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

Condition(s) targeted: Prostatitis

Intervention: Levofloxacin oral tablets (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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

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

Study design: Other, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome: 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.

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Male.

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.

GSK Clinical Trials Call Center, Bagno a Ripoli 50011, Italy

GSK Clinical Trials Call Center, Roma 00168, Italy

GSK Clinical Trials Call Center, Napoli 80131, Italy

GSK Clinical Trials Call Center, Avellino 83100, Italy

GSK Clinical Trials Call Center, Matera 75100, Italy

GSK Clinical Trials Call Center, Bari 70124, Italy

GSK Clinical Trials Call Center, Udine 33100, Italy

GSK Clinical Trials Call Center, Milano 20123, Italy

GSK Clinical Trials Call Center, Lecco 23900, Italy

GSK Clinical Trials Call Center, Lanzo Torinese 10074, Italy

GSK Clinical Trials Call Center, Firenze 50139, Italy

GSK Clinical Trials Call Center, Foggia 71100, Italy

GSK Clinical Trials Call Center, Catania 95124, Italy

GSK Clinical Trials Call Center, Messina 98125, Italy

GSK Clinical Trials Call Center, Sassari 07100, Italy

GSK Clinical Trials Call Center, Torino 10126, Italy

GSK Clinical Trials Call Center, Milano 20122, Italy

GSK Clinical Trials Call Center, Milano 20142, Italy

GSK Clinical Trials Call Center, Milano 20132, Italy

GSK Clinical Trials Call Center, Orbassano 10043, Italy

GSK Clinical Trials Call Center, Bologna 40138, Italy

GSK Clinical Trials Call Center, BARI 70124, Italy

GSK Clinical Trials Call Center, ROMA 00189, Italy

Starting date: January 2005
Ending date: April 2007
Last updated: March 10, 2008