An ongoing trial known as ‘Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate’ (DASL-HiCaP) can potentially benefit men with aggressive prostate cancer types in addition to standard treatment.

DASL-HiCaP is a prostate cancer trial for patients with aggressive types of prostate cancer that remain confined to the prostate area. The purpose of this study is to see if a new drug — combined with modern radiotherapy and hormonal treatment — can improve outcomes for people with localised prostate cancer that is considered to have a high risk of recurrence.

Improving treatment for aggressive prostate cancer

The trial is randomised and controlled. This means that, in addition to the best standard treatments, half the participants in the trial will receive the new drug, and the other half will receive a placebo — a substance that has no active medicine in it. To be clear: All patients receive the current standard of care plus or minus the drug being studied.

The main aim of the study is to see if the addition of the study medication (darolutamide) to standard treatment is better for improving the outcomes of people with this type of prostate cancer compared to standard treatment.

The drug has already been shown to be beneficial in men with advanced prostate cancer, and the question to be answered by this trial is: Will this drug improve the rate of cure for patients with localised but aggressive prostate cancer?

Will this drug improve the rate of cure for patients with localised but aggressive prostate cancer?

Additional outcomes the trial aims to determine

• The impact of the new medicine on prevention of recurrence and survival
• How safe the new treatment is
• Whether the medication is cost-effective
• The effects of the new treatment on quality of life
• Differences in the costs of care for people on the new treatment
• Tests that might identify people who are more or less likely to benefit from this kind of treatment

Clinical trials ongoing in sites across Ireland

The study opened here in the summer of 2021 and has recruited participants at nine sites around the country: Bons/UPMC Cork, St. Luke’s Rathgar, Mater Misericordiae University Hospital, Mater Private Hospital, Tallaght University Hospital, SLRON at St. James’s Hospital, Cork University Hospital, Galway University Hospital, and the Beacon Hospital.

The trial has now recruited over 1,000 patients globally and is on target to complete recruitment by the end of June this year. This includes a significant contribution of 76 participants, so far, randomised across Ireland and the UK. If successful and properly distributed, it can improve outcomes for prostate cancer patients and complement existing treatment.

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National Cancer Registry Ireland (NCRI) data shows the number of invasive cancer cases (excluding non-melanoma skin cancer) diagnosed in both males and females averaged 24,327 during 2018–2020. The most common cancer in males was prostate cancer.

Prostate cancer accounted for 30% of all cancers diagnosed in men. Colorectal (bowel) cancer, lung cancer, melanoma of the skin, and non-Hodgkin lymphoma were the second, third, fourth and fifth most common cancers in males, respectively. For the same period, the most common cancer which caused death was lung cancer for both males and females in Ireland, followed by prostate cancer and colorectal cancer in men.

The most common cancer in males and the statistics

Prostate cancer diagnosed in men accounted for an average of 3,941 cases in 2018–2020 (30% of cancer diagnosed in men, excluding the non-melanoma skin cancers).

Prostate cancer occurs most commonly in older men with 97% diagnosed over the age of 50 years.

It is the second most common cause of death due to cancer in males, after lung cancer, accounting for 605 deaths on average in the same period. However, the chances of survival five years after diagnosis with prostate cancer are high at 93% (2014–2018).

Prostate cancer diagnosed at a later stage has a poorer prognosis and overall survival. Early information from the NCRI has demonstrated that the number of people diagnosed with prostate cancer was reduced during the Covid-19 pandemic, so people should see their GP if concerned about any urinary symptoms.

Risk factors and treatment for prostate cancer

Prostate cancer occurs most commonly in older men with 97% diagnosed over the age of 50 years. Race is also a risk factor with Black-African men at higher risk compared to White men — and the lowest risk in Asian men. Men with a family history of prostate cancer in a father, son or brother are at higher risk; and those with genetic mutations (BRCA 1 and BRCA 2) and certain syndromes (Lynch Syndrome) are also at higher risk.

A recent major report by the NCRI demonstrated that prostate cancer is more common in men living in more affluent areas in Ireland. However, survival five years after diagnosis with prostate cancer is poorer in those living in more deprived areas. Men living in more deprived areas have a higher risk of presenting with a more advanced stage at diagnosis compared to men in more affluent areas.

The most common treatment regimens for prostate cancer are radiotherapy, hormone therapy and surgery.

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The phrase ‘Man Box’ has emerged in psychology in recent years to describe the constraints that exist around men and the conformity to masculine beliefs, which have a significant impact on men’s health and mental health.

From childhood, men are often ‘boxed in’ by what they can and cannot feel, say and do. Anything that doesn’t fit or falls outside this box — playing with dolls, expressing fear or sadness — can pay a heavy social price. Boys learn quickly that they need to prove they fit in the box and as they grow into men, the box begins to feel smaller and smaller — more and more suffocating.

Constraints of the ‘Man Box’

Speaking at Mental Health Ireland’s ‘Man I Am’ webinar, Dr Shane O’Donnell, Health Promotion and Improvement Officer with the HSE says: “We know from research that men who feel that they have to live up to these expectations often have negative mental health outcomes. They feel they have to be the breadwinner; self-reliant; emotionally withdrawn; the provider for the family; be physically strong; to drink alcohol.

“It really is a very limited frame we feel we have to fit into. Men who don’t fit into this frame can feel as if they’re failing as a man. It also leaves us with a limited set of tools to respond to the stresses in life.”

Men often go undiagnosed for mental health issues and are more reluctant to seek help than women.

Men don’t seek help

The box is surrounded by a code of silence — real men don’t talk about their problems; real men don’t ask for help. This prevents men from seeking professional help and care when going through emotional or personal crises. This can lead to a propensity for poor mental health, substance use, and suicidal tendency.

In Ireland, men are four times more likely to die by suicide than women. However, there are higher rates of depression and anxiety among women. This indicates that men often go undiagnosed for mental health issues and are more reluctant to seek help than women when they’re struggling.

Getting out of the ‘Man Box’

Poor mental health and high suicide rates among men are a modern-day epidemic, and we’re taking action. Ireland was the first country to have a men’s health policy — largely driven by the Men’s Health Forum in partnership with the HSE to support men’s health and mental health. We must work hard to break the cycle of silence and shame among men and provide a safe and supportive space outside of the confines of the ‘Man Box.’

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Males constitute almost 50% of the population on the island of Ireland and, therefore, deserve to have a gender lens focused on their specific health needs.

Research shows that men experience a high burden of ill health and die too young. Their poorer lifestyles are responsible for a high proportion of chronic diseases and men’s late presentation to health services can lead to a large number of problems becoming untreatable.

Policy supporting men’s health

In response, the Republic of Ireland developed a National Men’s Health Policy — the first country in the world to do so. The Policy recognised the important role played by service providers and local practitioners in improving the health of men and boys and acknowledged that these stakeholders also have training and support needs.

Men are (contrary to public perception)
interested in their health.

In 2017, the Policy was followed by a Healthy Ireland – Men Action Plan. This action plan has been reviewed and updated. It provides both the bedrock of and a mandate for a focus on men’s health needs.

Men’s health initiatives in Ireland

There are many practical initiatives which have been piloted in Ireland to improve men’s health. These include:

• Men’s Health Week, which runs from 12th to 18th June (Father’s Day).
• Farmers Have Hearts, run by Irish Heart Foundation and supported by HSE and Glanbia, aims to promote and support health behaviour change to improve the cardiovascular health of Irish farmers.
• Men on the Move is a physical activity and lifestyle programme that targets overweight men to engage in exercise and improve their mental health.
• HSE ‘Engaging Men’ and ‘Masculinities and Men’s Health’ webinars are run four times a year, covering topics such as the ‘what,’ ‘why,’ ‘when’ and ‘how’ of men’s health.
• Cairde (Construction Alliance to Reduce Suicide) was set up to investigate why construction workers are at higher risk of suicide and develop suicide prevention training and resources for the Irish construction industry.
• One of the best initiatives is the Engage National Men’s Health Training Programme. The course, called ‘Engage – Connecting with Men’, is a one-day workshop offered to a broad range of practitioners. It aims to increase participants’ understanding of best practices when seeking to connect males with health and social services. Following a train-the-trainer programme in 2022, HSE Health Promotion and Improvement staff are now running workshops for frontline health and social care staff throughout the country.
  
  These initiatives, and more, demonstrate that men are (contrary to public perception) interested in their health — if we offer them the right things in the right ways.

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Not too long ago, we were unaware of the full extent of men’s poor health status and the specific health issues that they are contending with. However, this is no longer the case.

In recent years, a broad range of research¹ has highlighted the health challenges which face men in Ireland and further afield. 

Tips for Men’s Health Week 

Men, themselves, need to play a central role in taking control of their health and wellbeing. Men’s health is not just an issue for individual men — their health can often be determined by other factors outside of their control. Thus, policymakers, service providers and society as a whole must recognise the role they need to play. 

International Men’s Health Week (MHW) 2023 (Monday 12th—Sunday 18th June) offers an ideal opportunity for the whole of Ireland to make these positive changes. MHW is celebrated in many European countries, as well as in the USA, Australia, New Zealand, Canada and several places worldwide. 

The overall aims are simple: 

• Heighten awareness of preventable health problems for males of all ages 
• Support men and boys to engage in healthier lifestyle choices/activities 
• Encourage the early detection and treatment of health difficulties in males 

Support men and boys to engage in
healthier lifestyle choices/activities.

Putting men in control of their health 

In Ireland, it’s very common to hear people say: ‘Ah, sure, your man’s the picture of health.’ During MHW 2023, everyone is being asked to think about what their ‘picture of health’ might look like and to go for it. 

While some aspects of our health are determined by things which are beyond our control (such as genetics, our income, the environment that we live in and our access to services), there are also simple, practical and realistic things we can all do to improve our health and live a longer life.  

To support MHW 2023, a new free Man Manual — ‘Action Man: ten top tips to improve men’s health’ — is available. This doesn’t preach or lecture, it simply explains: 

• Why an action is needed 
• What can be done about it 
• How to find support if you need it 

The 10 top tips put men into the driving seat and give them the tools and DIY instructions to make positive changes — if they choose to be their own ‘Action Man.’ 

[1] https://www.mhfi.org/MensHealthInNumbers1.pdf

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