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*This section of the website is for UK healthcare professionals only and contains promotional content regarding our medicines.

Reporting of adverse events (healthcare professionals in the UK)

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk. Adverse events should also be reported to Ipsen via email at pharmacovigilance.uk-ie@ipsen.com or phone on 01753 627777

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I am a member of the general public in the UK

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

For UK-based Healthcare Professionals only
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Decapeptyl® SR (triptorelin) Data

See evidence from Decapeptyl® SR clinical data including those supporting the efficacy and safety of 1-, 3- and 6-monthly LHRHa administration.1–4

You can also review the results of the peer-reviewed, real-world, retrospective, multicentre Decapeptyl SERvice Evaluation (DESERVE) study.5

Decapeptyl® SR has efficacy you can trust

Maintain castrate testosterone levels with Decapeptyl® SR 6-monthly (every 24 weeks).1

Decapeptyl® SR 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

Mean testosterone levels in patients treated with 6-monthly Decapeptyl® SR

Adapted from Lundström EA et al., 2009

Key findings

Almost all (97.5%, n=120) patients achieved castrate testosterone levels by day 29.1

Moreover, 93% (n=115) maintained castrate testosterone levels month 2 to 12.1

The median relative decrease in serum PSA vs baseline was 97% after 6 months and 96% after 12 months.1

Study information1

Design: A Phase 3, multicentre, open-label, non-comparative study conducted in South Africa.

Aim: To evaluate the efficacy, pharmacokinetics and safety of Decapeptyl® SR 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.

Achieve durable results with Decapeptyl® SR

Clinical data have shown that Decapeptyl® SR formulations maintained castrate testosterone levels versus baseline in patients with advanced prostate cancer patients over a 12-month period.2

Proportion of patients achieving a testosterone level <50 ng/dL (green bars) and <20 ng/dL (orange bars) after 1 to 12 months’ treatment with any Decapeptyl® SR formulation

Adapted from Breul J et al., 2017

Key finding

The majority (95-99%) of patients achieved and maintained castrate testosterone levels (≤50 ng/dL) for 12 months.

Study information2

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® SR 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 had to be eligible for ADT and to be either naïve to hormonal treatment or have undergone an appropriate washout prior to enrolment.

Alleviate your patients’ lower urinary tract symptoms and improve QoL3

Decapeptyl® SR (1- and 3-monthly) had 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.

 

Improved LUTS vs baseline in patients with locally advanced or metastatic prostate cancer 3

Adapted from Gil T et al., 2015

*For overall time effect at week 48; † According to total International Prostate Symptom Score (IPSS)

Study information3

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® SR 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® SR 1- or 3-monthly.

Improved LUTS-related QoL seen with Decapeptyl® SR 1-monthly and 3-monthly3

Adapted from Gil T et al., 2015

Study information3

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® SR 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® SR 1- or 3-monthly.

Decapeptyl® SR 3mg showed similar efficacy to goserelin and leuprorelin4,6

Decapeptyl® SR vs goserelin

Decapeptyl® SR 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

Reduction in prostate volume after 12 weeks of treatment*

*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®SR and goserelin, respectively, with no significant differences between groups (p=0.36).

Adapted from Bahl A et al., 2016

Study information4

Design: Single-blind, single-centre, randomised controlled trial.

Aim: To determine the effect of Decapeptyl® SR 3mg (every 12 weeks) 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 first LHRHa injection.

Patients: A total of 70 patients with localised prostate cancer who were candidates for and had selected radical radiotherapy.

Treatment: Decapeptyl® SR 3mg (n=36) or goserelin 3.6mg (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® SR vs leuprorelin

Decapeptyl® SR 3 mg and leuprorelin 3.75 mg significantly reduced plasma testosterone levels vs baseline to a similar extent
in prostate cancer patients who were not candidates for surgical treatment.*6

Percentage of patients who achieved pre-defined plasma testosterone levels in PCa patients who were unsuitable for surgery after 3 months on Decapeptyl® SR 3mg (a) vs leuprorelin 3.75mg (b)†

†p<0.01 Decapeptyl® SR group vs leuprorelin group

Adapted from Kuhn JM et al., 1997

Study information6

Design: Open, randomised comparison. Laboratory evaluations included plasma prostate-specific antigen and testosterone level assays.

Aims: To compare the efficacy of Decapeptyl® SR (1-monthly, every 28 days) 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, 24 and 72 h 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® SR 3mg 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.

Decapeptyl® SR side effects

As seen with other LHRHa therapies or after surgical castration, the most commonly observed adverse events related to Decapeptyl® SR treatment were due to its expected pharmacological effects (lowering of serum testosterone to castration levels).

In the treatment of prostate cancer, Decapeptyl® SR is generally well tolerated with the side effects of Decapeptyl® SR 6-monthly being consistent with the 1- and 3-monthly formulations.7

Side effects of Decapeptyl® SR across the 1-,3- and 6-monthly formulations7

Please refer to the relevant Summary of Product Characteristics for the full tolerability profile of Decapeptyl® SR.

Very common (≥ 1/10)7

Libido decreased, Paraesthesia in lower limbs, Hot flush, Asthenia, Hyperhidrosis, Back pain, Erectile dysfunction (including ejaculation failure, ejaculation disorder).

Common (≥ 1/100, < 1/10)7

Hypersensitivity, Depression*, Loss of libido, Mood change*, Dizziness, Headache, Hypertension, Dry mouth, Nausea, Musculoskeletal pain, Pain in extremity, Pelvic pain, Injection site reaction (including erythema, inflammation and pain), Oedema, Weight increased.

* This  frequency is based on class-effect frequencies common for all LHRHa.

Uncommon (≥ 1/10)7

Thrombocytosis, Anorexia, Diabetes mellitus, Gout, Hyperlipidaemia, Increased appetite, Insomnia, Irritability, Paraesthesia, Visual impairment, Tinnitus, Vertigo, Dyspnoea, Epistaxis, Abdominal pain, Constipation, Diarrhoea, Vomiting, Acne, Alopecia, Erythema, Pruritus, Rash, Urticaria, Arthralgia, Bone pain, Muscle cramp, Muscular weakness,Myalgia, Nocturia, Urinary retention, Breast pain, Gynaecomastia, Testicular atrophy, Testicular pain, Lethargy, Oedema peripheral, Pain, Rigors, Somnolence, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatinine increased, Blood pressure increased, Blood urea increased, Gamma-glutamyl transferase increased, Weight decreased.

Rare7

Nasopharyngitis, Anaphylactic reaction, Confusional state, Decreased activity, Euphoric mood, Memory impairment, Abnormal sensation in eye, Visual disturbance, Hypotension, Orthopnoea, Abdominal distension, Dysgeusia, Flatulence, Blister, Purpura, Joint stiffness, Joint swelling, Musculoskeletal stiffness, Osteoarthritis, Chest pain, Dysstasia, Influenza like illness, Pyrexia, Blood alkaline phosphatase increased.

Additional post-marketing AEs7

Frequency not known:

Anaemia, Convulsions, Anaphylactic shock, Anxiety, QT prolongation, Angioneurotic oedema, Urinary incontinence, Malaise, Pituitary apoplexy.

The DESERVE Study: Effects of Initiating or Switching to a Six-Monthly (every 24weeks) Triptorelin Formulation on Prostate Cancer Patient-Healthcare Interactions and Hospital Resource Use: Decapeptyl Service Evaluation

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. 5

The results showed that switching to Decapeptyl® SR 6-monthly had the potential to save NHS resources and costs versus 1- and 3-monthly LHRHa injection frequencies.5

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).5

PSA control with switch to Decapeptyl® SR 6-monthly5

Decapeptyl® SR 6-monthly maintained control of PSA in patients* who switched from 1- and 3-monthly LHRHa injection frequencies.5

Decapeptyl® SR 6-monthly also reduced PSA levels in newly initiated patients versus baseline.‡ 5

* 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

Cost saving impact of switching to Decapeptyl® SR 6-monthly5

Potential cost impact of switching from 1- and 3-monthly LHRHa injection frequencies to Decapeptyl® SR 6-monthly*

Adapted from Cornford P et al., 2018

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)

References

  1. 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.
  2. Breul J, Lundström EA, Purcea D, et al. Efficacy of testosterone suppression with sustained-release triptorelin in advanced prostate cancer. Adv Ther. 2017;34(2):513–23.
  3. 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.
  4. 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
  5. Cornford P, et al. 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.
  6. 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.
  7. Merseburger AS, Hupe MC. An update on triptorelin: current thinking on androgen deprivation therapy for prostate cancer. Adv Ther. 2016; 33:1072–93.
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