6 minutes Adam Gaines

Prostate Scotland welcomes SMC acceptance of darolutamide for prostate cancer in Scotland.

Statement from Prostate Scotland.
We very much welcome the decision earlier today of the Scottish Medicines Consortium to make darolutamide available as an option on the NHS in Scotland for the treatment of non-metastatic castrate resistant prostate cancer. This is a very welcome and positive decision which will potentially benefit men with prostate cancer where the prostate cancer is at high risk of spreading and no longer responds to medical or surgical treatment that lowers testosterone.

Research has shown that treatment for men with non-metastatic castrate resistant (nmCRPC) prostate cancer with darolutamide in combination with hormone treatment could lead to increased metastasis free survival by comparison with men receiving hormone treatment alone[i]). Further research from the trial has also shown a 31% reduction in risk of death from darolutamide by comparison with a placebo [ii].  Men with prostate cancer in Scotland supported darolutamide’s availability for men with nmCRPC, where it was clinically indicated it was likely to be beneficial, given the potential for delaying progression of the cancer.

For men with high risk non-metastatic prostate cancer there are currently few treatment options to help stop the prostate cancer spreading where hormone treatment has stopped working. Whilst the number of men who may have high risk non-metastatic castrate resistant prostate cancer may be relatively small, the benefit of delaying/or preventing the onset of metastatic disease for these men is very high.

Prostate cancer is an important issue in Scotland – with it being the most common cancer in men in Scotland, with a lifetime risk of one in ten. We are pleased that there have been advances in treatment over the past few years, but there is still a need for further progress- especially in the field of advanced prostate cancer. To this end the availability of darolutamide as an option for men with non-metastatic castrate resistant prostate cancer is a very helpful step forward and the decision of the SMC to approve its availability on the NHS in Scotland is most positive.

9 November 2020 – 15.05


Notes to Editors

For further information please contact Prostate Scotland at info@prostatescotland.org.uk or 0131 603 8660

In many cases where the prostate cancer has not spread, men will be offered surgery or radiotherapy treatments, with a curative intent. In some men following treatment the cancer may not be completely removed or may return. Often men in such situations are offered hormone treatment/ Androgen Deprivation Treatment (ADT) to halt the growth of the cancer cells.  In some men after a period of time the cancer cells may adapt to or get used to lower levels of androgen, which fuels the cancer and start to grow again – this is known as castrate resistant prostate cancer.  In most men with castrate resistant prostate cancer this occurs when the cancer has spread/metastasized, but in some men it can happen when the cancer has not spread and this is known as non -metastatic castrate resistant prostate cancer (nmCRPC).

Prostate cancer is the most common cancer amongst men in Scotland, with a lifetime chance of one in ten men developing it[iii]. There were over 37,009 new registrations of men with prostate cancer between 2008 and 2018 and 9,782 deaths of men in Scotland from prostate cancer during that period.[iv]. In 2018 in Scotland 4193 (Lothian 575 men) men were diagnosed with prostate cancer and 923 men in Scotland died from it[v]. Encouragingly survival rates amongst men with prostate cancer have doubled over the past two decades with 84% of men with prostate cancer now surviving it [vi]. Projections by the NHS show that the diagnosis of men with prostate cancer is likely to rise by up to 35% between now and 2027[vii]. Non-metastatic castrate resistant prostate cancer.
Prostate Scotland is a registered Scottish charity no SC037494. It was set up in 2006 as a Scottish charity to develop awareness of prostate disease, to support men and their families/ partners with the disease through providing advice and information and to advance treatment and research into prostate disease. Its aim is to reach out across Scotland to create greater awareness amongst men and their families/partners about prostate disease and to advance treatment. It has established an award winning website www.prostatescotland.org.uk providing a wide range of information about prostate disease and treatments, as well as providing information and advice about prostate disease to men and their families across Scotland. In 2010 the charity won a national award for its impact on community health and in 2013 and 2015 was commended in the British Medical Association Patient information Awards, and in 2017 was awarded Scottish health charity of the year.

[i] The research showed that treatment with darolutamide delayed occurrence of metastases of 40.4 months, as compared with 18.4 months with placebo.  See Fizazi et al  in N Engl J Med 2019; 380:1235-1246 DOI: 10.1056/NEJMoa1815671

[ii]  Fizazi K et al. Overall survival results of the phase III ARAMIS study of darolutamide added to androgen deprivation therapy for nmCRPC. ASCO Virtual Scientific Program 2020

[iii] See Cancer Incidence in Scotland 2018 Public Health Scotland April 2020 pp21

[iv] See Cancer Incidence in Scotland 2018 Public Health Scotland April 2020, Cancer mortality in Scotland 2018 Public Health Scotland October 2019

[v] See Cancer in Scotland Public Health Scotland April 2020 and Scottish cancer registry Cancer mortality in Scotland 2018 Public Health Scotland October 2019 p8

[vi] Cancer in Scotland: ISD, NHS National Services Scotland, October 2018 pp 16-2

[vii]  See Scottish Cancer Registry May 2016 and Cancer Incidence in Scotland (2014), and Information Services Division NHS National Services Scotland November 2015