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Focal Therapy for Prostate Cancer: 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 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 experimentalThere’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 >40% of patients have MRI-invisible tumors, and standard prostate biopsies sample <1% 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 say 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. “At the PCF, ‘experimental’ means ‘not proven,’” says molecular biologist and medical oncologist Jonathan Simons, M.D., CEO of the PCF.

Why is it not yet proven?   This 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.”

Janet Worthington
Janet Farrar Worthington is an award-winning science writer and has written and edited numerous health publications and contributed to several other medical books. In addition to writing on medicine, Janet also writes about her family, her former life on a farm in Virginia, her desire to own more chickens, and whichever dog is eyeing the dinner dish.