P urpose of the research is to establish which clinical and biopsy parameters could predict extra-capsular spread of prostate carcinoma for 2-10 ng/ml PSA values, in patients submitted to radical retropubic prostatectomy. Methodology: In the period of 30 months, 80 patients were treated with radical retro-pubic prostatectomy with bilateral pelvic lymphadenectomy, for whom clinical, biopsy, radiological and biochemical analysis were positive to organ limited tumor. Serum PSA, fpsa/tpsa, PSAD,values are evaluated, and other parameters as number of positive biopsies, percentage of positive biopsies, localization of positive biopsies, and perineural invasion and biopsy Gleason score. Results: from total number of 80 patients with 2-10 ng/ml PSA, 7 (9%) patients had extra-capsular spread of prostate carcinoma. Upon using multivariate regression analysis, following parameters were proved as significant predictors of extra-capsular spread: biopsy Gleason score, number of positive biopsy samples and invasion, while serum PSA, FPSA/TPSA ratio, PSAD, prostate age and volume have not shown as significant predictors for extra-capsular extension. Conclusion: Biopsy GS, perineural invasion and number of biopsy samples are statistically significant predictors of extra-capsular spread of prostate carcinoma for 2-10 ml PSA. Percentage of positive biopsies, tumor length in a sample and the localization of positive biopsies are on the borderline of statistical significance and as such should be taken into consideration.

This observational clinical study was composed of two substudies: a non-comparative one (n = 166), testing only lysozyme-based compounds (LBCs), and a comparative substudy (n = 275), testing both LBCs and bicarbonate-based local compounds (BBCs) on the healing of oral mucositis during radio- or chemotherapy. The density of ulcerations has decreased significantly after the treatment with lysozyme in both substudies. The density of ulcerations in the radiotherapy group was lower in patients treated with LBCs compared to patients treated with BBCs (p < 0.001). In the chemotherapy group, reduction of ulceration density was similar with both LBCs and BBCs. The LBCs reduced pain intensity during the intake of solid food and speech more than BBCs in both patient cohorts (p < 0.05). In the radiotherapy cohort, pain intensity when consuming liquid foods was reduced more with LBCs than with BBCs (p < 0.05). No adverse events were recorded. This study demonstrates the advantages of treating oral mucositis during radiotherapy or chemo-therapy with LBCs.

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