Prophylactic tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: final report of a double-blind placebo-controlled randomized study.
OBJECTIVE
To evaluate the effectiveness of prophylactic tamsulosin (Flomax) in reducing the urinary symptoms in patients undergoing 125I prostate implantation (PI) for prostate adenocarcinoma.


METHODS
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.


RESULTS
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).


CONCLUSIONS
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.
Elshaikh
Mohamed A
MA
Department of Radiation Oncology, Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
Ulchaker
James C
JC
Reddy
Chandana A
CA
Angermeier
Kenneth W
KW
Klein
Eric A
EA
Chehade
Nabil
N
Altman
Andrew
A
Ciezki
Jay P
JP
D000230:Adenocarcinoma / Q000532:radiotherapy*; D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D019540:Area Under Curve; D001918:Brachytherapy / Q000009:adverse effects*; D004311:Double-Blind Method; D006801:Humans; D007457:Iodine Radioisotopes / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin; D016055:Urinary Retention / Q000517:prevention & control; D014555:Urination Disorders / Q000517:prevention & control*
D000317:Adrenergic alpha-Antagonists; D007457:Iodine Radioisotopes; D013449:Sulfonamides; D000077409:Tamsulosin