A prospective observational cohort study on patients with PSA levels ranging from 4 to 10 ng/ml at opportunistic screening: Management and responses to ciprofloxacin 1000 mg

Objective: To analyze in the real life clinical setting the effect of fluorchinolones treatment in the management of elevated (4-10 ng/ml) prostate-specific antigen level we conducted an observational prospective cohort study. Material and methods: Eligible for the study were subjects aged 45-75 years with a PSA level 4-10 ng/ml, consecutively observed during their routine practice by first level outpatients urologic centres. Results: A total of 740 patients, mean value of total PSA at study entry: 5.8 (SD = 1.6) entered the study. A total of 616 subjects were treated with ciprofloxacin. The mean serum t-PSA value decreased between study entry and final visit of 1.31 ng/ml (SD 4.19) (p <0.05). At follow up visit the 49.4% (95% CI 44.1-55.5) of patients had PSA level <4 ng/ml. In comparison with patients with t-PSA <= 5.0 ng/ml, the OR of having normal t-PSA value at follow up were respectively 0.61 (95% CI 0.4-0.9) and 0.23 (0.1-0.3) for patients with t-PSA 5.1-6.2 and ≥ 6.3. Conclusion: The results of this large observational prospective study showed that a 2-3 week course of treatment with ciprofloxacin 1000 mg is able to significantly reduce the PSA level in about 50% of men aged 45-75 years with t-PSA levels of 4-10 ng/ml.