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Prostate Cancer and Genetics

Although prostate cancer is the most common cancer found in men, the pathophysiology of this disease remains poorly understood. No definite behavioral or environmental risk factors have been identified, but genetics are an important and likely the strongest contributing factor to the development and progression of the disease. Indeed it has been shown that first degree relatives of affected men are at over two-fold higher risk of developing prostate cancer.

In contrast to other types of cancer, it’s still unclear which individual genes dictate prostate cancer. There are only a few genes with known mutations that cause prostate cancer, and furthermore these mutations explain less than 10% of the risk. Given this, it’s likely that variations in the lower penetrance loci may contribute to disease susceptibility. Multiple case-control genome wide association studies have identified numerous single nucleotide polymorphisms associated with prostate cancer risk. Nevertheless, the problem still lies in how to interpret their combined and individual contributions to disease risk.

Recent studies have examined these potential indicators and have discovered more than 30 loci that may contribute to prostate cancer. However, due to the large number of possible loci, it’s necessary to perform more analyses in a large population of cases and controls testing all of the genetic variants. Hopefully these future studies will reveal a more complete understanding of the individual and cumulative risks associated with these loci.

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Study Shows Good Outcome for Delayed Prostate Surgery

Men with early prostate cancer who put off surgery is almost the same as men who had prompt surgery. On average, their tumors were no likely to develop into a more aggressive form than men who had surgery immediately after diagnosis. Additionally, after eight years, .9 percent of men who delayed surgery had died compared to .7 percent of men who had prompt surgery.

“Our findings show that if a man is diagnosed with a localized low-risk prostate cancer, there is no rush to decide which treatment choice (is) best,” said lead researcher Dr. Benny Holmstrom, of Gavle Hospital in Sweden.

The results add to data that some patients can safely opt for “active surveillance” — where the prostate cancer is monitored with regular PSA blood tests, digital rectal exams and possibly prostate biopsies and costly, painful surgical procedures are avoided.

A study published last year in the Journal of the National Cancer Institute estimated that since 1986, around 1 million U.S. men received unnecessary treatment for prostate tumors that were not life threatening.

As experts and health providers are increasingly calling for expanded use of active surveillance in monitoring prostate cancer, this study is particularly significant. However, Holmstrom warned that further, long-term studies are still needed to insure that active surveillance is truly the best option for prostate cancer patients.

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New Prostate Cancer Treatment Criticized

The device called NanoKnife is undergoing scrutiny as a cancer killing machine throughout the United States.  NanoKnife uses electrical jolts to zap tumors, but a thorough analysis, including a large clinical trial to prove it is safe and effective in people, has not been conducted.

Currently, 13 United States hospitals including Baptist Health Medical Center in Little Rock, Arkansas, University of Louisville, and Shands Hospital/University of Florida in Gainesville, Florida are using the device.  Each machine costs $300,000.  And some of the hospitals are aggressively promoting the device in ads and media presentations.  In fact, a radio ad developed by the University of Miami’s Sylvester Comprehensive Cancer Center says NanoKnife offers “real hope” to patients with cancer with “almost no side effects.”

Although the NanoKnife has been tested on animals and a small number of human patients, a large, controlled clinical trial has not been conducted.  Jan Keltjens, the company executive of AngioDynamics, Inc. of Queensbury, N.Y., the manufacturer of the product, states, “We have not done randomized controlled clinical trials, the so-called gold-standard studies.  We think this is a very promising technology for treating cancer that is otherwise untreatable.”

“There is growing concern in the interventional oncology community that the NanoKnife is being widely adopted prior to having gone through the necessary rigors of controlled investigations and clinical trials,” says Riad Salem, chief of interventional oncology at Chicago’s Northwestern Memorial Hospital.  Salem says that Northwestern does not have a NanoKnife.

The reason NanoKnife has been allowed to take shortcuts through the ordinary long process of becoming FDA approved deals with a modification enacted in 1976 by Congress.  During that time, Congress enacted a change that allows for granting regulatory approval to certain medical devices quickly, often with little or no clinical evidence, if the device is similar enough to another already on the market.  This change was allowed in order to encourage innovation in the industry and to get improved products quickly to market.  Now, since August of this year, the FDA panel recommends that the regulation be tightened by requiring manufacturers to provide more safety data on new devices and more detail about the connection between new and previously approved devices.  Manufacturers have 60 days to comment.

But as a result of the 1976 enactment, the NanoKnife went from being tested in animals to being directly promoted as a cancer fighter.  Some fear a situation where the product has been approved by the FDA only to be later recalled due to major side effects.  These concerns are based on the Bausch & Lomb Inc.’s situation where its contact-lens solution Renu with MoistureLoc was removed from the world market in 2006 after being linked to cases of fungal eye infection that can cause blindness.  Bausch & Lomb was approved through the same shortcut that applied to NanoKnife and was allowed marketing without large clinical studies.

In 2008, NanoKnife was originally approved because it was shown capable of destroying tissue similar to other existing devises that are used in heart surgery.  This time around, the NanoKnife is being used to treat cancer by excising malignant tumors near arteries, airways, or other vulnerable tissues and thus difficult to remove.

The device works through disposable electrode needles, which are inserted into the tumor.  Powerful electrical jolts are emitted from one needle to the other, creating microscopic holes in the cell membranes of cancer cells.  This is what allegedly destroys the tumor, but the large electrical bursts are also what cause side effects such as fast heartbeats.

Tim Clark, director of interventional radiology at Penn Presbyterian Medical Center in Philadelphia, which does not have a NanoKnife, says the device “has potential to treat cancers next to delicate structures.”  But for the time being, he says, there is not enough clinical data to be certain of its safety and efficacy.

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Prostate Surgery Causing Problems for Sexual Function

A new long-term follow-up study indicates that many men continue to feel distressed about their reduced sexual function years after prostate surgery.  In fact, the study reveals that sexual function is so important to them that adapting to a lower level of functioning is much more difficult than adapting to temporary urinary problems, explains Dr. Walter R. Parker and colleagues from the University of Michigan Health System in the Ann Arbor report.

Of the 434 men in the study with localized prostate cancer, all underwent radical prostatectomy, which is the complete removal of the gland.  This type of surgery is creating controversy among urologists and surgeons because it is commonly used to treat early-stages of the disease.  Men with early-stage prostate cancer are at a low risk that the disease will be fatal, yet the impact of the surgery is quite negative on the men’s quality of life.

Long-term quality of life is extremely important in men when they have a high likelihood of survival from prostate cancer.  Parker’s team at the University of Michigan developed a survey called the Expanded Prostate Cancer Index Composite (EPIC), which is designed to assess various aspects of quality of life after prostate cancer treatment.  This study is the first to compare men’s scores before the surgery and five years after the surgery.

The study shows that 38 percent of the men who had undergone radical prostatectomy reached baseline levels of urinary function 12 months after the surgery (despite an instantaneous, but temporary, decrease in urinary function and incontinence right after the surgery).  But by four years the improvement declined.

The study revealed even less promising results in regards to sexual function of the men.  Although sexual function began to improve after the surgery, only 28 percent had actually returned to the level of sexual function they reported before the surgery.  After three years from the surgery, 37 percent reported the same level of sexual trouble they reported before undergoing the surgery.  Only 11 percent of the men returned to their pre-surgery sexual function after two years from when they underwent the surgery.  This means that about 63 percent of the men were experiencing low sexual function after undergoing prostatectomy surgery.

The recommended recovery program for sexual function after the surgery includes Kegel exercises and prescription drugs.  These are intended to restore erectile function.  Yet studies have shown that many prescription drugs for erectile dysfunction leave the patients feeling sick and with many side-effects.

Researchers are initiating a “structured early and long-term erectile rehabilitation program to augment sexual recovery as early as possible, yet also convince patients to maintain their erectile rehabilitation efforts long-term,” states Reuters.

But something different needs to be included in these rehabilitation programs.  Many men are searching for alternative treatments for their erectile dysfunction and sexual function problems.  Natural supplements offer safe, often effective, and clinically proven results.  If you have undergone prostatectomy surgery and are considering natural supplements, contact your urologist for further information.

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Beta-Sitosterol and Your Prostate Health

For men who are suffering from prostate related symptoms and are seeking for safe alternative therapies, beta-sitosterol may be the answer.

Beta-sitosterol is a plant sterol found in several everyday foods and has effectively been shown to -
* Inhibit growth of prostate cancer cells and can even destroy the cells through protein phosphatase.
* Decrease inflammation by binding to the prostate.
* Improve urinary flow and help with urinary incontinence and urgency.
* Prevent difficult urination.

To incorporate beta-sitosterol in your diet, use vegetable oil as this is its best food source. Canola, corn and soybean oil, vegetable shortening, margarine made from corn or soybean oil, and tofu or soybean mayonnaise all contain high amounts of beta sitosterol.

Other significant sources of beta sitosterol are avocados, grape leaves, fava beans, saw palmetto, pumpkin seed, cashew fruit, rice bran, wheat germ, pistachio nuts, almonds, hazel nuts, walnuts, macadamia and pecans.

Another pleasant source of beta sitosterol is unsweetened baking chocolate. Now brownies will be a good source of beta sitosterol by using ingredients with high beta sitosterol – vegetable oil or margarine, unsweetened baking chocolate with chopped nuts of your choice.

Beta sitosterol is safe when taken in normal amounts such as amounts found in food. Clinical studies though have shown it may cause side effects, most of which are not usually dangerous.

An added benefit of beta-sitosterol is it has been found to lower cholesterol, by inhibiting the amount of cholesterol that is permitted to enter the body.

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Chemicals in Plastics May Increase the Risk of Prostate Cancer

A chemical found in babies’ bottles, as well as many other plastics, has been linked to an increased risk of prostate cancer, warns scientists.

In experiments, newborn rats were fed bisphenol A, which is a building block of many commonly used plastics.  The results showed that these rats were more likely to develop pre-cancerous cells as they aged.  Scientists have agreed that rats have chemical levels similar to those commonly found in the human body, and researchers said the findings of the bisphenol A study are directly relevant to babies’ health.

Recently, the Food Standards Agency said that bisphenol A does not carry a risk; however, this most recent study clearly shows that the compound is linked to cancer.  And bisphenol A is found in many of our plastics, including CD cases, tin can linings, sunglasses, plastic knives and forks, mobile phones, and dental sealants.

The American researchers showed that the newborn rats that were fed bisphenol A were more likely to develop cellular damage that can lead to prostate cancer later in life.  And, according to University of Illinois researcher Gail Prins, “There was no difference in the number of lesions, whether the bisphenol A was given by injection or orally, the prostate pathology was the same.  It mattered nothing which way it was given.”

This statement is important because it suggests that the latest research findings are revealing that the damage seen in experiments may span to how we access it through food and drink.

Dr. Prins wrote in the journal Reproductive Toxicology, “These findings on prostate health are directly relevant to humans at current bisphenol A exposure levels…[and] support the proposal that exposures to bisphenol A during fetal and neonatal life may increase the risk of carcinogenic events during adult life and in the human population.”

Elizabeth Salter Green, of the Chemicals, Health and Environment Monitoring Trust, seems to uphold the findings of the study and suggests, “Responsible governments need to find alternatives to bisphenol A as so many consumer products are made using this chemical and we are all constantly exposed.”

Other campaigners are urging people to use bisphenol A-free baby bottles, cut down on their use of canned foods, and opt for glass, porcelain, or stainless steel containers when possible.  In addition, those who are concerned with the findings of the recent bisphenol A rat study should avoid heating foods, including baby meals, in polycarbonate plastic food containers as the chemical has been known to leak out of plastics at high temperatures.

Despite the campaign against bisphenol A, the Prostate Cancer Charity urged people not to worry, citing information that the chemical breaks down much more quickly in the human body than in a rat.  In fact, Dr. Kate Holmes of the charity said, “This is a field of research that remains highly controversial.  Bisphenol A is still considered to be a safe product for use by the food industry and the exposure of humans to this product is considered to be minimal.”

Dr. Holmes insists that the best way to take control of a man’s overall health is to maintain a healthy diet rich in fruit and vegetables while engaging in a physically active lifestyle.  She says, “Moving away from a diet rich in meat and saturated fat will improve overall health and reduce the risk of chronic conditions like heart disease, as well as possibly helping to prevent prostate cancer.”

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The Importance of Knowing Your Baseline PSA For Prostate Health

If you have been recently diagnosed with prostate cancer, then your urologist most likely provided you with a PSA score. The PSA baseline score is your prostate specific antigen at the time of your first measurement of the antigen. This baseline is important because subsequent PSA values that are higher than the baseline may indicate a disease of the prostate, such as prostate cancer or benign prostatic hyperplasia. Further, your oncologist or urologist may consider your PSA before treatment has been administered.

One of the first questions patients who have been diagnosed, or re-diagnosed, with metastatic prostate cancer ask is, “How long do I have to live?” The answer to this question has changed over the years. While in the 1980s and early 1990s men were given an estimated 18 to 36 months from the time of diagnosis to live, the current understanding and estimation of survival is 5 to 6 years, maybe longer. The difference in survival rates is, in part, due to treatments; however, the major factor is the inclusion of PSA scores, velocity numbers, etc. These numbers allow researchers to form a clearer picture of the individual cancer and a closer estimation of survival.

And for those who have already been diagnosed with prostate cancer and have been treated, recurrence is a reality. According to the Prostate Cancer Foundation, out of those who have undergone treatment for prostate cancer, 20-30% will relapse after the five-year mark and begin to show signs of disease recurrence.
But survival for recurrence has also been extended. Many men in the United States are actually diagnosed at an earlier stage of the disease because of wide-spread PSA testing. Further, we now have a better understanding of cancer therapies, including hormone manipulation and taxane chemotherapy.

According to Duke University Medical Center researchers, men with a baseline PSA value of 10 or higher are up to 11 times more likely to die from prostate cancer than are men with lower initial values. In the study conducted by Duke University, 4,568 men over the past 20 years who have had PSA tests and were eventually diagnosed with prostate cancer were followed. With age and race taken into account, the risk of death from prostate cancer was calculated.

The study released showed a median age for their study as 65 years. The median baseline PSA was 4.5. Nearly 3.5% of the men died from prostate cancer during the study period, while more than 20 percent died from other causes. The analysis showed that men with a baseline PSA of less than 4 had a very low risk of death from prostate cancer, but those with 4 to 9.9 baselines were three times more likely to die from prostate cancer. And men with a baseline PSA value of greater than 10 were 11 times more likely to die than were men with PSAs under 2.5.

Given these results, it is evident that early diagnosis of prostate cancer, when the baseline PSA is lower, will decrease the mortality rate from prostate cancer. With PSA screenings and digital rectal exams, men may be saved from early, unnecessary death.

Baseline PSA scores are important in determining predicted survival rates for men who have been diagnosed with prostate cancer. Ping Tang, MD, a member of the Duke Prostate Center and the department of urology at Guangzhou First Municipal People’s Hospital, Guangdong, China comments, “It’s commonly held that men over the age of 75 don’t need to bother with PSA screening any longer, but [this study] tells us that chronological age alone may not be enough. Patients need to take into account their initial baseline value, and if it’s over 4, continuous screening may be beneficial.”

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Prostate Cancer Patients on ADT Not Affected by Provenge

A recent study, led by Tomasz Beer, MD, Professor of Medicine at Oregon Health & Science University (OHSU) in Portland, Oregon, found that prostate cancer (PCa) patients on androgen deprivation therapy (ADT) and receiving sipuleucel-T (Provenge) have no adverse outcomes in terms of quality of life.  These findings were presented at the 47th Annual Meeting of the American Society of Clinical Oncology.

The study involved 176 men who were placed on ADT for three to four months after experiencing PSA recurrence after radical prostatectomy.  Sipuleucel-T, which received FDA approval for the treatment of late-stage PCa last year, is not usually used in men with earlier states of prostate cancer.  This is the first study to explore the effect of the autologous cellular immunotherapy on quality of life.

After three to four months, ADT was stopped and all men were randomized to treatment with sipuleucel-T (117 patients) or control (59 patients). Using survey techniques, the researchers assessed quality of life at baseline (following ADT and prior to randomization) and at weeks 13 and 26 after treatment.  Ninety-eight percent of subjects completed baseline quality of life assessment and 92% had at least one post-treatment assessment.  During ADT in the three months before sipuleucel-T treatment, quality of life measures decreased comparably in both study arms.  After the start of the study treatment, there were no significant differences found in the quality of life between the two groups.

Dr. Beer emphasized that the results from the study suggest that a larger study in early disease patients is needed.

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Gene Test Effectively Predicts Presence of nearby Prostate Cancer

Data from a large group of tissue samples showed that gene expression in prostate stroma predicted the presence of nearby cancer with 97% overall accuracy.  Stroma adjacent to or near prostate tumors expressed genes significantly differently from normal stroma.

In a recent issue of Cancer Research, it was reported that the correlation between stromal gene expression and cancer increased with proximity to cancer.  The 144-gene panel had 98% sensitivity and 88% specificity for predicting the presence of cancer, whereas, a randomly selected 100-gene panel had no predictive value.  If replicated in additional studies, the gene test has multiple therapeutic implications.

The research team compared gene expression profiles in 13 prostate biopsy specimens containing stroma near tumor and in 15 biopsy specimens from men without prostate cancer and identified 3,800 significant changes in expression.

The authors developed a 114-gene stroma-specific classifier for nearby tumor after filtering for age-related genes and for genes known to be expressed at detectable levels in tumors.  They tested the classifier in 364 prostate specimens, consisting of 243 tumor-bearing samples and 121 normal specimens.  These 364 specimens included samples from normal prostate biopsies, normal prostate tissue obtained from autopsies, stroma remote to tumor, and stroma from within a few millimeters of tumor.  The gene panel correctly identified all but two of the 243 tumor-containing specimens. Analysis of the two misclassifications suggested the tissue might not have come from patients with prostate cancer.

The research team also compared expression patterns in stromal tissue near and far from the tumor and found a gradient of classification frequency values of 98%, 75%, and 36% for stromal samples adjacent to, close to, and remote (>15 mm) from the tumor.

These findings suggest several practical applications of the gene test, such as assessment of suspicious initial biopsies and possibly therapeutic targeting of stromal expression changes indicating the presence of tumor while leaving normal stroma relatively untouched.

Some of the authors of the gene expression study disclosed relationships with Proveri, a company involved in translational research related to the study.

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No Significant Association Found Between Androgen Deprivation Therapy and Cardiovascular Death

Treatment with androgen deprivation therapy (ADT) does not significantly increase the risk of cardiovascular mortality according to evaluation of mortality data in a large registry of men treated for prostate cancer.

ADT is commonly used to treat prostate cancer.  Some studies have shown that it may increase the risk of cardiovascular disease, but other studies have not confirmed the association and it remains controversial.  The authors of the recent study tried to explore the evidence further by analyzing the patients registry CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor), which includes men with confirmed prostate cancer recruited from 40 mostly community-based US urological practices.

Men who are diagnosed with localized prostate cancer between 1995 and 2007 were included in the analysis, and in order to try to control for factors that may confound the relationship between ADT and cardiovascular death, patients who used and did not use ADT were matched by their propensity to receive ADT.  These patients were categorized into three groups: primary ADT monotherapy, local treatment plus ADT, and watchful waiting/active surveillance (WW/AS).  Initial outcomes were associations between treatment and cardiovascular cause, prostate cancer, and other causes.  Study investigators assessed cause of death using death certificates.

At the point of data capture, there were 13,887 men in the registry, of whom 7,248 were eligible for the analysis.  The majority (71.3%) received local treatment only, 6.7% received local treatment plus ADT, 15% received primary ADT, and 7 percent WW/AS.  It was found that 21.7% received AFT at some point.  Nine hundred seventy six of these men died during the study period, 1.4% from prostate cancer, 2.7% from cardiovascular disease, and 9.4 percent due to other causes.  Patients treated with ADT or WW/AS had a higher likelihood of death due to prostate cancer than those treated just with local therapy.

The largest risk of cardiovascular death was in those treated with WW/AS compared to those only receiving local therapy.  The difference for those treated with local therapy plus ADT was not significant.

The authors’ conclusion is that the increased rate of cardiovascular death in the WW/AS group compared to the ADT group suggests that there are possibly unmeasured variables that affect treatment selection and that confound the association between ADT and cardiovascular death.  The research team notes that when patients were match on propensity to receive ADT, there was no significant association.  The limitation so the study included the relatively small number of deaths in some groups, and the assignment of cause of death from death certificates.

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