Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA)

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.