By Mark A. Moyad, M.D., M.P.H.

First of all we get lots of mail about the new oral drug for advanced prostate cancer that will go to the FDA this fall and it is called “atrasentan” or “Xin-lay®.” The company has set up an 800 number for questions about it and the new number is 1-800-633-9110. Also, we get mail on the potential new vaccine and clinical trials by the company Dendreon and their vaccine is known as “Provenge” and their phone number for additional information is 1-866-477-6782. I will try to provide other numbers for other potential treatments as they come into the office.

Anyhow, here we go again! Let´s review some interesting preliminary findings from some of the largest and most recent oncology/urology meetings. Oh, and by the way “GO PISTONS!!!” Also, the University of Michigan Women´s softball team is ranked number 1 in the country (thought that you might want to know this stuff). Highlights from the American Society of Clinical Oncology (ASCO) Multidisciplinary Prostate Cancer Symposium - February 17-19, Orlando, Florida

51) Higher Vitamin D Blood Levels May Reduce The Risk of Aggressive Prostate Cancer? (Reference: Li H, et al. ASCO Prostate Meeting 2005;abstract #2, page 35.) This should not be a surprise, but part of the reason that this study has received some attention is also probably due to the fact that doctors were actually studied. Researchers looked at blood levels of vitamin D (yes, there is a blood test for vitamin D and it is a wonderful test that I love to see many people get to determine whether or not they need to supplement with additional vitamin D) from the famous Physician´s Health Study (PHS). This was the study that was stopped early many years ago because they found that doctors taking a regular aspirin every other day significantly reduced their risk of a first heart attack compared to placebo. Anyhow, the researchers looked at some of the blood samples for vitamin D and followed these docs for an average of 13-18 years, and found that those with higher vitamin D blood levels compared to men with lower vitamin D levels had a 45% reduction in the risk of being diagnosed with aggressive prostate cancer. In addition, the benefit was especially observed in men with a certain genetic trait, but either way this is one of several studies to suggest a lower rate of aggressive prostate cancer in men with adequate levels of vitamin D in their blood. Vitamin D is not that easy to get unless you get some sun exposure or consume a lot of fish, but a cheap multivitamin is another good way to get vitamin D. For example, most multivitamins contain about 400 International Units (I.U.) of vitamin D. It is also possible to get a vitamin D individual tablet from most health food stores and pharmacies, or some men and women can get a vitamin D injection from their doctor. Either way, vitamin D is important for bone health, so if your doctor tells you to get more after getting a blood test then it may provide numerous benefits for you. Also, keep in mind that everything in life comes with a catch, so if you already have normal to high levels of vitamin D in your blood then please do not supplement with more because too much vitamin D can create a whole host of other problems. The bottom line is that many men should at least have a vitamin D blood test, and after the test is done talk to your doctor about the results. I have noticed that a lot of men on androgen deprivation treatment (ADT) for prostate cancer have either never had this test done or have low levels of this vitamin in their blood. So, talk to your doctor about getting this test done.

52) Did Obesity In The Same Docs Described Above Have Any Impact On Prostate Cancer? (Reference: Ma J, et al. ASCO Prostate Meeting 2005;abstract #6, page 37.) You bet! Looking at this same study described above (PHS), docs that were followed for 21 years that were obese had a greater chance of being diagnosed with metastatic prostate cancer. Obesity means that your body mass index or BMI is 30 or more. Well, how do you determine BMI? Good question and I have no idea - just kidding – BMI = pounds/inches squared multiplied by 704 (lbs/inches 2 x 704). This is still a very controversial issue because some studies have not found an impact of obesity on prostate cancer, but who gives a hoot (notice that I could have inserted a swear word there but I decided not to do this because I would probably get in trouble). The reason I do not give a hoot is because obesity still reduces your chances of living a longer life because of a potential increased risk of cardiovascular and other problems. Regardless, a serious discussion about weight should occur between every man and his doctor. Some studies have also found that the greater the weight the greater the potential for having a reduced PSA, and this may be an artificial reduction that does not lead the doctor to further investigate a potential prostate problem. It seems that obese men may have higher levels of estrogen that could theoretically reduce their PSA in an artificial way.

53) Can Smoking Reduce Your Chances Of Surviving Prostate Cancer? (Reference: Kobrinsky NL, et al. ASCO Prostate Meeting 2005;abstract #11, page 40.) What do you think? Researchers found simply that smoking shortens survival, and this in line with other studies that have shown that smoking may increase the risk of an aggressive prostate cancer, if you continue to smoke after being diagnosed it can encourage the growth of your cancer. Well, again as with the case with obesity who gives a hoot! I do not give a hoot because smoking still increases your chances of living a shorter life so never smoking or quitting smoking just makes sense. If this study does not convince you to quit then the risk of lung cancer should convince you anyway. Put another way, “smoking is not cool” (this is for all of the hippie types that miss all of the vernacular from the 1960´s or those that attended Woodstock!).

54) Should Men Also Be Offered A Cholesterol Test And Asked About Their Alternative Medicine Use When They Get A PSA Test Done? (Reference: Moyad MA, et al. ASCO Annual Meeting 2005;Abstract 4623, page 408.) Hey! One of the authors of this study has the same name as you! Is this a shameless promotion of your study? You bet! We did research with the National Prostate Cancer Coalition (NPCC) and we found some very disturbing things at a prostate cancer screening for African-American men. More than 50% of the men at the screening in 2 different large metropolitan cities had a high cholesterol level! Also, more than 25% of these men were taking alternative medicines. However, this is not much different from studies that have been done in other races or ethnic groups of men (as was recently studied from the PCEC or Prostate Cancer Education Council national screening studies). It seems that a lot of men getting PSA testing also have high cholesterol levels and this is a big concern. Therefore, the next time you get your PSA done you should make sure that you know your cholesterol level, and if you have not had a cholesterol test then you should go see your doctor ASAP. Also, it was interesting that many of the alternative medicines that men were taking have not been studied in terms of their effects on prostate cancer. For example, saw palmetto was popular in men getting a PSA because they thought it could prevent prostate cancer or slow the progression of this disease, but researchers have no idea if saw palmetto has any benefit or detriments against prostate cancer. Also, high doses (400 I.U. or more) of vitamin E were popular but we have no idea if large doses of vitamin E can impact prostate cancer. In fact, large amounts of vitamin E should not be taken by men with prostate cancer until some studies suggest a benefit, which has currently not been the case.

55) Can Waist Size Increase A Man´s Chance Of Dying From Prostate Cancer? (Marcella S, et al. ASCO Annual 2005;abstract #4626, page 409.) This is a great study because many other studies have just looked at BMI or just stepping on a scale and measuring weight. These researchers decided to look at the waist size or the belly fat area. It is the belly fat that is associated with bad changes in cholesterol and unfavorable changes in hormone levels. Anyhow, they found that in 380 cases of men that died from prostate cancer compared to a similar number of controls, that having a waist size of 40 inches or more was associated with 3.8 times the risk of death from prostate cancer compared to men with a waist of 32 inches or less. Regardless, carrying a lot of belly fat is not healthy overall so this should be measured and discussed with your doctor. However, there is another point that does not get mentioned much in these studies. When a man has his testosterone reduced for prostate cancer there is an increased chance of gaining some belly fat. So, it is also possible that this finding is a false one because men with more serious prostate cancer naturally can have more belly fat because of the standard treatments for prostate cancer. So, maybe the belly fat did not increase the risk of dying from prostate cancer, but the treatments increased belly fat in men with more serious prostate cancer, so it falsely appeared to look as if belly fat increases the risk of dying of prostate cancer. This still needs to be worked out, but in the meantime this is a great study because it looked at something different besides the BMI of a man. In addition, carrying a lot of belly fat can cause so many other health problems that it just makes sense to exercise more and to try to reduce belly fat regardless of your situation (prostate cancer or not).

56) Does The Drug Modafinil (Also Known as Provigil®) Reduce Fatigue That Some Cancer Patients Experience After Treatment? (Reference: Morrow GR, et al. ASCO Annual Meeting 2005;abstract 8012, page 732.) Modafinil is a drug used in psychiatry for a number of things (like a condition called “narcolepsy”), but since it has a stimulatory effect and a low rate of side effects some researchers have thought that it may reduce fatigue after cancer treatment. Now, this study was conducted in women that had completed breast cancer treatment about 2 years earlier and were still experiencing significant fatigue. This trial was with 51 women and it did not include a placebo so we have to be careful here before we can definitely determine the impact. Regardless, women taking 200 mg of this drug with breakfast daily reported an improvement with sleep, less drowsiness, improvement in mood and activity, and less fatigue. Currently, this drug is being tested in a larger trial with a placebo, but the initial reports are encouraging because fatigue from cancer treatment can be a significant problem. Talk to your doctor about the latest results with this drug if you are interested.

57) Does The Dietary Supplement Black Cohosh Help With Hot Flashes More Than A Placebo? (Reference: Pockaj BA, et al. ASCO Annual Meeting 2005;abstract 8013, page 732.) Black cohosh is a popular supplement in the U.S. and in Europe to help reduce hot flashes, but it really has not been tested well in cancer patients despite the fact that sales in cancer patients are very, very good. Patients took 20 mg of the supplement twice a day versus placebo, and this study was done in breast cancer patients. The treatment was short and the duration of the study was short (just 8 weeks) and the dosage was low, but researchers found that black cohosh did NOT work any better than a placebo. Although, the side effects were low and similar in both groups this study did show that using a lower dosage of black cohosh for a short period of time did not reduce hot flashes better than a sugar pill. We have to wait for more studies in men and with higher dosages, but in the meantime this is not good initial news for this supplement. Highlights from the American Urological Association (AUA) Annual Meeting – May 21-26, 2005, San Antonio, Texas

58) What Is The Number One Cause Of Death In Prostate Cancer Patients Besides Prostate Cancer Itself? (Reference: Groome PA, et al. AUA Annual Meeting 2005;abstract #193, page 53.) Canadian researchers attempted to answer the question “What are other diseases or conditions that are a threat to a man´s life after deciding on treatment for prostate cancer?” A total of 587 patients diagnosed and treated for prostate cancer with surgery and radiation therapy that still died within 10 years after treatment were considered or included in this study. The most common cause of death apart from prostate cancer was actually heart disease (36.6% of the patients)! Therefore, this is a great study because it identifies other things that clinicians and patients should be aware of after being treated for prostate cancer. What does this mean to you? It means that if you have been treated for localized prostate cancer then one of the best things that you can do is to make sure that you reduce your risk of heart disease! This is why I tell patients with localized prostate cancer that have been treated with conventional therapy to make sure to followup with their primary care doctor or even cardiologist to make sure that their risk of heart disease is brought down to as close to zero as possible. What is the point of being treated for prostate cancer if a man still dies young of heart disease?!

Therefore, after your prostate cancer doctor and you have been considered cancer free please make sure that someone is following you and treating you for other conditions to make sure that you live a long and better life. I have no doubt that most men being treated for localized prostate cancer are reducing their risk of dying from prostate cancer, but it also means it is time to reduce your risk of dying from other conditions. In other words, it has never made sense to me to move you out of the way of an on coming truck (prostate cancer) only to have you walk in front of an on coming car (heart disease). We need and can move you out of the way of both vehicles and part of the responsibility is up to you.

59) Can Some Men On Androgen Deprivation Therapy (ADT) Experience A Reduction In Thyroid Hormone Levels? (Reference: Cecchini L, et al. AUA Annual Meeting 2005; abstract #817, page 221.) It is easy to argue that ADT can improve the chances of living longer after being diagnosed with more advanced prostate cancer. However, since men are living longer on ADT for prostate cancer it seems that the side effects from this treatment are gaining more attention. This should not be surprising because men are using this therapy earlier and earlier and with a variety of treatments; therefore, side effects that can be prevented or treated should receive attention. In the old days (not that long ago), docs only gave ADT to men with very advanced prostate cancer, so side effects from this treatment were not really discussed because the more immediate issue was one of life and death. However, now some men are on or on and off this therapy for years and years so we are beginning to learn more and more about the side effects of ADT. For example, we all know that ADT can cause hot flashes in most men and now we are learning that the longer you are on ADT the greater the chance of bone loss and osteoporosis. Other side effects that have gained some attention are things like reduced sexual function, fatigue, some muscle wasting, weight gain around the belly area, cholesterol changes, decreases in body hair and an increase in scalp hair, and the list goes on. So, researchers in Spain decided to look at thyroid hormone levels because thyroid hormones can impact so many areas of the body. Researchers looked at 182 patients on ADT (LHRH alone) and 119 men on ADT with an anti-androgen pill. The average age of the patients was 70 years old and the average time on ADT was a little more than 3 years. It turns out that the men on ADT with or without an anti-androgen had significantly lower thyroid hormone levels. The researchers theorized that the lower thyroid levels could be responsible for some of the side effects of ADT. Now this was only one study, but it was a good one. Therefore, men should be monitored for a lot of side effects while on ADT and perhaps following thyroid function should be added to the list of things that your doc should follow. Some cases can be treated for low levels of thyroid hormone while others may simply need to be followed. Either way I thought this was a good study because it adds more information on possible side effects of ADT and how they can be potentially treated.

60) Can Pomegranate Juice Help Men With A Rising PSA After Surgery Or Radiation Therapy? (Reference: Pantuck AJ, et al. AUA Annual Meeting 2005; abstract #831, page 225.) Okay, let me see if I get this straight - blueberry or carrot juice is good for the eyes, orange juice is good for the heart, cranberry juice reduces the risk of uri-nary tract infections, coffee can reduce the risk of memory problems, green tea can prevent cancer, herbal tea may reduce blood pressure, tomato juice is good for the prostate, ….blah, blah, blah, blah… So, what is next on the list?! Men in this study were followed for 2 years and had at least a PSA greater than 0.2 ng/ml and less than 5 ng/ml, and a Gleason score of 7 or less. Patients were told to consume 8 ounces of pomegranate juice daily. A total of 48 patients were recruited. Mean PSA doubling time significantly increased from an average of 14 to 26 months. Not bad at all, and so now these same researchers believe that a placebo-controlled trial is needed. Well, what can I say except drinking pome-granate juice may be prostate healthy, but a study of another juice versus pomegranate juice is needed to see if this juice is superior, to say, any other juice such as carrot juice. Have you ever tried pomegranate juice? I have and it tastes quite good, but it also contains a lot of calories like many of the other juices. Therefore, sticking with 8 ounces a day may not be a bad idea, but in the meantime it will not replace my spicy tomato juice that I love to consume when I´m on the airplane going to my next meeting. Some people say to me “Mark, how can you drink that spicy tomato juice, it contains too much salt!” My answer is quite simple - I love the stuff, I do not drink it with any alcohol, and it is low in calories, high in lycopene, and did I mention that it just tastes so damn good!! Either way, I also like pomegranate juice so what the heck – I´m going to add this to my diverse group of juices that I drink during the week. Also, you have to give these researchers and patients a lot of credit for doing this unique study, and they were perfectly objective in their conclusions calling for a randomized placebo-controlled trial. Perhaps these men with not very aggressive disease or not very high PSA numbers could have done as well drinking any other healthy juice, but only time will tell. In the meantime, when is someone going to do a trial of patients that drink spicy tomato juice? I would love to see this study. In the meantime there is such a study, but it has only involved 1 patient (myself) and I will let you know about the results in the future.

61) Does Lycopene Help Men With Recurrent Prostate Cancer After Being Treated With Surgery or Radiation Therapy? (Reference: Borden LS Jr., et al. AUA Annual Meeting 2005; abstract #1014, page 275.) Researchers studied 36 men that had a recurrence of prostate cancer after conventional therapy. Patients were treated with lycopene supplements at one of six dosage levels (15, 30, 45, 60, 90, or 120 mg/day) for 12 months. The patients had their PSA levels checked every month. No patient experienced a PSA reduction of greater than 50%, and 37% of the patients experienced progression while on this treatment. Only 1 patient had to discontinue lycopene supplements and this was because of diarrhea. Does this mean that lyycopene supplements are worthless for men with a rising PSA after localized treatment? Not necessarily, because this was a small study and we need to learn more about it from the researchers after they publish their paper. For example, it would be interesting to know the Gleason scores of these patients. Did they have mostly non-aggressive or aggressive initial tumors??? Regardless, it certainly does not provide an endorsement for lycopene supplements in this situation, but let´s wait until we hear more about the study before we make a definitive conclusion. Regardless, you have to give these researchers and patients a lot of credit for doing this study because they had no outside source of funding!

62) Does Saw Palmetto Work Any Better Than A Sugar Pill For Men With NonCancerous Prostate Enlargement (BPH)? (Reference: Bent S, et al. AUA Annual Meeting 2005; abstract #1637, page 443.) 225 men were randomly assigned to 320 mg/day of saw palmetto or placebo for BPH. The study lasted for 1 year. No differences overall were observed for saw palmetto compared to placebo. Interestingly, many men improved their symptoms on either agent, but one was not better than the other. Also, without wasting the reader´s time, this study was very well done and looked at subjective as well as objective results. The researchers also mentioned that a higher dose of saw palmetto may or may not help men with BPH, but this has yet to be studied. So, does this mean that saw palmetto at 320 mg/day is worthless for men? Well, this has to be decided between you and your doctor, but perhaps saw palmetto just does not work as well as we thought it did. In addition, the drug treatments for BPH and other out patient treatments have been getting better and better, while the impact of the herbal products have always been controversial. In the meantime, saw palmetto may help some men with mild BPH, but again this is controversial especially after the publication of this study. One thing that cannot be argued is that saw palmetto is very cheap compared to the prescription options, and that is why some men and docs continue to use it. My biggest problem with saw palmetto is that many men continue to take it to prevent prostate cancer, but this has never been well studied, so I do not encourage any man to take it for prostate cancer prevention. Also, does saw palmetto artificially reduce PSA levels? Well, we have to wait for more information from this trial, but there was no significant impact with saw palmetto on prostate size. Either way, you should talk to your doctor about this latest study because it was so objective and so well done.

OTHER NEWS 63) MORE BAD NEWS FOR HIGH-DOSE VITAMIN E SUPPLEMENTS? (Reference: Bairati I, et al. Journal of the National Cancer Institute 2005;97(7):481-488.) This study really bothers the living heck out of me!!! I am not bothered by the researchers, because they did such a wonderful study, but the lack of media attention that occurred after this study really bothers me, and it proves to me once again that many negative papers do not get much attention. This was a randomized study of a lot of patients with stage I or II head and neck cancer, treated by radiation therapy. Patients were then randomized to 400 I.U./day of synthetic vitamin E or placebo on the first day of radiation treatment and continued this for 3 years after the end of radiation treatment. These patients were followed for a little over 4 years!!! Compared to patients taking a placebo, the patients on vitamin E had a higher rate of being diagnosed with a second primary cancer. In fact, the risk of being diagnosed with a second cancer was more than 2 times greater than the placebo group!!! Also, after supplementation of vitamin E was stopped then there was a lower risk of being diagnosed with another tumor. Well, this is head and neck cancer patients so what does this have to do with me??? I think this large and powerful study is a great take home message for anyone receiving radiation therapy for cancer. It is very difficult to recommend a high-dose of any supplement either during or after radiation therapy for cancer. No man in my opinion should be taking high-dose vitamin E to prevent cancer recurrence after treatment until someone comes out with some positive news, because all the news lately has been very negative. The only men that should be taking such a high-dose are those individuals that are in some clinical trial. Otherwise, the dosage of vitamin E from a tablet should be 50 I.U. or less and most men can get this from a cheap multivitamin. Stay tuned because other trials will be out soon. In the meantime it is better to stay away from high-dosages of any supplement. Please remember that less is more.

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