Abiraterone [ABI1]

Abiraterone for treating metastatic hormone-relapsed prostate cancer before chemotherapy is indicated

  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. 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 hormone-relapsed (castrate-resistant) metastatic prostate cancer.
  4. The patient has no or only mild symptoms after androgen deprivation therapy has failed.
  5. Chemotherapy is not yet indicated.
  6. One of the following applies to this patient as regards any previous use of 2nd generation receptor inhibitors (such as enzalutamide, darolutamide or apalutamide) or CYP17 enzyme inhibitors (such as abiraterone). Please enter below as to which scenario applies to this patient:
  • the patient has not been previously received any treatment with enzalutamide or darolutamide or apalutamide or abiraterone or
  • the patient has previously received enzalutamide for this same pre-chemotherapy indication in hormone-relapsed (castrate-resistant) prostate cancer but it was stopped within 3 months of it starting due to dose-limiting toxicity and in the clear absence of disease progression
  1. Abiraterone is to be given in combination with prednisolone
  2. The patient has an ECOG performance status (PS) of 0 or 1 or 2.
  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 4-weekly cycle of treatment.
  5. 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.
  6. Abiraterone is to be otherwise used as set out in its Summary of Product Characteristics.

[NHS funded]{.badge .rounded-pill .bg-success} From: 26 July 2016

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CDF Managed Access: NA

NICE Technology Appraisal: TA387 (27 April 2016)

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