Focal Therapy for Localized Prostate Cancer, Part 1

Why I agonized over writing about it, and why I have (cautiously and for very selected men) altered my opinion.  In three parts.

            Four years ago, I wrote a VJ post on focal therapy.  I didn’t publish it.  I just couldn’t.  It started off:  “Dear Readers, if you ever want to start a veritable spitstorm in the world of prostate cancer, here’s a grenade:  it’s called focal therapy.  It’s like the idea of a lumpectomy; just treating the part of the prostate with cancer, and leaving the rest alone.”

Back then, in 2020, I wrestled with the story for months.  A wonderful man named Bill had contacted me on Facebook and wanted to tell his story.  A happily married man in his early 50s with young kids and an active life, he had undergone focal cryotherapy and was thrilled with the results.  He wanted me to write his story so he could help other men.

I turned him down.

Why would I do that?  I will tell you, but first, a couple things you need to understand:  First, if you don’t know it already, I agonize over you guys.  I do.  I worry about so many men, some I know personally, some I have interviewed, and some I’ve just corresponded with or talked to on the phone.  I’ve been writing about this disease for a long time, and I have known way too many men who died of it.  That’s why I push for you to get screened for prostate cancer, to get a second opinion if your PSA is going up and there’s no good reason for it, to get MRI or second-line blood tests even though your doctor says “it’s probably fine,” and that’s why I have been very cautious about any treatment that sounds too good to be true.  I have been very wary of focal therapy because there aren’t long-term results and, although it is becoming more common, I don’t know that it’s a long-term cure.

            Second:  On this website, I answer only to you, to myself, and to God.  Not in that order.  But nobody else.  I don’t make a dime from VitalJake.com.  As you may have noticed, I don’t accept medical ads.  Actually, I don’t have any advertising; I don’t even know how to go about it.  I’m not saying I would turn down an ad for clothing, or dog toys, gardening tools or fishing lures.  In fact, it would be a novelty to actually make money from this site, but that’s not why I do this; I do have a day job.  What I will turn down, and have turned down many times, are medical ads.  I get a lot of offers, and I always say no.  Because if I let somebody else sponsor these pages, they might think they get to control the content.  No. It’s just me, agree with me or not.

Now… back to the grenade.

I told Bill what Patrick Walsh and I said in our book – back then, the 4^th edition – about it.  Actually, we devoted 10 pages of the 4^th edition (I keep mentioning this because the 5^th edition discussion of focal therapy is different, as we will discuss).  The bottom line is this:  Prostate cancer is a multifocal disease:  like dandelions in a field, cancer can spring up in several places within the prostate at the same time.  That is why the gold standard for localized disease is to treat the entire prostate through surgery or radiation. 

The average prostate specimen, when examined by a pathologist after prostatectomy, has between three and seven separate sites of cancer cells.

Focal therapy doesn’t kill the whole prostate, and thus it has minimal side effects.  That’s why so many men are really interested in it.  I would be, too.

This form of treatment – killing, or ablating, only the known spot or spots of clinically significant cancer within the prostate – has been around for decades in various forms; the most common approaches are cryo (freezing) therapy and high-intensity focused ultrasound (HIFU), and other technologies are emerging.  But it doesn’t kill the whole prostate.  So there is the strong possibility that some cancer could be missed, or inadequately treated, and $30,000 out-of-pocket later, there you are looking down the barrel of surgery or radiation.

In the first edition of our book, back in 1993, we wrote about the side effects of cryotherapy, and there were a lot.  There was a huge learning curve, and it was often not pretty.  There were also many cases of men who paid a lot of money for HIFU, whose PSAs didn’t go down because there was still cancer in their prostates.  Also they had some of the key side effects they were trying to avoid; in this study, at one year, nearly 30 percent were impotent after HIFU and 27 percent still had cancer in their prostate.

Then, for Discovery, a magazine I write and edit for the Brady Urological Institute at Johns Hopkins, I interviewed a urologist for whom I have great respect:  Michael Gorin (now at Mount Sinai), who saved my husband’s life with his amazing biopsy skills.  To my great surprise, he was doing studies of focal therapy.  He believed MRI imaging had gotten good enough for urologists to see what was actually clinically significant disease in the prostate, and to kill it.

So, I got on Facebook, messaged Bill and said, “I think I owe you an apology.”  I told him they’re doing this at Hopkins, and asked if his offer to let me interview him was still open.  He agreed.

But then, in the ping-pong nature of this saga, for the Prostate Cancer Foundation’s website, I happened to be interviewing a University of Michigan radiation oncologist and Prostate Cancer Foundation (PCF)-funded investigator, Daniel Spratt, M.D., on a different subject.  I asked him what he knew about focal therapy.  He knew plenty; he has had to treat men for whom focal therapy has failed.  I’m including some of what he had to say below.  This, in turn, prompted a man named Greg to write to me here at Vital Jake.  He had seen the story on the PCF website and was not happy with it.  He was a fan of focal therapy.

Enough with the Backstory

             Let’s get to it.  This three-part series is my effort at a balanced discussion.  The rest of this first part is from the interview with Dan Spratt.  If you’re looking for the quick story, it’s a no on focal therapy.  But stay with me.  Parts two and three are a qualified yes.  For some men.  Some very selectively chosen men.  Men who must then receive rigorous, long-term follow-up monitoring.  The bottom line here is that this story is evolving.  Here’s that PCF interview:

If It Sounds Too Good To Be True…

            If you have been diagnosed with cancer that is contained within the prostate, you may be thinking:

            “Hey, there’s just a spot of cancer that showed up on the MRI,” or:

            “Only three of the needles came back with any cancer at all.”

            And this may lead you to think:  “Why do we have to treat the whole thing?  Why can’t I just get a prostate version of a lumpectomy?”

            Or:  “Why not just zap that one spot of cancer?”

            Wouldn’t that be great? 

            This is called focal therapy – just treating part of the prostate.  In just a few seconds’ search on the internet, you can see that there’s a lot of this focal therapy out there, and it all sounds great!  No erectile dysfunction (ED) or urinary incontinence!  If your PSA rises, no problem!  Treat it again!  A lot of doctors are offering focal treatment, using methods including cryotherapy (freezing the tissue), high-intensity focused ultrasound (HIFU), or even with highly focused radiation.

            There’s just one problem with every type of focal therapy for prostate cancer, says University of Michigan radiation oncologist and Prostate Cancer Foundation (PCF)-funded investigator Daniel Spratt, M.D.:  “I would say, strongly, that it’s experimental.  There’s a very high risk of recurrence, usually within the first three years and it may increase your risk of side effects if you later need curative treatment.  There is a reason it is not considered a standard-of-care treatment by most national and international guidelines.”

            Prostate cancer is usually a multi-focal disease, meaning it is in more than just 1 or 2 spots in your prostate.  This is true even if your biopsies or MRI show only 1 area being involved with cancer.  Some studies suggest more than 40 percent of patients have MRI- invisible tumors, and standard prostate biopsies sample less than 1 percent of your prostate gland.  This is why focal therapy is often ineffective:  it treats only part of your cancer.

            Also, a lot of what they promise about not having side effects is not true.  “Side effects are often lower than men experience with a radical prostatectomy, but there are side effects,” says Spratt.  “There’s still the potential for erectile dysfunction (ED) and other side effects, and one of the biggest concerns is that with subsequent treatment, if the patient needs surgery or radiation, sometimes you can have severe or unexpected side effects.  I’ve seen it in patients who previously had focal therapy,” including one man after HIFU, whose entire urethra (the tube that carries urine from the bladder through the prostate and into the penis) became necrotic – the tissue died.   “He had to have emergency surgery.  They killed healthy tissue.”

            That’s why focal therapy for prostate cancer is still considered experimental. As molecular biologist and medical oncologist Jonathan Simons, M.D., then-CEO of PCF put it:  “’Experimental’ means ‘not proven.’”

            How does something become proven?  It requires well-designed studies to see how patients do in the short run and then over several years.  “There’s so little evidence in the literature,” says Spratt and most are retrospective studies or small single arm trials.  “No well-powered trials with long-term follow-up have been done to even inform us of how effective these therapies are, and to show the safety of doing subsequent curative treatment (surgery or radiation).”

            Spratt has seen many men in recent years who have come from around the country to see him after focal therapy has failed.  “Most of the patients I see who have had it are very upset.  Insurance often does not cover it, and they have spent $20,000-$30,000 out of pocket, thinking they’re going to get a cure with no side effects.  But some do get side effects and all of them who see me were not cured.  And when I tell them, ‘Look, you need a second treatment and you’re at a higher risk of having more side effects,’ they are very upset.”

            The best way to try focal therapy, Spratt continues, is in a clinical trial, “where you are fully informed of all the risks.  Many top centers offer focal therapy, and they should be offering it in the context of a clinical trial.  If not, this is concerning.  These trials are critical to learn how to quantify and optimize focal therapy.  Maybe if they improve it, in the years to come, it will be better than surgery or radiation.  But right now, it’s definitely not.  We’re learning.  There’s a lot of misinformation out there. We must remember that if patients want a non-invasive option other than radical surgery, there are multiple forms of radiotherapy that are completely non-invasive and have better cure rates and long-term potency rates than focal therapy.”

            In a recent trial of HIFU, “within one year, about 30 percent of men developed ED and 25 percent still had cancer in their prostate.  Most of these men had low- or intermediate-risk disease, and could safely have been monitored on active surveillance.  In comparison, in a similar risk group of patients receiving radiotherapy one would expect close to zero percent chance of recurrence within one year, no incontinence, and fewer than 10 percent would experience ED so soon.  Similarly, surgical removal of the prostate would also have excellent long-term cure rates.

            “So why do centers and providers offer focal therapy?  This is very complex.  I fear it comes back to money, trying to advance one’s academic career with something different, and the pervasive avoidance of working as a multi-disciplinary team.  A lot of doctors are trying to offer something less invasive than removal of the prostate for patients looking to avoid the risks of incontinence or impotence, rather than simply offering radiotherapy.  Focal therapy is new and it entices patients – like they found the magic bullet.  However, external-beam radiotherapy has extensive, high-quality evidence with very long-term follow-up beyond 20 years, and has essentially zero percent incontinence and superior erectile function outcomes compared to the focal therapy literature.”

            Spratt says, “Bottom line:  the two standard-of-care treatments for prostate cancer are surgery and radiotherapy.  Lots of emerging treatments and technologies, including focal therapy and proton-beam therapy, may have a role for the management for prostate cancer.  Well-done randomized trials are necessary to determine what, if any, role they will have in the management of prostate cancer.  Until then…proceed with caution.”

Still with me?  Okay, next, let’s look at two centers where they are proceeding with caution, with studies of focal therapy for localized prostate cancer.

In addition to the book, I have written about prostate cancer on the Prostate Cancer Foundation’s website, pcf.org.  The stories I’ve written are under the categories, “Understanding Prostate Cancer,” and “For Patients.”  I firmly believe that knowledge is power.  Saving your life may start with you going to the doctor and knowing the right questions to ask.  I hope all men will put prostate cancer on their radar. Get a baseline PSA blood test in your early 40s, and if you are of African descent, or if cancer and/or prostate cancer runs in your family, you need to be screened regularly for the disease.  Many doctors don’t do this, so it’s up to you to ask for it.

©Janet Farrar Worthington