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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Levofloxacin; Ofloxacin

Criteria

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.