International Journal of Radiation Oncology*Biology*Physics
Clinical investigationsProstateProphylactic tamsulosin (Flomax) in patients undergoing prostate 125I brachytherapy for prostate carcinoma: Final report of a double-blind placebo-controlled randomized study
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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Cited by (61)
Consequential late effects up to >10 years following primary and postoperative radiotherapy for prostate cancer
2021, Radiotherapy and OncologyCitation Excerpt :Decreasing the total prescription dose should probably be considered for some patients with serious acute toxicities. An effective symptomatic treatment during radiotherapy might also be helpful to reduce long-term side-effects, as shown for alpha-blockers after prostate brachytherapy and external beam radiotherapy in randomized studies [23,24]. Most important, modern techniques with the best possible image guidance to reduce treatment margins and intensity-modulated RT techniques need to be applied [7] – these have not been possible in our patient population that has been treated many years ago.
Estimating acute urinary retention risk post prostate high dose-rate (HDR) brachytherapy: A clinical-based recursive partitioning analysis
2021, Radiotherapy and OncologyCitation Excerpt :It may be that alpha-blocker is capable of reducing obstructive symptoms and IPSS score, but not necessarily the risk of urinary retention. Similar conclusion has been previously presented in the LDR brachytherapy setting by other authors [12,13]. Neoadjuvant use of androgen deprivation was also found to be associated with higher rates of urinary retention.