Last updated: 11/04/2018 08:54:01
Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA)
GSK study ID
LEV102341
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A national, multicentric, randomised, controlled trial. Applications of a critical pathway using Levofloxacin for the management of patients with abnormal PSA.
Trial description: 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
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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:
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)
Interventions:
Drug: Levofloxacin oral tablets
Enrollment:
240
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Prostatic Hyperplasia
Product
levofloxacin
Collaborators
Not applicable
Study date(s)
March 2005 to April 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Male
Age
45+ years
Accepts healthy volunteers
No
- Only subjects who meet all of the following criteria will be eligible to participate in this study:
- Male patients
- 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;
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Lanzo Torinese (TO), Piemonte, Italy, 10074
Status
Study Complete
Location
GSK Investigational Site
Orbassano (TO), Piemonte, Italy, 10043
Status
Study Complete
Location
GSK Investigational Site
Bagno a Ripoli (FI), Toscana, Italy, 50126
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2007-07-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website