Randomized Controlled Trial of Anti-inflammatory Medications in Patients With Elevated Serum Prostate-specific Antigen
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Change of serum PSA compared with baseline
研究概览
简要总结
The purpose of this study is to assess the impact of ibuprofen in men with elevated serum PSA.
详细描述
Serum prostate-specific antigen (PSA) is widely used as a screening marker for prostate cancer. However, elevated serum PSA level could result from various conditions other than malignancy such as benign prostatic hyperplasia (BPH), urinary tract infection, or inflammation (prostatitis). Inflammation within the prostate is often sub-clinical, not readily visible on urinalysis, and can putatively and artificially elevate PSA. Non-steroidal anti-inflammatory drugs (NSAIDs) have shown benefits in reducing symptoms in patients with inflammatory conditions of the prostate. Ibuprofen (Advil, Motrin) is a widely available, cheap, and commonly used over the counter NSAID. NSAID's are routinely given to men with an elevated PSA for empiric treatment of inflammation; however, the impact of NSAIDs in men with elevated serum PSA is unknown.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients age between 18-80 years old with a screening PSA > 3 ng/ml being considered for additional diagnostic testing (e.g., MRI, biopsy)
- •Normal digital rectal examination.
- •No clinical symptoms concerning acute urinary tract infection (e.g. dysuria, malodorous urine, positive urine culture)
排除标准
- •Active urinary tract infections or bacteriuria
- •Known prostate cancer
- •Urethral catheter within the last 6 weeks
- •History of hypersensitivity or allergy to ibuprofen or NSAIDs.
- •Known severe chronic kidney disease: eGFR < 30 mL/min/1.73 m2
- •Known history of severe liver disease (elevated AST or ALT greater than 3 times upper limit of normal)
- •History of gastrointestinal bleeding or NSAIDs induced GI adverse events
- •Concomitant dual-antiplatelet use or anticoagulants
- •Concomitant anti-inflammatory or steroidal drugs
- •Known bleeding disorder(s)
- •Patients with a solitary kidney or history of a kidney transplant
- •Any other medical contraindication to NSAIDs
研究组 & 干预措施
Ibuprofen
Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days
干预措施: Ibuprofen 400 mg (Drug)
结局指标
主要结局
Change of serum PSA compared with baseline
时间窗: Baseline, 6 weeks
serum prostatic specific antigen
次要结局
- Change of International Prostate Symptom Score (IPSS) compared with baseline(Baseline, 6 weeks)