The National Institute for Clinical Excellence (NICE) has just approved the use of a new drug, Darolutamide, as an option for treating hormone-relapsed prostate cancer in adults at high risk of developing metastatic disease. This stage of the disease is variably described as:
- Non-metastatic castrate resistant prostate cancer
- Non-metastatic hormone resistant prostate cancer
- Non-metastatic hormone relapsed prostate cancer
- Biochemical recurrence of prostate cancer
Such terms can be confusing for patients. However, the journey that many patients can relate to is:
- Localised disease treated with surgery or radiotherapy (or a combination of both)
- A subsequent rise in PSA treated successfully with hormone therapy (Androgen Deprivation Therapy – ADT)
- A further subsequent rise in PSA as ADT fails to work.
High risk patients are defined by NICE as having a PSA level of 2ng/ml or more and a doubling time of less than 10 months. It is frequently found in patients who have few physical symptoms and where, by definition, conventional scanning shows no detectable metastases. These patients will inevitably progress to the metastatic phase – often quite rapidly – when significant symptoms of bone pain or even pathological fractures will require strong analgesics and quality of life will be significantly diminished. In this metastatic phase, both Abiraterone and Enzalutamide can be prescribed. Neither are approved for use in the non-metastatic phase. Chemotherapy with docetaxel could also be offered as an alternative if it is appropriate.
None of these men expect miracle cures at this non-metastatic stage of their disease, but they now have the chance of an increase in both quality and quantity of life. For them and for their families it is a major step-change in the possibilities for treatment.
Darolutamide is the first (and currently only) drug to be approved for use at this stage of prostate cancer. The drug can not only slow the progression of their cancer but potentially also increase length of life.
For patients and for their families it is a major advance in the possibilities for treatment. By their approval of Darolutamide, NICE have acknowledged an area of great unmet need.
This decision does not apply to Scotland, but the Scottish Medicines Consortium are already in the process of appraising Darolutamide for similar usage.
Further information from Steve Allen, Tackle Patient Representative: firstname.lastname@example.org