So, Dr. Scholz, today we're talking about intermittent hormone therapy and
before we go into that I'd like to kind of discuss the history
of intermittent hormone therapy and also kind of what hormone therapy is in general.
So, in a nutshell, hormone therapy means blocking the male hormone testosterone in a patient who
has prostate cancer. Prostate cancer cells need testosterone to grow and medicines that block
it cause the cancer to shrink and die, and the idea of intermittent therapy, of course—just
as an overview—is the taking a holiday from that treatment and allowing testosterone to come back.
Going back, you know, we have these new scans and everything that we can do there,
how did you start knowing—like—where did doctors start doing intermittent hormone therapy? I know
obviously, the treatments came out; who came up with this concept of "yes we can pause it?"
Yeah, it... It's fascinating because the use of these medicines these shots back in the
1990s was typically reserved only for men that had metastatic disease in their bones. The thought was
that the toxicity was excessive and that generally cancer's slow-growing, so why not just wait till
the cancer got really bad? There was no proof back in the 1990s that men would live longer if they
started the hormone treatment at an earlier stage. Now we know that people with serious
types of cancer do live longer if they start at an earlier stage and that policy has become routine,
but when we first started giving hormone therapy back in the 1990s, we were quite amazed if the men
had earlier stage disease that their PSAs would always go down to undetectable levels and just
remain there for extended periods of time. No one knew at that point if those individuals had been
cured, so we were some of the early adopters of taking a holiday not so much with the idea
of resuming treatment later but just finding out maybe they got cured from the hormone treatment.
We later discovered that very few people are cured by hormone therapy alone, and so
thus, when they were put back on hormone treatment and their PSAs went back to zero again,
it was very comforting to see that the disease remained responsive and that the patients didn't
lose any ground from a cancer point of view. Later, large randomized trials were done comparing
the outcomes of people that stayed continuously on treatment versus those that took holidays
and they discovered that the 10-year outcomes were identical—same incidence of hormone resistance,
same incidence of people passing away from cancer and other causes. So, it has been
validated; I believe there are now three large randomized trials that show that same outcome.
So, what is the criteria for somebody to go on intermittent hormone therapy?
Well, first, you have to already be on it, and the men that are taking hormone therapy you can think
of kind of two broad categories: One category is men that are trying to be cured, they're having
radiation and hormone therapy is added for a specified period of time and when they stop
hormone therapy it's not considered intermittent because they're hoping to be have been cured.
The men, however, that have relapsed disease that the doctors figure, "it's spread it's not curable,
we're going to just control it hopefully for many many years by giving the hormone
treatment," those are the people where the hormone treatment might be stopped even though
we know they're not cured. In other words, take a holiday from the treatment with the idea that
you can go back on treatment again later if thE PSA—if and when—the psa starts rising again.
What would a time period of a holiday look like?
Well, it varies from patient to patient, but I would say that it can be as short as three
to six months in an unfavorable situation and as long as three to five years in a favorable one.
Okay, and what is the monitoring situation during that process?
Our usual policy is to check PSAs every three months
and, of course, check testosterone levels because when you stop the treatment in elderly men you
never know how long it's going to take for their testicles to wake up, in fact, some individuals
their testicles give up the ghost and they just have indefinitely low testosterone levels.
So, it's sort of a pyrrhic victory; there's no real holiday because the testosterone stays down.
So. who can't go on like this type of intermittent hormone therapy?
Most people probably that have been on treatment long enough are eligible,
but in my opinion, I think it's a little bit iffy if someone can't get their PSA
all the way down to undetectable levels (that would be like less than 0.1 or 0.05)
those individuals might even need more treatment not less because it's a high—what we call—the high
PSA nadir is the sign of some hormone-resistant cells present. So, rather than lightening up and
taking time off, it's maybe time to drill down and look at adding treatment to try and make sure
that that patient's going to get into a complete remission. So, I would stay away from intermittent
therapy in people that have high PSA nadirs. The other group of people, I'm often asked,
maybe had radiation and they were put on Lupron as, you know, for 18 months if they were
what we call a "high-risk" patient and the idea in those individuals is to get cured and so
I've had patients ask me after you know six, eight, ten months and they're tired of the
hormone treatment, "Can I take a holiday? I want to do intermittent," but the goal is to be
cured not to simply suppress the the cancer, but eradicate it permanently so it never comes back,
and the studies that have been done show that with specified time periods in high-risk 12
to 18 months minimum treatment period that the cure rates are optimized. So, people by
going intermittent early on could be compromising their chance for cure by taking an early holiday.
Can you define cure for the patients?
Yeah so I've had patients, in fact, in the early years with prostate cancer—the
concept of cure was disputed. There was always a thought, "well, prostate cancer is slow growing;
It may not come back, you know, in two or three years but someday it will," "that no one
is cured," and that belief was commonplace up to like around the change of the millennium. Finally,
studies came out showing people stay cured and probably the threshold is that if someone's been
treated and they're five years out from their treatment period and their testosterone is back
to normal and their PSAs remaining low and stable for all intents and purposes they're cured. There
are rare relapses after five years, but i think that—especially in people that have had radiation
compared to surgery, it's more common to see very delayed relapses after surgery sometimes
out to 10 years—but properly treated radiation patients, they rarely relapse after five years.
So, the definition of cure is someone who has had a stable low PSA, not rising,
usually less than one, far less than one in most cases, a recovered testosterone, and five years of
treatment interval since radiation to the present. That's what we would consider someone who's been
cured and the chances of them ever having another problem with prostate cancer is very small.
That's really interesting to me because i think a lot of patients don't get that concept that
there is a cure they either think it's either one and done or it's a multiple thing but there
actually is some middle ground there. One of the questions I'd like to ask is, you know, you've had
25 years plus of experience when it comes to you know medical oncology and prostate
so what is the longest, you know, period of time that you've seen a patient,
you know, go on and off intermittent therapy and it still keep their PSA down?
Over 20 years. Yeah, now people, you know, the general average for developing hormone-resistance
for people that are relapsed after surgery radiation is about 10 years
but for some people, unfortunately it'll be five, you know, they have a worse genre of
prostate cancer, but in others they never do develop hormone resistance. So men can
can truck along, I think actually I have one guy that's pushing close to 25 years now.
What if somebody doesn't want to do intermittent hormone therapy?
What if they just want to do continuous hormone therapy? They're concerned about
going off they don't want to deal with the fluctuations... That's fine with you, right?
Yes, it's a lifestyle choice. We know, now, from the studies that people don't live longer
or shorter by taking holidays. So the real issue is what how do you want to live your life? Some
people are so nervous about their rising PSAs and they talk and some people, these same individuals,
may also tolerate the low testosterone state well. They exercise, they eat right, they do
have a good quality of life. It's perfectly fine if they want to remain on treatment;
they have to take precautions against osteoporosis and all the other things that we've talked about,
but it's not something where you have to mandate that someone take a holiday
or in people that decide that they just like the stable low PSAs on an ongoing basis
and they're willing to put up with the side effects of low testosterone is perfectly fine.
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