title: Five-year outcomes from 3 prospective trials of image-guided proton therapy for prostate cancer.
abstract: OBJECTIVE
  To report 5-year clinical outcomes of 3 prospective trials of image-guided proton therapy for prostate cancer.
  
  
  METHODS
  A total of 211 prostate cancer patients (89 low-risk, 82 intermediate-risk, and 40 high-risk) were treated in institutional review board-approved trials of 78 cobalt gray equivalent (CGE) in 39 fractions for low-risk disease, 78 to 82 CGE for intermediate-risk disease, and 78 CGE with concomitant docetaxel therapy followed by androgen deprivation therapy for high-risk disease. Toxicities were graded according to Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Median follow-up was 5.2 years.
  
  
  RESULTS
  Five-year rates of biochemical and clinical freedom from disease progression were 99%, 99%, and 76% in low-, intermediate-, and high-risk patients, respectively. Actuarial 5-year rates of late CTCAE, version 3.0 (or version 4.0) grade 3 gastrointestinal and urologic toxicity were 1.0% (0.5%) and 5.4% (1.0%), respectively. Median pretreatment scores and International Prostate Symptom Scores at >4 years posttreatment were 8 and 7, 6 and 6, and 9 and 8, respectively, among the low-, intermediate-, and high-risk patients. There were no significant changes between median pretreatment summary scores and Expanded Prostate Cancer Index Composite scores at >4 years for bowel, urinary irritative and/or obstructive, and urinary continence.
  
  
  CONCLUSIONS
  Five-year clinical outcomes with image-guided proton therapy included extremely high efficacy, minimal physician-assessed toxicity, and excellent patient-reported outcomes. Further follow-up and a larger patient experience are necessary to confirm these favorable outcomes.
authors: University of Florida Proton Therapy Institute, Jacksonville, Florida. Electronic address: menden@shands.ufl.edu.
authors: Nancy P
authors: NP
authors: Mendenhall
authors: University of Florida Proton Therapy Institute, Jacksonville, Florida.
authors: Bradford S
authors: BS
authors: Hoppe
authors: University of Florida Proton Therapy Institute, Jacksonville, Florida.
authors: Romaine C
authors: RC
authors: Nichols
authors: University of Florida Proton Therapy Institute, Jacksonville, Florida.
authors: William M
authors: WM
authors: Mendenhall
authors: University of Florida Proton Therapy Institute, Jacksonville, Florida.
authors: Christopher G
authors: CG
authors: Morris
authors: University of Florida Proton Therapy Institute, Jacksonville, Florida.
authors: Zuofeng
authors: Z
authors: Li
authors: University of Florida Proton Therapy Institute, Jacksonville, Florida.
authors: Zhong
authors: Z
authors: Su
authors: Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida.
authors: Christopher R
authors: CR
authors: Williams
authors: Division of Urology, College of Medicine, University of Florida, Jacksonville, Florida.
authors: Joseph
authors: J
authors: Costa
authors: University of Florida Proton Therapy Institute, Jacksonville, Florida.
authors: Randal H
authors: RH
authors: Henderson
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D018450:Disease Progression; D019583:Dose Fractionation, Radiation; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy / Q000401:mortality / Q000532:radiotherapy*; D061766:Proton Therapy / Q000009:adverse effects / Q000379:methods*; D011880:Radiotherapy Planning, Computer-Assisted; D061089:Radiotherapy, Image-Guided / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D017430:Prostate-Specific Antigen