A phase III randomized trial of the timing of meloxicam with iodine-125 prostate brachytherapy

Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):496-501. doi: 10.1016/j.ijrobp.2009.04.078. Epub 2010 Mar 28.

Abstract

Purpose: Nonsteroidal anti-inflammatory medication is used to reduce prostate edema and urinary symptoms following prostate brachytherapy. We hypothesized that a cyclooxygenase-2 (COX-2) inhibitor regimen started 1 week prior to seed implant might diminish the inflammatory response, thus reducing edema, retention rates, and symptom severity.

Methods and materials: From March 2004 to February 2008, 316 men consented to an institutional review board-approved randomized study of a 4-week course of meloxicam, 7.5 mg orally twice per day, starting either on the day of implant or 1 week prior to implant. Brachytherapy was performed using iodine-125 seeds and was preplanned and performed under transrectal ultrasound (TRUS) and fluoroscopic guidance. Prostate volume obtained by MR imaging at 1 month was compared to baseline prostate volume obtained by TRUS planimetry and expressed as an edema factor. The trial endpoints were prostate edema at 1 month, International Prostate Symptom Score (IPSS) questionnaire results at 1 and 3 months, and any need for catheterization.

Results: Results for 300 men were analyzed. Median age was 61 (range, 45-79 years), and median TRUS prostate volume was 35.7 cc (range, 18.1-69.5 cc). Median IPSS at baseline was 5 (range, 0-24) and was 15 at 1 month, 16 at 3 months, and 10 at 6 months. Catheterization was required for 7% of patients (6.2% day 0 arm vs. 7.9% day -7 arm; p = 0.65). The median edema factor at 1 month was 1.02 (range, 0.73-1.7). 1.01 day 0 arm vs. 1.05 day -7 arm. Baseline prostate volume remained the primary predictor of postimplant urinary retention.

Conclusions: Starting meloxicam 1 week prior to brachytherapy compared to starting immediately after the procedure did not reduce 1-month edema, improve IPSSs at 1 or 3 months, or reduce the need for catheterization.

Trial registration: ClinicalTrials.gov NCT00152919.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Brachytherapy / adverse effects*
  • Brachytherapy / methods
  • Cyclooxygenase 2 Inhibitors / administration & dosage*
  • Drug Administration Schedule
  • Edema / drug therapy
  • Edema / etiology
  • Humans
  • Iodine Radioisotopes / therapeutic use*
  • Male
  • Meloxicam
  • Middle Aged
  • Ontario
  • Prostatic Diseases / drug therapy
  • Prostatic Diseases / etiology
  • Thiazines / administration & dosage*
  • Thiazoles / administration & dosage*
  • Urinary Retention / drug therapy*

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Cyclooxygenase 2 Inhibitors
  • Iodine Radioisotopes
  • Thiazines
  • Thiazoles
  • Meloxicam

Associated data

  • ClinicalTrials.gov/NCT00152919