Prophylactic tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: final report of a double-blind placebo-controlled randomized study

• Published in: International journal of radiation oncology, biology, physics Vol. 62; no. 1; p. 164
• Main Authors: Elshaikh, Mohamed A, Ulchaker, James C, Reddy, Chandana A, Angermeier, Kenneth W, Klein, Eric A, Chehade, Nabil, Altman, Andrew, Ciezki, Jay P
• Format: Journal Article
• Language: English
• Published: United States 01-05-2005
• Subjects: Adenocarcinoma - radiotherapy; Adrenergic alpha-Antagonists - therapeutic use; Adult; Aged; Aged, 80 and over; Analysis of Variance; Area Under Curve; Brachytherapy - adverse effects; Double-Blind Method; Humans; Iodine Radioisotopes - therapeutic use; Male; Middle Aged; Prostatic Neoplasms - radiotherapy; Sulfonamides - therapeutic use; Urinary Retention - prevention & control; Urination Disorders - prevention & control
• ISSN: 0360-3016
• DOI: 10.1016/j.ijrobp.2004.09.036

To evaluate the effectiveness of prophylactic tamsulosin (Flomax) in reducing the urinary symptoms in patients undergoing 125I prostate implantation (PI) for prostate adenocarcinoma.
This is a single-institution, double-blind, placebo-controlled, randomized trial for patients undergoing PI for prostate adenocarcinoma comparing prophylactic tamsulosin versus placebo. Eligibility criteria included patients not taking tamsulosin or other alpha-blockers treated with PI. The patients were randomly assigned to either tamsulosin (0.8 mg, orally once a day) or matched placebo. All patients started the medication 4 days before PI and continued for 60 days. The American Urologic Association (AUA) symptom index questionnaire was used to assess urinary symptoms. The AUA questionnaire was administered before PI for a baseline score and weekly for 8 weeks after PI. Patients were taken off the study if they developed urinary retention, had intolerable urinary symptoms, or wished to discontinue with the trial.
One hundred twenty-six patients were enrolled in this study from November 2001 to January 2003 (118 were evaluable: 58 in the tamsulosin arm and 60 in the placebo group). Pretreatment and treatment characteristics were comparably matched between the two groups. The urinary retention rate was 17% (10 patients) in the placebo group compared with 10% (6 patients) in the tamsulosin group (p = 0.3161). Eighty-eight percent (14 patients) of those who developed urinary retention experienced it within 2 weeks after the PI. Intolerable urinary symptoms were reported equally (10 patients in each group) with 70% occurring in the first 2 weeks after PI. There was a significant difference in mean AUA score in favor of tamsulosin at Week 5 after PI (p = 0.03).
Prophylactic tamsulosin (0.8 mg/day) before prostate brachytherapy did not significantly affect urinary retention rates, but had a positive effect on urinary morbidity at Week 5 after PI.