title: Phase I-II study of intraoperative radiation therapy (IORT) after radical prostatectomy for prostate cancer.
abstract: OBJECTIVE
  Recent studies have suggested an alpha/beta ratio in prostate cancer of 1.5-3 Gy, which is lower than that assumed for late-responsive normal tissues. Therefore the administration of a single, intraoperative dose of irradiation should represent a convenient irradiation modality in prostate cancer.
  
  
  METHODS
  Between February 2002 and June 2004, 34 patients with localized prostate cancer with only one risk factor (Gleason score > or =7, Clinical Stage [cT] > or =2c, or prostate-specific antigen [PSA] of 11-20 ng/mL) and without clinical evidence of lymph node metastases were treated with radical prostatectomy (RP) and intraoperative radiotherapy on the tumor bed. A dose-finding procedure based on the Fibonacci method was employed. Dose levels of 16, 18, and 20 Gy were selected, which are biologically equivalent to total doses of about 60-80 Gy administered with conventional fractionation, using an alpha/beta ratio value of 3.
  
  
  RESULTS
  At a median follow-up of 41 months, 24 (71%) patients were alive with an undetectable PSA value. No patients died from disease, whereas 2 patients died from other malignancies. Locoregional failures were detected in 3 (9%) patients, 2 in the prostate bed and 1 in the common iliac node chain outside the radiation field. A PSA rise without local or distant disease was observed in 7 (21%) cases. The overall 3-year biochemical progression-free survival rate was 77.3%.
  
  
  CONCLUSIONS
  Our dose-finding study demonstrated the feasibility of intraoperative radiotherapy in prostate cancer also at the highest administered dose.
authors.affiliation: Department of Radiotherapy, Regina Elena Cancer Institute, Rome, Italy. saracino@ifo.it
authors.forename: Biancamaria
authors.initials: B
authors.lastname: Saracino
authors.forename: Michele
authors.initials: M
authors.lastname: Gallucci
authors.forename: Piero
authors.initials: P
authors.lastname: De Carli
authors.forename: Antonella
authors.initials: A
authors.lastname: Soriani
authors.forename: Rocco
authors.initials: R
authors.lastname: Papalia
authors.forename: Simona
authors.initials: S
authors.lastname: Marzi
authors.forename: Valeria
authors.initials: V
authors.lastname: Landoni
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Petrongari
authors.forename: Stefano
authors.initials: S
authors.lastname: Arcangeli
authors.forename: Ester
authors.initials: E
authors.lastname: Forastiere
authors.forename: Steno
authors.initials: S
authors.lastname: Sentinelli
authors.forename: Giorgio
authors.initials: G
authors.lastname: Arcangeli
mesh_terms: D000368:Aged; D005240:Feasibility Studies; D006801:Humans; D007430:Intraoperative Care; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000517:prevention & control*; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000532:radiotherapy* / Q000601:surgery*; D020266:Radiotherapy, Conformal; D016896:Treatment Outcome