Cyclooxygenase-2 (COX-2) Inhibitor Reduces Serum Prostatic Specific Antigen (PSA) Levels

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: Male

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Buddhist Tzu Chi General Hospital
• Treatments: Celecoxib; Doxazosin

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:

1. Aspartate aminotransferase (AST) > 3 x upper limit of normal range

2. Alanine aminotransferase (ALT) > 3 x upper limit of normal range

3. 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