Darolutamide in combination with androgen deprivation therapy (ADT) [DARO1]

For the treatment of non-metastatic hormone-resistant (castration-resistant) prostate cancer in patients who are at high risk of developing metastatic disease where the following criteria have been met

  1. This application is being made by and the first cycle of systemic anti-cancer therapy with darolutamide will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. This patient has a proven histological or cytological diagnosis of adenocarcinoma of the prostate without neuroendocrine differentiation or features of a small cell carcinoma.
  3. This patient has non-metastatic prostate cancer as defined by recent imaging with conventional imaging with both a whole body isotope bone scan and a CT/MR scan of the chest, abdomen and pelvis. Note: patients with the sole abnormality of pelvic lymph nodes measuring <2cm in short axis diameter and which are below the aortic bifurcation are eligible for darolutamide in this indication.
  4. The patient has hormone-resistant (castrate-resistant) disease as defined by 3 rising PSA levels (after the nadir PSA level) and taken at least 1 week apart during androgen deprivation therapy.
  5. The patient’s serum testosterone level is <1.7nmol/L on gonadotrophin releasing hormone agonist/antagonist therapy or after bilateral orchidectomy.
  6. The current PSA level is ≥2ng/ml.
  7. The patient is at high risk of developing metastatic disease as defined by a PSA doubling time of ≤10 months. Please document the actual PSA doubling time in the box below:
  8. The patient has an ECOG performance status of either 0 or 1 or 2.
  9. The patient has not previously received any 2nd generation androgen receptor inhibitors (such as enzalutamide, darolutamide, apalutamide) or CYP17 enzyme inhibitors (such as abiraterone) unless the patient received apalutamide for non-metastatic hormone-resistant (castration-resistant) 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. Please mark below which of these 2 clinical scenarios applies to this patient:
  • the patient has not previously received any androgen receptor targeted agent
  • the patient received apalutamide for non-metastatic hormone-resistant (castration-resistant) 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
  1. Darolutamide is being given only in combination with androgen deprivation therapy.
  2. Darolutamide is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment.
  3. A formal medical review as to how darolutamide is being tolerated and whether treatment with darolutamide should continue or not will be scheduled to occur at least by the start of the third 4-weekly cycle of treatment.
  4. Where a treatment break of more than 6 weeks beyond the expected 4-week 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 COVID19.
  5. Darolutamide is to be otherwise used as set out in its Summary of Product Characteristics

[NHS funded]{.badge .rounded-pill .bg-success} From: 23 February 2021

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CDF Managed Access: NA

NICE Technology Appraisal: TA660 (25 November 2020)

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