title: Macroscopic Hematuria After Conventional or Hypofractionated Radiation Therapy: Results From a Prospective Phase 3 Study.
abstract: To assess the macroscopic hematuria rates within a single-institution randomized phase 3 trial comparing dose-escalated, conventionally fractionated radiation therapy (CFRT) and moderately hypofractionated radiation therapy (MHRT) for localized prostate cancer.
  
  
  
  Patients with intermediate- to high-risk localized prostate cancer were treated with conformal RT and short-course androgen deprivation. Both the prostate and the entire seminal vesicles were treated to 80 Gy in 40 fractions over 8 weeks (CFRT) or 62 Gy in 20 fractions over 5 weeks (MHRT). The endpoint of the present study was the development of any episode or grade of macroscopic hematuria. The median follow-up period was 93 months (range 6-143).
  
  
  
  Macroscopic hematuria was reported by 25 of 168 patients (14.9%). The actuarial estimate of hematuria at 8 years was 17.0% (95% confidence interval [CI] 10.7%-23.3%). The number of patients with hematuria was 6 and 19 in the CFRT and MHRT arms, respectively, for an actuarial 8-year estimate of 9.7% and 24.3%, respectively (hazard ratio 3.468, 95% CI 1.385-8.684; P=.008). Overall, 8 of 25 patients were found to have biopsy-proven urothelial carcinoma (3 in the CFRT arm and 5 in the MHRT arm; P=.27). Thus, the 8-year actuarial incidence of macroscopic hematuria (after censoring urothelial cancer-related episodes) was 4.1% and 18.2% after CFRT and MHRT, respectively (hazard ratio 4.961, 95% CI 1.426-17.263; P=.012). The results were confirmed by multivariate analysis after accounting for several patient-, treatment-, and tumor-related covariates.
  
  
  
  MHRT was associated with a statistically significant increased risk of macroscopic hematuria compared with CFRT.
authors.affiliation: Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy. Electronic address: sanguineti@ifo.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Sanguineti
authors.affiliation: Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Arcidiacono
authors.affiliation: Department of Physics, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Landoni
authors.affiliation: Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Bianca Maria
authors.initials: BM
authors.lastname: Saracino
authors.affiliation: Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Alessia
authors.initials: A
authors.lastname: Farneti
authors.affiliation: Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Arcangeli
authors.affiliation: Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Petrongari
authors.affiliation: Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Sara
authors.initials: S
authors.lastname: Gomellini
authors.affiliation: Department of Physics, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Lidia
authors.initials: L
authors.lastname: Strigari
authors.affiliation: Department of Radiation Oncology, Regina Elena National Cancer Institute, Rome, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Arcangeli
mesh_terms: D015984:Causality; D015897:Comorbidity; D018572:Disease-Free Survival; D004307:Dose-Response Relationship, Radiation; D005260:Female; D005500:Follow-Up Studies; D006417:Hematuria / Q000175:diagnosis / Q000401:mortality*; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008137:Longitudinal Studies; D008297:Male; D015995:Prevalence; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000401:mortality* / Q000532:radiotherapy*; D000069473:Radiation Dose Hypofractionation; D011832:Radiation Injuries / Q000175:diagnosis / Q000401:mortality*; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000401:mortality*