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A - Regimen Name

 

BICAGOSE Regimen
Bicalutamide-Goserelin

 

 

Disease Site
Genitourinary - Prostate

 

 

Intent
Neoadjuvant
Adjuvant
Palliative

 

 

Regimen Category
Evidence-Informed :

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.

 

 

Rationale and Uses
  • 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

 

 

 

 

 

 

Supplementary Public Funding

goserelin
ODB - General Benefit (goserelin) (

ODB Formulary

)
 

 

bicalutamide
ODB - General Benefit (bicalutamide) (

ODB Formulary

)
 

 

 

 
B - Drug Regimen

 

goserelin
 

3.6mg             SC depot                  EVERY 4 WEEKS
OR
10.8mg           SC depot                  EVERY 3 MONTHS (Q 13 weeks)
(Outpatient prescription in fixed-dose injection kits of 3.6mg and 10.8mg)

bicalutamide
 
50 mgPODaily
(Outpatient prescription in multiples of 50mg tablets)
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C - Cycle Frequency

 

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

 

 
D - Premedication and Supportive Measures
 
Antiemetic Regimen:

Not applicable

 
E - Dose Modifications

 

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

 

Goserelin
Dosage with myelosuppression:  No adjustment required.

Bicalutamide:

Toxicity Action
Myelosuppression No adjustment required
PneumonitisHold; investigate.  If confirmed, discontinue.
Cardiac failure, arterial or venous thromboembolismDiscontinue
Grade 3 or 4 LFT increasesDiscontinue

 

 

Hepatic Impairment

Goserelin:  No adjustment required.

Bicalutamide:  No adjustment required in the presence of mild hepatic impairment. Caution should be exercised in moderate to severe hepatic impairment, as bicalutamide is extensively metabolized in the liver. Elimination is lower in subjects with severe hepatic impairment, leading to increased accumulation.
 

Renal Impairment

Goserelin:  No adjustment required. (Although half-life is longer in patients with CrCl < 20 mL/min, it is not likely to cause drug accumulation.)

Bicalutamide:  No adjustment required.
 
 
Dosage in the elderly:
 
Goserelin:  No adjustment required. 

Bicalutamide:  No adjustment required.
 
 
Children:
 
Goserelin:  Safety and efficacy not established.

Bicalutamide:  Do not use.
 
F - Adverse Effects

Refer to goserelin, bicalutamide drug monograph(s) for additional details of adverse effects

 

Most Common Side Effects

Less Common Side Effects, but may be
Severe or Life Threatening

  • Androgen withdrawal symptoms
  • Myelosuppression (mild)
  • Musculoskeletal pain
  • Diarrhea / constipation
  • Fatigue
  • Nausea/vomiting
  • Cough, dyspnea (may be severe)
  • Edema
  • Abdominal pain
  • Infection
  • Urinary symptoms
  • Dizziness
  • Osteoporosis
  • ↓ Glucose tolerance
  • Cardiotoxicity, arrhythmia
  • Arterial thromboembolism
  • Venous thromboembolism
  • GI obstruction/hemorrhage
  • Hypersensitivity
  • ↑ LFTs
  • Pneumonitis
  • Pituitary hemorrhage
  • Injection site injury/vascular injury
 
G - Interactions

Refer to goserelin, bicalutamide drug monograph(s) for additional details

Goserelin:

  • Caution with concomitant QT-prolonging drugs, as androgen deprivation can have an additive QT-prolonging effect.


Bicalutamide:

  • Bicalutamide inhibits CYP3A4 (and 2C9, 2C19, 2D6 to a lesser extent); exercise caution when using drugs metabolized by CYP enzymes, especially those with a narrow therapeutic index.
  • Bicalutamide displaces warfarin from protein binding, and can increase prothrombin time.
  • Monitor when used with concomitant QT-prolonging drugs, as bicalutamide and goserelin (see above) can have an additive QT-prolonging effect.
 
H - Drug Administration and Special Precautions

Refer to goserelin, bicalutamide drug monograph(s) for additional details
 

Administration:

Goserelin:

  • Subcutaneous injection of the depot into the anterior abdominal wall, below the naval line. Injection usually given at the Cancer Centre or physician's office. Should be administered by a healthcare professional experienced in administering deep subcutaneous injections under the supervision of a physician. Drug supplied by outpatient prescription.
  • Store in original packaging between 2ºC and 25ºC. Protect from light and moisture. 

Bicalutamide:

  • Outpatient prescription for home administration.
  • May be taken with or without food.


Contraindications:

Goserelin:

  • In patients who have a hypersensitivity to this drug or any of its components.
  • In females with undiagnosed abnormal vaginal bleeding.

Bicalutamide:

  • In patients with hypersensitivity to the drug or any of its components.
  • In localized prostate cancer undergoing "watchful waiting"
  • In females and children.

 

 

Other Warnings/Precautions:

Goserelin:

  • 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. 
  • Patients who experience anaphylaxis/anaphylactoid shock while on goserelin may require removal of the implant. If implant removal is necessary, it may be located by ultrasound.
  • Goserelin required administration by deep subcutaneous injection and is not recommended in patients with low body mass index (BMI <18.5) or in patients who are fully anticoagulated (INR >2).

Bicalutamide:

  • Bicalutamide 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.
  • It contains lactose; use should be carefully considered in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
     

Pregnancy and Lactation:

Goserelin:

  • Genotoxicity: No
  • Embryotoxicity: Yes
  • Fetotoxicity: Yes
    Not recommended for use in pregnancy. Adequate non-hormonal contraception must be used by both sexes during treatment and for at least 6 months after goserelin cessation (general recommendation).
  • Breastfeeding: Not recommended.
    Goserelin is secreted into milk in animals.
  • Fertilitiy effects: Fertility may be affected in males and females, but may be reversible.

Bicalutamide:

  • Bicalutamide has shown to be non-genotoxic, but is fetotoxic and is contraindicated in pregnancy and nursing.
  • It effects on long-term fertility have not been established.
  • Bicalutamide may lead to inhibition of spermatogenesis. 
 
I - Recommended Clinical Monitoring

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

  • Liver function tests; baseline and regular
  • Clinical assessment of disease flare, pneumonitis, androgen withdrawal symptoms, osteoporosis, injection site reactions, hepatic, lung or cardiovascular effects, hyperglycemia, thromboembolism, signs of abdominal hemorrhage 
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • Hemoglobin; baseline and periodic

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J - Administrative Information
Outpatient prescription; Goserelin to be injected at Cancer Centre or physician's office
 
 
 
K - References

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: 2006 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 updated adverse effects, added interactions, administration and precautions

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M - Disclaimer

Regimen Abstracts
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.
Regimen Monographs
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.
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