title: Phase II multi-institutional clinical trial on a new mixed beam RT scheme of IMRT on pelvis combined with a carbon ion boost for high-risk prostate cancer patients.
abstract: OBJECTIVE
  Definition of the optimal treatment schedule for high-risk prostate cancer is under debate. A combination of photon intensity modulated radiotherapy (IMRT) on pelvis with a carbon ion boost might be the optimal treatment scheme to escalate the dose on prostate and deliver curative dose with respect to normal tissue and quality of dose distributions. In fact, carbon ion beams offer the advantage to deliver hypofractionated radiotherapy (RT) using a significantly smaller number of fractions compared to conventional RT without increasing risks of late effects.
  
  
  METHODS
  This study is a prospective phase II clinical trial exploring safety and feasibility of a mixed beam scheme of carbon ion prostate boost followed by photon IMRT on pelvis. The study is designed to enroll 65 patients with localized high-risk prostate cancer at 3 different oncologic hospitals: Istituto Europeo di Oncologia, Fondazione IRCCS Istituto Nazionale dei Tumori, and Centro Nazionale di Adroterapia Oncologica. The primary endpoint is the evaluation of safety and feasibility with acute toxicity scored up to 1 month after the end of RT. Secondary endpoints are treatment early (3 months after the end of RT) and long-term tolerability, quality of life, and efficacy.
  
  
  RESULTS
  The study is not yet recruiting; in silico studies are ongoing and we expect to start recruitment by 2017.
  
  
  CONCLUSIONS
  The present clinical trial aims at improving the current treatment for high-risk prostate cancer, evaluating safety and feasibility of a new RT mixed-beam scheme including photons and carbon ions. Encouraging results are coming from carbon ion facilities worldwide on the treatment of different tumors including prostate cancers. Carbon ions combine physical properties allowing for high dose conformity and advantageous radiobiological characteristics. The proposed mixed beam treatment has the advantage to combine a photon high conformity standard of care IMRT phase with a hypofractionated carbon ion RT boost delivered in a short overall treatment time.
authors.affiliation: Department of Radiotherapy, European Institute of Oncology, Milan - Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Marvaso
authors.affiliation: Department of Radiotherapy, European Institute of Oncology, Milan - Italy.|Department of Oncology and Haemato-oncology, University of Milan, Milan - Italy.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Jereczek-Fossa
authors.affiliation: Clinical Division, National Center of Oncological Hadrontherapy, Pavia - Italy.
authors.forename: Barbara
authors.initials: B
authors.lastname: Vischioni
authors.affiliation: Department of Radiotherapy, European Institute of Oncology, Milan - Italy.
authors.forename: Delia
authors.initials: D
authors.lastname: Ciardo
authors.affiliation: Medical Physics, Fondazione IRCCS Istituto Nazionale Tumori, Milan - Italy.
authors.forename: Tommaso
authors.initials: T
authors.lastname: Giandini
authors.affiliation: Clinical Division, National Center of Oncological Hadrontherapy, Pavia - Italy.
authors.forename: Azusa
authors.initials: A
authors.lastname: Hasegawa
authors.affiliation: Department of Medical Physics, European Institute of Oncology, Milan - Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Cattani
authors.affiliation: Medical Physics, Fondazione IRCCS Istituto Nazionale Tumori, Milan - Italy.
authors.forename: Mauro
authors.initials: M
authors.lastname: Carrara
authors.affiliation: Medical Physics Division, National Center of Oncological Hadrontherapy, Pavia - Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Ciocca
authors.affiliation: Division of Radiation Oncology, IRCCS Istituto Nazionale Tumori, Milan - Italy.
authors.forename: Nice
authors.initials: N
authors.lastname: Bedini
authors.affiliation: Division of Radiation Oncology, IRCCS Istituto Nazionale Tumori, Milan - Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Villa
authors.affiliation: Division of Radiation Oncology, IRCCS Istituto Nazionale Tumori, Milan - Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Morlino
authors.affiliation: Medical Physics Division, National Center of Oncological Hadrontherapy, Pavia - Italy.
authors.forename: Stefania
authors.initials: S
authors.lastname: Russo
authors.affiliation: Department of Radiotherapy, European Institute of Oncology, Milan - Italy.
authors.forename: Dario
authors.initials: D
authors.lastname: Zerini
authors.affiliation: Department of Radiotherapy, European Institute of Oncology, Milan - Italy.
authors.forename: Sarah Pia
authors.initials: SP
authors.lastname: Colangione
authors.affiliation: Medical Physics, Fondazione IRCCS Istituto Nazionale Tumori, Milan - Italy.
authors.forename: Costanza Maria Vittoria
authors.initials: CMV
authors.lastname: Panaino
authors.affiliation: Department of Radiotherapy, European Institute of Oncology, Milan - Italy.
authors.forename: Cristiana
authors.initials: C
authors.lastname: Fodor
authors.affiliation: Department of Epidemiology and Biostatistics, European Institute of Oncology, Milan - Italy.
authors.forename: Luigi
authors.initials: L
authors.lastname: Santoro
authors.affiliation: Medical Physics, Fondazione IRCCS Istituto Nazionale Tumori, Milan - Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Pignoli
authors.affiliation: Clinical Division, National Center of Oncological Hadrontherapy, Pavia - Italy.
authors.forename: Francesca
authors.initials: F
authors.lastname: Valvo
authors.affiliation: Division of Radiation Oncology, IRCCS Istituto Nazionale Tumori, Milan - Italy.|Department of Oncology and Haemato-oncology, University of Milan, Milan - Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Valdagni
authors.affiliation: Department of Urology, European Institute of Oncology, Milan - Italy.
authors.forename: Ottavio
authors.initials: O
authors.lastname: De Cobelli
authors.affiliation: Scientific Direction, European Institute of Oncology, Milan - Italy.|Department of Oncology and Haemato-oncology, University of Milan, Milan - Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Orecchia
mesh_terms: D000328:Adult; D000368:Aged; D019583:Dose Fractionation, Radiation; D063193:Heavy Ion Radiotherapy / Q000009:adverse effects / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010388:Pelvis / Q000473:pathology / Q000528:radiation effects*; D017785:Photons / Q000627:therapeutic use; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011788:Quality of Life; D011829:Radiation Dosage; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods*; D016896:Treatment Outcome