Phase I/II trial of single-fraction high-dose-rate brachytherapy-boosted hypofractionated intensity-modulated radiation therapy for localized adenocarcinoma of the prostate

Brachytherapy. 2012 Jul-Aug;11(4):292-8. doi: 10.1016/j.brachy.2011.07.006. Epub 2012 Mar 30.

Abstract

Purpose: 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 and materials: 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.

Publication types

  • Clinical Trial, Phase I
  • Clinical Trial, Phase II

MeSH terms

  • Adenocarcinoma / complications
  • Adenocarcinoma / pathology
  • Adenocarcinoma / radiotherapy*
  • Aged
  • Aged, 80 and over
  • Brachytherapy / adverse effects*
  • Brachytherapy / methods
  • Combined Modality Therapy
  • Dose Fractionation, Radiation
  • Feasibility Studies
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Prospective Studies
  • Prostatic Neoplasms / complications
  • Prostatic Neoplasms / pathology
  • Prostatic Neoplasms / radiotherapy*
  • Radiation Injuries / diagnosis
  • Radiation Injuries / etiology*
  • Radiotherapy, Conformal / adverse effects*
  • Radiotherapy, Conformal / methods
  • Treatment Outcome