cycle
Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle
Dutasteride: 0.5 mg capsule given orally on daily basis
|
B: Placebo During First Off-Cycle
Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle
Placebo: Identical placebo
|
|---|---|---|
|
First Off-cycle
Cancer progression
|
1
|
0
|
|
Second AAT Treatment (On-cycle 2)
Cancer progression
|
2
|
1
|
Baseline Characteristics
Effect of Dutasteride on Androgen-Response Gene Expression in Patients With Advanced Prostate Cancer
Baseline characteristics by cohort
| Measure |
A: Dutasteride During First Off-Cycle
n=10 Participants
Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle
Dutasteride: 0.5 mg capsule given orally on daily basis
|
B: Placebo During First Off-Cycle
n=10 Participants
Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle
Placebo: Identical placebo
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 20 • n=5 Participants
|
67 years
STANDARD_DEVIATION 20 • n=7 Participants
|
67 years
STANDARD_DEVIATION 20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)Population: Only patients from each arm with biopsies at the end of off-cycle 1 are included.
Calculation of the level of gene expression of the U19 tumor suppressor gene compared between the 2 arms at the end of "off-treatment" cycle 1.
Outcome measures
| Measure |
A: Dutasteride During First Off-Cycle
n=4 Participants
Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle
Dutasteride: 0.5 mg capsule given orally on daily basis
|
B: Placebo During First Off-Cycle
n=3 Participants
Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle
Placebo: Identical placebo
|
|---|---|---|
|
Relative Expression of U19 Gene in Tumor From Prostate Gland During First Off-cycle.
|
0.24 Relative expression
Standard Deviation 0.5
|
0.28 Relative expression
Standard Deviation 0.45
|
SECONDARY outcome
Timeframe: At month 9 and ongoing monthly until end of off-cycle 1 defined by when the testosterone level reaches normal (approximately 6 months)Population: Only patients from each arm with biopsies at the end of off-cycle 1 are included.
Calculation of number of months when baseline PSA doubles compared between the 2 arms at the end of "off-treatment" cycle 1.
Outcome measures
| Measure |
A: Dutasteride During First Off-Cycle
n=4 Participants
Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle
Dutasteride: 0.5 mg capsule given orally on daily basis
|
B: Placebo During First Off-Cycle
n=3 Participants
Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle
Placebo: Identical placebo
|
|---|---|---|
|
Determination of Prostate-specific Antigen (PSA) Doubling Time During First Off-cycle
|
1.42 Months
Standard Deviation 0.8
|
1.56 Months
Standard Deviation 0.9
|
Adverse Events
A: Dutasteride During First Off-Cycle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B: Placebo During First Off-Cycle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A: Dutasteride During First Off-Cycle
n=7 participants at risk
Arm A patients received dutasteride (0.5 mg/day) during the first off-cycle and received placebo during the second off-cycle
Dutasteride: 0.5 mg capsule given orally on daily basis
|
B: Placebo During First Off-Cycle
n=6 participants at risk
Arm B patients received placebo during the first off-cycle and received dutasteride (0.5 mg/day) during the second off-cycle
Placebo: Identical placebo
|
|---|---|---|
|
Reproductive system and breast disorders
Decrease in libido
|
0.00%
0/7
|
0.00%
0/6
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place