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

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ClinicalTrials.gov Identifier: NCT00169585
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Prostatic Hyperplasia Prostatitis Drug: Levofloxacin oral tablets Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A National, Multicentric, Randomised, Controlled Trial. Applications of a Critical Pathway Using Levofloxacin for the Management of Patients With Abnormal PSA.
Study Start Date : March 2005
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  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. [ Time Frame: 6/7 week after treatment ]

Secondary Outcome Measures :
  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. [ Time Frame: 24 weeks (follow-up visit) ]


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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00169585


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00169585     History of Changes
Other Study ID Numbers: LEV102341
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by GlaxoSmithKline:
diagnostic-therapeutic pathway
PSA
DRE
Levofloxacin

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Prostatitis
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors