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Prostate metastatic goserelin

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Cycle 1 and further cycles

Drug Dose Route Day
Goserelin 10.8 mg Subcut 1
Frequency:
12 weeks 
Cycles:
Continuous until disease progression or unacceptable toxicity
Drug status:

Goserelin is PBS restricted benefit

Cost:
~ $680 per 3 month "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

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 and further cycles

Day 1
Goserelin 10.8 mg (Subcut) inject subcutaneously into the upper anterior abdominal wall every 12 weeks (or 3 months)
Frequency:
12 weeks 
Cycles:
Continuous until disease progression or unacceptable toxicity

Cycle 1 and further cycles

Drug Dose Route Day
Goserelin 10.8 mg Subcut 1
Frequency:
12 weeks 
Cycles:
Continuous until disease progression or unacceptable toxicity
Drug status:

Goserelin is PBS restricted benefit

Cost:
~ $680 per 3 month "How this cost is calculated"

The cost displayed on the protocol is intended as rudimentary guide only for the Australian context.

The cost includes anti-cancer drugs only (not antiemetics, supportive medications or consumables), unless otherwise indicated.

Drug unit costs are taken directly from the Pharmaceutical Benefits Scheme (PBS) website (www.pbs.gov.au). These costs are reviewed and updated on eviQ at 6 monthly intervals. Anti-cancer drugs that are not included on the PBS do not have a cost included in eviQ protocols.

Where there are differing unit costs based on vial sizes and tablet strengths, the mean unit cost is used. The cost of oral continuous therapy is based on a 28 day month.

Where oral drugs are available on the PBS for both 30- and 60-day prescriptions, the unit cost for the 30-day supply is used.

The protocol cost is derived from drug dose calculations based upon a default body surface area (BSA) of 1.8 m2; weight of 75 kg; and creatinine clearance of 75 mL/min.

One off loading doses and ongoing maintenance doses are not included in protocol cost calculations.

The cost displayed is the actual drug cost and does not necessarily reflect the cost incurred by the patient as many anti-cancer drugs are reimbursed on the PBS.

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 and further cycles

Day 1
Goserelin 10.8 mg (Subcut) inject subcutaneously into the upper anterior abdominal wall every 12 weeks (or 3 months)
Frequency:
12 weeks 
Cycles:
Continuous until disease progression or unacceptable toxicity

Indications:

  • locally advanced or metastatic hormone sensitive prostate cancer

Caution:

  • GnRH (or LHRH) agonists (e.g. goserelin, leuprorelin, triptorelin) are contraindicated as a single agent in patients who have impending spinal cord compression, urinary obstruction or pain, due to the potential to exacerbate symptoms (see tumour flare below).
Tumour flare

Gonadotrophin-releasing hormone agonists (e.g. goserelin, leuprorelin and triptorelin) can cause short-term (2 to 3 weeks) stimulation of testosterone before suppression of androgen production, which may cause new or worsening signs and symptoms e.g. increased bone pain.

This syndrome can be prevented by administrating an antiandrogen (e.g. flutamide, bicalutamide or nilutamide) 1 to 2 weeks before first dose of gonadotrophin releasing hormone agonists and continuing for approximately 1 month in total.
Bone mineral density (BMD)

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

A reduction in glucose tolerance has been observed in males receiving GnRH (LHRH) agonists. This may manifest as diabetes or loss of glycaemic control in those with pre-existing diabetes mellitus. Consideration should therefore be given to monitoring of blood glucose and/or glycosylated haemoglobin (HbA1c) in patients receiving a GnRH agonist.
Supplements

Consider daily oral supplements of at least calcium 500 mg and vitamin D 400 International Units for the duration of the therapy.
Blood tests

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

Live 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.

Read more about COVID-19 vaccines and cancer.
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 anti-cancer 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, published guidelines and reference committee consensus . The dose reduction applies to each individual dose and not to the total number of days or duration of treatment cycle unless stated otherwise. 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.
Kidney dosing recommendations 
No dose modification necessary
Hepatic impairment
No dose modification necessary

The drug interactions shown below are not an exhaustive list. For a more comprehensive list and for detailed information on specific drug interactions and clinical management, please refer to the specific drug product information and the following key resources: 

For more information see References & Disclaimer.

Goserelin
  Interaction Clinical management
Drugs that may prolong the QTc interval (e.g. azole antifungals, tricyclic antidepressants, antiarrhythmics etc.) Additive effect with goserelin; 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

eviQ provides safe and effective instructions on how to administer cancer treatments. However, eviQ does not provide every treatment delivery option, and is unable to provide a comprehensive list of cancer treatment agents and their required IV line giving set/filter. There may be alternative methods of treatment administration, and alternative supportive treatments that are also appropriate. Please refer to the individual product information monographs via the TGA and Australian Injectable Drugs Handbook websites for further information.

Day 1

Subcutaneous injection

Goserelin SafeSystem™ implant

  • administer goserelin as a subcutaneous injection into the anterior abdominal wall (below the umbilicus):
    • apply local anaesthetic (e.g. EMLA®, LMX4®, lignocaine 1%) to the injection site (if indicated) and wait for it to take effect. An ice pack with no local anaesthetic may also be used
    • wipe residual topical anaesthetic cream from chosen injection site (if used).

For correct administration of Zoladex®, refer to the instructions supplied with the product:

  • put patient in a comfortable position with upper body slightly raised
  • swab abdominal injection site below the navel line
  • open pouch at the arrows and remove syringe
  • hold the syringe at a slight angle to the light
  • check that at least part of the goserelin implant is visible
  • grasp the plastic safety tab and pull away from the syringe and discard
  • remove the needle cover. Unlike liquid injections, there is no need to remove air bubbles and attempts to do so may displace the implant
  • hold the syringe around the protective sleeve
  • pinch the patient's skin and insert the needle at a slight angle 30 to 45 degrees to the skin, with the opening of the needle facing up, until the protective sleeve touches the patient's skin
  • do not penetrate into muscle or peritoneum
  • to discharge goserelin implant and to activate the protective sleeve, depress the plunger until you cannot depress it any further. If the plunger is not depressed fully the protective sleeve will NOT activate. You may hear a click and will feel the protective sleeve automatically begin to slide to cover the needle.
  • withdraw the needle and allow the protective sleeve to continue to slide and cover the needle
  • rotate the injection site each time to avoid soreness at any one site.

Continue safe handling precautions (reproductive risk only) for 7 days after completion of drug(s).

Discharge information

Supplements - daily oral supplements of calcium 500 mg and vitamin D 400 International Units are recommended.

Patient information

Ensure patient receives protocol 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)
Headache

Early (onset days to weeks)
Hot flushes
Tumour flare reaction

An increase in bone and/or tumour pain, associated with a transient increase in tumour size. This may occur after initiation with hormonal treatment.
Hyperglycaemia

High blood sugar, an excess of glucose in the blood stream.
Hyperlipidaemia and hypercholesterolaemia

Abnormally elevated levels of lipids and cholesterol in the blood.

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. 

Delayed (onset months to years)
Osteoporosis

The evidence supporting this regimen comes from a review by Loblaw et al. The initial review consisted of 10 randomised controlled trials, six systemic reviews and one Marko model to formulate the guidelines. Bilateral orchidectomy or luteinising hormone releasing hormone agonists (LHRH) are the recommended initial treatments.r An update of these guidelines were published in 2007 with no change in the above standard first-line treatments.r

A meta-analysis of the literature (10 RCTs, 1,908 patients) addressed the relative benefit of LHRH agonists with orchidectomy, diethylstilbestrol (DES), or the choice of DES or orchidectomy. No improvement in survival rate, time to progression of disease, or time to treatment failure was observed (which included drug discontinuations indicative of adverse events in the medically managed patients). Two-year hazard ratio for OS was 1.26 (95% CI, 0.91 to 1.39) compared to orchidectomy.r

Efficacy

Meta-analysis of the literature reporting survival at 2 years for different androgen deprivation therapiesr

DES: diethylstilbestrol

© Annals of Internal Medicine 2000

Toxicity

Event/Reactionr Maximum androgen blockade**
(n=102)		 LHRH agonist monotherapy***
(n=101)
Adverse event
(%)		 Adverse drug reactions
(%)		 Adverse event
(%)		 Adverse drug reactions
(%)
Any* 88.2 59.8 83.2 58.4
Any serious* 14.7 2.9 14.9 6.9
Any grade 3/4 13.7 5.9 17.8 9.9
Hot flushes 19.6 18.6 31.7 31.7
Nasopharyngitis* 18.6 1.0 12.9 1.0
Any abnormal hepatic function test N/A 13.7 N/A 17.8
Back pain 10.8 1.0 5.9 2.0
Anaemia 8.8 7.8 5.0 4.0
Increased blood alkaline phosphatase 8.8 8.8 5.0 4.0
Increased alanine aminotransferase 7.8 2.9 10.9 7.9
Increased blood lactate dehydrogenase 7.8 3.9 6.9 3.0
Pruritus* 7.8 0.0 2.0 0.0
Increased aspartate aminotransferase 6.9 2.9 8.9 6.9
Arthralgia 6.9 0.0 3.0 0.0
Ezcema 6.9 3.9 2.0 1.0
Increased y-glutamyltransferase 5.9 3.9 5.0 3.0
Constipation* 2.9 0.0 7.9 1.0
Abnormal hepatic function 2.0 1.0 6.9 5.9

*adverse events with a frequency greater than 5% between the arms

** maximum androgen blockade (goserelin/leuprorelin + bicalutamide 80 mg)

*** LHRH (luteinizing hormone-releasing hormone): goserelin or leuprorelin

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Bibliography

Australian Medicines Handbook Pty Ltd. January 2011 Edition

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Version 5

Date Summary of changes
31/01/2024

Protocol assessed by eviQ medical oncology reference committee and deemed suitable to be reviewed as required. Flag added, review date removed and version number increased to V.5. Read more about as required review protocol status in this factsheet.

Version 4

Date Summary of changes
27/07/2023

Protocol updated with ADDIKD guideline recommendations. 

PDF of previous protocol.

Version number changed to V.4.

Version 3

Date Summary of changes
11/01/2010 Review, new dose modifications and transferred to eviQ.
21/02/2011 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.
06/01/2012 PHC view updated.
12/04/2013 Protocol reviewed by Medical Oncology Reference Committee via email. 
Option to use monthly administration removed.
Toxicity table added.
Next review in 2 years.
09/05/2014 Protocol reviewed electronically by Medical Oncology Reference Committee; no change. PHC view removed. Next 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. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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Review due:
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https://www.eviq.org.au/p/308

10 Sep 2024