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

NCT00169585 | Completed Phase 3

• 1 other identifier: LEV102341
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 19

Brief 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

Conditions

Prostatic Hyperplasia; Prostatitis

Keywords

diagnostic-therapeutic pathway; PSA; DRE; Levofloxacin

Outcome Measures

Primary Outcomes (1)

• 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.

  6/7 week after treatment

Secondary Outcomes (1)

• 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)

Interventions

Levofloxacin oral tablets DRUG

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (19)

GSK Investigational Site

Bari, Apulia, 70124, Italy

Location

GSK Investigational Site

Foggia, Apulia, 71100, Italy

Location

GSK Investigational Site

Matera, Basilicate, 75100, Italy

Location

GSK Investigational Site

Avellino, Campania, 83100, Italy

Location

GSK Investigational Site

Napoli, Campania, 80131, Italy

Location

GSK Investigational Site

Bologna, Emilia-Romagna, 40138, Italy

Location

GSK Investigational Site

Rome, Lazio, 00168, Italy

Location

GSK Investigational Site

Rome, Lazio, 00189, Italy

Location

GSK Investigational Site

Lecco, Lombardy, 23100, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20123, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20132, Italy

Location

GSK Investigational Site

Milan, Lombardy, 20142, Italy

Location

GSK Investigational Site

Lanzo Torinese (TO), Piedmont, 10074, Italy

Location

GSK Investigational Site

Orbassano (TO), Piedmont, 10043, Italy

Location

GSK Investigational Site

Turin, Piedmont, 10126, Italy

Location

GSK Investigational Site

Sassari, Sardinia, 07100, Italy

Location

GSK Investigational Site

Catania, Sicily, 95124, Italy

Location

GSK Investigational Site

Messina, Sicily, 98125, Italy

Location

GSK Investigational Site

Bagno A Ripoli (FI), Tuscany, 50126, Italy

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatitis

Interventions

Levofloxacin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ofloxacin; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: March 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

IT (19)