NCT01678313已完成2 期
COX-2 Inhibitor Reduces Serum PSA Levels Might Predict a Lower Risk of Prostatic Cancer in Men With LUTS/BPH With an Elevated PSA Level
Buddhist Tzu Chi General Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2012年8月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level
研究概览
简要总结
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:
- Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)
- Doxazosin 4mg every day (QD)
详细描述
Study Procedure
- Male patients aged 40 years or older, having LUTS for at least 3 months (IPSS ≥ 8), a serum PSA level ≥ 4 ng/mL, without a palpable prostatic nodule will be enrolled into this prospective randomized trial to investigate whether COX-2 inhibitor can decrease serum PSA level and acts as a biomarker to differentiate between chronic inflammation and prostate cancer.
- Eligible subjects will be randomly assigned to the study and control groups at 2:1 ratio. The study group will receive doxazosin 4mg every day (QD) plus celecoxib 200mg QD for 3 months and the control group will receive doxazosin 4 mg QD for 3 months. Patients will be investigated for IPSS, total prostatic volume, transition zone index, maximum flow rate, voided volume, postvoid residual, serum PSA, free PSA and serum C-reactive protein (CRP) levels at baseline and 3 months after treatment. If the serum PSA levels remained higher than 4 ng/mL, patients of either group will be advised to receive prostatic biopsy for histopathological investigation.
- The prostatic biopsy will be advised at the end of the study in both groups of patients. Ten prostatic biopsied strips will be sent to pathological department for investigating the existence of prostatic cancer. The other two strips will be stored in liquid nitrogen for further investigation of inflammatory biomarkers.
Data Analysis
- The efficacy evaluation will be performed on intention-to-treat populations (ITT) and per-protocol populations (PPP) datasets while the safety evaluation will be performed on ITT datasets. The primary conclusion will be made for the primary endpoint and secondary endpoint on the ITT population.
Efficacy Endpoint Analysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Study group
Experimental
Doxazosin 4 mg daily plus celecoxib 200 mg every day (QD)
干预措施: Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD) (Drug)
Control group
Experimental
Doxazosin 4 mg every day (QD)
干预措施: Doxazosin 4 mg every day (QD) (Drug)
结局指标
主要结局
Change From Baseline in the Serum Prostate Specific Antigen (PSA) Level
时间窗: Baseline and 3 months after initial treatment
Efficacy: Change from Baseline in the serum PSA level from baseline and 3 months Change = Month 3 minus Baseline value
次要结局
- Change From Baseline in the IPSS Subscore (IPSS Storage) Questionnaires(Baseline and 3 months after initial treatment)
- Change From Baseline in the IPSS Subscore (IPSS Voiding) Questionnaires(Baseline and 3 months after initial treatment)
- Change From Baseline in the Void Volume (VV)(Baseline and 3 months after initial treatment)
- Change From Baseline in the Maximum Flow Rate (Qmax)(Baseline and 3 months after initial treatment)
- Change From Baseline in the International Prostate Symptom Score (IPSS) Questionnaires(Baseline and 3 months after initial treatment)
研究者
Hann-Chorng Kuo
Department of Urology
Buddhist Tzu Chi General Hospital
研究点 (1)
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