NCT00169585已完成3 期
A National, Multicentric, Randomised, Controlled Trial. Applications of a Critical Pathway Using Levofloxacin for the Management of Patients With Abnormal PSA.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 20
- 主要终点
- To evaluate if the application of 3 weeks treatment of levofloxacin, compared with the execution of a prostatic biopsy, after biochemical monitoring of total PSA, could decrease significantly the level of serum concentration of total PSA in 6-7 weeks.
研究概览
简要总结
Multicentric, national, prospective, parallel group, controlled. The Subjects in every center will be randomized and assigned to the pharmacologic arm or the one with the biochemical monitoring
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Only subjects who meet all of the following criteria will be eligible to participate in this study:
- •Male patients
- •Age ≥ 45 years
- •Suspected presence of prostate inflammatory foci, defined according to the following criteria:
- •PSA ≥ 2.6 ng/mL and age ≥ 50 and < 60 years (or ≥ 45 years if the patient has known family predisposition to carcinoma of the prostate) or,
- •PSA ≥ 4.1 ng/mL and age ≥ 60 and < 75 years, and
- •normal digito-rectal examination (DRE) (see section 5.2), and normal urine test with dipstick and/or microscopy carried out within 5 days of the baseline visit
- •Patients willing and able to provide their written informed consent and to comply with study procedures.
- •Patients with LUTS/BPH on watchful waiting or already under treatment with alpha-blockers or 5-ARI (5-alpha reductase inhibitors) for at least 6 months will also be considered eligible to participate in the study.
排除标准
- •Patients who meet any of the following criteria will not be eligible to participate in this study:
- •Diagnosis of NIH class I-III prostatitis or clinical evidence of active acute urinary infection and/or known or suspected active bacterial infection at other sites;
- •Diagnosis of prostate carcinoma (or PIN or ASAPS) or prior radical prostatectomy or radiotherapy or other treatments for prostate cancer;
- •PSA > 20 ng/mL;
- •PSA values (including high values) stable over time;
- •Start of a pharmacological therapy with 5-ARI in subjects with LUTS/BPH;
- •Permanent catheter;
- •Prior treatment (within 4 weeks) with levofloxacin for genital-urinary infections;
- •Known or suspected allergy to levofloxacin, including the excipients contained in the pharmacological preparation and/or confirmed tendency to photosensitivity reactions after fluoroquinolone therapy;
- •Concomitant treatment with drugs not allowed in the study
- •Reluctance to undergo prostate biopsy and/or risk of non-compliance;
- •History or current evidence of alcohol or drug abuse in the last 12 months;
- •History of any conditions that, in the opinion of the investigator, may confound the study results or create additional risks for the patient.
- •Participation in any study of investigational or marketed drugs within 30 days before the baseline visit or during the study.
结局指标
主要结局
To evaluate if the application of 3 weeks treatment of levofloxacin, compared with the execution of a prostatic biopsy, after biochemical monitoring of total PSA, could decrease significantly the level of serum concentration of total PSA in 6-7 weeks.
时间窗: 6/7 week after treatment
次要结局
- Normalization of serum concentration of total PSA; Changes in the time of levels of total PSA concentrations; Impact on patients''Qol(Quality of Life); Costs associated to both choices.(24 weeks (follow-up visit))
研究者
研究点 (20)
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