A Phase III Randomized Trial to Assess the Efficacy of Intraoperative Steroid Use in Decreasing Acute Urinary Retention Following Transperineal Radioactive Seed Implantation for Prostate Cancer

Article Outline

• Purpose/Objective(s)
• Materials/Methods
• Results
• Conclusions
• Copyright

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Purpose/Objective(s) 

Prostate brachytherapy is a frequently employed treatment for early to intermediate stage prostate cancer. Acute urinary retention is a known potential complication of brachytherapy with prospective trials estimating 10–15% of patients requiring catheterization within 48 hours post-implant. In theory, post-implant edema could be reduced by using intraoperative steroids. We conducted a prospective single institution trial randomizing patients to a single intraoperative dose of dexamethasone versus no steroid use.

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Materials/Methods 

204 patients who received I-125 interstitial brachytherapy alone as definitive treatment for low to intermediate risk prostate cancer were randomized to receive either dexamethasone 6 mg IV in a single intraoperative dose (arm A) or no steroids (arm B). 196 patients were evaluable. All patients completed the International Prostate Symptom Score (IPSS) prior to treatment. Patients were contacted by phone 72–96 hours after treatment, and acute urinary toxicities were reported according to the Common Toxicity Criteria (CTC) version 2.0. All patients received tamsulosin 0.4 mg daily on the operative day and first post-operative day.

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Results 

Between 2003–2005, 99 patients were randomized to arm A, and 97 patients to arm B at the University of Cincinnati and the Cincinnati VA Hospital. Treatment arms were balanced with respect to pretreatment characteristics. Pretreatment clinical stages included T1a-T2b, N0, Gleason score 6 or 7 and PSA < 20 ng/ml. No patient received hormonal treatment. Pretreatment IPSS scores ranged from 3 to 28, prostate volumes ranged from 20 to 92 cm³, total dose prescribed was 14,400 cGy to the periphery of the prostate. 19 patients in arm A and 17 patients in arm B were treated with long term pre-implant alpha blockers. Implants were performed by two Radiation Oncologists.

A total of 3 patients required catheterization within 48 hours post-implant, 2 in arm A and 1 in arm B. The overall rate of catheterization was 1.5%, with no statistically difference between treatment arms. The 3 patients requiring catheterization had no statistical differences from the remainder of patients with respect to pretreatment characteristics, pretreatment IPSS score, or brachytherapy dose.

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Conclusions 

There was no statistical difference between treatment arms in this study, concluding that intraoperative dexamethasone did not decrease the rate of catheterization required. The overall rate of post-implant catheterization in this study was 1.5%, lower than reported elsewhere in the literature and in a retrospective review from our institution. This low catheterization rate may be explained by perioperative treatment of all patients with tamsulosin.