Official Title: “A National, Multicentric, Randomised, Controlled Trial. Applications of a Critical Pathway Using Levofloxacin for the Management of Patients With Abnormal PSA.”

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

Study Type: Interventional

Study Design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2007

Intervention(s) in this Clinical Trial

• Drug: Levofloxacin oral tablets

Primary Measures

• 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.

Secondary Measures

• 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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00169585

Study ID Number: LEV102341

ClinicalTrials.gov Identifier: NCT00169585

Health Authority: Italy: Ministry of Health