title: High-dose-rate brachytherapy as a monotherapy for favorable-risk prostate cancer: a Phase II trial.
abstract: OBJECTIVE
  There are multiple treatment options for favorable-risk prostate cancer. High-dose-rate (HDR) brachytherapy as a monotherapy is appealing, but its use is still investigational. A Phase II trial was undertaken to explore the value of such treatment in low-to-intermediate risk prostate cancer.
  
  
  METHODS
  This was a single-institution, prospective study. Eligible patients had low-risk prostate cancer features but also Gleason scores of 7 (51% of patients) and stage T2b to T2c cancer. Treatment with HDR brachytherapy with a single implant was administered over 2 days. One of four fractionation schedules was used in a dose escalation study design: 3 fractions of 10, 10.5, 11, or 11.5 Gy. Patients were assessed with the Common Terminology Criteria for Adverse Events version 2.0 for urinary toxicity, the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring schema for rectal toxicity, and the Expanded Prostate Cancer Index Composite (EPIC) questionnaire to measure patient-reported health-related quality of life. Biochemical failure was defined as a prostate-specific antigen (PSA) nadir plus 2 ng/ml.
  
  
  RESULTS
  Between 2003 and 2008, 79 patients were enrolled. With a median follow-up of 39.5 months, biochemical relapse occurred in 7 patients. Three- and 5-year actuarial biochemical control rates were 88.4% (95% confidence interval [CI], 78.0-96.2%) and 85.1% (95% CI, 72.5-94.5%), respectively. Acute grade 3 urinary toxicity was seen in only 1 patient. There was no instance of acute grade 3 rectal toxicity. Rates of late grade 3 rectal toxicity, dysuria, hematuria, urinary retention, and urinary incontinence were 0%, 10.3%, 1.3%, 9.0%, and 0%, respectively. No grade 4 or greater toxicity was recorded. Among the four (urinary, bowel, sexual, and hormonal) domains assessed with the EPIC questionnaire, only the sexual domain did not recover with time.
  
  
  CONCLUSIONS
  HDR brachytherapy as a monotherapy for favorable-risk prostate cancer, administered using a single implant over 2 days, is feasible and has acceptable acute and late toxicities. Further follow-up is still required to better evaluate the efficacy of such treatment.
authors.affiliation: Division of Radiation Oncology, Peter MacCallum Cancer Centre, East Melbourne, Australia.
authors.forename: Maroie
authors.initials: M
authors.lastname: Barkati
authors.forename: Scott G
authors.initials: SG
authors.lastname: Williams
authors.forename: Farshad
authors.initials: F
authors.lastname: Foroudi
authors.forename: Keen Hun
authors.initials: KH
authors.lastname: Tai
authors.forename: Sarat
authors.initials: S
authors.lastname: Chander
authors.forename: Sylvia
authors.initials: S
authors.lastname: van Dyk
authors.forename: Andrew
authors.initials: A
authors.lastname: See
authors.forename: Gillian M
authors.initials: GM
authors.lastname: Duchesne
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000473:pathology / Q000523:psychology / Q000532:radiotherapy*; D000368:Aged; D001918:Brachytherapy / Q000009:adverse effects / Q000379:methods*; D007172:Erectile Dysfunction / Q000209:etiology; D005240:Feasibility Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000097:blood; D009367:Neoplasm Staging; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology / Q000523:psychology / Q000532:radiotherapy*; D011788:Quality of Life; D011832:Radiation Injuries / Q000150:complications; D011879:Radiotherapy Dosage; D012007:Rectum / Q000528:radiation effects; D012306:Risk; D014555:Urination Disorders / Q000209:etiology
chemical_list: D017430:Prostate-Specific Antigen