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National Cancer Institute - Selenium and Vitamin E Cancer Prevention Trial

October 31st, 2005

VITAMIN E CAPSULES

Source: National Cancer Institute

1. What is SELECT?

SELECT stands for the Selenium and Vitamin E Cancer Prevention Trial, a clinical trial to see if one or both of these dietary supplements prevent prostate cancer. The trial is funded by the National Cancer Institute (NCI) and is being coordinated by the Southwest Oncology Group (SWOG), an international network of research institutions that receives NCI funding. Enrollment began in 2001 and ended in 2004, 2 years ahead of the originally planned 5 years. The study will continue for 7 years after the last man enrolled, meaning that each man will participate for 7 years or more, depending on when he joined the study. More than 400 sites in the United States, Puerto Rico, and Canada are taking part in the study. Over 35,000 men are participating in SELECT.

2. What are a man’s chances of developing prostate cancer?

Except for skin cancer, prostate cancer is the most common type of cancer in men in the United States. In 2005, there will be an estimated 232,090 new cases of prostate cancer and 30,350 deaths from this disease in the United States (1).

Approximately 1 in 6 men in the United States (or 17.8 percent) will develop prostate cancer during his lifetime (1). All men are at risk, but those at highest risk fall into one or more of the following categories: age 55 or older; black; or have a father or brother with prostate cancer.

3. What is selenium? Why study it for prostate cancer prevention?

Our bodies need selenium, a nonmetallic trace element that we get from food—especially plant foods like rice and wheat, seafood, meat, and Brazil nuts. Selenium is an antioxidant that might help control cell damage that can lead to cancer.

The Nutritional Prevention of Cancer Trial, published in 1996, included 1,312 men and women who had skin cancer. Men who took selenium to prevent nonmelanoma skin cancer received no benefit from selenium in preventing skin cancer. However, men who had taken selenium for 6½ years had approximately 60 percent fewer new cases of prostate cancer than men who took the placebo (2). In 2002, study data showed that men who took selenium for more than 7½ years had about 52 percent fewer new cases of prostate cancer than men who took the placebo (3). This study is one of the reasons selenium is being studied in SELECT. (See Question 11 for more information about selenium.)

4. What is vitamin E? Why study it for prostate cancer prevention?

We get vitamin E in a wide range of foods, especially vegetables, vegetable oils, nuts, and egg yolks. Vitamin E, like selenium, is an antioxidant, which might help control cell damage that can lead to cancer.

In a 1998 study of 29,133 male smokers in Finland, men who took vitamin E to prevent lung cancer had 32 percent fewer new cases of prostate cancer than men who took the placebo. Some men also took beta carotene, but neither substance helped prevent lung cancer (4). (See Question 12 for more information about vitamin E.)

5. What do researchers hope to learn from SELECT?

SELECT is the first study to look directly at the effects of selenium and vitamin E on the risk of prostate cancer. This study is designed to find out if selenium, vitamin E, or both prevent prostate cancer.

A large trial of selenium and vitamin E is needed to substantiate earlier, separate findings from studies in which prostate cancer was not the primary outcome. Although two earlier studies suggested that these two supplements might prevent prostate cancer, this cancer was not the focus of those studies. The primary goal of SELECT is to assess the effect of these substances on the number of new cases of prostate cancer diagnosed during routine clinical practice. Other objectives are to assess the impact of selenium and vitamin E on the incidence of lung and colon cancer, as well as on survival. SELECT will study the molecular genetics of cancer risk and associations between diet and cancer. Additionally, SELECT will examine quality of life.

6. Who was eligible to participate in SELECT? Were there restrictions on eligibility?

Many diseases, including prostate cancer, occur more frequently in older persons. The risk of developing prostate cancer increases with age. More than 92 percent of prostate cancer cases occur in men age 55 and older.

Black men had to be age 50 or older to participate, and men of other races and ethnicities had to be 55 or older. The age for eligibility was lower for black men because, on average, they get the disease at an earlier age. In addition, black men in the United States have the highest incidence of prostate cancer in the world. Thus, the SELECT age requirement ensured that men at risk for the disease were the ones who could enroll.

Men who had taken, or were taking, vitamin E and/or selenium on their own had to stop using these supplements and any multivitamins and use only what is provided by SELECT. These supplements are provided to participants free of charge, including a multivitamin that does not contain vitamin E or selenium. Past use of these supplements did not disqualify men from joining SELECT.

Participants must have had no history of prostate cancer. Men who joined SELECT also must not have had any other cancer, except nonmelanoma skin cancer, in the last 5 years. They must have been in generally good health. Many of the 18,000 men who participated in another prevention study sponsored by NCI and run by SWOG, known as the Prostate Cancer Prevention Trial (PCPT), were eligible to participate in SELECT if they had no evidence of prostate cancer.

Some SELECT study sites are located at Veterans Administration hospitals run by the Department of Veterans Affairs. Veterans could enroll at these sites even if they did not receive their routine medical care at that hospital.

7. Could men with benign prostatic hyperplasia (BPH) join SELECT?

Men with BPH, an abnormal growth of benign prostate cells, could join SELECT because BPH is not a cancerous or precancerous condition. In BPH, the prostate grows larger and presses against the urethra and bladder, interfering with the normal flow of urine. More than half of the men in the United States between the ages of 60 and 70, and as many as 90 percent of men between the ages of 70 and 90, have symptoms of BPH.

BPH can be treated with four different FDA-approved drugs: finasteride (Proscar®), terazosin (Hytrin®), doxazosin (Cardura®), and tamsulosin (Flomax®). Most men taking one of these drugs were eligible to participate in SELECT.

8. What tests were used to determine eligibility for SELECT?

Tests included a digital rectal examination (DRE) and a prostate-specific antigen (PSA) test. During a DRE, a doctor inserts a gloved finger into the rectum and feels the prostate gland through the rectal wall to check for bumps or abnormal areas. The PSA test measures the level of PSA (a protein produced by the cells of the prostate gland) in the blood. PSA levels can rise due to cancer or benign (not cancerous) conditions. Doctors often use the PSA test and DRE as prostate cancer screening tests in men who have no symptoms of the disease.

To be eligible for the SELECT trial, participants had to have a DRE that found no signs of prostate cancer and a total PSA level less than or equal to 4.0 ng/ml.

During the trial, DREs and PSA tests are suggested, but not required, on an annual basis throughout the course of the study.

9. Who pays for these tests?

Physician, medical examination, and general clinic costs, including DREs, are charged to the participant in the same way as if he were not part of the trial. These costs may be covered by a participant’s health insurance. Financial assistance may be available for some men. SELECT, however, pays for follow-up PSA tests. Men with questions about insurance coverage or reimbursement should check with their local SELECT site.

10. Who gets which supplement?

Men who participate in this study take two capsules a day. Participants were randomized (assigned by chance) to receive:
* selenium and vitamin E
* selenium and a placebo
* vitamin E and a placebo
* two placebos

Two placebos are used in the trial: one looks and tastes like a selenium capsule; the other looks and tastes like a vitamin E capsule. Each placebo contains only inactive ingredients. Neither the participants nor the researchers will know who is receiving the selenium and vitamin E, or the placebos, until the end of the study.

DSM Nutritional Products, Inc. (formerly Roche Vitamins, Inc.), Parsipanny, New Jersey, is donating bulk vitamin E and vitamin E placebo oils; Tishcon Corporation, Westbury, New York, is currently encapsulating the vitamin E and vitamin E placebo; and Sabinsa Corporation, Piscataway, New Jersey, is providing selenium and selenium placebo capsules at cost.

11. How much selenium is being used in SELECT? What risks might be involved?

The amount of selenium (provided as l-selenomethionine) is 200 “>micrograms (µg) daily. Although the initial results of the Nutritional Prevention of Cancer Trial showed an overall decrease in cancer incidence from selenium, a 2003 update reported 17 percent more new nonmelanoma skin cancers in the selenium group compared with the placebo group (5). It is not clear how these results would apply to men who did not already have skin cancer when they enrolled in SELECT, or to men who are not at increased risk for skin cancer.

12. How much vitamin E is being used in SELECT? What risks might be involved?

The amount of vitamin E (provided as dl-alpha-tocopherol acetate) is 400 milligrams (mg), which is equivalent to 400 International Units (IU) per day. This dose of vitamin E can thin the blood somewhat. Men with uncontrolled high blood pressure were not eligible to take part in SELECT because taking this much vitamin E might have increased their risk of stroke.

Vitamin E has been shown to increase the risk of some cardiovascular conditions. In a 2005 study, men and women with vascular disease or diabetes who took 400 IU of vitamin E daily for 7 years had a 13 percent increased risk of heart failure compared with participants taking a placebo (6). Heart failure is a condition in which the heart’s ability to pump blood is weakened. A 2005 analysis of several studies in which people with various medical problems took vitamin E suggested a link between high doses of vitamin E (400 IU or more) and increased mortality (7).

13. What other requirements were there for SELECT participants?

Upon enrollment, men were asked to have toenail clippings collected to assess selenium levels in the body because selenium concentrates in fingernails and toenails. Toenails were chosen over fingernails because they take longer to grow and thus contain more history of someone’s selenium intake. Blood samples were collected upon enrollment to assess levels of vitamin E.

Upon enrolling, men filled out a questionnaire on their diet and past supplement use. There is also an annual questionnaire that asks for updates of some of this information. Men do not have to change their diets during this study. Each man is offered a supply of a special daily multivitamin, manufactured by The Perrigo Company, Allegan, Michigan, that contains no selenium or vitamin E, to take if he chooses. Vitamin E, selenium, placebo capsules, and multivitamins will be provided free of charge to enrollees for the duration of the study.

Participants are asked to return to the study site every 6 months to pick up a 6-month supply of capsules.

14. What are the benefits of participating in SELECT?

Men involved in SELECT are partners in medical research that may decrease their chances of getting prostate cancer. Information learned from this study may also help future generations of men avoid this cancer.

15. What happens if a participant develops prostate cancer while involved in SELECT?

Participants diagnosed with prostate cancer during the study will be referred for treatment, will stop taking the study supplements, and will continue to be followed by the SELECT study staff, although less frequently.

Costs for diagnosis and treatment of prostate problems, prostate cancer, or other medical conditions during the study are charged to the participant in the same way as if he were not part of the trial. A participant’s insurance will pay for diagnosis and treatment according to the plan’s policies. If the participant has no insurance, social services may be available at the local level to cover costs for diagnosis and treatment.

16. What other clinical trials are under way for prostate cancer prevention?

In addition to SELECT, smaller trials are also being conducted with a variety of agents, including a vitamin D analog; soy isoflavones; and lycopene (a plant pigment common in tomatoes).

17. Where is more information about SELECT available?

In the United States and Puerto Rico, call the National Cancer Institute’s Cancer Information Service at 1–800–4–CANCER (1–800–422–6237) for information in English or Spanish. People with TTY equipment can call 1–800–332–8615 for information in English. In Canada, call the Canadian Cancer Society’s Cancer Information Service at 1–888–939–3333 for information in English or French.

The following Web sites provide additional information:
* http://www.swog.org—choose the SELECT option
* http://www.cancer.gov/clinicaltrials/digestpage/SELECT—from the NCI
* http://www.cancer.gov/newscenter/SELECT—provides images of the prostate, the crystalline and chemical structures of vitamin E, and selenium and vitamin E capsules

Selected References

1. American Cancer Society (2005). Cancer Facts and Figures 2005. Atlanta, GA: American Cancer Society. Retrieved May 24, 2005, from http://www.cancer.org/downloads/STT/CAFF2005f4PWSecured.pdf

2. Clark LC, Combs GF Jr., Turnbull BW, et al. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. A randomized controlled trial. Nutritional Prevention of Cancer Study Group. Journal of the American Medical Association 1996; 276(24):1957–1963.

3. Duffield-Lillico AJ, Reid ME, Turnbull BW, et al. Baseline characteristics and the effect of selenium supplementation on cancer incidence in a randomized clinical trial: A summary report of the Nutritional Prevention of Cancer Trial. Cancer Epidemiology, Biomarkers & Prevention 2002; 11(7):630–639.

4. Heinonen OP, Albanes D, Virtamo J, et al. Prostate cancer and supplementation with alpha-tocopherol and beta-carotene: Incidence and mortality in a controlled trial. Journal of the National Cancer Institute 1998; 90(6):440–446.

5. Duffield-Lillico AJ, Slate EH, Reid ME, et al. Selenium supplementation and secondary prevention of nonmelanoma skin cancer in a randomized trial. Journal of the National Cancer Institute 2003; 95(19):1477–1481.

6. Lonn E, Bosch J, Yusuf S, et al. Effects of long-term vitamin E supplementation on cardiovascular events and cancer: A randomized controlled trial. Journal of the American Medical Association 2005; 293(11):1338–1347.

7. Miller ER III, Pastor-Barriuso R, Dalal D, et al. Meta-analysis: High-dosage vitamin E supplementation may increase all-cause mortality. Annals of Internal Medicine 2005; 142(1):37–46.

Intake of Carotenoids And Retinol In Relation To Risk Of Prostate Cancer

October 28th, 2005

lycopene and tomatoes
Giovannucci E, Ascherio A, Rimm EB, Stampfer MJ, Colditz GA, Willett WC.
Channing Laboratory, Department of Medicine, Harvard Medical School, Boston, MA 02115, USA.
BACKGROUND: Several human studies have observed a direct association between retinol (vitamin A) intake and risk of prostate cancer; other studies have found either an inverse association or no association of intake of beta-carotene (the major provitamin A) with risk of prostate cancer. Data regarding carotenoids other than beta-carotene in relation to prostate cancer risk are sparse. PURPOSE: We concluded a prospective cohort study to examine the relationship between the intake of various carotenoids, retinol, fruits, and vegetables and the risk of prostate cancer. METHODS: Using responses to a validated, semiquantitative food-frequency questionnaire mailed to participants in the Health Professionals Follow-up Study in 1986, we assessed dietary intake for a 1-year period for a cohort of 47,894 eligible subjects initially free of diagnosed cancer. Follow-up questionnaires were sent to the entire cohort in 1988, 1990, and 1992. We calculated the relative risk (RR) for each of the upper categories of intake of a specific food or nutrient by dividing the incidence rate of prostate cancer among men in each of these categories by the rate among men in the lowest intake level. All P values resulted from two-sided tests. RESULTS: Between 1986 and 1992, 812 new cases of prostate cancer, including 773 non-stage A1 cases, were documented. Intakes of the carotenoids beta-carotene, alpha-carotene, lutein, and beta-cryptoxanthin were not associated with risk of non-stage A1 prostate cancer; only lycopene intake was related to lower risk (age- and energy-adjusted RR = 0.79; 95% confidence interval [CI] = 0.64-0.99 for high versus low quintile of intake; P for trend = .04). Of 46 vegetables and fruits or related products, four were significantly associated with lower prostate cancer risk; of the four–tomato sauce (P for trend = .001), tomatoes (P for trend = .03), and pizza (P for trend = .05), but not strawberries–were primary sources of lycopene. Combined intake of tomatoes, tomato sauce, tomato juice, and pizza (which accounted for 82% of lycopene intake) was inversely associated with risk of prostate cancer (multivariate RR = 0.65; 95% CI = 0.44-0.95, for consumption frequency greater than 10 versus less than 1.5 servings per week; P for trend = .01) and advanced (stages C and D) prostate cancers (multivariate RR = 0.47; 95% CI = 0.22-1.00; P for trend = .03). No consistent association was observed for dietary retinol and risk of prostate cancer. CONCLUSIONS: These findings suggest that intake of lycopene or other compounds in tomatoes may reduce prostate cancer risk, but other measured carotenoids are unrelated to risk. IMPLICATIONS: Our findings support recommendations to increase vegetable and fruit consumption to reduce cancer incidence but suggest that tomato-based foods may be especially beneficial regarding prostate cancer risk.

PROSTATE RESOURCES

What I need to know about Prostate Problems

October 25th, 2005

prostate anatomy
What I need to know about Prostate Problems

What is the prostate?
The prostate* is part of a man’s sex organs. It’s about the size of a walnut and surrounds the tube called the urethra, located just below the bladder.
The urethra has two jobs: to carry urine from the bladder when you urinate and to carry semen during a sexual climax, or ejaculation. Semen is a combination of sperm plus fluid that the prostate adds.

The male urinary tract. The prostate surrounds the urethra, where urine leaves the bladder.

What are prostate problems?
For men under 50, the most common prostate problem is prostatitis.
For men over 50, the most common prostate problem is prostate enlargement. This condition is also called benign prostatic hyperplasia or BPH. Older men are at risk for prostate cancer as well, but this disease is much less common than BPH. More information about prostate cancer is available from the National Cancer Institute.

For younger men, the most common prostate problem is prostatitis. For older men, it’s an enlarged prostate.

What is prostatitis?
“Prostatitis” means that the prostate is inflamed; it could be swollen, red, and warm. If you have prostatitis, you may have a burning feeling when you urinate, or you may have to urinate more often. Or you may have a fever or just feel tired.
Inflammation in any part of the body is usually a sign that the body is fighting germs or repairing an injury. Some kinds of prostatitis are caused by germs, or bacteria. If you have bacterial prostatitis, your doctor can look through a microscope and find bacteria in a sample of your urine. Your doctor can then give you an antibiotic medicine to fight the bacteria.

If you have bacterial prostatitis, your doctor can look through a microscope and find bacteria in a sample of your urine.
If you keep getting infections, you may have a defect in your prostate that allows bacteria to grow. This defect can usually be corrected by surgery.
Most of the time, doctors don’t find any bacteria in men with prostatitis. If you have urinary problems, the doctor will look for other possible causes, such as a kidney stone or cancer.
If no other causes are found, the doctor may decide that you have a condition called nonbacterial prostatitis.
Antibiotics will not help nonbacterial prostatitis. You may have to work with your doctor to find a treatment that’s good for you. Changing your diet or taking warm baths may help. Your doctor may give you a medicine called an alpha blocker to relax the muscle tissue in the prostate. No single solution works for everyone with this condition.

Work with your doctor to find a treatment that’s good for you.

What is prostate enlargement, or BPH?
If you’re a man over 50 and have started having problems urinating, the reason could be an enlarged prostate, or BPH. As men get older, their prostate keeps growing. As it grows, it squeezes the urethra. Since urine travels from the bladder through the urethra, the pressure from the enlarged prostate may affect bladder control.
If you have BPH, you may have one or more of these problems:
• A frequent and urgent need to urinate. You may get up several times a night to go to the bathroom.
• Trouble starting a urine stream. Even though you feel you have to rush to get to the bathroom, you find it hard to start urinating.
• A weak stream of urine.
• A small amount of urine each time you go.
• The feeling that you still have to go, even when you have just finished urinating.
• Leaking or dribbling.
• Small amounts of blood in your urine.
You may barely notice that you have one or two of these symptoms, or you may feel as though urination problems have taken over your life.

Frequent urination at night may be a sign of an enlarged prostate.

Is BPH a sign of cancer?
No. It’s true that some men with prostate cancer also have BPH, but that doesn’t mean that the two conditions are always linked. Most men with BPH don’t develop prostate cancer. However, because the early symptoms are the same for both conditions, you should see a doctor to evaluate these symptoms.

Is BPH a serious disease?
By itself, BPH is not a serious condition, unless the symptoms are so bothersome that you can’t enjoy life. But BPH can lead to serious problems. One problem is urinary tract infections.
If you can’t urinate at all, you should get medical help right away. Sometimes this happens suddenly to men after they take an over-the-counter cold or allergy medicine.
In rare cases, BPH and its constant urination problems can lead to kidney damage.

What tests will my doctor order?
Several tests help the doctor identify the problem and decide on the best treatment.
• Digital rectal exam. This exam is usually the first test done. The doctor inserts a gloved finger into the rectum and feels the part of the prostate that sits next to it. This exam gives the doctor a general idea of the size and condition of the prostate.
• Blood test. The doctor may want to test a sample of your blood to look for prostate-specific antigen, or PSA. If your PSA is high, it may be a sign that you have prostate cancer. But this test isn’t perfect. Many men with high PSA scores don’t have prostate cancer.
• Imaging. The doctor may want to get a picture of your prostate using either x rays or a sonogram. An IVP, or intravenous pyelogram, is an x ray of the urinary tract. For an IVP, dye will be injected into a vein. Later, when the dye passes out of your blood into your urine, it will show up on the x ray. A rectal sonogram uses a probe, inserted into the rectum, to bounce sound waves off the prostate.
• Urine flow study. You may be asked to urinate into a special device that measures how quickly the urine is flowing. A reduced flow may mean that you have BPH.
•

Cystoscopic view of enlarged prostate from inside the urethra.
• Cystoscopy. Another way to see a problem from the inside is with a cystoscope, which is a thin tube with lenses like a microscope. The tube is inserted into the bladder through the urethra while the doctor looks through the cystoscope.

How is BPH treated?
Several treatments are available. You’ll have to work with your doctor to find the one that’s best for you.
• Watchful waiting. If your symptoms don’t bother you too much, you may choose to live with them rather than take pills every day or have surgery. But you should have regular checkups to make sure your condition isn’t getting worse. With watchful waiting, you can be ready to choose a treatment as soon as you need it.
• Medicines. In recent years, scientists have developed several medicines to shrink or relax the prostate to keep it from blocking the bladder opening.
• Nonsurgical procedures. A number of devices have been developed to remove parts of the prostate. These procedures can usually be done in a clinic or hospital without an overnight stay. The procedures are transurethral, which means the doctor reaches the area by going through the urethra. The doctor’s devices use thin tubes inserted through the urethra to deliver controlled heat to small areas of the prostate. A gel may be applied to the urethra to prevent pain or discomfort. You won’t need general drugs that make you go to sleep. These procedures are called transurethral microwave thermotherapy (TUMT) and transurethral needle ablation (TUNA).

In TUMT, microwaves heat part of the prostate.
• Surgical treatment. Surgery to remove a piece of the prostate can be done through the urethra or in open surgery, which requires cutting through the skin above the base of the penis. Your doctor may recommend open surgery if your prostate is especially large. The most common surgery is called transurethral resection of the prostate, or TURP. In TURP, the surgeon inserts a thin tube up the urethra and cuts away pieces of the prostate with a wire loop under direct vision through a cystoscope. TURP and open surgery both require general anesthesia and a stay in the hospital.

Is TURP the same as removing the prostate?
No. TURP and other procedures for BPH remove only enough tissue to relieve urine blockage. In a few cases, the prostate may continue to grow, and urinary problems return. You should continue to have your prostate checked once a year even after surgery to make sure that BPH or prostate cancer has not developed.
A prostate removal, or prostatectomy, is usually done only to stop prostate cancer from spreading.

In TURP, a wire loop cuts away pieces of the prostate.

What are the side effects of prostate treatments?
Surgery for BPH may have a temporary effect on sexual function. Most men recover complete sexual function within a year after surgery. The exact length of time depends on how long you had symptoms before surgery was done and on the type of surgery. After TURP, some men will find that semen does not go out of the penis during orgasm. Instead, it goes backwards into the bladder. In some cases, this condition can be treated with a drug that helps keep the bladder closed. A doctor who specializes in fertility problems may be able to help if this backwards ejaculation causes a problem for a couple trying to get pregnant.
If you have any problems after treatment for a prostate condition, talk with your doctor or nurse. Erection problems and loss of bladder control can be treated, and chances are good that you can be helped.
If your prostate is removed completely to stop cancer, you’re more likely to have long-lasting sexual and bladder control problems (leaking or dribbling). Your doctor may be able to use a technique that leaves the nerves around the prostate in place. This makes it easier for you to regain bladder control and sexual function. Not all men can have this technique, but most men can be helped with other medical treatments.

Hope Through Research

Problems with bladder control and sexual function can be treated. Chances are good that you can be helped.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) has many research programs aimed at finding treatments for urinary disorders, including prostatitis and BPH. The Medical Therapy of Prostate Symptoms (MTOPS) program is studying the results of medical therapy used to treat thousands of men with BPH in several research centers throughout the country. MTOPS will provide valuable information about the effectiveness and side effects of drugs being used for BPH.
Research is also under way to evaluate new approaches to surgical treatment of BPH. The Minimally Invasive Surgical Therapies (MIST) treatment group is looking at TUMT, TUNA, and other transurethral treatments for BPH that generally do not require a hospital stay. Studies are planned to assess the effectiveness of saw palmetto and other herbal remedies for this disorder.

Prostate Problems Glossary
antibiotic (AN-tee-by-AH-tik): A medicine that kills bacteria.
bacteria (bak-TEER-ee-uh): Tiny organisms that cause infection or disease.
benign (be-NINE) prostatic (prah-STAT-ik) hyperplasia (HY-per-PLAY-sha) (BPH): An enlarged prostate not caused by cancer. BPH can cause problems with urination because the prostate squeezes the urethra at the opening of the bladder.
cystoscope (SIS-toh-scope): A tube-like instrument used to look inside the urethra and bladder.
ejaculation (ee-JAK-yoo-LAY-shun): The sudden release of semen through the penis during sexual climax.
intravenous (IN-truh-VEE-nus) pyelogram (PY-loh-gram) (IVP): An x ray of the urinary tract. A dye is injected to make urine visible on the x ray and show any blockage in the urinary tract.
prostate (PRAH-state): In men, a walnut-shaped gland that surrounds the urethra at the neck of the bladder. The prostate supplies fluid that goes into semen.
prostatectomy (PRAH-stuh-TEK-tuh-mee): Removal of the entire prostate gland.
prostatitis (PRAH-stuh-TY-tis): Inflammation of the prostate gland. Chronic prostatitis means the prostate gets inflamed over and over again. The most common form of prostatitis is not associated with any known infecting organism.
transurethral (TRANZ-yoo-REE-thrul): Through the urethra. Several transurethral procedures are treatments for BPH:
TUMT (transurethral microwave thermotherapy): Destroys excess prostate tissue interfering with the exit of urine from the body by using a probe in the urethra to deliver microwaves.
TUNA (transurethral needle ablation): Destroys excess prostate tissue with electromagnetically generated heat by using a needle-like device in the urethra.
TURP (transurethral resection of the prostate): Removes the excess prostate tissue by using an instrument with an electrical loop.
urethra (yoo-REE-thrah): The tube that carries urine from the bladder to the outside of the body.

For More Information
The National Kidney and Urologic Diseases Information Clearinghouse (NKUDIC) has a fact sheet, Prostate Enlargement: Benign Prostatic Hyperplasia, that gives more information about BPH. Another fact sheet, Prostatitis: Disorders of the Prostate, discusses four types of prostate inflammation. A summary of an NIDDK workshop on chronic prostatitis is also available. Call 1–800–891–5390 to speak to an NKUDIC information specialist and request these publications or use the online catalog.
More information is available from the following organizations:
American Foundation for Urologic Disease, Inc. (AFUD)
1000 Corporate Boulevard
Suite 410
Linthicum, MD 21090
Phone: 410–689–3990 or 1–800–828–7866
Email: admin@afud.org
Internet: www.afud.org
The Prostatitis Foundation
1063 30th Street, Box 8
Smithshire, IL 61478
Phone: 1–888–891–4200
Fax: 309–325–7184
Email: mcapstone@aol.com
Internet: www.prostatitis.org
For information about prostate cancer, contact the
National Cancer Institute (NCI)
Cancer Information Service
Phone: 1–800–4CANCER (1–800–422–6237)
TTY: 1–800–332–8615
Email: cancermail@icicc.nci.nih.gov
Internet: www.nci.nih.gov (NCI’s primary web site)
or http://cancernet.nci.nih.gov (material for professionals, patients, and the public)

Source: http://kidney.niddk.nih.gov

What Are the Key Statistics About Prostate Cancer?

October 23rd, 2005

prostate cancer statisticsProstate cancer is the most common cancer, excluding skin cancers, in American men. The American Cancer Society (ACS) estimates that during 2005 about 232,090 new cases of prostate cancer will be diagnosed in the United States. About 1 man in 6 will be diagnosed with prostate cancer during his lifetime, but only 1 man in 34 will die of this disease. A little over 1.8 million men in the United States are survivors of prostate cancer.

Prostate cancer is the second leading cause of cancer death in American men, exceeded only by lung cancer. The American Cancer Society estimates that 30,350 men in the United States will die of prostate cancer during 2005. Prostate cancer accounts for about 10% of cancer-related deaths in men.

Among men diagnosed with prostate cancer, about 99% survive at least 5 years, 92% survive at least 10 years, and 61% survive at least 15 years. These figures include all stages and grades of prostate cancer but do not account for men who die from other causes. In other words, many of the men who died before 15 years, died from causes other than prostate cancer. A recent review of death rates in men with localized prostate cancer found that they had the nearly the same 5- and 10-year survival as men without prostate cancer.

Ninety percent of all prostate cancers are found in the local and regional stages (local means it is still confined to the prostate; regional means it has spread from the prostate to nearby areas, but not to distant sites such as bone). The 5-year relative survival rate for all of these men is nearly 100%.

Of the men whose prostate cancers have already spread to distant parts of the body at the time of diagnosis, about 34% will survive at least 5 years.

Five-year and 10-year survival rates refer to the percentage of men who live at least 5 or 10 years after their prostate cancer is first diagnosed. Relative (also known as disease-specific) survival rates exclude patients dying of other diseases. This means that anyone who died of another cause, such as heart disease, is not counted. Because prostate cancer usually occurs in older men who often have other health problems, relative survival rates are generally used to produce a standard way of discussing prognosis (outlook for survival).

Unfortunately, it is impossible to have completely up-to-date survival figures. To realistically measure 10-year survival rates, we must have records of patients diagnosed at least 13 years ago. We need 10 years of follow-up plus the time it takes to assemble the data.

Modern methods of detection and treatment now mean that prostate cancers are detected earlier and treated more effectively, which has led to a yearly drop in death rate of about 3.5% in recent years. This means that if you are diagnosed this year, your outlook is probably better than the numbers above.

source: American Cancer Society

Prostate cancer - Sparkling cider… and rectal exams? 

October 22nd, 2005

Sparkling cider… and rectal exams? 
San Jose Mercury News - Oct 21 8:39 AM
Sparkling cider? Check. Mandolin player? Check. Rectal exams? Got those, too. Officials from San Jose’s Good Samaritan Hospital are daring to go where few medical centers have gone before, pairing free prostate or breast cancer screening exams with soft lights and refreshments.

Prostate cancer treatments - PSA Remains Best Indicator Of Prostate Cancer Progression

October 17th, 2005

PSA TEST
PSA Remains Best Indicator Of Prostate Cancer Progression
Science Daily - year > full storyCombining Radiation Modalities Increases Prostate Cancer Cure Rates (August 4, 2004) — High-risk

Prostate cancer cures - Leading Researchers, Survivors, Policymakers Tackle African American Prostate Cancer Disparity at First-Ever Summit 

October 17th, 2005

Leading Researchers, Survivors, Policymakers Tackle African American Prostate Cancer Disparity at First-Ever Summit 
[Press Release] PR Newswire via Yahoo! Finance - Sep 19 7:06 AM
Today, the first national summit of healthcare stakeholders, researchers, and cancer survivors focused on tackling prostate cancer in African American men convened on Capitol Hill. Here, experts called for national focus on the alarming prostate cancer disparity crisis: African American men suffer the highest rate of prostate cancer in the world and the lowest rate of survival.Save to My Web

Prostate cancer treatments - Dendreon to apply for FDA approval of prostate cancer treatment

October 16th, 2005

Dendreon to apply for FDA approval of prostate cancer treatment
Puget Sound Business Journal, WA - Sep 14, 2005 said it will seek marketing approval for its Provenge prostate cancer treatment, following a review of the safety and effectiveness of the drug in two late

Cytogen, Progenics Report Positive Data
Forbes - Sep 30, 2005 and Cytogen Corp., said Friday that animal studies showed its experimental prostate cancer treatment has potential to prolong survival.

Solving one of the biggest challenges in treating prostate cancer
Canada NewsWire (press release), Canada - Sep 23, 2005 Dr. Chi is about to open a clinical trial on a targeted "smart" drug he hopes will overcome the problem of prostate cancer treatment resistance.

LIVER CANCER RATES RISING
National Center for Policy Analysis, France - Oct 12, 2005 While there is a dispute over what is the most appropriate prostate cancer treatment, in general, black men receive less aggressive care than white men.

EDAP Opens Its First HIFU Prostate Cancer Treatment Center in
Yahoo! News (press release) - Oct 12, 2005 These studies, along with many others, conclude that Ablatherm-HIFU is an effective prostate cancer treatment that offers patients a logical alternative to the

Prostate cancer treatments - Lilly Icos drug achieves success in prostate study 

October 15th, 2005

Lilly Icos drug achieves success in prostate study 
Pharmaceutical Business Review - Oct 13 6:14 PM
Lilly Icos, a joint venture between Eli Lilly and Icos Corporation, has released positive results from a phase II trial of tadalafil, the active ingredient in the erectile dysfunction drug Cialis, in the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia.Save to My Web

This month, go pink for charity 
Daily Mail - 1 hour, 57 minutes ago
Check out our comprehensive guide to breast cancer awareness month… moreSave to My Web

FDA refuses to approve Abbott’s Xinlay 
Crane’s Chicago Business - Oct 14 2:53 PM
(Reuters) Abbott Laboratories Inc. said on Friday U.S. regulators have refused to approve its experimental prostate cancer drug, Xinlay, which failed to delay progression of the disease in two clinical trials.Save to My Web

Patient arrested at Canadian hospital released from King County Jail 
SanLuisObispo.com - Oct 13 8:45 PM
SEATTLE - An American medical-marijuana advocate who says he was arrested at a Canadian hospital while waiting to be admitted for prostate surgery, turned over to U.S. authorities and held for several days without having his catheter removed was released from a Seattle jail to seek medical care Thursday.Save to My Web

Abbott issues meter alert 
Chicago Tribune - 1 hour, 9 minutes ago
Capping a day of unpleasant news for Abbott Laboratories, the company Friday issued a public warning that incorrect use of its blood glucose meters could lead to inaccurate test results and hyperglycemia.Save to My Web

Stakeholder Insight: Prostate Cancer - A Prostrate Market Waiting for Innovations 
Pharmaceutical Business Review - Oct 10 6:00 PM
Introduction The prostate cancer market is reaching maturity, and major players’ sales have been eroded by the launch of various LHRH agonist depot formulations. Safety concerns with AstraZeneca’s Casodex (bicalutamide) have also seen a significant proportion of physicians switching to alternatives.Save to My Web

Prostate cancer - Obesity increases risk of prostate cancer return 

October 14th, 2005

Obesity increases risk of prostate cancer return 
MSNBC - Oct 11 3:41 PM
Men who gain weight rapidly between the ages of 25 and 40 are twice as likely to experience a recurrence of prostate cancer after surgery as men who keep the pounds off, research suggests.Save to My Web

Lycopene shown to prevent bone turnover and oxidative stress 
Medical Post Online - Oct 12 6:39 PM
NASHVILLE, TENN. | Consuming more of the tomato pigment lycopene in the diet reduces oxidative stress and bone turnover in postmenopausal women, according to a University of Toronto study.Save to My Web

Rapid weight gain between the ages of 25 and 40 doubles likelihood of prostate cancer recurrence 
News-Medical-Net - Oct 04 5:10 AM
Men who gain weight rapidly between the ages of 25 and 40 are twice as likely to have recurrence of prostate cancer after surgery as men without rapid rates of weight gain, researchers from University of Texas M. D. Anderson Cancer Center reported in the October 1 issue of “Clinical Cancer Research.”Save to My Web

Taking science to next stage 
Baltimore Sun - Oct 13 4:46 AM
NIH to pay $500 million yearly to turn research into practical remedies WASHINGTON // The National Institutes of Health unveiled yesterday a $500-million-a-year program to turn promising laboratory discoveries in genetics and other fields into drugs and treatments. Save to My Web

Hormone Therapy May Fight Localized Prostate Cancer 
Health Scout - Oct 06 8:13 AM
But experts question whether the study’s findings remain relevant.Save to My Web

Prostate cancer - Natural Source International, Ltd., and Columbia University

October 13th, 2005

Natural Source International, Ltd., and Columbia University
PR Newswire (press release), NY - 21 hours ago Collaboration with the Beljanski Foundation and the Urologic Cancer Research Treatment Institute, will Present Promising Anti-Prostate Cancer Activity Findings

Hormone Therapy May Fight Localized Prostate Cancer
ABC News - Oct 6, 2005 6 (HealthDay News) For men with advanced prostate cancer confined to the prostate, radiation treatment along with a six-month program of androgen (male

US HIFU Begins Enrollment for Locally Recurrent Prostate Cancer
Elites TV, TX - 15 hours ago today that the US Food and Drug Administration (FDA) has granted approval to initiate a clinical trial for locally recurrent prostate cancer utilizing High

Stakeholder Insight: Prostate Cancer - A Prostrate Market Waiting
Pharmaceutical Business Review - Oct 10, 2005 The prostate cancer market is reaching maturity, and major players' sales have been eroded by the launch of various LHRH agonist depot formulations.

Obesity Associated with Cancer Progression Following Prostatectomy
Cancer Consultants (press release), TN - 10 hours ago According to a recent article published in Clinical Cancer Research, men with early prostate cancer who are obese have a greater risk of cancer progression

New Prostate Test May Improve Cancer Detection
PakTribune.com, Pakistan - Oct 7, 2005 Robert Getzenberg from the University of Pittsburgh Cancer Institute and others stained 29 prostate tissue samples from patients with prostate cancer who had

Prostate cancer - Natural Source International, Ltd., and Columbia University

October 13th, 2005

Natural Source International, Ltd., and Columbia University
PR Newswire (press release), NY - 9 hours ago Ltd., in Collaboration with the Beljanski Foundation and the Urologic Cancer Research Treatment Institute, will Present Promising Anti-Prostate Cancer Activity

New Prostate Test May Improve Cancer Detection
PakTribune.com, Pakistan - Oct 7, 2005 against a protein, called EPCA, Dr. Robert Getzenberg from the University of Pittsburgh Cancer Institute and others stained 29 prostate tissue samples from

Trinity United Methodist forms prostate cancer support group
Orangeburg Times Democrat, SC - Oct 10, 2005 More than 230,000 men in the United States will be diagnosed with prostate cancer this year, and 4,210 of them will be from South Carolina alone.

Ex-Gov. Martin Being Treated For Prostate Cancer
WRAL.com, NC - Oct 10, 2005 RALEIGH, NC — Former Gov. Jim Martin said Monday he is being treated for prostate cancer. Martin, who attended a Raleigh luncheon speech by Massachusetts Gov.

US HIFU Begins Enrollment for Locally Recurrent Prostate Cancer
Elites TV, TX - 3 hours ago today that the US Food and Drug Administration (FDA) has granted approval to initiate a clinical trial for locally recurrent prostate cancer utilizing High

Prostate - Liver cancer up, other kinds improving 

October 12th, 2005

Liver cancer up, other kinds improving 
TimesLeader.com - Oct 04 2:28 PM
WASHINGTON - Liver cancer seems to be on the rise, a blip of bad news in the nation’s otherwise optimistic annual report on cancer that shows survival continuing to improve.Save to My Web

Cytogen, Progenics Report Positive Data 
AP via Yahoo! Finance - Sep 30 9:07 AM
PSMA Development Co., a joint venture between biopharmaceutical companies Progenics Pharmaceuticals Inc. and Cytogen Corp., said Friday that animal studies showed its experimental prostate cancer treatment has potential to prolong survival.Save to My Web

Number of Americans dying from cancer down 
Gainesville Sun - Oct 05 3:14 AM
WASHINGTON - Liver cancer seems to be on the rise, a blip of bad news in the nation’s otherwise optimistic annual report on cancer that shows survival continuing to improve.Save to My Web

Cancer group training set for Saturday 
Benton Courier - Oct 01 4:17 PM
The American Cancer Society, Mid-South Division Inc. Arkansas Region, will hold a Man to Man facilitator training seminar on Saturday.Save to My Web

Draxis Creates New Executive Position 
AP via Yahoo! Finance - Oct 04 6:53 AM
Canadian drug company Draxis Health Inc., maker of radiopharmaceuticals including a prostate cancer treatment, said Tuesday it named Dan Brazier to the newly created position of chief operating officer, effective immediately.Save to My Web

Liver Cancer Up, Other Kinds Improving 
The Herald-Sun - Oct 05 10:04 AM
Liver cancer seems to be on the rise, a blip of bad news in the nation’s otherwise optimistic annual report on cancer that shows survival continuing to improve.Save to My Web

Prostate cancer cures - Hormone Therapy May Fight Localized Prostate Cancer

October 12th, 2005

Hormone Therapy May Fight Localized Prostate Cancer
ABC News - Oct 6, 2005 6 (HealthDay News) For men with advanced prostate cancer confined to the prostate, radiation treatment along with a six-month program of androgen (male

Trinity United Methodist forms prostate cancer support group
Orangeburg Times Democrat, SC - 18 hours ago More than 230,000 men in the United States will be diagnosed with prostate cancer this year, and 4,210 of them will be from South Carolina alone.

Anti-cancer diet helps fight prostate cancer
The South End, MI - Oct 3, 2005 According to the Prostate Cancer Foundation, there is no evidence that a single food item reduces the chances of developing cancer.

Skin test could screen prostate cancer
DetNews.com, MI - Oct 3, 2005 The blood test most commonly used to screen men for prostate cancer isn't reliable. Some men are given a clean bill of health when

Robots for Prostate Cancer
Medgadget.com, CA - 8 hours ago surgery is minimally invasive and no large incisions are involved, robotic-assisted surgery provides numerous benefits for prostate cancer patients, including

Prostate cancer cures - Consumer Reports Medical Guide Web Site Introduces New Prostate

October 11th, 2005

Consumer Reports Medical Guide Web Site Introduces New Prostate
PharmaLive.com (press release), PA - Sep 21, 2005 Prostate Cancer Treatment: When a biopsy confirms cancer, men must choose among several treatments that pose serious risks or simply do nothing unless symptoms

Pomegranates May Prevent Prostate Cancer
WebMD - Sep 28, 2005 Now, researchers say the next step in evaluating pomegranates as a potential prostate cancer treatment is to conduct studies in humans.

Health & Fitness Guide
commercialappeal.com (subscription), TN - Sep 25, 2005 Call 377-5646. Prostate Cancer Treatment Techniques: 6-7 pm Thursday at Baptist Centers for Cancer Care-Powell Library. Reservations encouraged. Call 227-8478.

Cytogen, Progenics Report Positive Data
Forbes - Sep 30, 2005 and Cytogen Corp., said Friday that animal studies showed its experimental prostate cancer treatment has potential to prolong survival.

Men's Weight Linked to Prostate Cancer Growth
WebMD - Oct 4, 2005 studies confirm these results, doctors should consider a man's weight and his history of weight gain when designing a prostate cancer treatment plan, such as

Prostate - Speed of PSA Rise Helps Predict Survival for Prostate Cancer Patients 

October 11th, 2005

Speed of PSA Rise Helps Predict Survival for Prostate Cancer Patients 
Newswise - Sep 30 9:23 AM
The clinical outcome for prostate cancer patients who have been treated with hormone therapy and radiation therapy can usually be determined by how rapidly their prostate specific antigen level rises following treatment, according to a report.Save to My Web

Promising new treatment options for prostate cancer 
News-Medical-Net - Oct 09 6:10 PM
Prostate cancer is the second leading cause of death among American men. It is estimated that one in six males will develop the disease during his lifetime. However, promising new treatment options have been developed to help combat this threatening disease.Save to My Web

For cancer patient, a new hope: Dirk DuBois, fighting an uphill battle with advanced-stage prostate cancer, will  
Springfield News - Oct 07 11:37 AM
Dirk DuBois and his daughters new kitten, B.B., have several traits in common. Both are courageous in adapting to unfamiliar environments, appreciative of kind attention, and fearless when facing their enemies.Save to My Web

Progenics and Cytogen Report Potent Anti-Tumor Activity for Experimental Prostate Cancer Drug 
[Press Release] Business Wire via Yahoo! Finance - Sep 30 2:00 AM
PSMA Development Company LLC , a joint venture of Progenics Pharmaceuticals, Inc. and Cytogen Corporation , today announced positive preclinical findings of its novel prostate cancer drug, prostate-specific membrane antigen antibody-drug conjugate .Save to My Web

Predicting the Risk of Prostate Cancer on Biopsy 
RedNova - Sep 30 4:01 AM
By Ebell, Mark H Clinical Question What is the risk of prostate cancer in a patient who is referred for biopsy? Evidence Summary Considerable uncertainty surrounds the screening, diagnosis, and management of prostate cancer.Save to My Web

PSMA reports potent anti-tumour activity for experimental prostate cancer drug 
PharmaBiz - Oct 02 7:44 PM
PSMA Development Company LLC (PDC), a joint venture of Progenics Pharmaceuticals, Inc. and Cytogen Corporation’s findings of novel prostate cancer drug, prostate-specific membrane antigen (PSMA) antibody-drug conjugate (ADC) resulted positive.Save to My Web

Prostate cancer cures - Prostate Cancer Information - A complete guide to prostate cancer

October 11th, 2005

Prostate Cancer Information - A complete guide to prostate cancer
Prostate cancer resource guide. Learn details about prostate cancer, the symptoms of prostate cancer, prostrate treatment and prevention. Welcome to Prostate Answers, an online resource created to

Arkansas Prostate Cancer Foundation
Welcome to the Arkansas Prostate Cancer Foundation Men s March / 10:30 am / Saturday, September 17 A group of prostate cancer survivors, family members and supporters will march

Prostate - Skin test could screen prostate cancer

October 10th, 2005

Skin test could screen prostate cancer
DetNews.com, MI - Oct 3, 2005 The blood test most commonly used to screen men for prostate cancer isn't reliable. Some men are given a clean bill of health when

October 10th, 2005

Prostate cancer, prostatitis, BPH and how Alternative Prostate
Prostate cancer, prostatitis, BPH and how Alternative Prostate Treatment was discovered. Discovery of Alternative Prostate Treatment This page has a link to prostate cancer, where prostate

Prostate Cancer Treatments - Cancer Treatment Centers
Prostate Cancer Treatment Alternatives - Alternative Treatments for Prostate Cancer. Prostate Cancer Treatments So you’ve been told you have prostate cancer What do I need to know about Prostate

Prostate Cancer: New Tests Create Treatment Dilemmas

October 9th, 2005

Prostate Cancer:
New Tests Create Treatment Dilemmas

by John Henkel

The names are familiar: actors Don Ameche, Bill Bixby, and Telly Savalas, entertainment mogul Steve Ross, rock musician Frank Zappa. Though show business links these men, they share another connection. Each has died of prostate cancer.

If there’s a silver lining to be found amid the clouds of these tragic deaths, it is that the fame of these men has helped spotlight a disease that now ranks as the second most common cancer men get–after skin cancer. The American Cancer Society says prostate cancer will strike 334,500 U.S. men in 1997, twice the number of male lung cancer cases. Some 41,800 will die. One out of every five American men will develop prostate cancer in their lifetime.

Public notice is something new to prostate cancer. For years, men didn’t worry much about the disease. They typically thought of it as a slow-moving condition that affects men well past retirement, when they are likely to die of something else before succumbing to cancer. In many cases, that’s still true. Most cases are in men 65 and older. But like Bixby, who was 59 when he died, and Zappa, who was 52, younger men also can fall victim.

Experts say the recent increase in reported cases can be attributed to new tests that make detection easier. Longer male lifespans also may play a part. With today’s methods, men who otherwise would be unaware of their cancer are learning sooner they have the disease. Thus, reported cases rise. Still undetermined, however, is whether improved early detection will reduce prostate cancer’s mortality rate.

A walnut-sized gland tucked away under the bladder and adjacent to the rectum, the prostate provides about a third of the fluid that propels sperm through the urethra and out of the penis during sex. Many males are what one cancer survivor called “abysmally ignorant” about where the prostate is and what it does. Also, health officials say, men tend to dismiss troubles related to their sex organs, so they may shy away from seeing a doctor, even after disease symptoms appear.

Though prostate cancer historically has kept a low profile, its visibility is rapidly changing. Like breast cancer a decade ago, prostate cancer suddenly is a topic on talk shows and in newspaper and magazine articles. Support groups now number over 300 nationwide. Screening booths are popping up at state fairs and shopping malls. Famous people are going public. Sen. Jesse Helms, and former Sen. Bob Dole have openly discussed their prostate cancer treatments. Others who have publicly fought the disease include retired Gen. H. Norman Schwarzkopf, Supreme Court Justice John Paul Stevens, comedian Jerry Lewis, and former financier Michael Milken.

Early Detection

All the attention, along with new scientific information, is contributing to a growing quandary for doctors and patients over how best to manage the disease. A relatively new blood test called the prostate specific antigen (PSA) test has increased early detection odds considerably. But the test alone cannot determine if a man has prostate cancer.

The PSA test measures a protein made only by the prostate. In all healthy men, a small amount of PSA protein passes into the bloodstream from the prostate. If a man’s prostate becomes enlarged, it may secrete increased amounts of PSA, creating higher blood levels of the protein. This also may occur when infection damages the prostate lining and allows more than normal PSA amounts to be released. Prostate cancer itself may produce increased PSA levels. Though the PSA test may be the first step toward a cancer diagnosis, elevated PSA levels may signal conditions other than cancer. These include benign prostatic hyperplasia (BPH) and an infection called prostatitis (see accompanying article).

“What the PSA test does is alert the physician that a man may have something wrong with his prostate,” says Max Robinowitz, M.D., medical officer in FDA’s Center for Devices and Radiological Health. “The doctor then must decide if more testing is needed to identify the problem.”

Since 1985, FDA has approved several PSA tests for monitoring possible recurrence of prostate cancer in men being treated for the disease. The PSA method is not intended for mass screening of men with no symptoms.

illustration of digital rectal examination First Approval

In August 1994, FDA approved the Hybritech Tandem PSA Assay, the first test the agency has sanctioned to help doctors detect prostate tumors in patients with or without symptoms who are suspected prostate cancer risks. FDA specifies that the Hybritech test be used with the traditional test for screening prostate cancer, the digital rectal exam (DRE). Physicians perform the DRE by inserting a lubricated, rubber-gloved finger into the rectum, where they can probe the prostate for lumps or enlargements that may indicate prostate or even rectal tumors.

The American Cancer Society and American Urological Association recommend annual PSA tests for men over 50 and for high-risk men over 40. Men at increased risk include African Americans, whose incidence of prostate cancer is about 30 percent higher than that of whites, and those with urinary tract symptoms or who are genetically predisposed to the disease. Study data show that if a man’s brother and father had prostate cancer, he may have as much as an l1-fold increase in risk and may be stricken before age 50. The National Cancer Institute is sponsoring a trial to find out whether extensive prostate cancer screening, as well as earlier detection and treatment, can improve survival rates.

PSA tests are simple, noninvasive, and cost $30 to $70. They are, however, not perfect. Doctors interpret cancer potential based on whether PSA results are elevated, a level usually defined as above 4 nanograms of the protein per milliliter of blood (ng/mL). But noncancerous conditions can increase this level. Also, a certain percentage of men with prostate cancer, such as those taking drugs for BPH, will show low or “normal” PSA amounts.

“A patient may have an elevated PSA test, but this doesn’t mean he has prostate cancer,” says Peter Maxim, Ph.D., who heads FDA’s immunology branch. He adds that it’s always best to use the DRE and PSA tests together to achieve maximum benefit. Despite drawbacks with both techniques, more than 50 percent of men referred for further testing have prostate tumors, says the American Cancer Society.

Making Sure

Doctors follow up an elevated PSA or positive DRE with more definitive testing. Some physicians employ transrectal ultrasound (TRUS), which uses a rectal probe that creates a video image of the prostate using harmless sound waves collected by a computer. TRUS helps the physician “map” uneven areas of firmness in the prostate, and it can help a doctor decide if a biopsy is needed. If so, the doctor will take tiny prostate tissue samples with a small-gauge needle, injected typically through the rectum. Another physician, a pathologist, then examines the samples under a microscope.

“No surgery or other anti-cancer therapy is done without first ensuring with a biopsy that a patient has cancer and not some other condition that can cause symptoms and other suspicious signs,” says FDA’s Robinowitz. Once cancer is diagnosed, other tests such as computerized tomography, lymph-node biopsies, and bone scans can determine if tumors have spread beyond the prostate.

For cancer confined to the prostate, opinions are split over what to do. Orthodox wisdom holds that cancer should be treated aggressively. With prostate cancer, this means removing the gland (radical prostatectomy) or bombarding it with radiation. Experts say these options may offer good prospects for curing the disease if exercised early enough. Treatment choice usually depends on what specialist the patient consults. Urologists tend to recommend surgery while oncologists generally advise radiation therapy.

Surgery may cause unpleasant adverse effects. Because radical prostatectomy can result in severing nerves and blood vessels related to sexual or bladder function, the operation in the past has left virtually all patients impotent, incontinent, or both. That is changing, however, thanks to pioneering research done in the 1980s by Patrick Walsh, M.D., urology chairman at Johns Hopkins University Hospital. His “nerve-sparing” surgical technique, which increasing numbers of doctors are adopting, now allows many men to preserve erectile functions. Walsh says his patients under age 50 have about a 90 percent chance of regaining potency, but that number drops to 25 percent for patients in their 70s.

Radiation therapy also has adverse effects, including impotence in about 40 to 50 percent of patients.

For older men with early-stage prostate cancer, a number of physicians are dispensing a different kind of advice: Wait and see.

Doctors clearly are divided on its merits, but this “watchful waiting” philosophy got a boost by a 1994 report in the New England Journal of Medicine. The study analyzed case records of 828 prostate cancer patients treated conservatively (watchful waiting or hormone treatments but no surgery or radiation therapy). It found that 10 years after diagnosis, 87 percent of those with slow-growing, localized prostate tumors still were alive. Of those diagnosed with more aggressive cancer, 34 percent remained alive at the 10-year mark. Supporters say watchful waiting is a practical alternative for men in their late 60s or older, whose lifespans may be limited by advanced age and serious ailments such as heart disease. If treated, these men could suffer the trauma and adverse effects of cancer therapy with little or no benefit.

Not all prostate cancer is equal. One type of tumor may lie dormant for years while another is virulent and deadly. Deciding whether to wait or act can be difficult because physicians often can’t judge conclusively which tumors might spread. Size can give some indication. Another gauge, the Gleason system, identifies a tumor’s growth potential based on its appearance under the microscope. The system distinguishes progressive grades of prostate cancer on a scale of 2 to 10. Clumped-together cancer cells with well-defined edges are less likely to grow rapidly and are given a low Gleason number. Cells distributed randomly with uneven edges are more apt to spread and receive a high Gleason number.

Also important is “staging”–a predictor of how extensively the disease has grown within or beyond the prostate. This ranges from stage A, where the tumor is still microscopic and confined, to stage D, where cancer has spread to the lymph nodes or to other organs outside the prostate. The lower the staging, the more likely the cancer can be cured. Stage D tumors are rarely curable. The ideal watchful waiting candidate is a man with a low Gleason score and a stage A or B tumor.

Prostate tumors are fueled by male hormones called androgens. Advanced prostate cancer is usually treated with therapy that reduces androgen levels–such as testicle removal or drug/hormone therapy.

Though prostate cancer research has yielded significant advancements in the last decade, there’s still a long way to go, says FDA’s Robinowitz. “The dilemmas [of treatment] are due to the power of the cancer and the limits to our current knowledge and therapies,” he says. “New tests [such as PSA] may be only partial solutions, but they are the best we can do for now.”