Active Surveillance for Men with Intermediate Risk Prostate Cancer

BY MARK SCHOLZ, MD

People are starting to become familiar with the modern way of conceptualizing prostate cancer.  When men are newly diagnosed, they are split into three broad categories: Low-Risk, Intermediate-Risk and High-Risk. This system, which was invented by Dr. Anthony D’Amico, is helpful for the proper selection of optimal treatment; men with more favorable types of prostate cancer can receive milder therapy and still maintain normal survival rates.

As far as treatment selection is concerned, as a general rule of thumb, men with Low-Risk disease are encouraged to simply monitor the disease, withholding therapy altogether unless tumor growth is detected on subsequent testing.  At the other extreme, men with High-Risk disease typically undergo combination treatment with three forms of therapy: seed radiation, IMRT and hormone therapy, which is continued for a year and a half.

Treatment recommendations for men with Intermediate-Risk range widely from surgery, to the many types of radiation—IMRT, seed implants, SBRT and Proton therapy to focal therapy, as well as the alternative of simply giving hormone therapy by itself. This wide variety of treatment options is not merely a result of physician bias.  It turns out that the types of cancer that occur in the Intermediate-Risk category also vary widely.  At the “good” end of the spectrum, men with the favorable type of Intermediate-Risk disease have a condition that behaves more like Low-Risk while cancers men at the unfavorable end of the Intermediate-Risk spectrum have a condition that behaves more like High-Risk.

The indicators that define an unfavorable type of Intermediate-Risk disease are multiple intermediate characteristics rather than having a single Intermediate-Risk factor.  For example, it is considered unfavorable when the PSA is over ten and the Gleason is 4 + 3 (instead of 3 + 4) and there are more than 50% of the biopsy cores containing cancer.  At the other extreme are men with the favorable type of Intermediate-Risk disease. These men are characterized by having all the Low-Risk factors in combination with only a single Intermediate-Risk factor.

Making a proper distinction between the favorable and unfavorable types of intermediate risk disease can be monumentally important as it relates to treatment selection. Studies show that men with favorable Intermediate-Risk disease are potential candidates for active surveillance.  A recently published report at this year’s Genitourinary ASCO meeting bears directly on this issue:

In Abstract #82 from the meeting, authored by Ann Caroline Raldow from Harvard, 6500 newly-diagnosed men treated with radiation and hormone therapy at the Chicago Prostate Cancer Center between 1997 and 2013 were evaluated.  Dr. Raldow calculated their survival rate after treatment based on their risk category: low, favorable-intermediate, unfavorable-intermediate, and high. Eight years after treatment 820 men had died, 72 of them from prostate cancer. Men in the favorable Intermediate-Risk category had the same survival rates as men in the Low-Risk category.  Men in either the High-Risk category or in the unfavorable Intermediate-Risk category demonstrated an increased mortality rate from prostate cancer.

Bottom line, the cancer of men with the favorable type of Intermediate-Risk prostate cancer behaves the same as Low-Risk.  Dr. Raldow’s analysis provides further clinical evidence that men with the favorable type of Intermediate-Risk prostate cancer can forgo immediate radical therapy and embark on active surveillance.

 

 

 

Too Many Prostate Biopsies

BY MARK SCHOLZ, MD

Every year in the United States one million men undergo a prostate biopsy.  Biopsy has a number of potential complications including serious infections requiring hospitalization and bleeding severe enough to require transfusions. One-percent of urologists have had a patient die from a biopsy-induced infection.

Despite these daunting risks, the real danger men face is the diagnosis of cancer.  In the United States, ninety percent of men who are diagnosed with prostate cancer undergo radical treatment, even when they have the Low-Risk variety of the disease that can be safely watched.  Treatment for prostate cancer is hardly innocuous, commonly causing impotence and urinary incontinence.

Misguided but well-intentioned experts have cogently argued that the rampant overuse of unnecessary biopsies and radical treatment have become so egregious that PSA screening should be discontinued. However, evidence is strong that PSA screening does reduce prostate cancer mortality.

So how can this dilemma be resolved? Is there a way to spare the men with Low-Risk disease while still detecting High-Risk prostate cancer while it is still curable?

Historically, biopsy has been the only accurate method for detecting prostate cancer.  However, for every case of High-Risk cancer detected, four or five men get the unpleasant news that they have Low-Risk disease, a diagnosis that usually leads to unnecessary treatment.

Two reports at this year’s American Urology Associate meeting indicate that modern multi-parametric MRI detects High-Risk prostate cancer very accurately.

In Abstract #2051 Dr. Noboru reported his findings in 320 men with PSA levels less than 10. They compared MRI with a standard 14-core biopsy. Only one man with very low volume disease in the Gleason 8-10 category was missed by MRI.

In Abstract # 1444 Dr. Emberton found that MRI accurately predicted the absence of any High-Grade cancer (Gleason score of 3 + 4 = 7 or above) with 95% accuracy.  Both Dr. Emberton and Dr. Noboru used a standard 1.5 Tesla MRI.  Enhanced, more accurate three Tesla MRI is available select centers.

High-quality prostate imaging is the only potential solution to the PSA screening conundrum.  Imaging detects High-Risk cancer that needs treatment. Men with Low-Risk disease can use the same technology for ongoing monitoring.

PSA screening is not the culprit for overtreatment in the U.S.   The policy of performing an immediate random, multi-core biopsy on every man with a PSA above 4.0 is the real problem. Fortunately, MRI imaging offers a viable alternative.

Prostate Cancer? Newly Diagnosed? Gearing Up for Your Journey (Part 1)

BY RALPH BLUM

You’ve just received what sounds and feels like a death threat. So what do you do? What steps do you take? You may have heard all this before. But we all absorb vital information at different rates, in different ways. Blessed are those of us to whom the Latin proverb applies: Verbum sat sapienti est: “A word to the wise is sufficient.” I know that in my case quite a few repetitions were required to spur me into action.

I’ve written about this subject in “A Strategy for Self-Empowerment,” and yes, now as then, we’re talking about “patient empowerment.” It is vital that you learn all you can about your disease because, like it or not, you are the final authority in making your treatment decisions. And it is equally important not to rush the treatment selection process or allow anyone else—including respected medical professionals—to stampede you into making a decision before you have done your due diligence.

Your first step after being diagnosed is to understand the concepts of staging and grading. The grade of your cancer will tell you how aggressive the cancer cells are; the stage tells you how extensive or advanced the cancer is—whether it is still confined within the prostate gland or has spread beyond the prostate. This information will determine your prostate cancer’s risk factor, and help you decide which treatment option is most appropriate for you.

Your risk level determines your treatment, and not all prostate cancer requires immediate treatment. If your stage and grade put you in the Low-Risk category, your least invasive choice would be Active Surveillance—simply monitor the situation with regular PSA testing, prostate exams, and periodic repeat biopsies.

If you fit into the Intermediate-Risk category you have many treatment choices, and in order to make the best decision you need to get opinions from multiple specialists with state-of-the-art knowledge, and equipment. You will have already seen an urologist who, if you are a candidate for surgery, is likely to have recommended a radical prostatectomy. If this is the case, don’t be shy.  You owe it to yourself to ask the tough questions: What are the risks? How many procedures has he performed overall, and how many within the past twelve months? Does he perform nerve-sparing surgery, and if so what is his success rate with preservation of potency and continence? You will usually find the most experienced surgeons at university centers. But an urologist who is well trained and does 100 procedures a year—and who you feel comfortable with—is also a good bet.

However, before making a decision, you should consider the other options available to you. Consult a radiation oncologist about brachytherapy (radioactive seed implantation). Learn the pros and cons of Intensity Modulated Radiation Therapy (IMRT), a precisely targeted procedure that delivers high doses of radiation to the prostate and, when necessary, to the seminal vesicles and other surrounding tissue. Once again you need to ask about success rates, and about the possible side effects of both radiation treatments.

Men in the Intermediate-Risk category also need to consult a medical oncologist about hormone therapy, a treatment that blocks the male hormone testosterone and significantly slows the spread of the cancer—often for years—during which time, less toxic and more effective treatments are likely to become available. Hormone therapy does not promise a cure, but it is a viable, noninvasive alternative to surgery or radiation.

If you are in the High-Risk category, you will usually need two or more different kinds of treatment—probably hormone therapy plus radiation, and possibly chemotherapy. But don’t panic. There are a number of exciting new treatment methods in the pipeline, so even if you fall into this more serious category you are not looking at an imminent death threat!
It goes without saying that there are pros and cons to all prostate cancer therapies. And when selecting a treatment plan, much will also depend on your age, your general health, your life expectancy, and your tolerance for the inevitable risks and undesirable side effects of whichever treatment you choose. I am not suggesting that you back off from a definitive form of treatment because of potentially adverse side effects, but bear in mind that quality of life is also a prime consideration when deciding which treatment is best for you. And remember: In most cases prostate cancer is the tortoise of cancers, and--especially if you are in your seventies or older--you are more likely to die with it, not from it. A word to the wise . . .