Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
- for cytoreduction before brachytherapy
- in combination with radiotherapy for the treatment of high-risk localized prostate cancer
- for palliative treatment of recurrent, progressive or metastatic prostate cancer
(Various dosage strengths and dose schedules available.)
7.5 mg EVERY MONTH
22.5mg EVERY 3 MONTHS
30mg EVERY 4 MONTHS
45mg EVERY 6 MONTHS
(Outpatient prescription in fixed-dose injection kits of 7.5mg, 22.5mg, 30mg, 45mg)
*Route of administration depends on product brand and formulation. Refer to the leuprolide drug monograph.
(Outpatient prescription in multiples of 50mg tablets)
Duration of therapy is dependent on the indication.
- Neoadjuvant - Generally up to 6 months in duration
- Adjuvant - Generally up to 3 years
- Palliative - Continue until disease progression
Doses should be modified according to the protocol by which the patient is being treated. The following recommendations have been adapted from clinical trials or product monographs and could be considered.
Dosage with toxicity
No adjustment required
Cardiotoxicity, arterial or venous thromboembolism
Grade 3 or 4 LFT increases
Hold until recovery then restart. If recurs consider discontinuing
No adjustment required
Leuprolide: No adjustment required. See table above for management of drug-related hepatotoxicity.
No adjustment needed
Bicalutamide and leuprolide: No adjustment required
Most Common Side Effects
Less Common Side Effects, but may be
- Outpatient prescription; administer in Cancer Centre or physician’s office
- Vary injection site
- For long-acting preparations, reconstitute with supplied diluent immediately before injection as directed (see product monograph).
- Do not give multiple monthly injections together to make up a q3 or q4 month dose, as the release characteristics are different
Lupron Depot® 7.5mg, 22.5mg and 30mg:
- For Intramuscular use only.
- Usual sites of injection include the anterior thigh, gluteal area or deltoid. Vary injection sites.
- Store at room temperature.
Eligard® 7.5mg, 22.5mg, 30mg, and 45mg:
- For Subcutaneous use only. Choose an injection site on the abdomen, upper buttocks, or anywhere with adequate amounts of subcutaneous tissue.
- Keep refrigerated, or may be stored at room temperature in original packaging for a period of 8 weeks before administration.
- Allow product to reach room temperature before using.
- Outpatient prescription for home administration
- May be taken with or without food
- contraindicated in patients with hypersensitivity to the drug, its components or similar nonapeptides
- contains benzyl alcohol and may cause local reactions.
- Use with caution in patients with osteoporosis (or risk factors for osteoporosis), diabetes, risk factors for QT prolongation, history of depression, cardiovascular disease, metastatic vertebral lesions and/or urinary tract obstruction due to the risk of disease flare, and in patients at risk of convulsions
- contraindicated in patients with hypersensitivity to the drug or any of its components, in localized prostate cancer undergoing ”watchful waiting”, in females and children.
- results in fluid retention and should be used with caution in patients with cardiac disease as well as in patients at risk for prolonged QTc.
- contains lactose; use should be carefully considered in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
- effects on long-term fertility have not been established; may lead to inhibition of spermatogenesis.
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Recommended Clinical Monitoring
- Blood glucose/HbA1c; baseline and periodic, especially in diabetic patients
- EKG, Electrolytes (including K, Ca, Mg); baseline, also regular for patients at risk of electrolyte abnormality and QT prolongation
- Liver function tests; baseline and regular
- PSA; baseline and periodic
- Clinical assessment for disease flare, osteoporosis, injection site reactions, fluid retention, pneumonitis, androgen withdrawal effects, psychiatric, cardiovascular, hepatic effects and thromboembolism; at each visit
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
- Hemoglobin; baseline and periodic
Outpatient prescription; Leuprolide drug administration at Cancer Centre or physician's office
Bicalutamide and leuprolide drug monographs, Cancer Care Ontario.
Crook JM, O'Callaghan CJ, Duncan G, et al. Intermittent androgen suppression for rising PSA levels after radiotherapy. N Engl J Med 2012;367:895-903.
Denham JW, Steigler A, Lamb DS, et al. Short-term neoadjuvant androgen deprivation and radiotherapy for locally advanced prostate cancer: 10-year data from the TROG 96.01 randomised trial. Lancet Oncol 2011;12(5):451-9.
Heidenreich A, Bellmunt J, Bolla M, et al. EAU Guidelines on Prostate Cancer. Part 1: Screening, Diagnosis, and Treatment of Clinically Localised Disease. European Urology 2011;59:61-71.
Loblaw DA, Virgo KS, Nam R, et al. Initial Hormonal Management of Androgen-Sensitive Metastatic, Recurrent, or Progressive Prostate Cancer: 2007 Update of an American Society of Clinical Oncology Practice Guideline. J Clin Oncol 2007; 25: 1596-605.
Mottet N, Bellmunt J, Bolla M, et al EAU guidelines on prostate cancer. Part II: Treatment of advanced, relapsing, and castration resistant prostate cancer. European Urology 2011:59;572-83.
October 2017 Aligned dosing with ST-QBP, modified drug administration and special precautions section
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph. Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.