Phase II trial of radiation dose escalation with conformal external beam radiotherapy and high-dose-rate brachytherapy combined with long-term androgen suppression in unfavorable prostate cancer: feasibility report

Int J Radiat Oncol Biol Phys. 2010 Feb 1;76(2):386-92. doi: 10.1016/j.ijrobp.2009.01.059. Epub 2009 May 8.

Abstract

Purpose: To determine the feasibility of combined long-term luteinizing hormone-releasing hormone agonist-based androgen suppressive therapy (AST) and dose escalation with high-dose-rate (HDR) brachytherapy for high-risk (HRPC) or very-high-risk prostate cancer (VHRPC).

Methods and materials: Between January 2001 and October 2006, 134 patients (median age, 70 years) with either National Comprehensive Cancer Network criteria-defined HRPC (n = 47, 35.1%) or VHRPC (n = 87, 64.9%) were prospectively enrolled in this Phase II trial. Tumor characteristics included a median pretreatment prostate-specific antigen level of 14.6 ng/mL, a median clinical stage of T2c, and a median Gleason score of 7. Three-dimensional conformal radiotherapy (54 Gy in 30 fractions) was followed by HDR brachytherapy (19 Gy in 4 b.i.d. treatments). Androgen suppressive therapy started 0-3 months before three-dimensional conformal radiotherapy and continued for 2 years.

Results: One implant was repositioned with a new procedure (0.7%). Five patients (3.7%) discontinued AST at a median of 13 months (range, 6-18 months) because of disease progression (n = 1), hot flashes (n = 2), fatigue (n = 1), and impotence (n = 1). After a median follow-up of 37.4 months (range, 24-90 months), the highest Radiation Therapy Oncology Group-defined late urinary toxicities were Grade 0 in 47.8%, Grade 1 in 38.1%, Grade 2 in 7.5%, and Grade 3 in 6.7% of patients. Maximal late gastrointestinal toxicities were Grade 0 in 73.1%, Grade 1 in 16.4%, Grade 2 in 7.5%, and Grade 3 in 2.9% of patients. There were no Grade 4 or 5 events.

Conclusions: Intermediate-term results show that dose escalation with HDR brachytherapy combined with long-term AST is feasible and has a toxicity profile similar to that reported by previous HDR brachytherapy studies.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Aged, 80 and over
  • Androgen Antagonists / adverse effects
  • Androgen Antagonists / therapeutic use*
  • Brachytherapy / adverse effects
  • Brachytherapy / methods*
  • Combined Modality Therapy / adverse effects
  • Combined Modality Therapy / methods
  • Dose Fractionation, Radiation
  • Feasibility Studies
  • Gastrointestinal Tract / radiation effects
  • Gonadotropin-Releasing Hormone / agonists
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Prostate-Specific Antigen / blood
  • Prostatic Neoplasms / blood
  • Prostatic Neoplasms / drug therapy*
  • Prostatic Neoplasms / pathology
  • Prostatic Neoplasms / radiotherapy*
  • Radiotherapy, Conformal / adverse effects
  • Radiotherapy, Conformal / methods*
  • Urogenital System / radiation effects

Substances

  • Androgen Antagonists
  • Gonadotropin-Releasing Hormone
  • Prostate-Specific Antigen