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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
240
GSK Investigational Site
Bari, Apulia, Italy
GSK Investigational Site
Foggia, Apulia, Italy
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
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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GSK Investigational Site
Matera, Basilicate, Italy
GSK Investigational Site
Avellino, Campania, Italy
GSK Investigational Site
Naples, Campania, Italy
GSK Investigational Site
Bologna, Emilia-Romagna, Italy
GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
Rome, Lazio, Italy
GSK Investigational Site
Lecco, Lombardy, Italy
GSK Investigational Site
Milan, Lombardy, Italy
...and 9 more locations