Darolutamide in combination with docetaxel and androgen deprivation therapy (ADT) [DARO2]
For the treatment of patients with newly diagnosed metastatic hormone-sensitive prostate cancer where the following criteria have been met:
- 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.
- 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.
- This patient has TNM M1 metastatic prostate cancer as documented on conventional imaging of isotope bone scanning, CT and/or MR scans.
- This patient has newly diagnosed metastatic prostate cancer that is hormone sensitive and has currently received androgen deprivation therapy (ADT) for no longer than 12 weeks. 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 12 weeks of ADT for metastatic prostate cancer
- The patient is fit enough for docetaxel chemotherapy, has consented such treatment and has not yet commenced upfront docetaxel chemotherapy for metastatic hormone sensitive prostate cancer.
- The patient has an ECOG performance status (PS) of 0 or 1. Please enter below as to which ECOG performance status applies to this patient:
- ECOG OS 0 or
- ECOG PS 1
- Darolutamide is being given in combination with both docetaxel and ADT.
- The patient has not previously received any androgen receptor targeted agent such as enzalutamide or apalutamide or abiraterone unless the patient has progressive metastatic disease following completion of 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 2 clinical scenarios applies to this patient:
- the patient has not previously received any androgen receptor targeted agent
- the patient has progressive metastatic disease following completion of treatment 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.
- Darolutamide is to be continued until disease progression or unacceptable toxicity or patient choice to stop treatment. Note: patients who discontinue docetaxel due to unacceptable toxicity may continue with darolutamide if that treatment-limiting toxicity is deemed to be due to the docetaxel.
- The patient will receive a maximum of 6 cycles of docetaxel chemotherapy.
- 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 3-weekly combination cycle of treatment.
- Where a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, a treatment break approval form will be completed to restart treatment.
- Darolutamide is to be otherwise used as set out in its Summary of Product Characteristics.
NHS funded From: 19 September 2023
Additional information
Current Form Version
Note
The data on this page was produced using version 1.363 of the CDF list, downloaded from an archive of NHS England’s website on 16 May 2025 at 14:00.
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.