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A prospective non-interventional study to evaluate the effect of Triptorelin Embonate (Diphereline (TM) 11.25mg) on lower urinary tract symptoms (LUTS) in Australian prostate cancer patients.

开始日期2011-03-08

申办/合作机构

Ipsen Pty Ltd.

ACTRN12609000226202 / CompletedN/A

An observational, multicentre, open label non interventional programme to assess the long-term safety and efficacy of Somatuline (registered trade mark) Autogel (registered trade mark) in the treatment of neuroendocrine tumours when administered by patients or their partners (Home Injection Group) or administered by healthcare professionals.

开始日期2009-08-05

申办/合作机构

Ipsen Pty Ltd.

ACTRN12608000606381 / CompletedN/A

An observational, multicentre, open label non interventional programme to assess the long-term safety and efficacy of Somatuline (registered trade mark) Autogel (registered trade mark) in the treatment of acromegaly when administered by patients or their partners (Home Injection Group) or administered by healthcare professionals.

开始日期2009-04-14

申办/合作机构

Ipsen Pty Ltd.

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项与 Ipsen Pty Ltd. 相关的文献（医药）

Research and Reports in Urology

Effect of triptorelin on lower urinary tract symptoms in Australian prostate cancer patients

Article

作者: Woo, Henry H ; Murphy, Declan G ; Grummet, Jeremy P ; Testa, Gerard M ; Stork, Andrew P ; Chong, Michael

PURPOSEProstate cancer is often comorbidly associated with lower urinary tract symptoms (LUTS), but few studies have assessed the effects of androgen deprivation therapy on LUTS in this patient group.PATIENTS AND METHODSWe conducted a prospective, noninterventional, multicenter, observational study to assess the effectiveness of triptorelin (11.25 mg every 12 weeks) over 48 weeks in men presenting with local stage T3/4 prostate cancer and moderate to severe LUTS (International Prostate Symptom Score [IPSS] >7) in a routine practice setting in Australia.RESULTSOf the 44 men who enrolled, effectiveness data were available for 39 men. By the end of the study, 30% of men no longer met the IPSS criteria for moderate to severe LUTS. The proportion of patients with moderate to severe LUTS was 69.6% (16/23) at week 48 and 76.9% (30/39) at the last available visit (coprimary outcomes). An IPSS reduction of ≥3 from week 0 was observed in 47% of men at week 4, 56% at week 24, 61% (14/23) at week 48, and 61.5% (24/39) at the last available visit. Quality of life was rated as mostly satisfied-to-delighted by 39.5% of patients at week 0, 53.9% at week 24, and 77.3% at week 48. Triptorelin was well tolerated with 8 treatment-related adverse events reported, half of which were hot flushes; 5 patients discontinued due to the reported treatment-related adverse events.CONCLUSIONThis observational study suggests that triptorelin improves moderate to severe LUTS in prostate cancer patients in a routine clinical practice setting.

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