Phase 2
Completed N=140
Cyclooxygenase-2 (COX-2) Inhibitor Reduces Serum Prostatic Specific Antigen (PSA) Levels
Source: ClinicalTrials.gov NCT01678313 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level — 10.8; 15.2; 9.42; 13.5 ng/mL
Summary
To investigate the therapeutic effect and safety of celecoxib adding on doxazosin and the potential predictive value of the absence of prostate cancer in the treatment of patients with LUTS/BPH and an elevated serum PSA level.
Patients who meet all eligible requirements for entry into the study will be randomized into one of the two treatment groups for 3 months in 2:1 ratio as shown below:
1. Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)
2. Doxazosin 4mg every day (QD)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level |
10.8; 15.2; 9.42; 13.5; -1.43; -1.70 | — |
| SECONDARY Change From Baseline in the Void Volume (VV) |
259; 175; 227; 231; -32.3; 55.7 | — |
| SECONDARY Change From Baseline in the Maximum Flow Rate (Qmax) |
12.2; 10.0; 12.2; 11.9; -0.09; 1.9 | — |
| SECONDARY Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires |
7.55; 5.54; 3.84; 3.45; -3.71; -2.09 | — |
| SECONDARY Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires |
5.59; 6.06; 3.09; 4.01; -2.5; -2.05 | — |
| SECONDARY Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires |
13.1; 12.0; 6.45; 7.70; -6.63; -4.31 | — |
Eligibility Criteria
Inclusion Criteria
- Male adults aged ≥ 40 years with LUTS/BPH, IPSS ≥ 8
- Free of active urinary tract infection
- Free of neurogenic voiding dysfunction
- No history of previous prostate biopsy within 6 months
- No treatment of BPH by alpha-blocker or 5-alpha-reductase inhibitor within 6 months
- Patient or his legally acceptable representative has signed the written informed consent form
Exclusion Criteria
- Patients with severe cardiopulmonary disease and such as congestive heart failure, arrhythmia, poorly controlled hypertension, not able to receive regular follow-up
- Patients with acute r chronic urinary retention and urodynamically proven detrusor underactivity
- Patients with postvoid residual > 250 mL
- Patients have laboratory abnormalities at screening including:
- Aspartate aminotransferase (AST) > 3 x upper limit of normal range
- Alanine aminotransferase (ALT) > 3 x upper limit of normal range
- Patients have abnormal serum creatinine level > 2 x upper limit of normal range
- Patients with any other serious disease or condition considered by the investigator not suitable for entry into the trial
- Patients participated investigational drug trial within 1 month before entering this study
Data sourced from ClinicalTrials.gov (NCT01678313). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.