PSA - JHGuideToYourPSATest.pdf

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JohnsHopkinsHealthAlerts.com

Guide toYour PSA Test

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Johns Hopkins Health AlertsJohnsHopkinsHealthAlerts.com

Guide to Your PSA Test

Guide to Your PSA Test

Table of Contents

Getting a PSA Test for Prostate Cancer .....................................................1

PSA Testing: Benefits and Caveats ........................................................ 1

What Should You Do? ............................................................................ 2

Improving PSA Accuracy ....................................................................... 2

Beyond the PSA Test ........................................................................................ 3

PSA Problems ........................................................................................ 3

New Risk Prediction Tools .................................................................... 4

New Biomarkers .................................................................................... 4

More Expert Health Advice from Johns Hopkins ......................................... 6

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The prostate-specific antigen (PSA) test measures an enzyme produced almost exclusively by the glandular cells of the

prostate. It is secreted during ejaculation into the prostatic ducts that empty into the urethra.

A blood test to measure levels of PSA was first approved by the U.S. Food and Drug Admin-istration (FDA) in 1986 as a way to determine whether prostate cancer had been treated successfully and to monitor for its recurrence. Today, however, PSA tests are FDA approved for prostate cancer detection and are widely used to screen men for the disease.

PSA Testing: Benefits and CaveatsClinical studies, including a random-ized trial known as the European Study of Screening for Prostate Can-cer (ESRPC), have shown that PSA testing saves lives by detecting and treating prostate cancer earlier. In the most recent results from this trial, prostate cancer deaths were reduced by approximately 40 percent among men who were screened with the PSA test compared with those who were not screened. This reduction in prostate cancer deaths is similar to the decline in prostate cancer deaths seen in the United States since the onset of wide-spread PSA testing in the late 1980s.

Clinical studies to date have demon-strated the following benefits of PSA testing:

1. An elevated PSA is the single best predictor of the presence of prostate cancer.

2. PSA testing detects prostate cancer about five to 10 years earlier than digital rectal exams. 3. Most cancers detected with PSA testing are curable.4. Regularly scheduled PSA testing virtually eliminates the diagnosis of advanced prostate cancer.5. A baseline PSA prior to age 50 can help pre-dict the risk of prostate cancer up to 25 years later.

Because some of the cancers detected by PSA screening are so small or slow growing that they might never become life threatening, the tradeoff of routine screening is the over diagnosis

Getting a PSA Test for Prostate Cancer


Guide to Your PSA Test 1

The prostate is a gland the size and shape of a crab apple that surrounds the upper portion of the male urethra. Its main function is to produce part of the fluid that makes up semen.

bladder

urethra

prostate

rectumpenis

testicle

ejaculatory duct

seminalvesicle

Normal Male Anatomy

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of non-life-threatening cancers for which treat-ment is not necessary. This occurs more often in older men, who have less to gain from screening because of a shorter life expectancy.

Another drawback of PSA testing is that most men with an elevated PSA do not have prostate cancer. Instead, prostate enlargement (BPH) or inflammation is to blame. Men should discuss both the benefits and limitations of PSA test-ing with their physician before having their PSA levels measured in order to avoid unnecessary diagnostic tests and treatments, as well as undue anxiety.

There is no PSA level below which physicians can reassure a man that he does not have pros-tate cancer. Therefore, it is not possible to define a “normal” level. In men in their 40s or men without prostate enlargement, PSA levels above 2.5 ng/mL can signal trouble. For older men, levels above 3 to 4 ng/mL usually indicate the need for a prostate biopsy. Most experts agree that PSA should be used in conjunction with other information (for example, family history, race and age) to assess the overall likelihood that prostate cancer is present after a discussion with the patient about the benefits and risks.

What Should You Do?The American Cancer Society and the Ameri-can Urological Association recommend that PSA testing and digital rectal exam (DRE) be offered beginning at age 50. Men at increased risk for prostate cancer—black men and men with a family history of prostate cancer—should be offered PSA and DRE beginning at age 40 or 45. Previously, both organizations recom-mended annual testing for men who chose to be screened. However, the American Cancer Soci-ety now recommends screening every two years for men with a PSA level below 2.5 ng/mL.

The U.S. Preventive Services Task Force, an organization that makes recommendations about

periodic health examinations) recommends that men age 75 and older not undergo screening for prostate cancer and contends that the current evidence is insufficient to assess the balance of benefits and harms of prostate cancer screening in men younger than age 75.

One recent study found that testing all men at age 40, age 45 and then every other year after age 50 might be a better strategy, saving more lives and being less expensive than other screen-ing schedules. Other studies have concluded that men age 50 and older who have PSA levels below 2 ng/mL do not need to be tested every year. However, the testing schedule should be more frequent if a man’s PSA is rising but has not reached a threshold level where a biopsy would be recommended.

Improving PSA AccuracySeveral factors may affect the results of a PSA test. For example, some studies show that ejacu-lation one or two days before a PSA test may increase PSA levels in the blood. Consequently, men should abstain from sex for 72 hours prior to a PSA test.

Digital rectal exams and biopsies of the pros-tate may also affect PSA levels, although the increase in PSA caused by a digital rectal exam is not believed to be significant enough to pro-duce a false-positive test result in most men. A prostate biopsy, however, may elevate PSA levels for as long as four weeks.

Other prostate problems (such as BPH or prostatitis) also can inflate PSA levels, and 5-alpha-reductase inhibitors for BPH treatment (Proscar and Avodart) can lower PSA levels by about 50 percent. When men who are taking 5-alpha-reductase inhibitors have a PSA test, this drug-related reduction in PSA level must be taken into account to avoid misinterpretation of the test result.



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If you have just had a prostate-specific antigen (PSA) screening test, the words “Your PSA level is 4,” are not particularly

welcome. In general, the higher the PSA, the greater the likelihood cancer is present. So, a score of 4 ng/mL is likely to sound warn-ing bells for your doctor to order a biopsy, the results of which are used to help confirm or rule out the presence of cancer. And, if cancer is identified, the biopsy results are also used to help decide whether immediate or delayed treatment is the best course of action.

Today, however, a number of prostate cancer experts argue that a PSA level of 4 is not the best cut-off point for triggering a biopsy. But given recent evidence showing that most can-cers identified by PSA screening are not life threatening, it might surprise you to learn that the new threshold is even lower.

What’s more, a growing number of doctors are questioning the value of using any single PSA value for all men. Instead, they consider the PSA result as just one of many pieces of information that can be used to help deter-mine a man’s risk of having prostate cancer that needs treatment.

PSA ProblemsExperts worry that a PSA screening cutoff of 4 ng/mL is not sufficiently sensitive. The term

“sensitivity” describes how good a test is at not missing people who have a condition—in this case, prostate cancer. This is referred to as a false negative.

In the Prostate Cancer Prevention Trial, for example, 7 percent of men who had a PSA level of below 0.5 ng/mL had cancer, and about 12 percent of those cancers were high-grade, aggressive tumors with the potential to become life threatening; among men with a PSA of 3.1 to 4 ng/mL, 27 percent had cancer, and 25 percent of those were high grade.

As a result of findings from this and other studies, many doctors now recommend lower-ing the threshold for a standard biopsy from 4 ng/mL to 2.6 ng/mL to pick up some of the men who were missed by using the higher threshold.

Of course, while lowering the threshold allows for the identification of more men with prostate cancer, it also means that even more men who don’t have cancer or who have non-life-threat-ening disease will be flagged. Those with cancer may be subjected to medical procedures they may not need, especially if they are older and have other medical problems—a concern that has prompted doctors to rethink their advice about who needs regular screening.

There also is the test’s specificity to consider. This term refers to how good a test is at not

Beyond the PSA Test



New strategies to help doctors and patients make more informed treatment decisions

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accidentally labeling people who don’t have a condition, such as prostate cancer, as having it. This is referred to as a false-positive result. Many factors, such as benign prostatic hyper-plasia (BPH), prostatic inflammation or even an ejaculation within 72 hours of a PSA test, can cause a false-positive result.

One answer to these dilemmas may be to combine the PSA test results with additional information from other sources to more accu-rately diagnose prostate cancer and predict the risk of disease progression.

New Risk Prediction ToolsOne method of predicting risk that is gaining popularity is the use of nomograms. A nomo-gram considers multiple weighted factors to cal-culate risk. For example, a nomogram that was developed using information from the Prostate Cancer Prevention Trial attempts to determine your risk of having biopsy-detectable prostate cancer based on information about your race, age, PSA level, family history of prostate can-cer, digital rectal examination (DRE) results, whether you’ve had a biopsy in the past and whether you take finasteride (Proscar).

Other nomograms that have been developed can calculate outcomes such as the chances that your disease will not progress if you choose a particular treatment or the probability of sur-vival if you have a radical prostatectomy.

It’s important to realize that the information obtained from a nomogram is simply a predic-tion based on population data, much like the insurance industry predicts longevity based on age, medical history and other factors. While such information can help patients in making decisions, it’s not a guarantee of a particular outcome nor is it a substitute for your doctor’s clinical judgment.

New BiomarkersBiomarkers are substances like PSA that can be measured in blood, urine or other body flu-ids and used to detect or monitor a disease. Researchers are investigating a number of potential biomarkers that, in the future, may improve upon the PSA test’s ability to detect prostate cancer and identify potentially life-threatening tumors. Two promising biomark-ers are PCA3 and gene fusions.

PCA3. PCA3 is a test that measures a gene that is overexpressed (60 to 100 times greater) in prostate cancer cells versus noncancerous cells. Cells shed by the prostate containing the PCA3 gene are detectable in the urine.

Researchers report that the lower the level of PCA3 in the urine, the less likely prostate can-cer is present. Because PCA3 is not produced or is produced only minimally by noncancer-ous cells, the presence of conditions like BPH or infection is less likely to produce falsely ele-vated PCA3 levels.

PCA3 testing is most reliable when done in conjunction with a DRE. Researchers report that when performed after a DRE, the results from PCA3 testing are valid in 98 percent of the cases. If the test is performed without a DRE, validity drops to 80 percent.

Rather than replacing PSA screening, researchers believe that the PCA3 test may help identify or rule out cancer in men with elevated PSA levels but no cancer on the initial biopsy. In addition, some evidence suggests that the test may be useful in helping to identify men who are appropriate candidates for active sur-veillance. Currently, in the United States PCA3 testing is available only through clinical trials.

Gene Fusions. A gene fusion is a hybrid gene formed from two previously separated genes. Scientists have discovered that many prostate cancer patients have gene fusions



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involving the ERG and TMPRSS2 genes that create a new gene that is thought to promote the development of prostate cancer—and, pos-sibly, a more aggressive form of the disease. Gene fusions are now being detected in urine and have promise as new biomarkers for pros-tate cancer. More research is needed, however, before this method of testing moves into the mainstream.

In the MeantimeRegular PSA screening still plays a valuable role for many men. If your doctor recommends regular screening, keep track of your PSA lev-els and monitor the trends over time. This can help you and your doctor identify trouble signs in the earliest stages. A sign that prostate can-cer may be present is a continuously rising PSA even if your absolute PSA score is in the “nor-mal” range.



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Rely on Expert Health Advice From Johns HopkinsConsistently ranked America’s #1 Hospital by U.S. News & World Report

Prostate Disorders White PaperThis all-in-one comprehensive guide explains everything you need to know about your pros-tate—what it is, what it does, and what problems can develop, such as prostatitis, benign prostatic hyperplasia (BPH, or enlarged prostate) and prostate cancer. You’ll learn key facts about prostate health, discover prostate treatments you never knew existed and understand what your options are if you’re ever diagnosed with prostate cancer.

The Johns Hopkins Prostate Disorders BulletinWritten by Dr. Jacek L. Mostwin and his esteemed colleagues at the world-renowned James Buchanan Brady Urological Institute, the Johns Hopkins Prostate Disorders Bulletin is an indispensable quarterly journal for men with prostate cancer. It also covers other prostate health prob-

lems, including benign prostatic hyperplasia (BPH) and prostatitis, and related concerns such as overactive bladder and erectile dysfunction. With in-depth reports from leading experts and summaries of critical research findings, the Bulletin goes far beyond the basics to inform you about the latest therapeutic treatments, advanced news of clinical trials, and new medica-tions, plus detailed answers to subscribers’ concerns about all aspects of prostate health. A subscription includes 5 FREE special reports.

Choosing the Right Treatment for Prostate CancerThis comprehensive report is a must-read for any man recently diagnosed with prostate cancer who is looking for answers to pressing questions about treatment options. Written by specialists at America’s #1 urology center, it takes you step-by-step through the decision-making process to help you make informed choices. Our experts explain: proactive surveillance, also known as expectant management ... nerve-sparing radical pros-tatectomy . . . radiation therapy, including EBRT, 3DCRT, IMRT, IGT and brachytherapy.

Advanced Prostate Cancer Treatments: Know Your Options When Your Cancer Comes Back

For anyone who has had a recurrence of prostate cancer, this 113-page report features detailed discussions with leading experts at Johns Hop-

kins on the treatment options currently available. You will learn about established therapies as well as new approaches being developed at Johns Hopkins and at other important medical centers. These treatments include gene therapy to stop the advance of the disease, mono-clonal antibodies that zap cancer cells throughout the body, and a variety of chemotherapy agents such as Taxotere and angiogenesis inhibitors (drugs that choke off the blood supply to tumors).

Provenge’s promise The first prostate cancer vaccine PAGE 62

Testosterone treatment: think twice A new study links testosterone to increased risk of prostate cancer in older men PAGE 27

Hormone therapy and your bones Proven methods to boost bone strength PAGE 70

A surprising cause of chronic prostatitis H. pylori bacteria may be to blame PAGE 77

Overactive bladder or BPH? Learn how to tell the difference PAGE 6

Th e Ye a r’s LaTe s T re s e a rc h

The Johns Hopkins White Papers

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H. Ballentine Carter, M.D.

Prostate Disorders

Choosing The RighT TReaTmenT FoR PRosTaTe CanCeR

Choosing the Right

Treatment forProstate Cancer

AdvancedProstate Cancer

TreatmentsKnow Your Options When Your

Cancer Comes Back

For more information, or to order, go to: JohnsHopkinsHealthAlerts.com/bookstore

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The information contained in this Special Report is not intended as a substitute for the advice of a physician. Readers who suspect they may have specific medical problems should consult a physician about any suggestions made.

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