title: Hypofractionated Dose Escalated 3D Conformal Radiotherapy for Prostate Cancer: Outcomes from a Mono-Institutional Phase II Study.
abstract: OBJECTIVE
  Based on a radiobiological assumption of a low alpha/beta (α/β) ratio for prostate cancer, hypofractionated radiotherapy has increasingly gained traction in the clinical practice and recent guidelines have confirmed the non-inferiority of this approach. Nevertheless, the largest studies that have used hypofractionation so far, employed image-guided radiation therapy/intensity modulated radiation therapy (IGRT/IMRT) facilities that might have overcome the radiobiological advantages, which remain to be fully confirmed. The aim of this trial was to evaluate the feasibility of a hypofractionated schedule delivered with 3D-Conformal Radiotherapy to prostate and seminal vesicles in combination with hormonal therapy.
  
  
  METHODS
  The study included 97 consecutive patients with localized prostate cancer (PCa), irrespective of risk class, treated with a schedule of 62 Gy in 20 fractions over 5 weeks (4 fractions of 3.1 Gy each per week). According to National Comprehensive Cancer Network (NCCN) prognostic classification, patients were divided into a favourable group (19%), intermediate group (41%) and unfavourable group (40%). Early and late toxicities were scored using the radiation toxicity grading/European Organisation for Research and Treatment of Cancer (RTOG/EORTC) criteria. Additionally, the international prostate symptom index (IPSS) for benign prostate hypertrophy was used to evaluate obstructive urinary symptoms. Biochemical outcome was reported according to the Phoenix definition for biochemical failure. Hormonal therapy (HT) was administrated in 92% of patients.
  
  
  RESULTS
  After a median follow-up of 39 months (range=25-52), maximum ≥G2 late genitourinary (GU) and gastrointestinal (GI) toxicities occurred in 8% and 11% patients, respectively. The corresponding figures for acute toxicities were 24% and 15%. Patients with higher IPSS score before enrolment had significantly worse urinary function after treatment. Only 2% of patients died from PCa. Biochemical non-evidence of disease (bNED) was 83% for all patients.
  
  
  CONCLUSIONS
  Our study confirms that 3D conformal radiotherapy (3DCRT) remains a safe and effective method to deliver a dose-escalated hypofractionated regimen for PCa patients in all risk classes with acceptable toxicity rates and optimal biochemical control.
authors.affiliation: S.C.Radioterapia, ASLBR Ospedale "A. Perrino" Brindisi, Brindisi, Italy francescotramacere@libero.it francesco.tramacere@asl.brindisi.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Tramacere
authors.affiliation: U.O.C Radioterapia Oncologica Az. Ospedaliera S. Camillo-Forlanini, Roma, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Arcangeli
authors.affiliation: S.C.Radioterapia, ASLBR Ospedale "A. Perrino" Brindisi, Brindisi, Italy.
authors.forename: Antonietta
authors.initials: A
authors.lastname: Pignatelli
authors.affiliation: S.C.Radioterapia, ASLBR Ospedale "A. Perrino" Brindisi, Brindisi, Italy.
authors.forename: Roberta
authors.initials: R
authors.lastname: Castagna
authors.affiliation: S.C.Radioterapia, ASLBR Ospedale "A. Perrino" Brindisi, Brindisi, Italy Associate Researcher National Council of Research, Institute of Clinical Physiology, Pisa, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Portaluri
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D019583:Dose Fractionation, Radiation; D006801:Humans; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011467:Prostate / Q000473:pathology / Q000528:radiation effects; D011471:Prostatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D011832:Radiation Injuries; D020266:Radiotherapy, Conformal / Q000009:adverse effects / Q000379:methods*; D061089:Radiotherapy, Image-Guided / Q000009:adverse effects / Q000379:methods*; D050397:Radiotherapy, Intensity-Modulated / Q000009:adverse effects / Q000379:methods*
keywords: 3D conformal radiotherapy; hypofractionated; prostate cancer; toxicity