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Reporting of side effects (patients and public in the UK)

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 via the Yellow Card Scheme at http://www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

TRI-UK-005698 Date of preparation: February 2024

Reasons to choose Decapeptyl^® SR

There are more than 25 years of experience of using Decapeptyl^® SR for prostate cancer treatment in the UK.⁷

Potential benefits of Decapeptyl^® SR for your practice

Efficacy you can trust

Decapeptyl^® SR clinical studies have shown that it can produce durable results that maintain castrate testosterone levels in patients with locally advanced and metastatic prostate cancer*.^1,3

At the 1- and 3-month dosing formulations, Decapeptyl^® SR has improved lower urinary tract symptoms (LUTS) and associated QoL versus baseline**.⁴

Prostate volume has been reduced to a similar extent with Decapeptyl^® SR versus goserelin and leuprorelin 1-monthly strength***.^5,6

^{*In the intent-to-treat population, 97.5% (95% CI 92.9, 99.5) of patients achieved castrate serum testosterone levels by day 29, and 93.0% (95% CI 86.8, 97.0) maintained castration at months 2-12}

^{**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)}

^{***At the first assessment, mean (± SD) prostate volume was similar between the triptorelin (39.4 ± 17.5 cc) and goserelin (38.1 ± 12.8 cc) groups. 12 weeks after the first LHRH agonist injection, prostate volume decreased by a mean of 32.5% and 36.8% with triptorelin and goserelin, respectively, with no significant differences between groups}

Generally well tolerated

Decapeptyl^® SR side effects are consistent across all three formulations.^7–10

Very common (≥ 1 in 10) Decapeptyl^® SR side effects in men have included:^7–9

Decreased libido
Paraesthesia in lower limbs
Hot flushes
Asthenia
Hyperhidrosis
Back pain
Erectile dysfunction.

Decapeptyl^® SR prescribing options

Decapeptyl^® SR gives you the flexibility of offering your patients 6-, 3- and 1-monthly dosing.^7–9

The 6-monthly (24 weeks) formulation is designed to deliver 22.5mg of triptorelin over a 6-month period after a single intramuscular injection.⁹

Patient-reported percieved benefits of 6-monthly LHRHa therapy*

Prostate cancer patients on 1- and 3-monthly LHRHa have perceived that 6-monthly LHRHa therapy could have potential benefits such as:¹²

Less discomfort and pain

Improved quality of life

Fewer reminders of the disease due to less frequent dosing

Ability to undertake activities without restriction

Adapted from Shulman C ¹²

Data are from face-to-face interviews (n=200) in France, Germany, Itlay, the Netherlands and Spain.¹²

The study was conducted in men diagnosed with prostate cancer who were receiving LHRHa treatment.¹² The survey was carried out before 6-monthly Decapeptyl^® SR was available. The majority (79%) of respondents received hormone injections once every 3 months and a fifth (21%) received injections once every month.¹²

*The aim was to: understand the attitudes of patients with prostate cancer toward the disease in general and to the use of hormone therapy as treatment; assess unmet needs in the management of prostate cancer; gauge patient receptivity to a potential 6-monthly formulation of LHRHa.¹²

Decapeptyl^® SR potential benefits for the NHS

Lowest list price of available LHRHa therapies

Decapeptyl^® SR has the lowest list price of available LHRHa therapies given at their most common doses. This can translate into notable savings per patient per year.¹¹

NHS-Patient interactions

The availability of 6-monthly Decapeptyl^® SR dosing means fewer NHS-Patient interactions for injections versus 1- and 3-monthly dosing, potentially freeing up time for discussing other patient concerns.¹³

Save time and resources

Using Decapeptyl^® SR 6-monthly potentially saves resources and time versus 1- and 3-monthly LHRHa injection frequencies as demonstrated by peer-reviewed, real-world, retrospective, multicentre data from the UK-based Decapeptyl SERvice Evaluation (DESERVE) study.¹³

Savings using Decapeptyl^® SR 6-monthly compared to 1 or 3-monthly

Adapted from Cornford P et al., 2018

* Cost reduction was based upon the reduction in total number of patient–healthcare interactions (41.5%; P<0.0001)

Save NHS resources with Decapeptyl^® SR 6-monthly

Switching to Decapeptyl^®SR 6-monthly from 1- and 3-monthly LHRHa injection frequencies has the potential to save resources as demonstrated by data from the Decapeptyl SERvice Evaluation (DESERVE) study.¹³

41.5% reduction in NHS-patient interactions (primary endpoint)
417 interactions pre-switch vs. 244 interactions post-switch
46.8% reduction in injection and review appointments
154 appointments pre-switch vs, 82 appointments post-switch
26.6% reduction in PSA tests*
109 tests pre-switch vs. 80 test post-switch

All reductions in resources were significant (p<0.0001).

*Control of PSA was maintained in patients who were switched to Decapeptyl^® SR 6-monthly from 1- and 3-monthly LHRHa injection frequencies.¹³ Read more about PSA control in the DESERVE study.

Reduced injection frequency over a patients’ lifetime

Click the tabs on the table below to see the reduction in injection frequency that can be achieved with Decapeptyl^®SR 6-monthly.

The graphical representations shown are based on the following assumptions:¹³

The average time patients remain on LHRHa therapy is 4.5 years = 1643.5 days (including an extra leap-year day), 234 weeks or 54 months
Decapeptyl^® SR 3mg is a 28-day regimen, Decapeptyl^® SR 11.25mg is a 3-monthly regimen and Decapeptyl^® SR 22.5mg is a 24-week regimen

Decapeptyl^® SR 3mg calculation: 1643.5 per 28-day administrations = approx. 59 injections
Decapeptyl^® SR 11.25mg calculation: 54 per 3-monthly administrations = approx. 18 injections
Decapeptyl^® SR 22.5mg calculation: 234 per 24-week administrations = approx. 10 injections

1-monthly injection (28 days)
3-monthly injection (12 weeks)
6-monthly injection (24 weeks)

How much can Decapeptyl^® SR 6-monthly potentially save the NHS?

According to a cost impact study, switching to Decapeptyl^® SR 6-monthly from 1- and 3-monthly LHRHa injection frequencies may save:*¹³

£249.14 per patient per year
£2.5m for every 10,000 patients
£11.2m per average patient lifetime per 10,000 patients

*Patient-healthcare interaction costs correct at the time of analysis. The costs do not contain other resource use costs and may vary between primary and secondary care.

^†Hours saved calculations: 73.8 mins x 100 patients / 60 mins = 123 hours; 73.8 mins x 200 patients / 60 mins = 246 hours; 73.8 mins x 300 patients / 60 mins = 369 hours; 73.8 mins x 400 patients / 60 mins = 492 hours; 73.8 mins x 500 patients / 60 mins = 615 hours. £££ saved calculations: £249.14 x 100 patients = £24,914; £249.14 x 200 patients = £49828; £249.14 x 300 patients = £74,742; £249.14 x 400 patients = £99,656; £249.14 x 500 patients = £124,570

^‡The DESERVE study assumed a patient lifetime of 4.5 years

NICE prostate cancer guidelines and hormone therapy

The National Institute for Health and Care Excellence (NICE) Guideline 131 (NG131) provides clear recommendations on how to optimally diagnose, manage and follow-up men with prostate cancer.¹⁴

The guidance covers the role of secondary care in diagnosing prostate cancer and in the management of patients and the key role of primary care in following men up and helping to manage adverse effects of treatment.¹⁴

With regards to the licensed indications* for Decapeptyl^® SR and the use of LHRHa, NICE NG131 provides several recommendations for managing localised or locally advanced prostate cancer and for managing metastatic prostate cancer with hormone therapy¹⁴

All NICE guidance is subject to regular review and may be updated or withdrawn. Please refer to the full NICE guidelines on prostate cancer treatment via the NICE website.

Managing localised or locally advanced disease ¹⁴

Summary of NICE recommendations

Offer people with CPG 2, 3, 4 and 5 localised or locally advanced prostate cancer 6 months of ADT before, during or after radical external beam radiotherapy
Consider continuing ADT for up to 3 years for people with CPG 4 and 5 localised or locally advanced prostate cancer and discuss the benefits and risks of this option with them

Managing metastatic prostate cancer

Summary of NICE recommendations related to androgen deprivation therapy

Offer bilateral orchidectomy to all people with metastatic prostate cancer as an alternative to continuous LHRH agonist therapy
For patients without significant comorbidities, docetaxel chemotherapy and Androgen Deprivation Therapy (ADT) (chemotherapy to start within 12 weeks of starting ADT) should be offered
Androgen Deprivation Therapy (ADT) + Novel hormone therapy (NHT)*

*refer to individual NICE Guidance

References

Lundström EA, Rencken RK, van Wyk JH, et al. Triptorelin 6-month formulation in the management of patients with locally advanced and metastatic prostate cancer: an open-label, non-comparative, multicentre, phase III study. Clin Drug Investig. 2009;29(12):757–65.
Breul J, Lundström EA, Purcea, et al. Efficacy of testosterone suppression with sustained-release triptorelin in advanced prostate cancer. Adv Ther. 2017;34(2):513–23.
Heyns CF, Simonin M-P, Grosgurin P, et al. Comparative efficacy of triptorelin pamoate and leuprolide acetate in men with advanced prostate cancer. BJU Int. 2003;92(3):226–31.
Gil T, Aoun F, Cabri P, et al. A prospective, observational grouped analysis to evaluate the effect of triptorelin on lower urinary tract symptoms in patients with advanced prostate cancer. Ther Adv Urol. 2015;7(3):116–24.
Bahl A, Challapalli A, Masson S, et al. A randomised controlled trial to determine the effect of triptorelin on reduction of prostate volume pre-radiotherapy compared with standard therapy (goserelin). Poster presentation at the American Society for Clinical Oncology Genitourinary Cancer Symposium 2016. Poster 30.
Kuhn JM, Abourachid H, Brucher P, et al. A randomized comparison of the clinical and hormonal effects of two GnRH agonists in patients with prostate cancer. Eur Urol. 1997;32(4):397–403.
Decapeptyl^® SR 3 mg Summary of Product Characteristics. Ipsen Ltd.
Decapeptyl^® SR 11.25 mg Summary of Product Characteristics. Ipsen Ltd.
Decapeptyl^® SR 22.5 mg Summary of Product Characteristics. Ipsen Ltd.
Merseburger AS, Hupe MC. An update on triptorelin: current thinking on androgen deprivation therapy for prostate cancer. Adv Ther. 2016; 33:1072–93.
MIMS Online. Available from www.mims.co.uk. Accessed April 2023
Schulman C. Assessing the attitudes to prostate cancer treatment among European male patients. BJU Int. 2007;100(Suppl1):6–11.
Cornford P, Jefferson K, Cole O, Gilbody J. Effects of initiating or switching to a six-monthly triptorelin formulation on prostate cancer patient–healthcare interactions and hospital resource use: a real-world, retrospective, non-interventional study. Oncol Ther. 2018;6:173–87.
National Institute for Health and Care Excellence. (2021). Prostate cancer: diagnosis and management [NICE guideline [NG131]. https://www.nice.org.uk/guidance/ng131