A prospective, observational grouped analysis to evaluate the effect of triptorelin on lower urinary tract symptoms in patients with advanced prostate cancer

Abstract

Objectives: Few studies have assessed the effect of gonadotropin-releasing hormone (GnRH) agonists, such as triptorelin, on lower urinary tract symptoms (LUTS) in patients with advanced prostate cancer. Therefore, multiple, national observational, noninterventional studies were initiated to assess the effectiveness of triptorelin in reducing moderate or severe LUTS [International Prostate Symptom Score (IPSS) >7] in men with prostate cancer starting triptorelin therapy in clinical practice. Methods: Prospective, noninterventional, multicentre studies of LUTS located in Algeria, Belgium, China, Hungary, Romania and South Korea, in patients who were scheduled to receive triptorelin (3-month extended release or 1-month formulation) in clinical practice. The primary effectiveness endpoint was the proportion of patients with moderate or severe LUTS after 48 weeks as assessed by IPSS. Secondary endpoints included the distribution of IPSS categories, total IPSS and prostate-specific antigen (PSA) levels at baseline, 24 and 48 weeks. Results: In total, 2461 patients were recruited in the studies; 1282 patients had moderate or severe LUTS at baseline (IPSS > 7), received triptorelin and had follow-up IPSS. Mean total IPSS was reduced from 18.2 [95% confidence interval (CI) 17.8-18.5] at baseline to 11.9 (95% CI 11.5-12.3; p < 0.001) and 10.6 (95% CI 10.2-11.0; p < 0.001) at weeks 24 and 48, respectively. Mean PSA levels were reduced from 117.9 ng/ml (95% CI 93.8-141.9) at baseline to 8.5 ng/ml (95% CI 5.2-11.7) and 16.6 ng/ml (95% CI 7.4-25.8) at weeks 24 and 48, respectively. There was a significant correlation between total IPSS change from baseline and PSA change from baseline at weeks 24 and 48 (ρ = 0.3 and 0.2, p < 0.001). Conclusions:The improvement in LUTS in men with locally advanced or metastatic prostate cancer after 24-48 weeks suggests that triptorelin is effective in improving LUTS in this subgroup of patients.

Are all gonadotrophin‐releasing hormone agonists equivalent for the treatment of prostate cancer? A systematic review

“…However, in another study, reductions in IPSS were greater in patients treated with the GnRH antagonist degarelix than in those receiving the combination of goserelin and bicalutamide . Recent non‐interventional studies have suggested an improvement in LUTS induced by triptorelin, as measured by the IPSS . In one study, mean total IPSS was reduced from 18.2 (95% CI 17.8–18.5) at baseline to 11.9 (95% CI 11.5–12.3; P < 0.001) and 10.6 (95% CI 10.2–11.0; P < 0.001) at weeks 24 and 48, respectively .…”

An Update on Triptorelin: Current Thinking on Androgen Deprivation Therapy for Prostate Cancer

“…Up to 40% of men with localized prostate cancer may have moderate or severe lower urinary tract symptoms (LUTS) [ 48 ], but data on the impact of ADT on LUTS are limited [ 49 – 51 ]. Recently, the preliminary results of an observational study in six countries suggested that treatment with triptorelin 1- and 3-month formulations improved LUTS after 6 and 12 months, as measured by a significant reduction in the International Prostate Symptom Score (IPSS) [ 52 ]. Interestingly, the improvement in LUTS after triptorelin therapy, correlated with reductions in PSA levels [ 52 ].…”

“…Recently, the preliminary results of an observational study in six countries suggested that treatment with triptorelin 1- and 3-month formulations improved LUTS after 6 and 12 months, as measured by a significant reduction in the International Prostate Symptom Score (IPSS) [ 52 ]. Interestingly, the improvement in LUTS after triptorelin therapy, correlated with reductions in PSA levels [ 52 ]. Similar results were observed in a prospective observational study that included 325 Belgian patients with locally advanced or metastatic prostate cancer, the majority of whom (62%) had moderate (IPSS 8-19) to severe (IPSS ≥ 20) LUTS at study entry [ 53 ].…”

“…Reports of triptorelin efficacy in clinical trials translate to real-world studies. For example, in a grouped analysis of 1241 men from six countries, mean PSA levels were 117.9 ng/ml before the men initiated triptorelin therapy and this was reduced to 8.5 and 16.6 ng/ml after 6 and 12 months treatment, respectively [ 52 ]. A recent preliminary report from the UK indicated that PSA remained suppressed when patients switched from any 3-month formulation of GnRH agonist to the triptorelin 22.5 mg 6-month formulation, and this switch may help reduce hospital resource use [ 55 ].…”

“…Studies of sustained-release formulations of triptorelin during routine clinical practice also demonstrate improvements in some aspects of health-related quality of life (HRQoL) and satisfaction in patients [ 52 , 53 , 55 – 58 ]. In an observational study of everyday practice in France, 1438 patients initiating treatment with triptorelin 3- or 6-month formulations for prostate cancer were evaluated for reasons for prescription and patient preference.…”