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About Prostap DCS (leuprorelin acetate)

  • The most widely used gonadotropin-releasing hormone (GnRH) agonist in the UK1
  • Benefits from 40 years of experience with leuprorelin2,3
  • Has a well-established tolerability: majority of adverse events are related to androgen deprivation; most common events are hot flushes, increased sweating, and decreased libido4-8
  • Includes a dual-chamber syringe, making it easy to administer7-9
  • Prostap DCS is fitted with a safety device that complies with the latest EU sharps directive and UK legislation, to help protect HCPs from needle stick injuries7-10
  • Can be used whenever a GnRH agonist is required for the management of prostate cancer, including neo-adjuvant to radiotherapy4,7-9,11

 

Please visit the safety and efficacy profile section of this website for full information on adverse events

Please choose the indication you would like to read more about

Therapeutic indications7,8

  • Metastatic prostate cancer
  • Locally advanced prostate cancer, as an alternative to surgical castration
  • As an adjuvant treatment to radiotherapy in patients with high-risk localised or locally advanced prostate cancer
  • As an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression
  • As neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced prostate cancer

Testosterone suppression

Prostate cancer depends on testosterone to grow. The production of testosterone is controlled by the release of luteinising hormone, a type of gonadotropin. As a GnRH agonist, leuprorelin acetate, the active ingredient in Prostap DCS, is able to inhibit the release of luteinising hormone, therefore reducing the level of testosterone made by the testes. This may shrink the cancer or slow its growth.12

Patients receiving leuprorelin acetate experienced long-term suppression of testosterone levels.5,6,13

Serum testosterone levels chart
Adapted from Kienle E and Lübben G, 1996.5

Long-term survival when combined with radiotherapy

At 8 years AST+RT significantly improved overall survival vs. RT alone, with 74% of men who received AST and RT surviving at 8 years vs. 61% receiving RT alone (p=0.01).4,14*

Comparable to orchidectomy

EAU guidelines15

Although there is no formal direct comparison between the various compounds, they are considered to be equally effective and comparable to orchidectomy.15
Mottet N et al. 2018. EAU guidelines on Prostate Cancer.

*In patients with localised but unfavourable risk prostate cancer.

Therapeutic indications7,8

  • As treatment in pre- and peri-menopausal women with advanced breast cancer suitable for hormonal manipulation
  • As adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine responsive early-stage breast cancer in pre- and peri-menopausal women at higher risk of disease recurrence (young age, high grade tumour, lymph node involvement)
  • In women who have received chemotherapy, pre-menopausal status must be confirmed after completion of chemotherapy

 

Therapeutic indications7,8

  • Management of endometriosis, including pain relief and reduction of endometriotic lesions
  • Endometrial preparation prior to intrauterine surgical procedures including endometrial ablation or resection (Prostap SR DCS only)
  • Preoperative management of uterine fibroids to reduce their size and associated bleeding (Prostap SR DCS only)

Oestrogen suppression

Prostap DCS provided significant suppression of serum 17ẞ-oestradiol at 12 and 24 weeks compared with baseline.18

Oestrogen suppression over 24 weeks

Adapted from Crosignani PG et al. 1996.18
Suppression of mean (SD) serum 17ẞ-oestradiol levels from baseline at 12 and 24 weeks in women with endometriosis (n=30) on leuprorelin 1-monthly or 3- monthly depot injections for 6 months for relief of chronic pelvic pain.18
*Significantly different from baseline, p<0.0118

Endometrial gland suppression

Leuprorelin inhibits the production of oestrogen, without which the endometrial glands become inactive. This decreases the growth of uterine tissue outside of the uterus, which helps decrease the pain associated with endometriosis. 19

With Prostap DCS, women with endometriosis experienced reductions in pain symptoms19

After receiving leuprorelin, patients with symptomatic endometriosis experiences ovarian suppression, lesion regression and pain relief.18

Pain symptom scores in women with endometriosis

Adapted from Crosignani PG et al, 1996.18
Pain symptom scores following 6 months’ treatment with leuprorelin (1-monthly, n=15; 3-monthly, n=15) in 30 women to relieve the chronic pain associated with their pelvic endometriosis.
Mean values according to the verbal rating scale.
*Significantly different from baseline, p<0.05

  • Non-menstrual pelvic pain and pelvic tenderness were significantly reduced by Prostap DCS (p<0.05)18
  • Treatment with Prostap DCS induced a significant reduction in endometriotic lesions18
  • Cessation of dysmenorrhea due to the amenorrhoeic state was induced by Prostap DCS18

Therapeutic indications7-9

  • Central precocious puberty in girls under 9 years of age and boys under 10 years of age

Hormone suppression7-9

In children with central precocious puberty, by reducing the levels of oestrogen and testosterone produced in the body, Prostap DCS allows for a delayed onset of puberty.

The following therapeutic effects can be demonstrated:7-9

  • Suppression of basal and stimulated gonadotropin levels to pre-pubertal levels
  • Suppression of prematurely increased sexual hormone levels to pre-pubertal levels and arrest of premature menstruation
  • Arrest/involution of somatic pubertal development (Tanner stages)
  • Improvement/normalisation of the ratio of chronological age to bone age
  • Prevention of progressive bone age acceleration
  • Decrease of growth velocity and its normalisation
  • Increase in final height

A brief history of Prostap DCS

Did you know...

…that leuprorelin was first discovered by a Takeda scientist, Dr Masahiko Fujino, in 1974?
He later went on to become chairman of Takeda, and leuprorelin went on to become the world’s most widely used GnRH agonist.1

AST = androgen suppression therapy; DCS = dual-chamber syringe; EAU = European Association of Urology; EAU = European Association of Urology; LHRH = Luteinising hormone-releasing hormone; RT = 3-dimensional conformational radiotherapy; SR = slow release.

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Contact us

If you are a healthcare professional and have a query about Prostap DCS, please contact Medical Information on:

Telephone: 03 333 000 181

If you are a healthcare professional and would like to be contacted about Prostap DCS, please enter your details in the short form below

C-APROM/GB/PRS/0193 - November 2024

References

1. UK LHRHa Market Share DOF-2026. C-APROM/GB/PRS/0209.
2. The Leuprolide Study Group. N Eng J Med 1984;311(20):1281-6.
3. Sharifi R, Ratanawong C et al. Adv Drug Deliv Rev 1997;28(1):121-38.
4. D’Amico AV et al. JAMA 2008;299(3):289-95.
5. Kienle E & Lübben G. Urol Int 1996;56(Suppl 1):23-30.
6. Tunn UW & Wiedey K. Prostate Cancer Prostatic Dis 2009;12(1):83-7.
7. Prostap SR DCS. Summary of Product Characteristics.
8. Prostap 3 DCS. Summary of Product Characteristics.
9. Prostap PD DCS. Summary of Product Characteristics.
10. Health and Safety Sharp Instruments in Healthcare Regulations 2013.
Available at: http://www.hse.gov.uk/pubns/hsis7.pdf. (last accessed May 2026).
11. National Institute for Health and Care Excellence (NICE). Clinical guideline NG131. May 2019.
12. Cancer Research UK. Hormone therapy for cancer, Jan 2021. Available at: https://www.cancerresearchuk.org/about-cancer/treatment/
hormone-therapy/for-cancer (last accessed May 2026).
13. Jocham D. Urol Int 1998;60:18-24.
14. D’Amico AV et al. JAMA 2004;292(7):821–7.
15. Mottet N et al. European Association of Urology Guidelines on Prostate Cancer. Update 2020.
16. Goel S et al. Cochrane Database Syst Rev 2009;7(4):CD004562.
17. NHS UK. Breast cancer in women – Treatment, September 2016. Available at: https://www.nhs.uk/conditions/breast-cancer-in-women/
treatment-for-breast-cancer-in-women/(last accessed May 2026).
18. Crosignani PG et al. Hum Reprod 1996;11(12):2732-5.
19. Guerrero, Anna, Santora, Emily, “Leuprorelin as a Treatment for Endometriosis”. Embryo Project Encyclopedia ( 2019-11-30 ). ISSN: 1940-5030
20. Abouelfadel Z & Crawford D. Therapeut Clin Risk Manag 2008;4(2):513-526.
21. Barnes R et al. Study M86-049 Report.
22. MHRA Prostap® 3 DCS UKPAR. Available at: https:/ /mhraproducts4853.blob.core.windows.net/docs
912f4a5b62d8b517ebae022c4231a49153685864 (last accessed May 2026).
23. MHRA. Prostap® SR DCS UKPAR, 2014. Available at: http:/ /www.mhra.gov.uk/home/groups/par/documents/websiteresources
con120442.pdf. Takeda Pharmaceutical Company Limited, Latest News Release, March 23, 2009 (last accessed May 2026).
24. Approval of Variation PL 0095/0218, Prostap SR 3.75mg (endometriosis).
25. Approval of Variation PL 0095/0218, Prostap SR 3.75mg (uterine fibroids).
26. Takeda UK Ltd. Data on file. UK/DF/1405/0020.

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