+” Summertime, and the livin’ is easy.” + And, as our long-term readers will recall, it’s that time of the year when the Sarasota Man-To-Man group suspends guest lectures for two months. This gives our editorial staff the opportunity to bring you current topics of interest and information from a variety of media sources. A veritable potpourri of goodies.

Life after treatment for prostate cancer or diagnosis of sexual dysfunction can be traumatic, frightening and lonely. Fears that one’s most priceless joys of intimacy have been banished hopelessly out of reach into the ever more distant past can grow into enormous burdens that crowd out the happiness from one’s life. Fortunately, this need not be the final verdict.

Two remarkable and tireless people, Ralph and Barbara Alterowitz, have offered a ‘second opinion’ to those who have been treated for prostate cancer or experience sexual disjunction. Their talks, counseling, articles and books empower couples to continue to live and love.

The Alterowitzs’ personal mission to restore life and love began almost ten years ago. “I was diagnosed with prostate cancer in May of 1995,” Ralph recounted. “It was hard to find information and I received seven second opinions. I had surgery two months later.” Following surgery, the couple recognized that their experience was not unique. Rather, it highlighted the real needs that were common among prostate cancer patients. “I wanted to devote time to patients who had prostate cancer. Patients needed guidance; they needed more information to help make choices before treatment,” he recalled. “And, they needed help in dealing with quality-of-life issues after treatment.”

In 1996, Ralph became the founding Vice-Chair and a Director of the National Prostate Cancer Coalition. “Since I wanted to focus on helping patients manage their disease so they would live longer with a better quality-of-life, I began to work with the Education Center for Prostate Cancer Patients,” Ralph explained. Since then, he has become its President whose mission is patient counseling and education.

Demanding as Ralph’s organization-building and promotion responsibilities might have been with the Coalition and the Education Center, the Alterowitzs participated in a large number of support groups and discussions. It was at one of these meetings that the idea for their first book, The Lovin’ Ain’t Over: The Couple’s Guide to Better Sex After Prostate Disease was born.

“I was at a planning committee for a support group, and the quality-of-life issues came up, including sexual problems,” Ralph continues. “I asked them what would be a good title for a talk about sex. Off the top of my head, I made a suggestion of my own; ‘the lovin’ ain’t over’ and they liked it a lot. Moreover, the group suggested that Ralph give the talk. At first he was reluctant. After all, he was a business consultant, not a sex therapist. Nevertheless, the group persisted. In the face of this urging, Ralph agreed to not wholly dismiss the idea. “I said that if we couldn’t find someone else to give the talk, then I’d do it.”

As things turned out, Ralph finally gave the talk. “We had done a lot of research on the topic, and it helped that I had a degree in zoology and over twenty years experience in health care. The support group liked it, and demand for such talks grew. Barbara and I started to do the talks as a couple,” he said. Such demand was not entirely surprising. “Up until 1999 men didn’t discuss sexual dysfunction,” he explained.

“Ralph had a decline in sexual function after surgery. We worked through it together, talking through the issues as we always do. We felt it didn’t have to be a big problem for other couples, either,” Barbara added. But it was. “A change in sexuality was very traumatic for the couples we came in contact with. We wanted to give an approach that would allow other couples to still have a good sex life,” Ralph continued.

When couples kept asking for notes because the Alterowitzs covered so much, they ended up writing their first book, which focused on helping couples navigate the challenges of sexual dysfunction. Barbara explained that the book addresses making love as an “integrated, holistic process -- from treatment options to ideas on sensual sex with or without medications. It allows people to choose their approach according to their own needs. We give people tools to help keep them physically connected. It is a tragedy for couples to drift apart because of sexual dysfunction.”

The Alterowitzs have now written a second book: Intimacy With Impotence: The Couples Guide to Better Sex After Prostate Cancer. By reaching out in a peer-to-peer fashion, they make a big difference in the lives of the people whom they come in contact with. “If we can reach even one couple in each session and have a positive effect on their life, it’s worthwhile. That’s why we’re doing the talks and books,” they summarized.

(With appreciation to the publication, Family Urology printed and distributed by American Foundation for Urological Diseases, Baltimore, Maryland. Summer Issue 2004)

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How many times do you remember being told to eat your vegetables? As children, eating vegetables was the last thing we wanted to do, and they were the last items left on the plate. However, as adults we know that eating vegetables yields great benefits.

Vegetables are thought to deter cancer of the prostate, mouth, larynx, stomach, lung, bladder, breast, colon, rectum and cervix, as well as reduce hypertension and fight diabetes. They provide long-term protection, as well as provide short-term benefits. For example, the fiber in vegetables aids digestion and contributes to feeling full, which reduces the temptation to overeat. It also relieves constipation, which can leave people feeling sluggish. A plant-rich diet also is thought to reduce cholesterol in the blood.

In addition to health-promoting vitamins and minerals, vegetables contain naturally occurring chemicals called phytochemicals. These protect cells from oxidation and prevent them from converting healthy cells to cancerous ones. Vegetables that offer the most disease-fighting protection are those high in vitamins A and C and those that are rich in folic acid, carotenoids such as beta-carotene and fiber. A single tomato contains hundreds of disease-fighting phytochemicals. Broccoli, Brussels sprouts, cabbage, onions and garlic are also rich in phytochemicals.

Eating three to five servings of vegetables or vegetable juice daily is recommended for healthy benefits. A serving is smaller than you think. Consider these servings:

• one-half cup cooked or canned vegetables

• 1 cup of raw leafy vegetables

• one-half cup cooked dry peas or beans

• three-fourths cup vegetable juice

One of the many benefits of eating more vegetables is that it helps control calories. Most vegetables contain only water and are virtually fat-free with minimum calories. Add a small salad to your evening meal; for example, a cup of lettuce and cucumber contains only 20 calories but adds bulk to a low calorie meal.

The Mayo Clinic recommends the following easy ways to get more vegetables into your diet:

• Include grated raw vegetables in batters and doughs for quick breads, muffins and cakes.

• Choose a wide variety of salad greens, including arugula, chicory, collard, dandelion and mustard greens, kale, spinach and watercress.

• Look for pasta made with vegetables such as spinach or beets. Order vegetable pizza instead of meat-based pizza.

• Stir-fry vegetables with tofu or just a small portion of poultry, seafood or meat.

• Use vegetables as a base for, or as added ingredients in, soups.

• Enrich and thicken soups and sauces with cooked and pureed vegetables in place of cream or whole milk.

• Try eating your vegetables without any butter or margarine. Or, use butter sprinkles or spray margarine.

• Add grated raw carrot to lean ground beef or turkey when making meat loaf or meatballs. Add chopped vegetables to your tomato sauce.

• Enjoy vegetables as snacks by keeping them ready to eat in the refrigerator at all times.

(Thanks to Hollie W. Best, published by the Gannett News Service on June 1, 2004.)

In recent years, doctors have become more willing to treat prostate cancer more aggressively with radiation therapy, and as a result, more patients are being cured of their cancer, according to a new study published in the July 15, 2004 issue of the International Journal of Radiation Oncology “Biology” Physics.

A 1998 Patterns Of Care survey reviewing the records of more than 550 patients from 59 institutions across the United States shows that in comparison to surveys from 1989 and 1994, radiation oncologists are using higher doses of external beam radiation therapy to treat both earlier stages and more aggressive forms of prostate cancer. In 1999, 45 percent of prostate cancer patients were treated with higher doses of radiation therapy compared to 3 percent in both 1989 and 1994.

In the study, researchers learned that the results of clinical trials have persuaded many radiation oncologists today to add androgen deprivation therapy (hormonal therapy) to radiation therapy to treat more aggressive or well-established cancers. Further, there has been a significant increase in the use of CT-based treatment planning and conformal radiation therapy for treatment delivery.

“This is an important study because it looks at changing trends over many years in the use of radiation therapy for curing prostate cancer in the United States, “ said Michael J. Zelefsky, M.D. lead author of the study and a radiation oncologist at Memorial Sloan-Kettering Cancer Center in New York. “After careful analysis, we have learned that in general, more radiation oncologists are applying the results of clinical trials, which have taught us to use higher dose levels of radiation and to integrate hormone therapy in conjunction with radiation therapy to achieve more successful outcomes for prostate cancer patients. In short, the trends are demonstrating more precise delivery of high-dose treatment.”

(Excerpted from ASTRO, the American Society for Therapeutic Radiology and Oncology, Fairfax, Virginia.)

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Promising Substitute For The Prostate Biopsy

Work by a University of Queensland (Australia) researcher may make the trip to the doctor for a prostate cancer check a lot more appealing for men. Associate Professor Frank Gardiner of UQ’s School of Medicine is developing a more precise and less invasive procedure for prostate cancer detection by retrieving prostate cells from ejaculate.

This project is designed to optimize retrieval of the cells and to compare two methods for profiling selected genetic changes to diagnose prostate cancer. The work has been given a boost by announcement from the Ministry for Health and Aging of more than $100,000 in funding for the project.

Associate Professor Gardiner was one of three UQ researchers who will share the grant money aimed at encouraging research with commercial potential.

Stay tuned.

{Reported by the University of Queensland to News-Medical website www.news-medical.net.

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Clinical Trials
What They’re All About

In the not so distant past, doctors treating breast cancer patients made a radical shift; instead of routinely recommending mastectomy to their patients, they began to mention lumpectomy, the removal of the tumor and a small margin of normal tissue, plus radiation. How did these doctors know that the far less invasive lumpectomy would give their patients the same results as a mastectomy? Because the results of clinical trials showed that lumpectomy with follow-up radiation was as effective as mastectomy in treating certain types of breast cancer.

While not all clinical trials change the practice of medicine in such a drastic way, clinical trials provide the most impartial evidence to help answer difficult medical questions. Additionally, clinical trials may offer many benefits, including possible access to a new treatment, excellent standard of care, and the chance to benefit society. But research shows that not everyone knows about clinical trials and that misperceptions about them exist.

Clinical trials are research studies involving people. This means that live human beings are participants in a highly structured, controlled process designed to answer a specific question. Before an intervention, such as a new drug or surgical procedure, can be tested on people, it must be tested and reviewed pre-clinically. Preclinical research uses tissue cultures of cancer cells or animals to test the new procedure, drug or theory [Ed. -- collectively called ‘interventions’ in medical terminology]. The preclinical phase gives an indication of how the intervention works and its possible risks and benefits. Because people are so different than animals or laboratory containers of cancer cells, the only way to know how the intervention will work in humans is through a clinical trial.

There are three main phases of clinical trials, each designed to address specific concerns. All three require informed consent , a process where the patient learns, in every detail, the protocol, the possible risks and the possible benefits of participating in the trial. They also learn their rights as a participant and their signature is required attesting that they thoroughly understand what they are volunteering for. All federally-funded clinical trials must be reviewed and approved by Institutional Review Boards (IRBs). IRBs also monitor the patients’ safety while in the trial and make sure the participants are treated fairly and ethically.

Phase I -- Safety

Phase I trials seek to answer the following questions:

Is the new treatment safe and if so, how much of it can be given, or done, safely? Through a process called escalation, in the case of drugs, the first participants will be given a small dose of the substance. If there are no or few adverse reactions, the next group is given higher levels, and so on until the doctors determine the optimal dose with the fewest side effects.

What is the best way to administer the treatment? In this phase, researchers will strive to answer questions such as: Should the drug be given by mouth or intravenously (through a vein)? During this phase, doctors are concerned mainly with safety. Participants in phase I trials receive high-quality care because they undergo many tests to monitor their response to the intervention. Phase I trials provide excellent medical care, but rarely cure cancer or slow its growth.

Phase II -- Effectiveness

Once researchers have determined that the intervention is safe, they may begin a phase II trial, where they evaluate its effectiveness. People in phase II trials are chosen to reflect more closely the target group for the new drug or other intervention. This might mean all participants have prostate cancer, for example.

Information from the phase I trial determines the dose and method of administration of the intervention being tested in the phase II trial. During this phase, doctors are looking for evidence that the new intervention is effective; does it shrink the tumor? decrease symptoms? lengthen remission? provide longer survival? If the intervention shows positive results during phase II testing, it will be recommended to continue on to phase III.

Phase III -- Comparison To Present
Standard Of Care

A phase III trial tests whether the new intervention is better than the current, conventional therapy. Patients are randomized (assigned to different groups by chance to prevent bias) to either receive the intervention being tested, or to receive the best available care. Patients will never receive less than the current medically-accepted standard of care. Placebos are rarely used in clinical trials.

Phase III studies are the largest clinical trials. They require hundreds, even thousands, of participants and are often performed in multiple locations using the same protocol. [Ed. A protocol is a blueprint of the trial outlining the purpose and the plan in detail; it also is intended to ensure that all participants are treated the same.] Phase III trials may offer a benefit, either because the therapy is superior to the current one, or because of the enhanced medical care patients in clinical trials receive.

Often, phase III trials are blind (only the doctor knows if the participant is receiving the experimental therapy of the current standard of care) or double-blind (neither the participant nor the doctor knows which therapy the patient is receiving), so there will be no bias from either the patient or the physician.

After Phase III?

If the clinical trial sponsor, which may be a physician or a drug company or a research facility, determines that the intervention is at least as good as the current therapy, an application is submitted to the U. S. Food and Drug Administration (FDA). The FDA reviews all the information from testing and clinical trials and decides whether or not to approve it for general use. This review may also include independent testing by the FDA to satisfy itself that the data submitted is valid and supportive. If the FDA takes this step, the sponsor is billed for the additional expense of processing the application.

Sometimes questions arise during the testing process that are important but not crucial to FDA review. Therefore, after FDA approval, physicians may continue to test the intervention in a phase IV clinical trial.

All medical professionals recognize that most medical advances have occurred because of people who enroll in clinical trials. Without such people, many questions would remain unanswered and the progress of medicine slowed. Since it is important for a clinical trial to enroll people of all demographics, the government is working with private insurers to cover costs related to clinical trials. Currently, coverage differs on a state-by-state basis. Additionally, Medicare covers routine costs related to phase II or phase III trials.

For Your Information

• Only about 4% of adults with cancer participate in clinical trials.

• Placebos are rarely used in cancer clinical trials.

• Clinical trials not only study drugs, but also new treatments such as surgery or radiation therapy techniques, complementary or alternative therapies, and treatments that might prevent cancer.

• Clinical trials are voluntary and participants may leave at any time.

• The National Cancer Institute maintains a database listing all cancer clinical trials. (www.national cancerinstitute.org).

(From the August 2004 Newsletter of the Kingston (NY) PCa101 organization. Thanks, Ron.)

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The Evolution In Treatments For
Erectile Dysfunction

Within the last 20 years the field of erectile dysfunction has been a growing and rapidly developing topic in urology. First there was the development and modification of the penile implant; then came the discovery of nitric oxide and how it effects penile erection. By identifying certain important physiological pathways in penile erection, doctors and researchers have been able to create new therapies to treat ED. With the discovery and introduction of Sildenafil (Viagra) more men and their partners have come forward. We now are realizing the scope of erectile dysfunction.

Yet, even now in the new millennium, we are still not seeing the true potential pervasiveness of the problem. In the United States an estimated 30 million men suffer from ED, and 150 million men worldwide are afflicted with this problem. With our baby boomer population aging, the prevalence of erectile dysfunction is sure to increase and with it, the pressure will be mounting to continue developing new and effective treatments for it.

How Does A Man Get An Erection?

Penile erection is a result of a complex interaction of various organs, cells and chemicals. Everything from the brain, spinal cord, peripheral nerves, blood vessels and penis is involved in the process. Because of this, any disruption or disease affecting these areas of the body may potentially effect a man’s erections to varying degrees.

When a man is sexually stimulated, signals are sent from the brain to the autonomic nervous system centers in the spinal cord. The sympathetic and parasympathetic nervous systems are responsible for penile flaccidity and erection. The signals then travel through the cavernosal [Ed. those much discussed erection-producing nerves that Dr. Patrick Walsh made so famous.] nerves to the penis. These nerves secrete nitric oxide at the level of the penile smooth muscle which causes a relaxation of that muscle. This, in return, results in an increase of blood flow into the penile veins, filling them. The process, in effect, traps the blood in the penis and results in an erection.

Pills That Stimulate Erections

The family of drugs known as phosphodiesterase inhibitors stimulate erections. These important medications were first brought into the limelight in the late 1990s with the advent of Viagra. Viagra served as a springboard for many men to seek treatment allowing the scope of the problem to be shortly thereafter realized. It is of some interest that Viagra was first clinically studied as an anti-angina agent in 1991 and during those initial studies, men complained of the “adverse effect” of erections.

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#l -- Viagra (Sildenafil)

Technically, Viagra, or sildenafil, is an inhibitor of phosphodiesterase type 5 (PDE-5), which promotes smooth muscle relaxation and penile erection. Worldwide clinical trials have shown 65 to 80 percent efficacy rates. Viagra has been studied among many different populations and among ED patients. The populations studied have been quite varied and have included patients whose ED was the result of various factors (diabetes, surgical and medical problems and psychological disabilities). Variable efficacy rates are quoted. However, a significant treatment effect is universally seen when compared to placebo. Viagra is recommended in the 25, 50 or 100 mg. dosages.

In general, the time to peak concentration of Viagra is approximately one hour and the medication is metabolized primarily by the liver. Within eight to twelve hours sildenafil is almost completely eliminated from the body. Approximately 50 percent of patients have clinical effects by 20 minutes. In order to optimize efficacy, patients are advised to avoid eating or drinking one to two hours before taking Viagra.

After its initial release, much has been publicized regarding Viagra and the inadvisability of men taking nitrates to use it. Studies have been made of men with stable heart disease not taking nitrates. Overall, most studies show a significant improvement in erectile function in patients with ED and stable heart disease and no lingering side effects. In these cases, Viagra appears to a safe and viable option.

#2 -- Levitra (Vardenafil)

Like Viagra, Levitra is a PDE-5 type inhibitor. In test tube studies, vardenafil has been shown to approximately 10 times more potent as an inhibitor of PDE-5. Many of the side effects experienced with sildenafil may be accounted for by the fact that it also inhibits other substances to certain extents. Levitra also has been found to be more selective for PDE-5. Levitra appears to be rapidly absorbed and has a median time to maximum drug concentration between 40 and 55 minutes.

Levitra may be given in a 5, 10 or 20 mg. dosage. One study of 580 men showed that patients receiving the drug at all three dosages improved erectile ability significantly compared to placebo-taking men. Responses may be dose dependent with patients taking 20 mg. dosage showing the greatest improvement from baseline data.

#3 -- Cialis (Tadalafil)

Cialis is another inhibitor of PDE-5. Studies have shown that Cialis is absorbed at a slower rate than either of the two drugs above. Peak concentrations occur in about two hours. The half-life of Cialis (17.5 hours) is substantially longer than its competitors, which allows it to work for upwards of 36 hours. The absorption of tadalafil does not seem to be affected by the age of the patient, nor alcohol or food intake.

Cialis may be taken at a 5, 10 or 20 mg. dosage. Treatment with this drug, especially at the 10 and 20 mg. dosages, significantly improves erectile function in a broad spectrum of men with ED regardless of disease, severity of dysfunction or age. The efficacy of Cialis over a 36 hour period has prompted investigators to refer to it as “the weekend pill”.

What Are The Risks, The Downside?

Clinical trials and experience have shown these medications to be generally safe and well tolerated by patients with ED. Headache, flushing and nasal congestion may occur secondary to dilution of blood vessels. Abnormal vision can occur also. As an exception, clinical studies of tadalafil have shown that these visual disturbances are not present, but up to 15 percent of men complained of backache or muscle ache.

At this point, no increased risk of serious cardiovascular problems has been observed with any of the three medications. The use of these agents, however, is still not recommended for men taking nitrates for heart disease. With the recent release of Levitra and Cialis, some attention has been given to those using alpha blockers. Currently, Levitra is not recommended when alpha blockers are in use. Patients taking these two medications in combination are at risk of hypotension [ Ed. abnormally low blood pressure] and it’s consequences. With Cialis, all alpha blockers except for Flowmax (Tamsulosin) 0.4 mg. once a day, are also not compatible for similar reasons. At the present time, Viagra does not have any prohibition for the combined use of any alpha blocker.

The introduction of these three inhibitors has greatly expanded the treatment options available for men with ED. All three have shown efficacy in a broad range of diseases, severity and age as well as being very well tolerated. What is required now is direct head-to-head-to-head trials of these medications to compare efficacy and adverse profiles.

(Condensed from the Spring 2004 edition of the FAMILY UROLOGY publication.)

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Exercise Fights Fatigue Of Radiation Therapy

To fight fatigue during radiation therapy, exercise is the best remedy according to a new study on men with prostate cancer. Fatigue during cancer treatment is a common problem. Among the causes; stress, depression, anemia, pain, sleep problems and poor nutrition. One survey in the United Kingdom shows that only 14% of cancer patients receive advice for fighting fatigue. The most common is rest and relaxation while only 4% of patients had been advised to exercise.

Inactivity may actually increase fatigue. Aerobic exercise such as walking, cycling, or swimming may be more beneficial in fighting fatigue and preventing further weakness. However, few studies have really looked at this issue.

The current study appears in the latest issue of the journal Cancer and involves sixty six men, all about sixty eight years old and all getting radiation therapy for prostate cancer. Half just took things easy while the other half were asked to walk for thirty minutes, three days a week, for the four week study period. They were told to exercise at a moderate intensity to achieve sixty to seventy percent of maximum heart rate. Maximum heart rate is calculated as 220 minus your age. For example, a sixty year old man should exercise so that his heart rate is between 96 and 112 beats per minute.

Before and after the four week radiation therapy treatment, men in both groups took a “fatigue test” that involved walking a short distance. The “resting” group showed significantly more fatigue after radiation therapy. They were unable to walk much. The “exercising” group did much better. In fact, those men were walking longer distances than previously.

(As reported by Jeanie Lerche Davis in the WebMD Medical News on August 3, 2204)

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Lycopene For Prostate Cancer

Experts say one-third of all cancers diagnosed in males is prostate cancer, making it the most common cancer among men. What if adding something to your diet could decrease the risk of the disease? It may be easier than you think.

Lunch today for Bill Lofgren is spaghetti and meatballs. For him it’s not about carbohydrates, but lycopene -- an antioxidant that could lower the risk of prostate cancer. “I can’t help but believe that a lot of cancer that we suffer got there because, perhaps, of improper eating, improper diets,” he says.

Lofgren was diagnosed with prostate cancer last year. He had surgery to remove his prostate, but not before helping scientists study lycopene’s effect on cancer cells. Researchers are now studying his cancer cells before lycopene and after. “If we can see a reduction in the cell growth of prostate cancer in six weeks, this has a great promise in prevention,” says the director of nutrition at Moffitt Cancer Center in Tampa, Florida.

While results from this study are pending, another study showed men who ate tomato sauce at least twice a week were at least twenty percent less likely to develop prostate cancer. While a lycopene supplement is used for the study, the Moffitt people recommend eating lycopene-rich foods.

“Large population-based studies have shown that what they are eating is what is lowering their risk of these cancers and not what they are taking as supplements,” Dr. Kumar of Moffitt says. You’ll find the most lycopene in processed tomato products including paste, sauces and juice.

Since Lofgren is married to an Italian woman, he says eating lycopene is a doctor’s order that’s easy to follow. Other foods high in lycopene include guava, apricots, watermelon, papaya and pink grapefruit. Dr. Kumar says lycopene may also prevent the aging process and improve skin health in both women and men.

(As reported on July 28, 2004 by Dr. C. Everett Koop, former Surgeon General of the U.S.)

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And, don’t forget to add www.boodrow.com to your computer Favorites page for a lot more prostate cancer news.