A phase III randomized trial of the timing of meloxicam with iodine-125 prostate brachytherapy.
OBJECTIVE
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
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.
Crook
Juanita
J
Department of Radiation Oncology, Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada. juanita.crook@rmp.uhn.on.ca
Patil
Nikhilesh
N
Wallace
Kris
K
Borg
Jette
J
Zhou
David
D
Ma
Clement
C
Pond
Greg
G
D000284:Administration, Oral; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage; D001918:Brachytherapy / Q000009:adverse effects* / Q000379:methods; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004487:Edema / Q000188:drug therapy / Q000209:etiology; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use*; D008297:Male; D000077239:Meloxicam; D008875:Middle Aged; D009864:Ontario; D011469:Prostatic Diseases / Q000188:drug therapy / Q000209:etiology; D013843:Thiazines / Q000008:administration & dosage*; D013844:Thiazoles / Q000008:administration & dosage*; D016055:Urinary Retention / Q000188:drug therapy*
D000894:Anti-Inflammatory Agents, Non-Steroidal; D052246:Cyclooxygenase 2 Inhibitors; D007457:Iodine Radioisotopes; D013843:Thiazines; D013844:Thiazoles; D000077239:Meloxicam