Coronavirus/Covid-19 - We are providing consultation and treatment in facilities that are fully compliant with government guidelines on infection prevention and control. Watch our video here.

The Overuse and Misuse of Hormone Therapy Treatment For Men With Early Stage Prostate Cancer

The Focal Therapy Clinic’s Raj Nigam discusses overuse and misuse of hormone therapy for men with early stage prostate cancer, and how this is reinforcing health inequalities.

Press play in the audio player below to hear the interview.

Please find below a written transcript of the interview.

Clare Delmar:
Hello and welcome to The Focal Therapy Clinic. My name is Claire Delmar, and in this audio series, I’m going to introduce you to some issues facing men diagnosed with prostate cancer that are little known, less understood and almost never talked about. Earlier this month, prostate cancer was acknowledged as the most commonly diagnosed cancer in the UK. And with this sombre fact comes a multitude of challenges and opportunities. In the second of our series, I’m speaking with Raj Nigam, consulting urologist at The Focal Therapy Clinic and a leading innovator in imaging led diagnostics and targeted treatment for prostate cancer. Raj has been a vocal advocate for focal therapy from his base at the Royal Surrey Hospital and has contributed to several pivotal clinical studies and trials on prostate imaging and focal therapy. He is also an acknowledged expert on andrology and in particular the use of hormones in treating urological disease. Raj, thanks for joining me.

Raj Nigam:
Thanks very much for having me.

Clare Delmar:
So why don’t we just dive right in? I think this is an issue that’s certainly of interest to a lot of our patients, which will come on, too, in a few seconds. But before I launch right into the role of hormones in treating urological disease, I really like you to just to say in your own way, what was your journey to becoming a leading practitioner and a champion of focal therapy?

Raj Nigam:
Yeah. So I’ve been treating men with prostate cancer as a consultant for over 20 years and I’ve seen huge changes over that time-frame from the advent of minimally invasive radical prostatectomy, for example, when I was training all the radical prostatectomies were open. Those then transitioned to laparoscopic or keyhole surgery and then moved on to robotic controlled robotic prostatectomy. So there’ve been huge changes there. There’ve been massive changes in the improvement of the operation and the side effect profiles that they create. We’ve also seen great changes in radiotherapy in terms of shortening the duration of therapy and the advent of intensity modulated radiotherapy. So whilst there have been significant changes in the two main radical treatment options, I still felt that there were a lot of men that were perhaps being over-treated. We had no way of confirming this prior to their procedures when we only found out once it had the radical prostatectomy that, oh, they only had a small amount of cancer there or they had a low grade cancer there. So therefore, we have been seeking new means of diagnosis and more accurate means of diagnosis. So I came to this from a little bit of disillusionment with the type of biopsies that we were doing. There were transrectal biopsies which have subsequently been shown to be very insensitive – in the best studies only 48 percent sensitivity. I was also concerned that there were significant septic complications in a small group of men who were having transrectal biopsies, but in that small group of men, they were quite severe infections, sometimes leading to intensive care. So when transperineal biopsies came along, it’s something that I jumped at and we moved forward fairly rapidly in developing transperineal biopsies and then moving on to far more precision diagnostics in the form of incorporating MRI scans into the fusion process of carrying out the biopsies.

Clare Delmar:
So all of that means it’s become a much more targeted in what you’re actually going to treat – is that a way to put it?

Raj Nigam:
Absolutely. So the concept of making an accurate diagnosis then leads on to adapting to techniques which will be minimally invasive and minimally harmful to the man and therefore creating less side effects than the two traditional radical options.

Clare Delmar:
And that’s where focal therapy obviously comes into play,

Raj Nigam:
That’s precisely where focal therapy comes in. Once you know where your cancer is and you know the type and the grade of the cancer on a well conducted MRI scan and that well targeted biopsies, you can then safely say, alright, we will treat that area of the prostate cancer with minimal damage to surrounding organs and therefore limit the side effects.

Clare Delmar:
I mean, it’s wonderful to hear that, you know, this is all a lot of great concern for your patients and for, you know, the sort of unnecessary and costly over-treatment that they’ve been receiving prior to this actually coming about.

Raj Nigam:
Absolutely. I mean, I was one of the first surgeons to go over to France to learn the techniques back in 2006. And at that stage, we were using high intensity focused ultrasound for the whole gland. But since then, we have found out that it actually it can be much more accurate in its treatment and therefore, we have moved on to focal therapy.

Clare Delmar:
So, you know, one way of looking at this is, you know, things are becoming more precise, more accurate, more targeted and, you know, can you actually extend that to say more more personalised?

Raj Nigam:
Absolutely. The one aspect of men and their diagnosis of prostate cancer is that we know that a number of treatment options for early localised prostate cancer are equivalent in their cancer outcomes, i.e. a lot of men will have the same outcome in terms of survival and so on, regardless of whether they have active surveillance, radical prostatectomy or radiotherapy. And that’s based on a 10 year study – ten to twelve year study – the ProtecT Trial. So we know that from an oncological i.e a cancer point of view, we are achieving good rates with all the treatments. But they all have differing side effect profiles. And that’s where we come in, in the sense that the radical treatments are far more morbid in terms of creating erectile dysfunction and far more morbid in terms of creating incontinence, both of which are very, very damaging to a man’s function and self-esteem. And we know from our own very large studies – multi-centre studies – that we have carried out in the UK that at five to six years, not only is oncological equivalence to the traditional radical treatments, but also a vast improvement in the side effect and complication profile following focal therapy.

Clare Delmar:
So, I mean, back to this idea of personalisation and bringing the patient into the decision process. How does your work in andrology play into this? Does it help this process?

Raj Nigam:
Yeah, absolutely, hugely. So for many, many years I have been managing andrology clinics whereby I have been seeing men who have had some of the traditional prostate cancer treatments in terms of radiotherapy and radical prostatectomy. Andrology, for those who don’t know it, is a field, is a sub-speciality of urology whereby we deal with men who have problems with hormones, who have problems with erectile dysfunction, who have infertility problems, and in particular penile problems, as well as incontinence. So therefore, I’d been seeing a lot of men over the years who had had a good cancer operation or good cancer treatments, but were paralysed by these side effects in terms of their ongoing function. You see, one has to look beyond oncological control when it comes to cancer treatments for early prostate cancer. One has to start thinking about, OK, after one year, two years, the man might be thinking, great, I’ve got over my cancer, but why am I incontinent for the rest of my life Why am I not able to have an erection again. So all of these things need to be taken into consideration at the time of discussion with the patient. And what sort of level of side effects they will tolerate? There are some men who will say, I will never want to be incontinent. There are some men who say, well, I’m not too fussed about erectile function at this stage, but I do not want to be incontinent.

Clare Delmar:
Well, can I add mental health into some of the side effects. Does that play into some of the whole sort of person approach?

Raj Nigam:
Yes, absolutely, absolutely. And it’s not always what one might think. So any cancer diagnosis has an effect on the mental health of the individual. We know that. But men in particular who are worried about what is now the commonest cancer in the UK by far will be considering what’s it going to leave me with? You know, is it worth me continuing with this treatment in terms of the side effects I’m going to get? So there are some men who will say, you know, I’ve got a cancer I don’t care what side effects I get. I just want the cancer cut out. But the numbers of those men I feel are now declining. That used to be the case. You know, the sort of cut it out doc policy. But now more more men are beginning to look round and saying, well, what are my alternatives? And are there less morbid treatments that I can have?

Clare Delmar:
Well, it’s interesting because, you know, we’re actually getting approached by quite a few men – and I’d say it’s it’s on the increase – who have early stage prostate cancer diagnosis and seem to have been put on hormone therapy. And again, this is know kind of observational and but it seems to be happening more during the Covid-19 pandemic. So I want to throw this out to you. Is there an increasing use of hormone therapy in the NHS during this time? And if there is, what effect do you think this is having?

Raj Nigam:
Oh, yes, absolutely. I mean, this is an unfortunate negative outcome of the Coronavirus era, if you like, that traditional treatments have all had to be halted for at least three or four months, in particular radical prostatectomy and radiotherapy. And as a result of this, men have inadvertently been advised to go onto hormonal therapy without, I hate to say, you know, proper and adequate discussion. Now, this is not the fault of any individual surgeon or doctor. It’s just the position that they have been placed in in terms of trying to control the condition, at least so we think with limited time and often in telephone consultation to say we’re having to put you on hormones until and unless we start just services up and running again.

Clare Delmar:
OK. And how are you seeing this play out with some of your patients?

Raj Nigam:
The men that have been put on hormones, the vast majority of them don’t like it. We have to start off by qualifying this because there are some men that have to have hormones. So there are men who have known metastatic disease, i.e. disease that has spread to the bones or to the lymph nodes and beyond. And they will have to have hormone therapy to try and control the disease. There are some men who they know that they are definitely going to have radiotherapy and it has been shown that those men will do better with at least a three month period of antigen deprivation therapy prior to having radiotherapy. So those two groups aside, there are a lot of other men that have been put on hormonal therapy, which under normal circumstances would not have been.

Clare Delmar:
Right. And this is a problem?

Raj Nigam:
This is a problem because hormone therapy does not come without side effects. And some men who have not been advised which side effects to experience are now complaining about it and wondering why they getting these side effects. So I see this in my sub-speciality of andrology quite a lot. Not necessarily because men have had hormonal treatment, but they are what we call hypogonadal in the sense that they have low testosterone levels. And the hormonal therapy that we are talking about in prostate cancer mimics that exactly. Because the hormonal therapy is designed to reduce the testosterone levels in men.

Clare Delmar:
Right. I mean, for example, some of the men who come to us will say that they are particularly fit. They may be in their 70s. A lot of them are very committed to sport, to exercise, to healthy, healthy living and a very high quality, active quality of life. And then they tell us they’ve been put on hormone therapy and it’s you know, they become a different person, both mentally and physically.

Raj Nigam:
Yeah. Absolutely. Like I said, we see this all the time in our andrology clinics and we are now seeing it in the hormone therapy population. So essentially, there are a number of serious side effects that hormonal therapy can have. We all know about sexual side effects that decrease testosterone level can have in particular loss of libido, erectile difficulties, ejaculatory difficulties and so on. And this can lead to a complete loss of confidence in the man. We also know about its effect on muscle mass and bone density, particularly with longer term treatment. And this can lead to increasing and early fatigue, a desire of not wanting to do exercise, a constant feeling of weakness. So those are physical, real physical issues that men are experiencing whilst on hormonal therapy.

Clare Delmar:
And cognitively?

Raj Nigam:
I think that the effects of testosterone on the brain are under recognised and underplayed. But men who come to my andrology  clinics often do complain of a loss of cognition or loss in the speed of thought. They may still be at work and they’re finding that they got sort of brain fog type symptoms. We know that you can also experience mood changes and depression with low levels of testosterone.

Clare Delmar:
Sounds like menopause. But unfortunately, it’s enforced on these people.

Raj Nigam:
Absolutely. Yes. I forgot to mention hot flushes. Hot flushes are very, very common sign of hormonal therapy.

Clare Delmar:
So it’s interesting because in talking with some of these men, you know, some of them haven’t had this hormone therapy, you know, sort of imposed or, you know, offered to them. And, you know, they’ve been offered other things or are simply waiting. So one of the things that has come into my mind is that there appears to be almost a health inequality around the country. And I know that we talk about health inequality, especially during the pandemic, amongst different different types of population groups, but I’m interested in your thoughts on how this might apply to men with prostate cancer.

Raj Nigam:
Yeah. So health inequalities exist in prostate cancer. This has been recognised over many years. In fact, there was indeed an all party parliamentary group which published a document about 10 years ago talking about health inequalities in cancer in general and also in prostate cancer in particular. And a number of authors have have discussed this field. There are essentially a number of areas where there are health inequalities. The most obvious one and the most current one you have alluded to is based on ethnicity. And we know factually, both here and in the United States, that black men in this country, we call them Afro Caribbean, in America they are called African-Americans, have double the average risk of being diagnosed with prostate cancer. We also know that in those men, that awareness appears to be quite low of prostate cancer. And there have been studies which have shown that they have poorer experiences of NHS care. And this is the same in the United States. We know that they have double the risk of dying from prostate cancer. They have higher grade disease. And it presents earlier. So this is an area that certainly needs targeting in terms of trying to address inequality based on ethnicity. But there are other inequalities, and I’m one of them that we’re finding appears to be partly geographical, is based upon age. We are finding and this is again, factually shown that men over the age of 75 tend to have a poorer outcome in prostate cancer, even though their level of fitness if you allow for all of those features, maybe just as good as a man of 65. So there appears to be a subconscious sort of bias saying, OK, you’ve reached seventy five and so on. Yes, you might be fit and well, but actually we may not go down this route or this treatment route and so on, and we may just watch things and so on. So there is a sort of inequality based upon age. And this is appears to be manifest in terms of mortality rates in the UK as well. That the largest area, largest group of men that die in terms of age between 75 and 84.

Clare Delmar:
Has this been documented or investigated in any way?

Raj Nigam:
Yeah, absolutely. I think it’s been highlighted quite a lot. And and so, you know, there should be targeted programs at least that was advised that men in that age range and above the age of 70 should have the same access to treatments and diagnosis that men of a younger age do. And there is definitely an inequality of access depending upon age, partly because we know that a lot of men who develop prostate cancer later in life are unlikely to succumb from it. But the actual mortality data suggests that that is the highest age group which men die.

Clare Delmar:
Yeah, I mean, I think one of the things that came to light during the pandemic was, you know, there’s this phrase that was used. A lot of the different country level data on Covid was, you know, some people are dying of Covid and some are dying with Covid. And, you know, this was kind of, you know, similar to prostate cancer?

Raj Nigam:
Yeah, absolutely. And this is one of the things that has been shown that the health inequalities which existed in a lot of other conditions, including prostate cancer, appear to now being replicated in the Covid era, in the sense that, you know, older people perhaps are not getting access to the high level intensive care. Older people are being diagnosed more and therefore they are dying more. Similarly, the ethnicity has come into into force as well. And the third area that I think it’s important to highlight, apart from age and ethnicity, is equality of access, access to diagnosis, access to good information and access to all the treatment options. One thing that I’ve discovered in my work in focal therapy is that there is a huge difference in different geographical areas around the country about awareness of other treatment options other than the two standard radical ones of radical surgery and radical radiotherapy.

Clare Delmar:
Even though all men have a right to this treatment, as you said before, and that it’s codified in law.

Raj Nigam:
Absolutely. And I think it is important that a discussion should take place with the man at the time of diagnosis of all of his treatment options and not just what is available locally. I think that is beholden on all of us to do that.

Clare Delmar:
Right. Raj, his has been really helpful. And I think both for our patients and anybody else interested in hearing about some of these things that are not very often talked about with regard to prostate cancer. So thank you so much for sharing your insights. I look forward to speaking with you again soon.

Raj Nigam:
Pleasure. Thank you.

Clare Delmar:
If you’d like to learn more about Raj’s work and about The Focal Therapy Clinic, visit www.thefocaltherapyclinic.co.uk. And from me, Claire Delmar, see you next time.

Leave a Reply

Your email address will not be published. Required fields are marked *

“HIFU is something people need to be aware of – I believe this treatment should be more widely available and more widely promoted. It wasn’t something suggested to me as a possibility by my urologist and I actually raised it myself. I would recommend HIFU and in fact have recommended it to others.”

Keith (The Focal Therapy Clinic Patient)

Get In Touch

As a group of consultants we are passionate about all prostate cancer sufferers knowing about all of their treatment options.

Based upon the details that you know and can provide to us, we will send you a Plain English personalised preliminary suitability report for HIFU Focal Therapy treatment of your prostate cancer.

You can use the information we provide in your conversations with your existing NHS and/or private treatment consultant. Should you wish to talk with us further we would be grateful to help you, but there is absolutely no obligation for you to do so whatsoever.