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Prostate locally advanced or metastatic degarelix

Check for clinical trials in this patient group. Link to Australian Clinical Trials website

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The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1

Day 1
Degarelix 240 mg (Subcut) (starting dose) administered as two subcutaneous injections of 120 mg

Cycle 2 and further cycles

Day 1
Degarelix 80 mg (Subcut) (maintenance dose) administered as a single subcutaneous injection
Frequency:
28 days 
Cycles:
Continuous until disease progression or unacceptable toxicity

The supportive therapies (e.g. antiemetics, premedications, etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Cycle 1

Day 1
Degarelix 240 mg (Subcut) (starting dose) administered as two subcutaneous injections of 120 mg

Cycle 2 and further cycles

Day 1
Degarelix 80 mg (Subcut) (maintenance dose) administered as a single subcutaneous injection
Frequency:
28 days 
Cycles:
Continuous until disease progression or unacceptable toxicity
  • Locally advanced (equivalent to stage C) or metastatic (equivalent to stage D) prostate cancer
Injection site reactions

This treatment has been associated with a high rate of injection site reactions (pain, erythema, swelling etc.) These reactions occurred more frequently with the starting dose and were transient and mostly mild to moderate.
Cardiovascular Risk

There may be a relation between androgen deprivation therapy (ADT) and cardiovascular events and death. The metabolic effects of ADT (increased body weight and abdominal girth, increased cholesterol and triglycerides, hyperinsulinaemia) may contribute to cardiovascular risk. Monitoring of blood pressure, lipid profile and blood glucose is recommended.
Bone mineral density (BMD)

Baseline BMD and repeat as clinically indicated. Lifestyle modification including regular exercise, particularly weight bearing exercises should be encouraged.
Blood tests

Lipid studies, calcium and vitamin D at baseline and repeat as clinically indicated. PSA and testosterone levels as clinically indicated.
Vaccinations

Live vaccines, including BCG, MMR, zoster and varicella vaccines, are contraindicated in cancer patients receiving immunosuppressive therapy and/or who have poorly controlled malignant disease.

Refer to the recommended schedule of vaccination for immunocompromised patients, as outlined in the Australian Immunisation Handbook.
Evidence for dose modifications is limited, and the recommendations made on eviQ are intended as a guide only. They are generally conservative with an emphasis on safety. Any dose modification should be based on clinical judgement, and the individual patient’s situation including but not limited to treatment intent (curative vs palliative), the antineoplastic regimen (single versus combination therapy versus chemotherapy versus immunotherapy), biology of the cancer (site, size, mutations, metastases), other treatment related side effects, additional co-morbidities, performance status and patient preferences. Suggested dose modifications are based on clinical trial findings, product information and reference committee consensus. Non-haematological gradings are based on Common Terminology Criteria for Adverse Events (CTCAE) unless otherwise specified. Renal and hepatic dose modifications have been standardised where possible. For more information see dosing considerations & disclaimer.
Renal impairment
No dose modification in mild to moderate renal impairment
No studies done in severe renal impairment
Hepatic impairment
No dose modification in mild to moderate hepatic impairment
No studies done in severe hepatic impairment

References & Disclaimer

Degarelix
  Interaction Clinical management
Drugs that may prolong the QTc interval (e.g. azole antifungals, tricyclic antidepressants, antiarrhythmics etc.) Additive effect with degarelix; may lead to torsades de pointes and cardiac arrest Avoid combination or minimise additional risk factors (e.g. correct electrolyte imbalances) and monitor ECG for signs of cardiac arrhythmia

Day 1

Subcutaneous injection

Degarelix

  • reconstitute this drug as per manufacturers instructions with the recommended diluent
  • administer immediately after reconstitution
  • via deep subcutaneous injection  
  • before injecting, gently pull back the plunger to check if blood is aspirated if blood appears in the syringe, the reconstituted product can no longer be used
  • discontinue the procedure and discard the syringe and needle (reconstitute a new dose for the patient)
  • rotate the injection site each time
  • do not massage or rub the injection site as this may disperse the depot resulting in altered release, avoid areas where the injection site is exposed to pressure i.e. waistband, rib area.

Discharge information

Patient information
  • Ensure patient receives patient information sheet.

The side effects listed below are not a complete list of all possible side effects for this treatment. Side effects are categorised into the approximate onset of presentation and should only be used as a guide.

Immediate (onset hours to days)
Flu-like symptoms

Early (onset days to weeks)
Hot flushes
Arthralgia and myalgia

Generalised joint pain or and/or stiffness and muscle aches, often worse upon waking or after long periods of inactivity. Can improve with movement. May be mild or severe, intermittent or constant and accompanied by inflammation. 

Read more about arthralgia and myalgia
Fatigue

Read more about fatigue
Constipation

Late (onset weeks to months)
Reduced libido and sexual dysfunction

Lowered sexual desire as well as any physical or psychological problem that interferes with the ability to have and/or enjoy sex. 
Gynaecomastia

Enlargement of male breast tissue usually due to hormone imbalance or hormone therapy

Delayed (onset months to years)
Osteoporosis
Risk of coronary artery disease

The evidence supporting this protocol comes from a 12-month, open-label, multi-centre, randomised phase III study comparing degarelix, a gonadotrophin-releasing hormone (GnRH) antagonist vs leuprorelin in achieving and maintaining testosterone suppression.r

A total of 620 patients were randomised to one of the following 3 regimens:

  1. Degarelix SC 240 mg (starting dose) for 1 month, followed by 80 mg monthly
  2. Degarelix SC 240 mg (starting dose) for 1 month, followed by 160 mg monthly
  3. Leuprorelin IM 7.5 mg monthly

The primary endpoint of the trial was suppression of testosterone to less than 0.5 ng/mL which was measured monthly.

Efficacy

Suppression of testosterone was achieved by 97.2%, 98.3% and 96.4% of patients in the degarelix 240/80 mg, degarelix 240/160 mg and the leuprorelin groups respectively. The median PSA levels at 14 and 28 days were significantly lower in the degarelix groups than in the leuprorelin group (P<0.001).r

© British Journal of Urology International 2008

Toxicity

The side effects of the three treatment groups were similar to previously reported effects for androgen-deprivation therapy. SC Degarelix was associated with a higher rate of injection-site reactions than with IM leuprorelin (40% vs < 1%; P<0.001). There were additional differences between the degarelix and leuprorelin groups for urinary tract infections (3% vs 9%; P<0.01), arthralgia (4% vs 9%; P<0.05) and chills (4% vs 0%; P<0.01).r

Cardiovascular side effects were reported by 13% and 9% of patients in the leuprorelin and degarelix groups respectively.r

There is currently no safety data on degarelix beyond 12 months and so the long term effects (cardiovascular complications and effects on bone mineral density) is not known.

© British Journal of Urology International 2008

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Version 3

Date Summary of changes
22/10/2010 New protocol taken to Medical Oncology Reference Committee meeting.
18/11/2010 Approved and published on eviQ.
22/02/2011 New format to allow for export of protocol information.
Protocol version number changed to V.2.
Additional Clinical Information, Key Prescribing table and Key Administration table combined into new section titled Clinical Considerations.
8/12/2011 Updated PHC view.
30/11/2012 Protocol reviewed at Medical Oncology Reference Committee meeting. No changes and next review in 2 years.
09/05/2014 Protocol reviewed by Medical Oncology Reference Committee meeting electronically; no changes. PHC view removed. Review 2 years.
31/03/2017 Protocol discussed and decided to have a 5 year review period. Next due for review in 2019.
31/05/2017 Transferred to new eviQ website. Protocol version number changed to V.3.
30/11/2017 Link to Androgen Deprivation Therapy (ADT) patient information sheet added to protocol and patient information.
25/03/2019 Protocol reviewed at Medical Oncology Reference Committee meeting on 15/03/2019. No changes. Next review in 5 years.

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/818

14 Jul 2020