Published

May 11, 2025

Apalutamide in combination with androgen deprivation therapy (ADT) [APA2]

For the treatment of patients with newly diagnosed metastatic hormone-sensitive prostate cancer who are ineligible for chemotherapy with docetaxel where the following criteria have been met:

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with apalutamide 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 currently received androgen deprivation therapy (ADT) for no longer than 3 months before starting an androgen receptor targeted agent. 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 received no more than 3 months of ADT before starting an androgen receptor targeted agent
  1. The patient has not received any upfront docetaxel chemotherapy for metastatic hormone sensitive prostate cancer.
  2. The patient has an ECOG performance status (PS) of 0 or 1 or 2.
  3. The prescribing clinician has assessed this patient’s status as regards receiving upfront docetaxel and have concluded that the patient is ineligible for docetaxel on the grounds of either having significant comorbidities (i.e. the patient should not be treated with docetaxel) or the patient is fit for upfront docetaxel but after fully informed consent has chosen not to receive upfront docetaxel. Please mark below which of these 3 clinical scenarios applies to this patient:
  • the patient has significant comorbidities which preclude 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 apalutamide
  • 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 apalutamide; that the use of upfront apalutamide 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 apalutamide (i.e. the patient is fit for chemotherapy with docetaxel and has CHOSEN NOT to be treated with docetaxel)
  1. Apalutamide is being given only in combination with ADT.
  2. The patient has not previously received any androgen receptor targeted agent unless the patient has either received enzalutamide or abiraterone 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 4 clinical scenarios applies to this patient:
  • the patient has not previously received any androgen receptor targeted agent
  • the patient commenced enzalutamide 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 commenced abiraterone 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. The patient has not previously received any apalutamide or any other androgen receptor targeted agent unless the patient has received apalutamide via a company early access scheme and the patient meets all the other criteria listed here.
  2. Apalutamide is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment.
  3. A formal medical review as to how apalutamide is being tolerated and whether treatment with apalutamide should continue or not will be scheduled to occur at least by the start of the third 4-weekly cycle of treatment. 12.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. Apalutamide is to be otherwise used as set out in its Summary of Product Characteristics.

NHS funded From: 26 January 2022

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA741 (28 October 2021)

Current Form Version

Note

The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.

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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