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Design, setting: From the clinical reality of a private consultation, a non-interventional, parallel, two-armed, non-randomized study was started in close cooperation with the Regional Clinical Cancer Register Dresden for the period 1996-2016, in order to objectively define the allocation algorithms for the primary therapy decision RPE vs. ERBT retrospectively in the curative setting for clinically, localized to locally advanced tumor. Furthermore, the implications of this decision on the result should be reviewed retrospectively in terms of multiple factors. For this purpose, univariate and multivariate models were sought based on clinically relevant predictors (variables), which from a large practice’s perspective could have a different prognostic significance for the two alternative therapy options. A total of 742 patients were included in the study chronologically after biopsy confirmation/staging. At the follow-up, the study participants were only subject to guideline-compliant [1,2], routine-based, diagnostic and course-based individual therapeutic regulations in accordance with GCP. The patients’ written consent to participate in the study, data storage and anonymized scientific processing was obtained immediately after the diagnosis before enrollment. Results: Variable for the allocation of therapy alternatives RPE (n 465) vs. EBRT (n 234) are age (p < 0.0001), PSA (p 0.43390), Gleason score total (p < 0.001), D’Amico index (p < 0.001), Charlson index (p < 0.001), biopsy score (p 0.4612) and the volume (p < 0.0001) here in a univariate comparison. The prediction precision at 89.6% is a good argument against a non-evidence decision. Overall survival (n 734 Patients, 20 years/all risks): RPE 56.8% and EBRT 19.2%. Relapses defined as per [2] in PSA/local/systemic situation in the RPE file 25.87%/ 4.48%/ 0.61%, and in the EBRT file 18.15%/ 4.03%/ 4.03%. In the competing risk analysis for cancer-specific death (CMR), on the other hand, between the two files (RPE 16.2%/EBRT 20.5%) post 20 years, there was no significant difference (p = 0.2122) in contrast to the comorbidity-specific risk analysis with a Pepe-Mori test of p < 0.0001 to the disadvantage of the RTx file (EBRT 60.4%/27.1% RPE). For the subgroup of high-risk tumors, a more effective local tumor control based on RPE can be found in comparison to EBRT, without being able to show a significant difference. Conclusions: It was possible to prove that the therapy decision between two guideline-covered, alternative therapy recommendations for the localized and locally advanced PCA can be made rationally based on defined variables and categories in a private consultation. Based on our results in the RPE arm at lower PSA, among younger patients, with a rather low D’Amico score, lower Charlson score, higher Gleason score and higher prostate volume. This means our outcome comparisons are permissible and ORiginAl ARtiCle

international archives of urology and complications

Radical Prostatectomy versus External Beam Radiotherapy - Indication and the Way to the Decision: A Cumulative Non-Interventional Unicentric Retrospective Trial of about 20 Years