title: Rectal and urinary dysfunction in the TROG 03.04 RADAR trial for locally advanced prostate cancer.
abstract: BACKGROUND
  The RADAR trial determines whether adjuvant androgen suppression, bisphosphonates and radiation dose escalation for localised prostate cancer (PC) may improve oncologic outcomes. This study examines whether these measures increase rectal and urinary dysfunction and are secondary trial endpoints.
  
  
  METHODS
  Using a 2×2 factorial trial design men with locally advanced PC were randomly allocated 6 months i.m. leuprorelin prior to radiotherapy either alone or followed by 12 months i.m. leuprorelin. These two groups received 18 months i.v. zoledronic acid (Z) commencing at randomisation or no further treatment. Radiotherapy dose was escalated in a regulated way using external beam techniques (EBRT) or by a high dose rate brachytherapy (HDRB) boost. Prevalence rates of rectal and urinary dysfunctional symptoms were compared at baseline, the end of RT, 18 and 36 months according to treatment arm, dose and technique using multiple regression models.
  
  
  RESULTS
  Between 2003 and 2007, 1071 men were randomly allocated and eligible for inclusion in this study. No persistent differences in rectal or urinary dysfunction were attributable to treatment arm or to increasing EBRT dose. However following HDRB statistical increases (p<0.001) in urinary dysfunction were measured using the EORTC PR25 instrument at 18 and 36 months.
  
  
  CONCLUSIONS
  Adjuvant androgen suppression, bisphosphonates and increasing EBRT dose did not increase rectal or urinary dysfunction in this trial. However dose escalation using HDRB increased urinary dysfunction.
authors.affiliation: University of Newcastle, Australia. Jim.Denham@newcastle.edu.au
authors.forename: James W
authors.initials: JW
authors.lastname: Denham
authors.forename: Chantelle
authors.initials: C
authors.lastname: Wilcox
authors.forename: David S
authors.initials: DS
authors.lastname: Lamb
authors.forename: Nigel A
authors.initials: NA
authors.lastname: Spry
authors.forename: Gillian
authors.initials: G
authors.lastname: Duchesne
authors.forename: Chris
authors.initials: C
authors.lastname: Atkinson
authors.forename: John
authors.initials: J
authors.lastname: Matthews
authors.forename: Sandra
authors.initials: S
authors.lastname: Turner
authors.forename: Lizbeth
authors.initials: L
authors.lastname: Kenny
authors.forename: Keen-Hun
authors.initials: KH
authors.lastname: Tai
authors.forename: Nirdosh Kumar
authors.initials: NK
authors.lastname: Gogna
authors.forename: Martin
authors.initials: M
authors.lastname: Ebert
authors.forename: Brett
authors.initials: B
authors.lastname: Delahunt
authors.forename: Patrick
authors.initials: P
authors.lastname: McElduff
authors.forename: David
authors.initials: D
authors.lastname: Joseph
mesh_terms: D001918:Brachytherapy / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000473:pathology / Q000532:radiotherapy*; D011879:Radiotherapy Dosage; D012007:Rectum / Q000503:physiopathology / Q000528:radiation effects*; D047368:Tumor Burden; D014555:Urination Disorders / Q000209:etiology*
chemical_list: D017430:Prostate-Specific Antigen