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Efficacy and Safety of Luteinizing Hormone-Releasing Hormone Antagonist Cetrorelix in the Treatment of Symptomatic Benign Prostatic Hyperplasia¹

Departments of Medicine (A.M.C.S., A.V.S.) and Urology (W.B., M.C., M.M.), Tulane University School of Medicine, and Veterans Administration Medical Center, New Orleans, Louisiana 70146

Address all correspondence and requests for reprints to: Ana Maria Comaru-Schally, M.D., Veterans Administration Medical Center, 1601 Perdido Street, New Orleans, Louisiana 70146.

As the life expectancy for men increases, more cases of benign prostatic hyperplasia (BPH) will be expected. Symptomatic BPH causes morbidity and can lower the quality of life. We investigated whether short term administration of the LH-releasing hormone antagonist cetrorelix could provide an improved treatment for men with BPH. Thirteen patients with moderate to severe symptomatic BPH were treated with cetrorelix (5 mg, sc, twice daily for 2 days followed by 1 mg/day, sc, for 2 months). Patients were evaluated at baseline, during treatment, and up to 18 months after therapy. We determined the effects of cetrorelix on the International Prostate Symptom Score (IPSS), Quality of Life score, sexual function, prostate size, uroflowmetry, and hormonal levels. Treatment with cetrorelix produced a decline of 52.9% (P < 0.0001) in IPSS, a 46% improvement in the Quality of Life score (P < 0.001), a rapid reduction of 27% (P < 0.006) in prostatic volume, and an increase in peak urinary flow rates by 2.86 mL/s. Serum testosterone fell to castrate levels on day 2, but was inhibited only by 64–74% during maintenance therapy, and after cessation of treatment returned to normal. During long term follow-up, most patients continued to show a progressive improvement in urinary symptoms (decline in IPSS from 67% to 72% at weeks 20 and 85, respectively) and an enhancement of sexual function, and prostatic volume remained normal. Our study demonstrates that in patients with symptomatic BPH, treatment with cetrorelix is safe and produces long term improvement.

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