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BioMed Research International
Volume 2014, Article ID 480725, 8 pages
Clinical Study

Intensified Adjuvant Treatment of Prostate Carcinoma: Feasibility Analysis of a Phase I/II Trial

1Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy
2Unità Operativa di Radioterapia, Fondazione di Ricerca e Cura “Giovanni Paolo II”, Università Cattolica del Sacro Cuore, Crt. Tappino 35, 86100 Campobasso, Italy
3Dipartimento di Diagnostica per Immagini e Radioterapia, Policlinico Federico II, Via Pansini 5, 80131 Napoli, Italy
4Istituto di Igiene e Medicina Preventiva, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy

Received 9 April 2014; Accepted 31 May 2014; Published 30 June 2014

Academic Editor: Giovanni Luca Gravina

Copyright © 2014 Giovanna Mantini et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Purpose. To perform a preliminary feasibility acute and late toxicity evaluation of an intensified and modulated adjuvant treatment in prostate cancer (PCa) patients after radical prostatectomy. Material and Methods. A phase I/II has been designed. Eligible patients were 79 years old or younger, with an ECOG of 0–2, previously untreated, histologically proven prostate adenocarcinoma with no distant metastases, pT2–4 N0-1, and with at least one of the following risk factors: capsular perforation, positive surgical margins, and seminal vesicle invasion. All patients received a minimum dose on tumor bed of 64.8 Gy, or higher dose (70.2 Gy; 85.4%), according to the pathological stage, pelvic lymph nodes irradiation (57.7%), and/or hormonal therapy (69.1%). Results. 123 patients were enrolled and completed the planned treatment, with good tolerance. Median follow-up was 50.6 months. Grade 3 acute toxicity was only 2.4% and 3.3% for genitourinary (GU) and gastrointestinal (GI) tract, respectively. No patient had late grade 3 GI toxicity, and the GU grade 3 toxicity incidence was 5.8% at 5 years. 5-year BDSF was 90.2%. Conclusions. A modulated and intensified adjuvant treatment in PCa was feasible in this trial. A further period of observation can provide a complete assessment of late toxicity and confirm the BDSF positive results.