title: Phase I/II trial of single-fraction high-dose-rate brachytherapy-boosted hypofractionated intensity-modulated radiation therapy for localized adenocarcinoma of the prostate.
abstract: OBJECTIVE
  A Phase I/II protocol was conducted to examine the toxicity and efficacy of the combination of intensity-modulated radiation therapy (IMRT) with a single-fraction high-dose-rate (HDR) brachytherapy implant.
  
  
  METHODS
  From 2001 through 2006, 26 consecutive patients were treated on the trial. The primary objective was to demonstrate a high rate of completion without experiencing a treatment-limiting toxicity. Eligibility was limited to patients with T stage ≤2b, prostate-specific antigen (PSA) ≤20, and Gleason score ≤7. Treatment began with a single HDR fraction of 6Gy to the entire prostate and 9Gy to the peripheral zone, followed by IMRT optimized to deliver in 28 fractions with a normalized total dose of 70Gy. Patients received 50.4Gy to the pelvic lymph node. The prostate dose (IMRT and HDR) resulted in an average biologic equivalent dose >128Gy (α/β=3). Patients whose pretreatment PSA was ≥10ng/mL, Gleason score 7, or stage ≥T2b received short-term androgen ablation.
  
  
  RESULTS
  Median followup was 53 months (9-68 months). There were no biochemical failures by either the American Society of Therapeutic Radiology and Oncology or the Phoenix definitions. The median nadir PSA was 0.32ng/mL. All the 26 patients completed the treatment as prescribed. The rate of Grade 3 late genitourinary toxicity was 3.8% consisting of a urethral stricture. There was no other Grade 3 or 4 genitourinary or gastrointestinal toxicities.
  
  
  CONCLUSIONS
  Single-fraction HDR-boosted IMRT is a safe effective method of dose escalation for localized prostate cancer.
authors.affiliation: Department of Radiation Oncology, Virginia Commonwealth University, Richmond, VA 23298, USA.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Myers
authors.forename: Michael P
authors.initials: MP
authors.lastname: Hagan
authors.forename: Dorin
authors.initials: D
authors.lastname: Todor
authors.forename: Lynn
authors.initials: L
authors.lastname: Gilbert
authors.forename: Nitai
authors.initials: N
authors.lastname: Mukhopadhyay
authors.forename: Jessica
authors.initials: J
authors.lastname: Randolf
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Heimiller
authors.forename: Mitchell S
authors.initials: MS
authors.lastname: Anscher
mesh_terms: D000230:Adenocarcinoma / Q000150:complications / Q000473:pathology / Q000532:radiotherapy*; D000368:Aged; D000369:Aged, 80 and over; D001918:Brachytherapy / Q000009:adverse effects* / Q000379:methods; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D005240:Feasibility Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000150:complications / Q000473:pathology / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000175:diagnosis / Q000209:etiology*; D020266:Radiotherapy, Conformal / Q000009:adverse effects* / Q000379:methods; D016896:Treatment Outcome