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

Presented at the 45th Annual Meeting of the American Society for Therapeutic Radiology and Oncology, October 19–23, 2003, Salt Lake City, UT.
https://doi.org/10.1016/j.ijrobp.2004.09.036Get rights and content

Purpose: To evaluate the effectiveness of prophylactic tamsulosin (Flomax) in reducing the urinary symptoms in patients undergoing 125I prostate implantation (PI) for prostate adenocarcinoma.

Methods and materials: 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 α-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.

Introduction

Adenocarcinoma of the prostate is currently the second most commonly diagnosed cancer in men in the United States and is the second leading cause of cancer mortality (1). In the last decade, owing to outcomes comparable with prostatectomy and external beam radiation therapy (2, 3), there has been an increased interest in treating early-stage prostate cancer with permanent radioactive seed implantation (PI).

After PI, almost all patients develop some degree of urinary irritative or obstructive symptoms, with 3–34% of patients developing acute urinary retention (4, 5, 6, 7). Alpha-blockers are widely used either prophylactically or therapeutically to ameliorate these urinary symptoms after the PI (4, 8). No prospective randomized data, however, are available regarding their benefits with PI.

The purpose of this study is to evaluate the effectiveness of prophylactic tamsulosin (Flomax) in reducing urinary symptoms for patients after receiving PI in the setting of a prospective, randomized, double-blind, placebo-controlled study.

Section snippets

Methods and materials

This is a single-institution, double-blind, placebo-controlled, randomized trial comparing tamsulosin versus placebo for patients undergoing PI for biopsy-proven adenocarcinoma of the prostate. Our Institutional Review Board approved this study. The study schema is illustrated in Fig. 1. Eligibility criteria include patients who chose PI as a treatment option (i.e., patients with low or intermediate-risk prostate cancer), were not taking tamsulosin or other α-blockers before PI, had no known

Results

Between November 2001 and January 2003, 126 patients were enrolled on the study. A total of 118 patients (58 and 60 patients in the tamsulosin and the placebo groups, respectively) were evaluable. See Fig. 2 for a breakdown of the 126 randomized patients. Table 1 summarizes the pretreatment characteristics of the 118 evaluable study patients. The two treatment groups were comparably matched for the pretreatment as well as posttreatment characteristics (Table 1, Table 2). None of the patients

Discussion

The efficacy of PI in treating prostate cancer is being shown to be on a par with the major competing modalities (2). As a result, investigations seeking to discriminate among therapeutic approaches will need to focus on toxicity: not only trying to understand its incidence but also attempting its amelioration. The present study illuminates both of these aspects of toxicity.

The implantation technique applied in this trial deviates slightly from those employed in other institutions in two

Conclusion

In conclusion, this study demonstrates that prophylactic tamsulosin (Flomax) has a positive impact on urinary symptoms at Week 5 after PI. A follow-up study, currently under way, will test the hypothesis that reducing prostate edema associated with the procedure in addition to an α-blocker may further improve urinary symptoms after prostate brachytherapy.

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