Enzalutamide in combination with androgen deprivation therapy (ADT) [ENZ3]

For the treatment of patients with newly diagnosed metastatic hormone-sensitive prostate cancer where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with enzalutamide will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. This patient either has a proven histological or cytological diagnosis of adenocarcinoma of the prostate or has presented with a clinical picture consistent with metastatic prostate cancer with both widespread bone metastases radiologically typical of prostate cancer and a serum PSA of ≥50 ng/mL.
  3. This patient has newly diagnosed metastatic prostate cancer that is hormone sensitive and has either not been treated with docetaxel and has currently received androgen deprivation therapy (ADT) for no longer than 3 months or has been treated with docetaxel and has received ADT for no more than 9 months. Please enter below as to which scenario applies to this patient:
  • the patient has not yet received any ADT for metastatic prostate cancer
  • the patient has not been treated with docetaxel and has received no more than 3 months of ADT (before starting an androgen receptor targeted agent)
  • the patient has been treated with docetaxel and has received no more than 9 months of ADT
  1. The patient has an ECOG performance status (PS) of 0 or 1 or 2.
  2. The prescribing clinician has assessed this patient’s status as regards receiving upfront docetaxel and have concluded that the patient completed planned docetaxel therapy or discontinued docetaxel before completion of planned treatment duration or should not have been treated with docetaxel or chose not to be treated with docetaxel. Please mark which of these 4 clinical scenarios applies to this patient:
  • the patient was treated with docetaxel and completed a planned treatment duration of 6 cycles of docetaxel
  • the patient commenced docetaxel and discontinued docetaxel prior to completion of 6 cycles on account of excessive toxicity (i.e. the patient COULD NOT complete planned treatment duration with docetaxel)
  • the patient had significant comorbidities which precluded treatment with docetaxel (i.e. the patient SHOULD NOT be treated with docetaxel) and this has been fully discussed with the patient. It is recommended that validated systems of scoring clinical frailty are used as part of the oncology assessment as to explaining the benefits and risks of the treatment options of chemotherapy and enzalutamide
  • the patient is fit for chemotherapy with docetaxel and has chosen not to be treated with docetaxel. The patient has been fully consented regarding all of the following: the advantages and disadvantages of upfront docetaxel chemotherapy vs upfront enzalutamide; that the use of upfront enzalutamide would result in there being no further possible treatment with any androgen receptor targeted agents when the patient’s disease progresses; and that the patient may not be fit enough to receive docetaxel when the patient‘s disease progresses. After such informed consent, I confirm that the patient has chosen to receive upfront enzalutamide (i.e. the patient is fit for chemotherapy with docetaxel and has CHOSEN NOT to be treated with docetaxel)
  1. Enzalutamide is being given in combination with ADT.
  2. The patient has not previously received any androgen receptor targeted agent unless the patient has either received apalutamide for newly diagnosed metastatic hormone-sensitive prostate cancer which had to be stopped because of dose- limiting toxicity in the clear absence of disease progression and the patient meets all the other criteria listed on this form or the patient has progressive disease following treatment with 2 years of ADT plus abiraterone with or without enzalutamide for high risk non-metastatic disease as part of the STAMPEDE trial (ISRCTN78818544) and did not progress whilst on such treatment and the patient meets all the other criteria listed on this form. Please mark below which of these 3 clinical scenarios applies to this patient:
  • the patient has not previously received any androgen receptor targeted agent
  • the patient commenced apalutamide which had to be stopped because of dose-limiting toxicity in the clear absence of disease progression and the patient meets all the other criteria listed here
  • the patient was treated with 2 years of ADT plus abiraterone with or without enzalutamide for high risk non-metastatic disease as part of the STAMPEDE trial and did not progress whilst on such treatment and the patients meets all the other criteria listed here.
  1. Enzalutamide is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment.
  2. A formal medical review as to how enzalutamide is being tolerated and whether treatment with enzalutamide should continue or not will be scheduled to occur at least by the start of the third 4-weekly of treatment.
  3. Where a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, I will complete a treatment break approval form to restart treatment, including indicating as appropriate if the patient had an extended break because of COVID 19.
  4. Enzalutamide is to be otherwise used as set out in its Summary of Product Characteristics.

[NHS funded]{.badge .rounded-pill .bg-success} From: 05 October 2021

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NICE Technology Appraisal: TA712 (07 July 2021)

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