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This website has been commissioned by Ipsen Pharmaceuticals Ltd. and is intended for an Irish audience
Decapeptyl® 6-monthly data show that men with locally advanced or metastatic prostate cancer can achieve and maintain castrate testosterone levels (≤50 ng/dL) versus their baseline values.1
Adapted from Lundström EA et al., 2009.1
Almost all (97.5%, n=120) patients achieved castrate testosterone levels by day 29.1
Moreover, 93% (n=115) maintained castrate testosterone levels from months 2-12.1
The median relative decrease in serum prostate-specific antigen (PSA) vs baseline was 97% after 6 months and 96% after 12 months.1
Design: A Phase 3, multicentre, open-label, non-comparative study conducted in South Africa.
Aim: To evaluate the efficacy, pharmacokinetics and safety of Decapeptyl® 6-monthly.
Primary endpoints: Proportion of patients achieving castrate serum testosterone levels (≤1.735 nmol/L or ≤50 ng/dL) by day 29 and the proportion maintaining castration at months 2–12.
Patients: 120 men with advanced prostate cancer with a life expectancy of at least 18 months and a baseline serum testosterone level of more than 5 nmol/L.
Clinical data have shown that Decapeptyl® formulations-maintained castrate testosterone levels versus baseline in patients with advanced prostate cancer patients over a 12-month period.2
Adapted from Breul J et al., 2017.2
The majority (95-99%) of patients achieved and maintained castrate testosterone levels (≤50 ng/dL) for 12 months.
Design: A pooled, retrospective analysis of data from 920 men with prostate cancer, who had been enrolled in nine prospective studies conducted in Europe and South Africa, and had used testosterone serum concentrations as the primary endpoint.
Aim: To assess the ability of 1-, 3- and 6-monthly Decapeptyl® formulations to suppress serum testosterone concentrations beyond current standards (<50 ng/dL).
Primary endpoints: Serum testosterone concentrations under treatment and success rates (overall and per formulation), based on a testosterone target threshold of 20 ng/dL.
Patients: Aged 42–96 years and had to be eligible for androgen deprivation therapy (ADT) and to be either naïve to hormonal treatment or have undergone an appropriate washout prior to enrolment.
Decapeptyl® (1- and 3-monthly) has been shown to improve lower urinary tract symptoms (LUTS) versus baseline in patients with locally advanced or metastatic prostate cancer.3 As a result, an improvement in quality of life (QoL) has been observed.
Adapted from Gil T et al., 2015.3
*For overall time effect at week 48.
†According to total International Prostate Symptom Score (IPSS).
Design: Prospective, non-interventional, multicentre studies of lower urinary tract symptoms (LUTS) conducted in Algeria, Belgium, China, Hungary, Romania and South Korea.
Aim: To evaluate the effect of Decapeptyl® on lower urinary tract symptoms (LUTS) in patients with advanced prostate cancer.
Primary endpoint: The primary efficacy endpoint was the proportion of patients with moderate or severe LUTS after 48 weeks, as assessed by the International Prostate Symptom Score (IPSS). Secondary endpoints included the distribution of IPSS categories, total IPSS and prostate-specific antigen (PSA) levels at baseline, 24 and 48 weeks.
Patients: In total, 2461 patients were recruited; 1282 had moderate or severe LUTS at baseline, as signified by an IPSS of greater than 7.
Treatment: Decapeptyl® 1- or 3-monthly.
Adapted from Gil T et al., 2015.3
Design: Prospective, non-interventional, multicentre studies of lower urinary tract symptoms (LUTS) conducted in Algeria, Belgium, China, Hungary, Romania and South Korea.
Aim: To evaluate the effect of Decapeptyl® on lower urinary tract symptoms (LUTS) in patients with advanced prostate cancer.
Primary endpoint: The primary efficacy endpoint was the proportion of patients with moderate or severe LUTS after 48 weeks, as assessed by the International Prostate Symptom Score (IPSS). Secondary endpoints included the distribution of IPSS categories, total IPSS and prostate-specific antigen (PSA) levels at baseline, 24 and 48 weeks.
Patients: In total, 2461 patients were recruited; 1282 had moderate or severe LUTS at baseline, as signified by an IPSS of greater than 7.
Treatment: Decapeptyl® 1- or 3-monthly.
Decapeptyl® 3 mg reduced prostate volume to a similar extent as goserelin 3.6 mg within a similar time frame in patients with localised prostate cancer receiving neoadjuvant LHRHa therapy prior to radiotherapy.4
*Boxes depict median values as a horizontal line plus 95% CIs, while range (minimum and maximum) values are represented by whiskers. 12 weeks after the first LHRHa injection, prostate volume decreased by a mean (±SD) of 32.5% ± 20.9 and 36.8% ±18.4 with Decapeptyl® and goserelin, respectively, with no significant differences between groups (p=0.36).
Adapted from Bahl A et al., 2016.4
Design: Single-blind, single-centre, randomised controlled trial.
Aim: To determine the effect of Decapeptyl® on the reduction of prostate volume pre-radiotherapy compared with standard therapy.
Primary endpoint: The primary endpoint was the reduction in prostate volume, as measured by transrectal ultrasound (TRUS). A secondary endpoint was the proportion of patients achieving castrate serum testosterone levels (50 ng/dl) during the 12 weeks from the first LHRHa injection.
Patients: A total of 70 patients with localised prostate cancer who were candidates for and had selected radical radiotherapy.
Treatment: Decapeptyl® 3 mg (n=36) or goserelin 3.6 mg (n=34) every 4 weeks for 12 weeks. Patients also received associated antiandrogen treatment with bicalutamide for 28 days and underwent radical radiotherapy after completion of LHRHa treatment.
Decapeptyl® 3 mg and leuprorelin 3.75 mg significantly reduced plasma testosterone levels vs baseline to a similar extent.*5
Percentage of patients who achieved pre-defined plasma testosterone levels in prostate cancer patients who were unsuitable for surgery after 3 months on Decapeptyl® 3 mg (a) vs leuprorelin 3.75 mg (b)
*In prostate cancer patients who were not candidates for surgical treatment.
Adapted from Kuhn JM et al., 1997.5
Design: Open, randomised comparison. Laboratory evaluations included plasma prostate-specific antigen and testosterone level assays.
Aims: To compare the efficacy of Decapeptyl® (1-monthly) and leuprorelin in men with prostate cancer, and to assess the pattern of plasma testosterone following each LHRHa injection.
Primary endpoint: Plasma prostate-specific antigen (PSA) and testosterone were measured before, 24h and 72h after each injection of LHRHa.
Patients: 67 patients who were previously untreated and not suitable for surgery, and had histologically proven prostate carcinoma, were randomised.
Treatment: Decapeptyl® or leuprorelin every 4 weeks for 3 months. All patients in the study received 250 mg flutamide or 100 mg nilutamide three times a day for 1 month. In 23 patients, this treatment was prolonged throughout the study. The first injection of LHRHa was performed 1 week after starting the treatment with pure antiandrogens.
The primary endpoint of the DESERVE study was to observe the reduction in service interactions for users switching to the 6-monthly LHRHa injection frequency from the 1 and 3-month injection frequencies. A secondary endpoint additionally identified a potential cost reduction impact in the switch.10
The results showed that switching to Decapeptyl® 6-monthly had the potential to save NHS resources and costs versus 1- and 3-monthly LHRHa injection frequencies.10
The cost reductions seen were based upon the decrease in the total number of patient–healthcare interactions (41.5%; p<0.0001, or 417 interactions pre-switch vs 244 interactions post-switch).10
Decapeptyl® 6-monthly maintained control of PSA in patients who switched from 1- and 3-monthly LHRHa injection frequencies.10
Decapeptyl® 6-monthly also reduced PSA levels in newly initiated patients versus baseline.*10
*In this group of switch patients with stable and controlled serum PSA levels, 6-monthly PSA testing is considered as appropriate and effective for disease monitoring as 3-monthly testing. Switch patients: PSA 0.35, 0.18 and 0.24 ng/ml at baseline, 6 months and 12 months respectively. Newly initiated patients: PSA 23.5, 0.84 and 1.3 ng/ml at baseline, 6 months and 12 months respectively.
Adapted from Cornford P et al., 2018.10
Potential cost impact of switching from 1- and 3-monthly LHRHa injection frequencies to Decapeptyl® 6-monthly*†10
Adapted from Cornford P et al., 2018.10
Cost assumptions correct as of December 2015.
*Cost reduction was based upon the reduction in total number of patient–healthcare interactions (41.5%; p<0.0001).
†Cost reduction estimates were reported in pound sterling by Cornford P et al., 2018 and converted to the euro for use in this figure. The currency conversion calculations were based on the closing exchange rate of 1 GBP = 1.1449 EUR,11 reported on the publication date of the DESERVE study (5th November 2018).
Adverse events should be reported.
Reporting forms and information can be found at www.hpra.ie or e-mail medsafety@hpra.ie.
The HPRA can also be contacted on +353 16764971. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on +353 1 8098256.
Reporting of side effects:
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly to the HPRA. Reporting forms and information can be found at www.hpra.ie or email medsafety@hpra.ie. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on +353 1 8098256. By reporting side effects, you can help provide more information on the safety of this medicine.
