PSA: Prostate Scandal Alert

Six years ago, Mike sat down with his doctor during his yearly checkup to go over the results of his blood tests. Everything looked good with one exception: His PSA was moderately elevated.

Mike was referred to a urologist for further evaluation who ordered a biopsy, found a malignancy, and recommended surgery. Mike underwent radical prostatectomy (removal of his prostate gland), and today, at age 75, Mike is alive, well, and convinced that he owes his life to the PSA test that found early-stage prostate cancer.

Mike is not alone. According to the Prostate Cancer Research Foundation of Canada, 19,000 Canadian men are diagnosed with prostate cancer every year, and many of them opt for surgery, radiation, or hormonal treatment. Men who go through this often feel, as Mike does, that early detection with PSA saved their lives. But did it?

What's a PSA Test?

Prostate-specific antigen (PSA) is a protein produced by the epithelial cells lining the prostate, a small, doughnut-shaped gland that wraps around the urethra and produces the fluid part of the semen. Levels of PSA, which can be measured by a simple blood test, rise in the presence of prostate diseases such as prostatitis (inflammation of the prostate), benign prostatic hyperplasia (BPH) (age-related enlargement of the prostate), and cancer.

When this test burst onto the scene 18 years ago, it was viewed as a godsend by physicians and patients alike. Finally a screening test was available for men that, like mammography for women, would find their most common type of cancer in its early, treatable stages. Experts espoused routine screening, and its popularity soared. But like many tests, drugs, and surgical procedures that are embraced by mainstream medicine, PSA testing has not lived up to the hype. In fact, it may do more harm than good.

Is the PSA Screen Too Fine?

Thomas Stamey, MD, professor of urology at Stanford School of Medicine, is often referred to as the "father of PSA." He was involved in the first study linking elevations in PSA to prostate cancer, and for two decades has remained at the forefront of PSA research, publishing more than 100 studies and journal articles on the subject. Dr. Stamey now believes that PSA testing as a screening tool for prostate cancer has outgrown its usefulness and has stated outright that the "prostate-specific antigen era… is over for prostate cancer."

He explains that in the early years of PSA testing, it was a fairly reliable tool for diagnosing prostate cancer. In his initial research, which was published in the New England Journal of Medicine in 1987, the size of prostate tumors removed by radical prostatectomy was compared to PSA levels before removal, and there was a reasonable relationship between the two. In almost half of the cases studied, PSA was predictive of size and severity of prostate cancer.

Today, however, it's a different story. In a follow-up study, published in 2004 in the Journal of Urology, Dr. Stamey's research team reviewed 1,317 specimens from radical prostatectomies performed from 1983 through 2003 and again compared preoperative PSA levels to tumor aggressiveness. They found that in the cases from 1983 through 1988, there was a reasonable correlation between blood levels of PSA and prostate cancer, reflecting the results of the 1987 study. Yet in the cases from 1999 through 2003, there was little connection between PSA and prostate cancer size and severity: a relationship was noted in only two percent. In fact, the only parameter clearly linked with PSA levels was overall prostate weight, leading the authors to conclude, "In the last 5 years, serum PSA has only been related to benign prostatic hyperplasia."

Why such a dramatic difference? Because we've taken PSA screening to ridiculous extremes. Eighteen years ago, the majority of prostate cancers were detected by digital rectal exam. (A physician inserts a gloved finger into the rectum to feel the prostate; hard lumps are indicative of tumor growth.) These tumors were large enough to generate appreciable levels of PSA, 25 nanograms per milliliter (ng/mL) on average. These cancers had clinical significance and needed to be treated.

Most prostate cancers detected today are too small to be felt on digital rectal exam. They are initially noted on PSA testing, and the threshold of concern is much lower. Today, PSA levels greater than or equal to 4 ng/mL are considered abnormal and merit further investigation. But this number might as well have been pulled out of a hat. Scientists from the National Cancer Institute recently found, from biopsies of 2,950 men over age 61 with "normal" PSAs, that 15 percent of them had low-grade prostate cancer including seven percent of those with PSA less than or equal to 0.5 ng/mL! Compare this with Dr. Stamey's latest research, which suggests that PSA scores between two and 10, and in many cases up to 20, are useless in determining the presence of prostate cancer.

Here's the bottom line: A low PSA score is no guarantee that a man does not have prostate cancer. Conversely, a high score is more indicative of run-of-the-mill, age-related, nonmalignant BPH than it is of prostate cancer. Nevertheless, many men are funneled into unnecessary procedures based solely on the results of this dubious test.

From Screening to Biopsy

If a man's PSA is elevated, the next step on the prostate cancer merry-go-round is a biopsy. Most of these are core needle biopsies quick and fairly painless procedures usually done in a doctor's office. They involve removing multiple tissue samples from several areas of the prostate with long, hollow needles inserted through the rectum or perineum. The samples are then examined under a microscope for the presence of malignant cells.

Given the unreliability of the PSA tests that lead to most prostate biopsies, it's no surprise that three-quarters of the biopsies reveal no signs of cancer whatsoever. Such a result is without doubt great news, but going through a biopsy and waiting for the results, good or bad, is an ordeal. In a 2004 study published in the American Journal of Medicine, researchers from Massachusetts General Hospital in Boston found that, no matter what the results, prostate biopsies were traumatic. "Men who underwent prostate biopsy more often reported having thought and worried about prostate cancer, despite having received a benign result. This under-recognized human cost of screening should be considered in the debate about the benefits and harms of prostate cancer screening."

There is another, darker side of needle biopsies that is rarely discussed, and that is their potential for spreading cancer. The vast majority of prostate cancers are encapsulated within the prostate. When you puncture a tumor with a needle, you risk introducing cancerous cells previously walled off and confined to the prostate, into the bloodstream or lymph system. Although needle biopsies, which are also commonly used to diagnose cancer in the breast, liver, and other organs, are declared to be completely safe by oncologists, not all experts share their confidence.

In a two-part article written in 2005, Ralph Moss, PhD, an astute researcher who has extensively studied cancer diagnosis and treatment, summarized research dating from 1940 to the present that questions the safety of needle biopsies. The most recent study, from the John Wayne Cancer Institute in Santa Monica, California, concluded that needle biopsies of breast tumors may increase metastasis, or spread, of cancer cells beyond the original tumor site. Although some physicians may shrug off this very important research, ask your doctor about other diagnostic options such as ultrasound, MRI, or CT scanning if a prostate biopsy is recommended to you.

The Fear Factor

Another downside of PSA screening is overly aggressive treatment. Since cancers detected by PSA are of questionable clinical significance, their future course slow-growing and harmless or aggressive and deadly is unknown. Yet once the dreaded diagnosis of cancer is pronounced, patients want nothing more than to get it out of their bodies. This means that many men suffer through the horrors of treatment for tumors that would never have given them a whit of trouble.

Aggressive treatments would be fine if they were safe and effective, but that simply isn't the case. Chemotherapy, radical prostatectomy, radiation, cryosurgery (freezing cancer cells to death with liquid nitrogen), and hormone therapy all come with debilitating side effects, including urinary and fecal incontinence and erectile dysfunction. As to their efficacy, none of them is all that helpful for advanced disease. According to oncologist Charles Simone, MD, despite all the "innovations" that modern medicine has conjured up over the past 75 years, the lifespan of patients with prostate cancer hasn't changed since 1930.

Rarely are any of these treatments more effective than "watchful waiting," or simply observing the course of disease without taking any aggressive action. Watchful waiting doesn't mean doing nothing. What I recommend for patients who have been diagnosed with prostate cancer is "aggressive watchful waiting:" a comprehensive program of safe, noninvasive therapies that target general health, boost the immune system, and specifically target the prostate. In most cases, prostate cancer is a chronic disorder, like diabetes or arthritis, which can be managed without jumping into aggressive and invasive measures.

The Future of PSA

Widespread PSA testing leads to more biopsies, more cancer diagnoses, and more aggressive treatment. Prostate cancer rates have risen dramatically in recent years, but only in countries where PSA testing is commonplace. In the 1990s, when such screening became routine in the United States, incidence rates skyrocketed. In England and Wales, where screening is much less common, it went up only slightly. Yet the death rates from prostate cancer in these countries have been virtually identical for the last 30 years.

If you're a man and you live long enough, you're probably going to develop prostate cancer: Autopsies reveal that 70 to 80 percent of men in their 70s and older have it. But it is highly unlikely that prostate cancer is going to kill you. Statistics show that only 226 of every 100,000 men over age 65 die of prostate cancer. That's a death rate of 0.003 percent, which is low by any standard, especially for that age group. Most men go to their graves with no inkling that their prostates harbour cancerous cells - unless, that is, they undergo regular PSA screening.

We need to rethink the way we use the PSA test. Just because this test has little specificity for prostate cancer doesn't mean it has no clinical value. We use it at my clinic, not as a one-shot screening test but to monitor the effectiveness of treatment for all prostate problems, including BPH and prostatitis.

We also look at changes that occur over the long term. A 2004 Harvard study suggests that the prognostic value of PSA can be increased by following PSA velocity, or the rate it rises annually. They discovered that yearly increases of more than 2.0 ng/mL were indicative of more aggressive cancers. The five-year death rate for these men was nine percent, compared to a mere 0.3 percent for those with more gradual increases. Tracking PSA velocity might be a valid way to determine clinical significance.

I do not want to minimize the impact of prostate cancer. For Canadian men, it is the second most lethal type of cancer, after lung cancer, and some men do benefit from early detection. But an isolated PSA test cannot definitively diagnose cancer, much less determine if it is an aggressive cancer, that needs to be treated, or a benign disease.

So what should you do? Beginning around age 50 younger, if you're black or have a family history of prostate cancer get an annual digital rectal exam. If a tumor can be felt in the prostate, further investigation is indicated. If you'd like to have annual PSA tests to monitor PSA velocity, fine. But to jump into treatment based solely on a spurious PSA reading is overkill.

A Prostate Protection Program

Men, if you're over age 45, now is the time to get started on a prostate protection program that will enable you to sidestep problems down the line.

First, clean up your diet. Researchers from the National Cancer Institute recently found that a diet heavy in fats from foods such as meat, cheese, mayonnaise, and salad dressings increased risk of aggressive prostate cancer, while fats from fish and chicken lowered risk. Salmon and other cold-water fish are particularly protective because of their abundance of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which have proven cancer-preventive effects. If you're not a fan of fish, take two 1,000 milligram capsules of fish oil a day.

Vegetables and fruits are loaded with vitamins, minerals, and phytonutrients that guard against cancer. Topping the list are lycopene-rich tomatoes. A 2002 Harvard study showed that two to four servings per week of tomato sauce cut risk of advanced prostate cancer in half. Soy foods are also beneficial because they contain isoflavones that blunt harmful hormonal influences and inhibit prostate cancer proliferation. And don't forget green tea, which contains a polyphenol called epigallocatechin gallate (EGCG) that binds to proteins on cancer cells and curbs their growth.

Second, take targeted nutritional supplements. Start with a potent daily multivitamin and mineral supplement with high doses of protective antioxidants, especially vitamins E (400 IU) and selenium (200 mcg). Vitamin D (600 to 1,000 IU) supplementation is also important, especially during Canada's dark winters when deficiencies of this cancer-preventive vitamin are not uncommon. Round out your program with 180 to 360 mg of saw palmetto. This herb, used primarily to reduce symptoms of BPH, also slows the growth of prostate cancer.

If you've been diagnosed with prostate cancer, add these supplements, regardless of the treatment program you're following: coenzyme Q₁₀ (200 to 300 mg), a powerful antioxidant that inhibits cancer cell growth; modified citrus pectin (15 g), which retards prostate cancer cell proliferation and metastasis; and active hexose correlated compound (AHCC), (1,500 to 3,000 mg), an immune booster that increases production of macrophages and natural killer cells.