Clinical trial NCT00169585: Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA)
Official title: A National, Multicentric, Randomised, Controlled Trial. Applications of a Critical Pathway Using Levofloxacin for the Management of Patients With Abnormal PSA.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Hyperplasia
Prostatitis
Keywords: diagnostic-therapeutic pathway
PSA
DRE
Levofloxacin
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 240
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 6/7 week after treatment
Secondary outcomes:
measure: 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.
timeFrame: 24 weeks (follow-up visit)
Other outcomes:
Locations:
city: Matera
country: Italy
facility: GSK Investigational Site
state: Basilicata
city: Avellino
country: Italy
facility: GSK Investigational Site
state: Campania
city: Napoli
country: Italy
facility: GSK Investigational Site
state: Campania
city: Bologna
country: Italy
facility: GSK Investigational Site
state: Emilia-Romagna
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Roma
country: Italy
facility: GSK Investigational Site
state: Lazio
city: Lecco
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Milano
country: Italy
facility: GSK Investigational Site
state: Lombardia
city: Lanzo Torinese (TO)
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Orbassano (TO)
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Torino
country: Italy
facility: GSK Investigational Site
state: Piemonte
city: Bari
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Foggia
country: Italy
facility: GSK Investigational Site
state: Puglia
city: Sassari
country: Italy
facility: GSK Investigational Site
state: Sardegna
city: Catania
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Messina
country: Italy
facility: GSK Investigational Site
state: Sicilia
city: Bagno a Ripoli (FI)
country: Italy
facility: GSK Investigational Site
state: Toscana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: