Prostate Scotland welcomes SMC acceptance of Apalutamide for metastatic hormone sensitive prostate cancer

Prostate Scotland, Scotland’s prostate disease charity, welcomes the decision of the Scottish Medicines Consortium to make Apalutamide available on the NHS in Scotland for the treatment of metastatic hormone sensitive prostate cancer.

‘This is a very positive and welcome decision and will potentially make a real difference for men where their cancer has spread but is still sensitive to hormone treatment.

‘Men with hormone sensitive metastatic prostate cancer can face an uncertain future as to whether their cancer will continue to respond to hormone treatment, or progress to becoming hormone resistant. Being able to maintain quality of life through keeping the period of hormone sensitivity as long as possible is very important. The availability of Apalutamide for men with hormone sensitive metastatic prostate cancer offers a further treatment option and the opportunity of improving the quality of their lives and the chances of progression free survival and potentially increasing overall survival. The decision by the SMC to approve the availability of apalutamide on the NHS in Scotland for metastatic hormone sensitive prostate cancer is therefore very helpful and very much to be welcomed’.

Research has shown that apalutamide with androgen deprivation therapy can lead to a reduction in the risk of metastatic cancer progression. It also showed that overall survival was higher for those on Apalutamide than those on a placebo and reduced the risk of PSA progression.

Men with prostate cancer in Scotland that we consulted felt strongly that the availability of Apalutamide for men with metastatic hormone sensitive prostate cancer in Scotland would be helpful and it should be made available on the NHS in Scotland.

Prostate cancer is an important issue in Scotland; it is 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.

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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. Men where the cancer has spread will usually be offered hormone treatment/Androgen Deprivation Treatment (ADT) to halt the growth of the cancer cells.  Where the prostate cancer is still sensitive to hormone treatment it is known as mHSPC.  The aim of treatment at this point is to continue to stop the cancer progressing to becoming hormone/castrate resistant. 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.

A recent trial (the TITAN study) demonstrated that Apalutamide with ADT can lead to a reduction in the risk of metastatic progression. Progression free survival at 24 months was 67.2% – 20.2 percentage points higher than those on placebo. It also showed that overall survival was higher for those on Apalutamide at 82.4% than those on placebo (73.5%)[i].

A further analysis of the TITAN study showed that overall survival at 44 months was 35% higher in the Apalutamide than in the standard-care group and where there was a crossover in the study those receiving Apalutamide had 48% higher overall survival. It also showed that compared with placebo, apalutamide significantly reduced the risk of PSA progression by 73%[ii].

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].  The most recent figures for Scotland prior to the pandemic show that 4066 men in Scotland were diagnosed with prostate cancer in 2019 – 3394 were diagnosed in 2020. In 2020 1038 men died from prostate cancer [[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]].

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] See Kim N. Chi et al N Engl J Med 2019;381:13-24

[ii] See Kim Chi et al J Clin Oncol 39:2294-2303.

[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 2021 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