Published

December 13, 2024

Abiraterone In combination with androgen deprivation therapy (ADT) [ABI4]

For the treatment of newly diagnosed high risk 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 abiraterone will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The 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 at least 50 ng/mL.
  3. The patient has newly diagnosed high risk metastatic prostate cancer that is hormone sensitive. Note: patients who fulfil the clinical picture of metastatic prostate cancer as outlined in criterion 2 above but who do not have histological or cytological confirmation are considered to have high risk metastatic disease. Note: an exception to this criterion is for the maintained supply of abiraterone following trial closure for patients who entered the STAMPEDE prostate cancer trial (ISRCTN78818544) and who continue to benefit from abiraterone treatment.
  4. The patient has an ECOG performance status of either 0 or 1 or 2.
  5. This patient has either not been treated with docetaxel and has currently received androgen deprivation therapy (ADT) for no longer than 3 months before starting an androgen receptor targeted agent or has been treated with docetaxel and has currently 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 or
  • the patient has not been treated with docetaxel and has currently received no more than 3 months of ADT before starting an androgen receptor targeted agent or
  • the patient has been treated with docetaxel and has currently received no more than 9 months of ADT before starting an androgen receptor targeted agent
  1. The prescribing clinician has assessed this patient’s status as regards receiving upfront docetaxel and has 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 below 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 the 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 abiraterone
  • 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 abiraterone; that the use of upfront abiraterone 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 abiraterone (i.e. the patient is fit for chemotherapy with docetaxel and has CHOSEN NOT to be treated with docetaxel) Note: an exception to this criterion is for the maintained supply of abiraterone following trial closure for patients who entered the STAMPEDE prostate cancer trial (ISRCTN78818544) and who continue to benefit from abiraterone treatment.
  1. The patient has not previously received any androgen receptor targeted agent unless the patient has received enzalutamide or apalutamide or darolutamide 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 here 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 or the patient has high risk hormone sensitive prostate cancer treated with abiraterone as part of the STAMPEDE trial and has not progressed whilst on such treatment and the patient meets all the other criteria listed on this form. Please mark below which of these 4 clinical scenarios applies to this patient:
  • the patient has not previously received any androgen receptor targeted agent
  • the patient commenced enzalutamide/apalutamide/darolutamide 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
  • the patient has high risk hormone sensitive prostate cancer treated with abiraterone as part of the STAMPEDE trial and has not progressed whilst on such treatment and the patient meets all the other criteria listed on this form
  1. Abiraterone plus prednisolone is being given in combination with ADT.
  2. The prescribing clinician is aware that the licensed dose of prednisolone in this abiraterone indication is 5mg once daily.
  3. Abiraterone is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment.
  4. A formal medical review as to how abiraterone is being tolerated and whether treatment with abiraterone should continue or not will be scheduled to occur at least by the start of the third cycle of treatment.
  5. No treatment breaks of more than 6 weeks beyond the expected cycle length are allowed (to allow any toxicity of current therapy to settle or intercurrent comorbidities to improve).
  6. Abiraterone is to be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 13 December 2024

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CDF Managed Access: NA

NICE Technology Appraisal: reference NHSE Urgent Interim Proposition 2424 (13 December 2024)

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Note

The data on this page was produced using version 1.338 of the CDF list, downloaded from an archive of NHS England’s website on 11 January 2025 at 21:05.

If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.

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