A total of 312 patients with a PSA level of 2.5 to 10 ng/mL and no nodules on digital rectal examination were randomized into 4 groups: no treatment, only antibiotics, combined treatment of antibiotic and alpha-blockers and only alpha-blockers. Serum PSA levels were repeated after 4 weeks and all patients underwent end of protocol prostate biopsies.
CaP was reported in 56 of the patients (18.5%) and there was no significant difference among the treatment arms in terms of CaP incidence. CaP was diagnosed in 19.3% (40/207) of the patients who had a decrease in PSA levels and in 16.7% (16/96) of the patients with an increase in PSA levels (p>0.05). In 16 patients (5.3%), PSA level decreased below 2.5 ng/mL and only one of them had CaP on biopsy (6.3%). PSA levels remained above 2.5 ng/mL in 287 patients and 55 (19.2%) of them had CaP, which was found to be significantly higher in comparison to patients with post-treatment PSA levels below 2.5 ng/ml (p<0.05). Since a decrease in PSA levels below the level for biopsy was very infrequent in this trial, it would not support use of antibiotics or alpha-blockers, nor would it avoid biopsy in the great majority of the patients. In concluding, the presenters also noted that the risk of prostate cancer is very low in patients who achieve a PSA level below 2.5 ng/ml after such treatment.
Presented by Levent N. Türkeri, MD, et al. at the 26th Annual European Association of Urology (EAU) Congress - March 18 - 21, 2011 - Austria Centre Vienna, Vienna, Austria