Trial Outcomes & Findings for Cyclooxygenase-2 (COX-2) Inhibitor Reduces Serum Prostatic Specific Antigen (PSA) Levels (NCT NCT01678313)
NCT ID: NCT01678313
Last Updated: 2014-07-15
Results Overview
Efficacy: Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value
COMPLETED
PHASE2
140 participants
Baseline and 3 months after initial treatment
2014-07-15
Participant Flow
140 Patients with lower urinary tract symptoms (LUTS)/benign prostatic hyperplasia (BPH) and PSA\>4 ng/dL underwent randomization 70 patients in study group 70 patients in control group
Participant milestones
| Measure |
Study Group
Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
|
Control Group
Doxazosin 4 mg every day (QD)
|
|---|---|---|
|
Completed the 3-month Therapy
STARTED
|
70
|
70
|
|
Completed the 3-month Therapy
COMPLETED
|
64
|
58
|
|
Completed the 3-month Therapy
NOT COMPLETED
|
6
|
12
|
|
PSA >4 ng/dL at 3 Months
STARTED
|
64
|
58
|
|
PSA >4 ng/dL at 3 Months
COMPLETED
|
56
|
49
|
|
PSA >4 ng/dL at 3 Months
NOT COMPLETED
|
8
|
9
|
|
Prostate Biopsy at 3 Months
STARTED
|
56
|
49
|
|
Prostate Biopsy at 3 Months
COMPLETED
|
45
|
37
|
|
Prostate Biopsy at 3 Months
NOT COMPLETED
|
11
|
12
|
Reasons for withdrawal
| Measure |
Study Group
Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
|
Control Group
Doxazosin 4 mg every day (QD)
|
|---|---|---|
|
Completed the 3-month Therapy
Lost to Follow-up
|
3
|
8
|
|
Completed the 3-month Therapy
Physician Decision
|
3
|
4
|
|
PSA >4 ng/dL at 3 Months
PSA≦4
|
8
|
9
|
|
Prostate Biopsy at 3 Months
Not received prostate biopsy
|
11
|
12
|
Baseline Characteristics
Cyclooxygenase-2 (COX-2) Inhibitor Reduces Serum Prostatic Specific Antigen (PSA) Levels
Baseline characteristics by cohort
| Measure |
Study Group
n=64 Participants
Doxazosin 4 mg daily plus celecoxib 200 mg daily, complete 3 month therapy N=64(91.4%)
|
Control Group
n=58 Participants
Doxazosin 4 mg alone everyday, complete 3 month therapy N=58(82.9%)
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.4 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
73.8 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
72.1 years
STANDARD_DEVIATION 8.75 • 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
|
64 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
64 participants
n=5 Participants
|
58 participants
n=7 Participants
|
122 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 months after initial treatmentEfficacy: Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value
Outcome measures
| Measure |
Study Group
n=45 Participants
Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
|
Control Group
n=37 Participants
Doxazosin 4 mg every day (QD)
|
|---|---|---|
|
Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level
Baseline
|
10.8 ng/mL
Standard Deviation 5.42
|
15.2 ng/mL
Standard Deviation 12.7
|
|
Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level
3 months
|
9.42 ng/mL
Standard Deviation 5.41
|
13.5 ng/mL
Standard Deviation 10.6
|
|
Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level
Change
|
-1.43 ng/mL
Standard Deviation 0.01
|
-1.70 ng/mL
Standard Deviation 2.15
|
SECONDARY outcome
Timeframe: Baseline and 3 months after initial treatmentEfficacy: Change from Baseline in the Void Volume (VV) from baseline and 3 months Change = Month 3 minus Baseline value
Outcome measures
| Measure |
Study Group
n=45 Participants
Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
|
Control Group
n=37 Participants
Doxazosin 4 mg every day (QD)
|
|---|---|---|
|
Change From Baseline in the Void Volume (VV)
Baseline
|
259 mL
Standard Deviation 113
|
175 mL
Standard Deviation 107
|
|
Change From Baseline in the Void Volume (VV)
3 months
|
227 mL
Standard Deviation 80.8
|
231 mL
Standard Deviation 134
|
|
Change From Baseline in the Void Volume (VV)
Change
|
-32.3 mL
Standard Deviation 32.1
|
55.7 mL
Standard Deviation 27.3
|
SECONDARY outcome
Timeframe: Baseline and 3 months after initial treatmentEfficacy: Change from Baseline in the maximum flow rate (Qmax) from baseline and 3 months Change = Month 3 minus Baseline value
Outcome measures
| Measure |
Study Group
n=45 Participants
Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
|
Control Group
n=37 Participants
Doxazosin 4 mg every day (QD)
|
|---|---|---|
|
Change From Baseline in the Maximum Flow Rate (Qmax)
Baseline
|
12.2 mL/s
Standard Deviation 4.67
|
10.0 mL/s
Standard Deviation 6.2
|
|
Change From Baseline in the Maximum Flow Rate (Qmax)
3 months
|
12.2 mL/s
Standard Deviation 4.19
|
11.9 mL/s
Standard Deviation 6.61
|
|
Change From Baseline in the Maximum Flow Rate (Qmax)
Change
|
-0.09 mL/s
Standard Deviation 0.49
|
1.9 mL/s
Standard Deviation 0.41
|
SECONDARY outcome
Timeframe: Baseline and 3 months after initial treatmentEfficacy: Change from Baseline in the IPSS Voiding from baseline and 3 months. The IPSS subscore (IPSS Voiding) questionnaires is a 4 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS Voiding score can therefore range from 0 to 20 (asymptomatic to very symptomatic). Change = Month 3 minus Baseline value
Outcome measures
| Measure |
Study Group
n=45 Participants
Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
|
Control Group
n=37 Participants
Doxazosin 4 mg every day (QD)
|
|---|---|---|
|
Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires
Baseline
|
7.55 units on a scale
Standard Deviation 6.84
|
5.54 units on a scale
Standard Deviation 5.12
|
|
Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires
3 months
|
3.84 units on a scale
Standard Deviation 4.57
|
3.45 units on a scale
Standard Deviation 4.22
|
|
Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires
Change
|
-3.71 units on a scale
Standard Deviation 2.27
|
-2.09 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline and 3 months after initial treatmentEfficacy: Change from Baseline in the IPSS Storage from baseline and 3 months The IPSS subscore (IPSS Storage) is a 3 symptom questions. The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The total IPSS Storage score can therefore range from 0 to 15 (asymptomatic to very symptomatic). Change = Month 3 minus Baseline value
Outcome measures
| Measure |
Study Group
n=45 Participants
Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
|
Control Group
n=37 Participants
Doxazosin 4 mg every day (QD)
|
|---|---|---|
|
Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires
Baseline
|
5.59 units on a scale
Standard Deviation 3.72
|
6.06 units on a scale
Standard Deviation 3.38
|
|
Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires
3 months
|
3.09 units on a scale
Standard Deviation 1.4
|
4.01 units on a scale
Standard Deviation 2.04
|
|
Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires
Change
|
-2.5 units on a scale
Standard Deviation 2.32
|
-2.05 units on a scale
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: Baseline and 3 months after initial treatmentEfficacy: Change from Baseline in the International Prostate Symptom Score (IPSS) from baseline and 3 months The International Prostate Symptom Score (IPSS) is an 7 symptom questions including 4 voiding questions (IPSS Voiding), 3 storage questions (IPSS Storage) The symptom score have 6-point scale ranging from 0 "Not at all" to 5 "Almost always". Total IPSS score = IPSS voiding + IPSS Storage Rang = 0 to 35 (asymptomatic to very symptomatic). Mild = 0 to 7; Moderate = 8 to 19; Severe = 20 to 35 Change = Month 3 minus Baseline value
Outcome measures
| Measure |
Study Group
n=45 Participants
Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
|
Control Group
n=37 Participants
Doxazosin 4 mg every day (QD)
|
|---|---|---|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires
Baseline
|
13.1 units on a scale
Standard Deviation 7.65
|
12.0 units on a scale
Standard Deviation 7.65
|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires
3 months
|
6.45 units on a scale
Standard Deviation 3.18
|
7.70 units on a scale
Standard Deviation 5.11
|
|
Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires
Change
|
-6.63 units on a scale
Standard Deviation 4.47
|
-4.31 units on a scale
Standard Deviation 2.54
|
Adverse Events
Study Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hann-Chorng Kuo
Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place