title: Intensified adjuvant treatment of prostate carcinoma: feasibility analysis of a phase I/II trial.
abstract: OBJECTIVE
  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.
  
  
  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.
authors.affiliation: Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Mantini
authors.affiliation: Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Fersino
authors.affiliation: Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Anna Rita
authors.identifier: 0000-0001-6718-4404
authors.initials: AR
authors.lastname: Alitto
authors.affiliation: Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Frascino
authors.affiliation: Unità Operativa di Radioterapia, Fondazione di Ricerca e Cura "Giovanni Paolo II", Università Cattolica del Sacro Cuore, Crt. Tappino 35, 86100 Campobasso, Italy.
authors.forename: Mariangela
authors.initials: M
authors.lastname: Massaccesi
authors.affiliation: Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Fionda
authors.affiliation: Dipartimento di Diagnostica per Immagini e Radioterapia, Policlinico Federico II, Via Pansini 5, 80131 Napoli, Italy.
authors.forename: Vincenzo
authors.identifier: 0000-0002-0249-5997
authors.initials: V
authors.lastname: Iorio
authors.affiliation: Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Luzi
authors.affiliation: Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Balducci
authors.affiliation: Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Gian Carlo
authors.identifier: 0000-0001-6500-0413
authors.initials: GC
authors.lastname: Mattiucci
authors.affiliation: Istituto di Igiene e Medicina Preventiva, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Francesco
authors.identifier: 0000-0003-3655-0904
authors.initials: F
authors.lastname: Di Nardo
authors.affiliation: Istituto di Igiene e Medicina Preventiva, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: De Belvis
authors.affiliation: Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy ; Unità Operativa di Radioterapia, Fondazione di Ricerca e Cura "Giovanni Paolo II", Università Cattolica del Sacro Cuore, Crt. Tappino 35, 86100 Campobasso, Italy.
authors.forename: Alessio Giuseppe
authors.initials: AG
authors.lastname: Morganti
authors.affiliation: Unità Operativa di Radioterapia, Dipartimento di Bio-Immagini e Scienze Radiologiche, Università Cattolica del Sacro Cuore, Policlinico Gemelli, Largo A. Gemelli 8, 00168 Roma, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
mesh_terms: D000328:Adult; D000368:Aged; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D017024:Chemotherapy, Adjuvant; D019583:Dose Fractionation, Radiation; D006801:Humans; D008297:Male; D008875:Middle Aged; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D011879:Radiotherapy Dosage; D016032:Randomized Controlled Trials as Topic
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