NICE (the National Institute for Health and Care Excellence) has published its latest technology appraisal guidance (TA1109) on the use of darolutamide with androgen deprivation therapy for treating hormone-sensitive metastatic prostate cancer (NICE, 2025). The new guidance states that darolutamide with androgen deprivation therapy can be used for treating people with hormone-sensitive metastatic prostate cancer if docetaxel is not suitable and if the company provide darolutamide according to a commercial arrangement agreed with NICE. 
 
Clinicians are advised to use the least expensive option of the suitable treatments (including darolutamide with androgen deprivation therapy and apalutamide with androgen deprivation therapy), having discussed the advantages and disadvantages of the available treatments with the person with the condition. 
 

Why these recommendations were made

Usual treatment for hormone-sensitive metastatic prostate cancer usually includes androgen deprivation therapy. Androgen deprivation therapy may be given alone, or with enzalutamide, apalutamide, docetaxel, or darolutamide plus docetaxel. Darolutamide plus androgen deprivation therapy works in a similar way to enzalutamide plus androgen deprivation therapy and apalutamide plus androgen deprivation therapy. It would be offered to the same population as apalutamide plus androgen deprivation therapy, ie people who cannot have docetaxel. Docetaxel may be contraindicated in patients with:
1. Severe prior hypersensitivity reaction to taxanes
2. Poor overall performance status (WHO performance status 3-4, caution for those with performance status 2)
3. Pre-existing significant peripheral neuropathy
4. Poor bone marrow function as a result of extensive disease or other prior haematological problems
5. Significant comorbidity (e.g. cardiovascular or respiratory disease) such that prostate cancer is not likely to be the life-limiting illness for the patient.
 
Clinical trial evidence shows that darolutamide plus androgen deprivation therapy is more effective than placebo (Saad et al, 2024). Darolutamide plus androgen deprivation therapy has not been directly compared in a clinical trial with apalutamide plus androgen deprivation therapy, but indirect comparisons suggest that it is likely to be as effective.
 
A cost comparison suggests that the costs for darolutamide plus androgen deprivation therapy are similar to or lower than those for apalutamide plus androgen deprivation therapy.