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

Prostatic Hyperplasia Clinical Trial

Official title:

A National, Multicentric, Randomised, Controlled Trial. Applications of a Critical Pathway Using Levofloxacin for the Management of Patients With Abnormal PSA.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00169585
• Other study ID #: LEV102341
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: May 24, 2017
• Start date: March 2005
• Est. completion date: April 2007

Study information

• Verified date: May 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hyperplasia
• Prostatic Hyperplasia
• Prostatitis

Intervention

Drug:
• Levofloxacin oral tablets

Locations

Country	Name	City	State
Italy	GSK Investigational Site	Avellino	Campania
Italy	GSK Investigational Site	Bagno a Ripoli (FI)	Toscana
Italy	GSK Investigational Site	Bari	Puglia
Italy	GSK Investigational Site	Bologna	Emilia-Romagna
Italy	GSK Investigational Site	Catania	Sicilia
Italy	GSK Investigational Site	Foggia	Puglia
Italy	GSK Investigational Site	Lanzo Torinese (TO)	Piemonte
Italy	GSK Investigational Site	Lecco	Lombardia
Italy	GSK Investigational Site	Matera	Basilicata
Italy	GSK Investigational Site	Messina	Sicilia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Milano	Lombardia
Italy	GSK Investigational Site	Napoli	Campania
Italy	GSK Investigational Site	Orbassano (TO)	Piemonte
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Roma	Lazio
Italy	GSK Investigational Site	Sassari	Sardegna
Italy	GSK Investigational Site	Torino	Piemonte

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)