A Landmark Study: Surgery for Prostate Cancer

BY MARK SCHOLZ, MD

Between in 1994 and 2002, 731 men with an average PSA of 7.8 and age 67 volunteered to have either immediate surgery or observation based on a coin flip. The New England Journal of Medicine reported the 10-year survival statistics this week. What follows is a summary of the statistical outcome of the study.  I think the raw numbers speak for themselves.

Of the 364 who had surgery, 21 men died of prostate cancer.  Of the 367 assigned to observation 31 men died of prostate cancer.  So with observation, the risk of dying was less than 9%.  However, there was still a 6% chance of dying even with immediate surgery.  The net difference between observation and immediate surgery was 3%.

During the first 30 days after surgery there were a number of very serious side effects including one death.  Additionally, there were two men with blood clots in their legs, one stroke, 2 with blood clots in the lungs, 3 heart attacks, 1 man with renal failure requiring dialysis, 10 who required additional corrective surgery, 6 who required additional blood transfusions and 6 who still had urinary catheters more than 30 days after surgery.

Forty-nine men (17%) who had surgery compared to 18 men (6%) who underwent observation “have a lot of problems with urinary dribbling,” some losing larger amounts of urine than dribbling but not all day,” others who “have no control over urine,” and the remainder who “have an indwelling catheter.”

Two hundred thirty one men (81%) who had surgery compared to 124 men (44%) who underwent observation had erectile dysfunction defined as the inability to attain an erection sufficient for vaginal penetration.

Further statistical analysis of a subgroup of men with High-Risk prostate cancer indicated an 8% improved chance of not dying of prostate cancer compared to observation. Also, men who had surgery who were in the Intermediate-Risk or High-Risk category were 10% less likely to develop bone metastases within 10 years compared to the men on observation.

There was no difference in the incidence of mortality or metastases between surgery and observation in the men in the Low-Risk category.

This high-quality study, published in the most prestigious medical journal in the world evaluating the risks and benefits of surgery, required 18 years to perform.  It shows a barely discernible benefit resulting from immediate surgery for men with High-Risk prostate cancer. These findings are quite similar to another large randomized trial of surgery versus watchful waiting that reported 15-year results in the New England Journal of Medicine in May 2011.

The bottom line is very clear:  For men with Low-Risk disease, where surgery is concerned, the treatment is definitely worse than the disease.  Even more striking, is the relatively small survival benefit for surgery in men with High-Risk disease. One can’t help but wonder if the substantial risks of immediate treatment-related side effects outweigh the small benefit in survival.  

Erection? Who said “Erection?”

BY RALPH BLUM

Although most men, when they are diagnosed with prostate cancer, are primarily concerned with staying alive, there is a surprisingly large constituency who, as my psychiatrist friend put it “vote with their dicks.” For these men, not being able to have an erection is literally a fate more awful than death. But for almost all of us, the degree to which sexual function returns—or fails to return—is a matter of serious concern.

The three basic questions doctors hear when discussing treatment options are:

Will it cure me?

Will I have to wear diapers?
And the big one:  Will I be able to get an erection?

No doctor can answer any of these questions with an unequivocal “Yes.” The reality is that there are no guarantees. It’s a tough call whether to go for a cure, or for quality of life—which for many of us means being able to get an erection.

“I gotta tell you, Betsy is so much younger than I am. She’s right at the peak of her sexuality,” my friend Calvin pointed out. “My ability to perform still matters a lot to her. And there are plenty of folks like us—the May and September couples. Far as I’m concerned, quality of life isn’t an option. It’s the name of the game."

 

Compared to other treatment options such as active surveillance or hormone therapy, surgery and radiation have one clear advantage: closure. But surgery is also the chief culprit when it comes to ruining your sex life. The nerve bundles that control erections are located perilously close to the prostate gland, so you’re cutting past a lot of delicate apparatus, and even with nerve-sparing surgery performed by an experienced and talented surgeon, it’s very easy for things to go wrong. Once those nerve bundles are cut, it’s goodbye to erections.

However, the two modern radiation options—permanently implanted radioactive seeds (Brachytherapy) and intensity modulated radiation therapy (IMRT)—are at least as effective as surgery at curing the disease. And more importantly, the precise targeting means less risk of “collateral damage.” In other words, Calvin has a better chance of keeping Betsy happy—especially with a little help from the wonders of modern pharmacology.  Calvin and Viagra are now wedded at the hip!

 

According to the TV commercials, part of the cure for erectile dysfunction appears to be lounging with your sweetie in adjacent bathtubs while holding hands and watching the sunset. Providing, of course, you have taken the pill that does increase blood flow to your penis.

 

Bottom line: While the use of Viagra and Cialis to prevent ED after treatment is still not totally proven, and despite the fact that these pills can be very expensive, most of us guys, when we find out that using them will probably contribute to sustaining our long term sexual function and keeping the physical side of our relationships sweet and nourishing, we feel that using these pills regularly is a must. Like an insurance policy for intimacy.

“Good” Prostate Cancer, “Bad” Prostate Cancer

BY MARK SCHOLZ, MD

How can anyone call a cancer “Good?” As time goes by, it seems that prostate cancer is becoming more confusing, not less. Many of us have heard the statement that, “Men die with prostate cancer, not from it.” Or another commonly repeated statement, “The treatment is worse than the disease.”

But then we hear about Merv Griffin or Dennis Hopper, men with immense financial resources, dying from prostate cancer.  How can we say that prostate cancer is “Good?”

When someone hears the word CANCER, they think they know what you are talking about.  Cancer is so common that it now vies with heart disease for being the most common cause of death in men. Cancer has touched the lives of most people, usually in a very negative way.

Perhaps the best way to get a feel for prostate cancer is to compare the “Bad” type of prostate cancer with cancer of the lung or colon, the other two most common types of cancer in men. Other cancers of the brain, bone, stomach, pancreas, kidney and bladder tend to behave in a way that is similar to lung or colon cancer.

	Lung, Colon Cancer	“Bad” Prostate Cancer
Blood test available for early detection	no	yes
Hormone therapy available	no	yes
Spreads to liver or brain	Yes	no
10-year survival rate	10-50%	90%
Average survival after relapse	1-2 years	More than10 years

Since the table tells us that it’s far better to have a “Bad” prostate cancer than just about any other type of cancer, imagine how confusing it is when people are told they have a “Good” type of prostate cancer.  What the heck does that mean?

Men are encouraged to refrain from fearing Low-Risk or “Good” prostate cancer because their life expectancy is identical to or even better than that of men who have never been diagnosed with prostate cancer, even without treatment. Since the survival rate is excellent, immediate administration of toxic therapies that ruin sexual and urinary function is inappropriate and often reprehensible.

There is a question that frequently arises: “How accurately can doctors discriminate between the good and bad types of prostate cancer? Do they ever make mistakes and advise men with “Bad” prostate cancer to forgo immediate treatment?

Until fairly recently, men with “Bad” prostate cancer were misdiagnosed because standard prostate biopsy techniques do not routinely sample the front half of the prostate gland.  While cancer in the front of the prostate is uncommon, and because the area is not routinely biopsied, high grade cancers could be missed.  Fortunately, recently developed imaging with multi-parametric Magnetic Resonance Imaging (MRI) can now detect high grade disease in the front or anterior half of the gland with a high degree of accuracy.

Imaging with MRI is so improved that preliminary studies presented in Atlanta at this year’s meeting of the American Urology Association indicate that multi-parametric MRI may be able to replace biopsy altogether.  I am planning to review these exciting reports in my next blog.

Prostate Cancer: The Stress Factor

BY RALPH BLUM

It’s no secret: Men are considerably less likely to seek medical help than women. The reluctance starts with a superficial cut or a bellyache. And when it gets to what’s happening “down there,” given half a chance, we go into “ostrich” mode.

There was an informative article some years ago in Psychiatric Times in which the authors, William F. Piri, MD, and Jeffrey Mello, MSW, focused on some of the factors that keep men from going to a doctor. In seeking care, men may fear being viewed as weak, appearing “unmanly,” feeling that they must live up to society’s image of them as strong and independent by “dealing with it” on their own. So we find ourselves in a bind and resort to denial: When we are questioned about this neglect, we offer excuses such as “I just don’t have the time because of . . .” and give reasons like our work, family obligations, and just plain preferring to “wait and see how things go.”

Moreover, even providing that an annual checkup propels a man into the doctor’s office, Piri and Mello point out that:

…there is no guarantee he will receive prostate cancer screening. The idea of a digital rectal exam typically makes men anxious, provoking concerns about discomfort and the violation of their manhood. Primary care physicians often join their patients in avoiding this sometimes uncomfortable and socially awkward test, which typically lasts less than a minute.

This problem is even more challenging in the African-American community since black men have a prostate cancer mortality rate  twice that of Caucasian men.

          
So what is the answer? Joining a support group is one good way to challenge the manly addiction to independence. However it depends on the group, and not all men find support groups beneficial. In which case counseling or psychotherapy—either individual or group—is a reasonable way to proceed.  

In his last blog, Mark quoted a recent New England Journal of Medicine report stating that in the first three months after a diagnosis of prostate cancer, the rate of heart attack and suicides both increase by about 200%. So instead of ignoring, denying or trying to minimize the psychological effect of prostate cancer, know that all the feelings you have are normal, and that they are common among the more than 200,000 men diagnosed with this disease each year. Getting treatment for your fear, anxiety and depression is as necessary as facing and dealing with the disease itself—and ultimately just as beneficial in recovering your health.

What is a Mindless Biopsy?

MARK SCHOLZ, MD

The recent recommendations by the U.S Preventative Services Task Force to stop PSA screening are articulated as follows:

1.  The magnitude of harms from screening (e.g., falsely high PSA, psychological effects, unnecessary biopsies, over diagnosis of indolent tumors) is “at least small.”

2.  The magnitude of treatment-associated harms (i.e., adverse effects of surgery, radiation and hormonal therapy) is “at least moderate”—particularly because of over treatment among men with low-grade disease.

3.  The 10-year mortality benefit of PSA-based screening is “small to none.”

4.       The overall balance of benefits and harms results in “moderate certainty that PSA-based screening … has no net benefit.”

In the United States a diagnosis of prostate cancer leads to radical treatment 90% of the time, even when men are diagnosed with the Low-Risk form, the type that experts agree can be safely monitored. In fact, since the definitive consensus conference of 2007 in San Francisco stipulated that active surveillance is a reasonable treatment methodology, the use of surgery has increased.  In 2005 approximately 56,000 men had radical prostate surgery.  This number ballooned to 88,000 in 2008.

Surgery is overused because of ignorance about the innocuous nature of Low-Risk prostate cancer and ignorance about the devastating consequences of surgery, which include impotence, incontinence, Peyronie’s disease (crooked penis disease), climactauria (ejaculating urine), urethral scaring and penile shrinkage.

Superstar surgeons are only successful in making 50% of 58-year-old men and 25% of 65 year old men “happy” when happy is defined as staying cured, not leaking urine and having a modicum of erectile function.

A prostate cancer diagnosis is dangerous, even if the terrible risks of over treatment are ignored.  This year the New England Journal of Medicine reported that in first 3 months after a diagnosis of prostate cancer, the rate of heart attack and suicides both increase by about 200%.

Even though the Task Force is entirely correct about the dangers of over treatment, PSA is an inexpensive test that’s proven to saves lives; it is here to stay. In reality, the essence of the problem is not PSA.  The problem resides in the mindsets of the doctors and patients. The doctors doing the biopsies, the urologists who are surgeons, are intensively trained to be action oriented.

The general populace is just as much to blame because the average person knows next to nothing about prostate cancer. When confronted with the shock of a cancer diagnosis, patients naturally assume prostate cancer just as deadly as other cancers.  Surgical removal seems like the most logical way to proceed.

No one has any idea what they are getting into before they are diagnosed. Yet more than a million men rush into a prostate biopsy every year wondering, “Do I have prostate cancer?”  But what are they wondering about?  It is a medical fact that more than half of elderly men harbor some form of prostate cancer. Even men with normal PSA levels will have a positive prostate biopsy 20% of the time.

If you are going to have a biopsy, prepare yourself to have prostate cancer.

So if PSA is abnormal, say between 2 and 10, what should a man do?  First, an individual’s risk of having cancer can accurately be estimated prior to biopsy using a calculator which is available on the web.  The calculator can be accessed by googling “PCPT Risk Calculator.” The real value in this calculator is its capacity to predict the risk of having high-grade prostate cancer, the type of prostate cancer that does require treatment.

In addition, men should consider measuring the size of their prostate gland with MRI or ultrasound. Men with a prostate gland that is in the 30-60 cc range are only one-fourth as likely to have prostate cancer as a man with a prostate that is less than 30 cc. Men with a prostate volume more than 60 cc are only one-tenth as likely to have prostate cancer as a man with a prostate less than 30 cc. High quality imaging with color Doppler ultrasound or 3T MRI can also “see” cancers, especially the larger more malignant types that need treatment.

It’s understandable that people are uninterested in these mundane issues prior to a diagnosis. They think they don’t have it.  The sad fact is that the majority of elderly men do have it.  All it takes is a biopsy to open Pandora’s Box.