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

May 24, 2017 updated by: GlaxoSmithKline

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Basilicata
      • Matera, Basilicata, Italy, 75100
        • GSK Investigational Site
    • Campania
      • Avellino, Campania, Italy, 83100
        • GSK Investigational Site
      • Napoli, Campania, Italy, 80131
        • GSK Investigational Site
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
        • GSK Investigational Site
    • Lazio
      • Roma, Lazio, Italy, 00168
        • GSK Investigational Site
      • Roma, Lazio, Italy, 00189
        • GSK Investigational Site
    • Lombardia
      • Lecco, Lombardia, Italy, 23100
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20132
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20142
        • GSK Investigational Site
      • Milano, Lombardia, Italy, 20123
        • GSK Investigational Site
    • Piemonte
      • Lanzo Torinese (TO), Piemonte, Italy, 10074
        • GSK Investigational Site
      • Orbassano (TO), Piemonte, Italy, 10043
        • GSK Investigational Site
      • Torino, Piemonte, Italy, 10126
        • GSK Investigational Site
    • Puglia
      • Bari, Puglia, Italy, 70124
        • GSK Investigational Site
      • Foggia, Puglia, Italy, 71100
        • GSK Investigational Site
    • Sardegna
      • Sassari, Sardegna, Italy, 07100
        • GSK Investigational Site
    • Sicilia
      • Catania, Sicilia, Italy, 95124
        • GSK Investigational Site
      • Messina, Sicilia, Italy, 98125
        • GSK Investigational Site
    • Toscana
      • Bagno a Ripoli (FI), Toscana, Italy, 50126
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 6/7 week after treatment
6/7 week after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 24 weeks (follow-up visit)
24 weeks (follow-up visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

April 1, 2007

Study Completion (ACTUAL)

April 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 15, 2005

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

May 24, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEV102341

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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