FDA Approves New Drug to Fight Advanced Prostate Cancer

Xofigo was fast-tracked for approval and is meant for tumors that have spread to the bones

By EJ Mundell

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that it has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.

The drug, Xofigo, is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.

The FDA said Xofigo was approved more than three months ahead of the original August 2013 deadline the agency had set for a complete review. Instead, the drug was reviewed under the agency's "priority" review program, designated for medicines that appear safe and effective in a context where no good alternative therapy exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer." The other drug, Xtandi, was approved by the FDA last August for men with hormone treatment-resistant prostate cancers that have spread or recurred, and who had previously been treated with the drug docetaxel.

According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.

Xofigo is co-marketed in the US by Wayne, N.J.-based Bayer Pharmaceuticals and Algeta US of Cambridge, Mass.

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Agent Orange Tied to Lethal Prostate Cancer

Findings from U.S. veterans should raise awareness of chemical warfare's hazards, researcher says

By Robert Preidt

HealthDay Reporter

MONDAY, May 13 (HealthDay News) -- A link exists between exposure to Agent Orange and deadly forms of prostate cancer in U.S. veterans, according to a new study.

Agent Orange was a chemical spray that was heavily used during the Vietnam War era. It was often contaminated with dioxin, a potentially cancer-causing chemical. Previous research suggests that exposure to Agent Orange increases the risk of prostate cancer, but it wasn't known if it specifically increases the risk of more dangerous forms of the disease.

In this study, researchers looked at more than 2,700 U.S. veterans who underwent a prostate biopsy. Prostate cancer was diagnosed in 33 percent of the veterans, including 17 percent with high-grade disease, according to the study, which was published online May 13 in the journal Cancer.

Exposure to Agent Orange was linked with a 52 percent increase in overall prostate cancer risk, a 75 percent increased risk of high-grade prostate cancer and a more than doubled risk of the deadliest forms of the disease.

The findings suggest that determining veterans' exposure to Agent Orange can help identify those who may be at increased risk for prostate cancer, leading to earlier detection and treatment, said Dr. Mark Garzotto, of the Portland Veterans Administration Medical Center and Oregon Health & Science University, and colleagues.

"It also should raise awareness about potential harms of chemical contaminants in biologic agents used in warfare and the risks associated with waste handling and other chemical processes that generate dioxin or dioxin-related compounds," Garzotto said in a journal news release.

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Prostate Cancer May Be Deadlier for the Uninsured

Study found they were more likely to have a higher PSA test score, advanced disease and shorter survival

By Kathleen Doheny

HealthDay Reporter

TUESDAY, May 7 (HealthDay News) -- Men who are uninsured or underinsured get advanced prostate cancer at nearly four times the national average and don't survive as long as other men with advanced disease, a new study says.

"We've identified a group of advanced prostate cancer patients who do not do well," said Dr. Jeffrey Reese, a clinical professor (affiliated) at Stanford University School of Medicine. He's also chief of urology at the Santa Clara Valley Medical Center, a county hospital serving a large underinsured population in San Jose, Calif.

"They come in invariably because they [are] having symptoms of metastatic disease," he said, which is when the cancer has spread to other parts of the body.

Of all men diagnosed with prostate cancer at the medical center from 1998 through 2008, Reese found 71 men, or more than 14 percent, had advanced prostate cancer. That's more than three times the national average of 4 percent who have advanced cancer at the time of diagnosis.

Even though the men were offered all available treatments, their five-year survival rate was also well below the national average, Reese found.

He is due to present the findings Tuesday at the annual meeting of the American Urological Association (AUA), in San Diego.

Testing for PSA measures the blood level of PSA, thought to be a key marker for prostate cancer. "A PSA of 4 is sort of the cutoff" before doctors begin doing other tests, Reese said. Some begin testing, such as a biopsy, even sooner, at 2.5 nanograms per milliliter (ng/mL).

In the study, the 71 men with advanced cancer all had prostate specific antigen (PSA) levels above 100 ng/mL. The median PSA in the men was nearly 400.

None of the 71 men -- whose average age was 66 -- had been tested for PSA before at the Santa Clara hospital, and Reese said he suspects most or all had never had a PSA test anywhere.

Under new, less stringent guidelines issued at the meeting, the AUA suggests PSA testing be discussed by men and their doctors, especially those aged 55 to 69, weighing the pros and cons of screening. The association says the best evidence of benefit from screening is among those men aged 55 to 69 screened every two to four years.

Survival of the men in the study was lower than the national average for men with advanced prostate cancer, Reese also found. The median survival was 18 months -- half of the men lived longer -- and less than 10 percent lived three years past the diagnosis.

In comparison, 29 percent of men with advanced disease, overall, live at least five years after diagnosis, Reese said.

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Obesity Linked to Prostate Cancer, Study Finds

TUESDAY, April 23 (HealthDay News) -- Obese men are more likely to have precancerous changes detected in benign prostate biopsies and are at increased risk for eventually developing prostate cancer, new research suggests.

For the study, researchers examined data from nearly 500 men who were followed for 14 years after undergoing an initial prostate biopsy that was found to be noncancerous, or benign.

Prostate abnormalities were detected in 11 percent of the patients, and these abnormalities were strongly associated with obesity, said study author Andrew Rundle, an associate professor of epidemiology at Columbia University Mailman School of Public Health in New York City.

After taking into account factors including family history of prostate cancer, the researchers concluded that obesity at the time of the initial biopsy was associated with a 57 percent increased risk of developing prostate cancer during the 14 years of follow-up.

This association, however, was seen only for prostate cancer that occurred earlier in the follow-up period, according to the study, which was published in the April 23 issue of the journal Cancer Epidemiology, Biomarkers & Prevention.

"We don't absolutely know what the true biology is," Rundle said in a news release from the American Association for Cancer Research. "In some ways, this reflects the association between the body size and larger prostate size, which is thought to reduce the sensitivity of the needle biopsy. It is possible that the tumors missed by initial biopsy grew and were detected in a follow-up biopsy."

The association found in this study does not prove cause and effect.

Rundle noted that previous studies "have attempted to determine if there are subpopulations of men diagnosed with benign conditions that may be at a greater risk for developing prostate cancer. This is one of the first studies to assess the association between obesity and precancerous abnormalities."

These findings indicate that obesity "should be considered a factor for more intensive follow-up after a benign prostate biopsy," Rundle said.

-- Robert Preidt
Copyright © 2013 HealthDay. All rights reserved. SOURCE: American Association for Cancer Research, news release, April 23, 2013

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New Procedure May Shrink Enlarged Prostate Without Surgery

By Serena Gordon
HealthDay Reporter

MONDAY, April 15 (HealthDay News) -- Men who need treatment for an enlarged prostate may soon have a new nonsurgical option, a small, early study suggests.

Called prostatic artery embolization (PAE), the technique uses a catheter threaded into an artery in the leg. The catheter is guided to the artery that supplies blood to the prostate. Then, tiny beads are injected into the artery, which temporarily block the blood supply to the prostate.

The temporary loss of blood supply causes the prostate to shrink, relieving symptoms, according to study lead author Dr. Sandeep Bagla. What's more, the new treatment doesn't appear to have the same risk of serious complications, such as incontinence and impotence, that often accompany enlarged prostate treatment.

"This is fantastic news for the average man with benign prostatic hyperplasia. Many men decline current treatments because of the risks. But, for the average man, PAE is a no-brainer," said Bagla, an interventional radiologist at Inova Alexandria Hospital, in Virginia.

The procedure has only been available as part of Bagla's trial until recently, but he said some interventional radiologists have started doing prostatic artery embolization, and he expects the procedure will become more widely available by the end of the year.

Benign prostatic hyperplasia is the medical term for an enlarged prostate. An enlarged prostate is very common as men get older. As many as half of all men in their 60s will have an enlarged prostate, according to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). By the time men are in their 70s and 80s, up to 90 percent have benign prostatic hyperplasia, according to the NIDDK.

Some men experience no symptoms, while others may feel the need to urinate frequently, but they have a weak urinary stream, the NIDDK says. There are a number of treatments available for benign prostatic hyperplasia, including medications and surgery.

Bagla said that interventional radiologists in Europe and South America have been using prostatic artery embolization, and that the current study is the first in the United States to test the procedure.

He and his colleagues hope to treat a total of 30 patients, but they're reporting on the results from the first 18 patients on Monday at the annual meeting of Society of Interventional Radiology, in New Orleans. The data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

For the study, the average age of the patients who underwent prostatic artery embolization was 67 years. None of the men had to be admitted to the hospital after the procedure.

Ninety-four percent of the men (17 of 18) had a significant decrease in their symptoms one month after surgery. And, none reported any major complications following the surgery.

Bagla said the exact cost of the new procedure is difficult to estimate right now, but prostatic artery embolization will be cheaper than most of the currently used procedures, he said, because there's no need for an operating room and overnight hospital stays. In addition, he said, because the new procedure doesn't appear to cause complications, that will save health care dollars as well.

"This may become part of the armamentarium of treatments that can be offered for [benign prostatic hyperplasia]," said Dr. Art Rastinehad, director of interventional urologic oncology at North Shore-LIJ Health System in New Hyde Park, N.Y. He was not involved with the new study.

"This was a small series and a limited study to draw significant conclusions from. But, it's very exciting to see it evaluated and moving forward," he said.

Copyright © 2013 HealthDay. All rights reserved. SOURCES: Sandeep Bagla, M.D., interventional radiologist, Inova Alexandria Hospital, Alexandria, Va.; Art Rastinehad, D.O., director of interventional urologic oncology, North Shore-LIJ Health System, New Hyde Park, N.Y.; April 15, 2013, presentation, Society of Interventional Radiology annual meeting, New Orleans

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Healthy fats may fight early-stage prostate cancer

Posted June 12, 2013, 2:38 pm

Each year, nearly a quarter of a million American men learn they have prostate cancer. Most are diagnosed with early-stage cancer that has not spread beyond the prostate gland. Traditional treatments include surgery, radiation therapy, and a “watch and wait” strategy called active surveillance. A new study published online this week in JAMA Internal Medicine indicates that diet may be an important add-on. The study, part of the ongoing Harvard-based Health Professionals Follow-up Study, suggests that eating more foods that deliver healthy vegetable oils can help fight the second leading cause of cancer death in men.

“It’s one of the first studies to look at dietary interventions after men have been diagnosed with prostate cancer,” says Dr. Marc B. Garnick, a prostate cancer specialist at Harvard Medical School and Beth Israel Deaconess Medical Center. “It supports the idea that you can potentially modify the behavior of prostate cancer that is still confined to the prostate gland.”

The study involved about 4,500 men who were diagnosed with nonmetastatic prostate cancer, which means it had not yet spread beyond the walnut-sized prostate gland. Since 1986, they have been reporting what they usually eat by completing detailed food surveys every four years.

Study participants who ate the largest amount of vegetable fats were less likely to die from prostate cancer—or any other cause—than men who consumed the most animal fats. Most of the vegetable fats consumed by the men came from oils in salad dressings and nuts.

The men who consumed the most vegetable oil lived longer, in part because their cancers were less likely to spread beyond the prostate gland. That suggests, but does not prove, that a diet rich in vegetable oils can slow the progression of the prostate cancer.

Earlier studies have implicated the traditional Western diet, which is relatively high in red meat and other sources of animal fats, with a higher risk for developing prostate cancer in the first place, while eating more vegetable oils and vegetable protein may help prevent it.

“One of the things I tell my patients is not to eat animal fat, or to at least limit its consumption,” Dr. Garnick says. He bases this advice on decades-old data that show a direct relationship between the amounts of animal fat consumed and incidence of prostate and other cancers. It’s never been possible to prove cause and effect between dietary fat and cancer, but this new study lends support to the idea that animal fats may modify the characteristics of prostate cancer.

Although the study focused on oils and fats, it’s important to consider what the men who consumed a lot of vegetable oils were not eating: refined carbohydrates, such as processed white bread, white rice, and desserts.

In the study, men who replaced 10% of their total calories from carbohydrates with calories from vegetable oils were 29% less likely to die from prostate cancer or any other cause over eight years of follow-up.

This one study, of course, can’t prove that a healthful diet fights prostate cancer. For one thing, this type of long-term follow-up study can only show an association between diet and prostate cancer. There were also some differences between the groups. The men who ate the most vegetable oil were healthier to start with. At diagnosis, their blood levels of PSA—a marker for cancer activity—were lower than in the group that ate the most animal fat. Conversely, the men who ate the most animal fats had more unhealthy characteristics. They were more overweight and less physically active, and more of them smoked (7% compared with about 1% in the vegetable-fat group).

Researchers used statistical methods to compensate for these important differences. “Any of these negative influences would independently lead to a worse outcome,” Dr. Garnick says. “Have they accounted for everything? In these studies, you can never be sure.”

So we don’t really know what contributed most to keeping prostate cancer in check—eating more beneficial vegetable oils, eating fewer (or healthier) carbohydrate-rich foods, or eating less meat. It may not matter, since all three are part of a healthful diet.

The JAMA Internal Medicine study, like so many others before it, endorses an overall healthy diet that goes easy on red meat and includes generous amounts of plant foods that deliver healthy mono- and polyunsaturated fatty acids. These come from foods like avocados, walnuts, and soybean, canola, and extra virgin olive oils. That kind of diet has been linked with lower risks of heart disease, cancer, and a host of other chronic conditions.

This week is Men’s Health Week. As we cruise toward Father’s Day, I hope that all men will give themselves the gift of health. One important step in that direction is adopting a diet that may fight prostate cancer and will benefit everything from the head to the feet.

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New Procedure May Shrink Enlarged Prostate Without Surgery

'Prostatic artery embolization' didn't cause troublesome side effects in study

By Serena Gordon

HealthDay Reporter

MONDAY, April 15 (HealthDay News) -- Men who need treatment for an enlarged prostate may soon have a new nonsurgical option, a small, early study suggests.

Called prostatic artery embolization (PAE), the technique uses a catheter threaded into an artery in the leg. The catheter is guided to the artery that supplies blood to the prostate. Then, tiny beads are injected into the artery, which temporarily block the blood supply to the prostate.

The temporary loss of blood supply causes the prostate to shrink, relieving symptoms, according to study lead author Dr. Sandeep Bagla. What's more, the new treatment doesn't appear to have the same risk of serious complications, such as incontinence and impotence, that often accompany enlarged prostate treatment.

"This is fantastic news for the average man with benign prostatic hyperplasia. Many men decline current treatments because of the risks. But, for the average man, PAE is a no-brainer," said Bagla, an interventional radiologist at Inova Alexandria Hospital, in Virginia.

The procedure has only been available as part of Bagla's trial until recently, but he said some interventional radiologists have started doing prostatic artery embolization, and he expects the procedure will become more widely available by the end of the year.

Benign prostatic hyperplasia is the medical term for an enlarged prostate. An enlarged prostate is very common as men get older. As many as half of all men in their 60s will have an enlarged prostate, according to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). By the time men are in their 70s and 80s, up to 90 percent have benign prostatic hyperplasia, according to the NIDDK.

Some men experience no symptoms, while others may feel the need to urinate frequently, but they have a weak urinary stream, the NIDDK says. There are a number of treatments available for benign prostatic hyperplasia, including medications and surgery.

Bagla said that interventional radiologists in Europe and South America have been using prostatic artery embolization, and that the current study is the first in the United States to test the procedure.

He and his colleagues hope to treat a total of 30 patients, but they're reporting on the results from the first 18 patients on Monday at the annual meeting of Society of Interventional Radiology, in New Orleans. The data and conclusions should be viewed as preliminary until published in a peer-reviewed journal.

For the study, the average age of the patients who underwent prostatic artery embolization was 67 years. None of the men had to be admitted to the hospital after the procedure.

Ninety-four percent of the men (17 of 18) had a significant decrease in their symptoms one month after surgery. And, none reported any major complications following the surgery.

Bagla said the exact cost of the new procedure is difficult to estimate right now, but prostatic artery embolization will be cheaper than most of the currently used procedures, he said, because there's no need for an operating room and overnight hospital stays. In addition, he said, because the new procedure doesn't appear to cause complications, that will save health care dollars as well.

"This may become part of the armamentarium of treatments that can be offered for [benign prostatic hyperplasia]," said Dr. Art Rastinehad, director of interventional urologic oncology at North Shore-LIJ Health System in New Hyde Park, N.Y. He was not involved with the new study.

"This was a small series and a limited study to draw significant conclusions from. But, it's very exciting to see it evaluated and moving forward," he said.

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Tweaking Dietary Fat Mix Might Boost Prostate Cancer Survival

Men who subbed vegetable oils, avocados, nuts for animal fats fared better in study

By Denise Mann

HealthDay Reporter

MONDAY, June 10 (HealthDay News) -- Men with prostate cancer may boost their survival chances if they replace animal fats and carbohydrates in their diet with healthy fats such as olive oils, nuts and avocados, new research suggests.

Men who substituted 10 percent of their daily calories from animal fats and carbs with such healthy fats as olive oil, canola oil, nuts, seeds and avocados were 29 percent less likely to die from spreading prostate cancer and 26 percent less likely to die from any other disease when compared to men who did not make this healthy swap, the study found.

And a little bit seems to go a long way. Specifically, adding just one daily tablespoon of an oil-based salad dressing resulted in a 29 percent lower risk of dying from prostate cancer and a 13 percent lower risk of dying from any other cause, the study contended.

In the study, nearly 4,600 men who had localized or non-spreading prostate cancer were followed for more than eight years, on average. During the study, 1,064 men died. Of these, 31 percent died from heart disease, slightly more than 21 percent died as a result of prostate cancer and slightly less than 21 percent died as a result of another type of cancer.

The findings appeared online June 10 in JAMA Internal Medicine.

The study can't say for sure that including healthy fats in the diet was responsible for the survival edge seen among men. "The main take-home message is that consuming healthy fats and nuts may have a protective role," said study author Erin Richman, a postdoctoral scholar in the department of epidemiology and biostatistics at the University of California, San Francisco.

In 2013, there will be nearly 239,000 men diagnosed with prostate cancer and nearly 30,000 men will die from the disease, according to estimates from the U.S. National Cancer Institute.

"The next step is to plan a randomized controlled trial of these healthier fats and see whether and how they affect the prostate," Richman said. "The novel finding in this study seems to be a benefit on prostate cancer survival." She noted that there is already a large body of evidence suggesting that healthy fats help reduce heart disease risks.

An editorial by Dr. Stephen Freedland of Duke University Medical Center accompanied the new study.

"We can say for sure that being obese increases the risk of dying of prostate cancer," Freedland said. "The new study gives us some more clues. It suggests that cutting out saturated fats and carbohydrates and replacing them with healthy fats can also lower the risk of dying from prostate cancer."

Another expert praised the new study while noting that the findings aren't conclusive.

"This study is well-designed and offers some evidence that a diet higher in vegetable fat and lower in carbohydrates might reduce risk of premature death from prostate cancer in men with prostate cancer that has not spread to other parts of the body," said Eric Jacobs, an epidemiologist at the American Cancer Society. "While these results are exciting, there have been few other studies in this area and more are needed before conclusions can be made about the effect of vegetable fat or other dietary factors on prostate cancer progression."

Moreover, Jacobs said, "there is stronger evidence that smoking and obesity increase risk of prostate cancer recurrence and death from prostate cancer, giving prostate cancer survivors one more reason to avoid smoking and maintain a healthy weight."

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I have elevated PSA levels and am scheduled for a prostate biopsy — what can I expect?

Posted June 04, 2013, 2:00 am

I recently had a PSA test and my levels came back elevated. I’m scheduled to have a prostate biopsy. What can I expect?

The prostate-specific antigen (PSA) blood test is a screening test designed to detect prostate cancer before symptoms develop. An elevated PSA value can suggest that cancer may be present. But only a prostate biopsy can confirm the actual presence of cancer.

A prostate biopsy involves removing snippets of tissue from the prostate and checking them for cancerous cells under a microscope. Your prostate gland lies right next to your rectum, and the rectum is a passageway inside your body.

During the biopsy, your doctor will insert an ultrasound probe into your rectum. The ultrasound probe sends out sound waves that travel into the prostate and bounce back like an echo in a canyon. When they bounce back, they create a picture of your prostate gland. The picture shows the parts of the prostate that look like they might have cancer. This helps identify the best targets for the biopsy.

Guided by the ultrasound picture, the doctor uses a spring-loaded “biopsy gun” that directs a needle into the part of the prostate that looks cancerous. The device quickly sends a needle through your rectal wall and into the prostate. The needle removes small tissue samples — a typical biopsy removes 10 to 12 samples. When the needle is withdrawn from the body, the prostate tissue inside the needle is examined with a microscope to look for cancer.

You may feel a slight pinch as the needle punches into the prostate gland and takes the sample. Most men feel only mild to moderate discomfort.

Possible risks of a prostate biopsy include:

painerectile problemsblood in the urine or stoolshort-term rectal bleedingblood in the semendifficulty urinatingurinary incontinenceurinary tract or prostate gland infection

If your biopsy result is positive, that means it has confirmed the presence of cancer in your prostate. If the biopsy specimen shows cancer, it’s cancer. But some prostate cancers just sit there for the rest of your life and never cause trouble, whereas others do cause problems. The main question your doctor asks when the biopsy is positive: What kind of prostate cancer is this?

The detailed biopsy findings will help you and your doctor decide what kind of prostate cancer you have, the extent and location of the cancer, and how malignant the cells look. This information helps your doctor determine how aggressive your cancer will be and the best course of action.

If no cancerous cells are found in the samples, that’s a good sign. But there’s still some room for doubt. About 10 percent of biopsies are “false negatives.” This means they have missed existing cancer.

Yes, the prostate biopsy can have side effects and can sometimes miss cancer. But the development of ultrasound pictures and biopsy guns and needles has made the diagnosis of prostate cancer much more accurate and has saved many lives.

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Experimental Drugs Show Promise Against Prostate Cancer

Tumor growth suppressed in lab tests; human trials still needed, study authors say

By Mary Elizabeth Dallas

HealthDay Reporter

FRIDAY, May 31 (HealthDay News) -- Researchers have identified a new class of drugs that show promise for treating advanced prostate cancer. The drugs, known as peptidomimetics, interfere with the signaling necessary for prostate cancer cells to grow, according to a new study.

Prostate cancer depends upon the actions of androgens, such as the hormone testosterone. Androgens activate androgen receptors, resulting in a signal that causes prostate cancer cells to grow.

To stop tumor growth, men with prostate cancer have been treated with drugs to block the production of androgens or block the receptor where androgens bind. However, tumors can grow despite this treatment because of mutations in androgens or receptors.

In the latest study, published online May 28 in Nature Communications, a team of researchers led by Dr. Ganesh Raj, associate professor of urology at UT Southwestern Medical Center at Dallas, found the nontoxic peptidomimetic agents could disrupt androgen-receptor signaling and prevent tumor growth.

When tested in mouse and human tissue models, the drugs blocked the activity of androgens by attacking the protein in a different spot from where the androgen binds, the researchers explained. As a result, prostate cancer cells do not receive the signal to grow -- even when the androgen receptor is activated.

"We are hopeful that this novel class of drugs will shut down androgen-receptor signaling and lead to added options and increased longevity for men with advanced prostate cancer," Raj, the study's senior author, noted in a university news release.

One expert was optimistic about the new findings.

"The study represents a significant step forward in the development of a new molecular targeted therapy for advanced prostate cancer," said Dr. Manish Vira, director of the Fellowship Program in Urologic Oncology at North Shore-LIJ's Arthur Smith Institute for Urology in Lake Success, N.Y.

He said the new drug works at "preventing the [cell] receptor from promoting cancer cell growth signaling," and added that "the study is proof in principle that rationale design of peptidomimetics can lead to the development of a new class of anti-cancer therapy."

The researchers noted more testing is needed before the drugs could progress to clinical trials involving humans. Results obtained in laboratory experiments are not always replicated in humans.

"Most drugs now available to treat advanced prostate cancer improve survival rates by three or four months," Raj added. "Our new agents may offer hope for men who fail with the current drugs."

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FDA Approves New Drug to Fight Advanced Prostate Cancer

Xofigo was fast-tracked for approval and is meant for tumors that have spread to the bones

By EJ Mundell

HealthDay Reporter

WEDNESDAY, May 15 (HealthDay News) -- The U.S. Food and Drug Administration announced Wednesday that it has approved a drug to help men with advanced prostate cancer whose disease has spread to the bones.

The drug, Xofigo, is targeted to patients with late-stage, metastatic disease that has spread to the bones but not to other organs, the FDA said in a news release. It is meant for patients who have already undergone surgery and/or drug therapies such as hormone-based treatments.

The FDA said Xofigo was approved more than three months ahead of the original August 2013 deadline the agency had set for a complete review. Instead, the drug was reviewed under the agency's "priority" review program, designated for medicines that appear safe and effective in a context where no good alternative therapy exists.

"Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, explained in the news release.

In a clinical trial involving more than 800 men with symptomatic prostate cancer that was resistant to hormonal therapy and had spread to the bones, men on Xofigo survived a median of 14 months compared to a little over 11 months for men taking a placebo. Side effects from Xofigo included nausea, diarrhea, vomiting and swelling of the legs and feet. Low levels of red and white blood cells, as well as platelets, were also reported among some patients taking Xofigo, the FDA said.

Pazdur noted that "Xofigo is the second prostate cancer drug approved by the FDA in the past year that demonstrates an ability to extend the survival of men with metastatic prostate cancer." The other drug, Xtandi, was approved by the FDA last August for men with hormone treatment-resistant prostate cancers that have spread or recurred, and who had previously been treated with the drug docetaxel.

According to the American Cancer Society, prostate cancer remains the leading cancer type among men outside of skin cancer, and about one man in every six will develop the illness during his lifetime. Caught early, it is often curable. About 239,000 new cases of prostate cancer are diagnosed among American men each year, and nearly 30,000 men die from the disease annually.

Xofigo is co-marketed in the US by Wayne, N.J.-based Bayer Pharmaceuticals and Algeta US of Cambridge, Mass.

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Agent Orange Tied to Lethal Prostate Cancer

Findings from U.S. veterans should raise awareness of chemical warfare's hazards, researcher says

By Robert Preidt

HealthDay Reporter

MONDAY, May 13 (HealthDay News) -- A link exists between exposure to Agent Orange and deadly forms of prostate cancer in U.S. veterans, according to a new study.

Agent Orange was a chemical spray that was heavily used during the Vietnam War era. It was often contaminated with dioxin, a potentially cancer-causing chemical. Previous research suggests that exposure to Agent Orange increases the risk of prostate cancer, but it wasn't known if it specifically increases the risk of more dangerous forms of the disease.

In this study, researchers looked at more than 2,700 U.S. veterans who underwent a prostate biopsy. Prostate cancer was diagnosed in 33 percent of the veterans, including 17 percent with high-grade disease, according to the study, which was published online May 13 in the journal Cancer.

Exposure to Agent Orange was linked with a 52 percent increase in overall prostate cancer risk, a 75 percent increased risk of high-grade prostate cancer and a more than doubled risk of the deadliest forms of the disease.

The findings suggest that determining veterans' exposure to Agent Orange can help identify those who may be at increased risk for prostate cancer, leading to earlier detection and treatment, said Dr. Mark Garzotto, of the Portland Veterans Administration Medical Center and Oregon Health & Science University, and colleagues.

"It also should raise awareness about potential harms of chemical contaminants in biologic agents used in warfare and the risks associated with waste handling and other chemical processes that generate dioxin or dioxin-related compounds," Garzotto said in a journal news release.

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Blood Thinners May Boost Survival for Prostate Cancer Patients: Study

Title: Blood Thinners May Boost Survival for Prostate Cancer Patients: Study
Category: Health News
Created: 2/21/2013 2:36:00 PM
Last Editorial Review: 2/22/2013 12:00:00 AM

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Side Effects of Prostate Cancer Treatments Similar in Long Run: Study

By Carina Storrs

HealthDay Reporter

WEDNESDAY, Jan. 30 (HealthDay News) -- For men with prostate cancer who are trying to decide between surgery or radiation therapy, new research shows that declines in sexual, urinary and bowel function do differ with each treatment in the short-term, but those declines tend to even out in the long run.

The study included more than 1,600 men treated for early stage prostate cancer. Researchers asked them about their urinary, sexual and bowel health following either surgery to remove the prostate or radiation therapy.

Although the rates of health decline in these areas differed at two and five years after treatment, men reported similar declines regardless of their treatment after 15 years.

While men who underwent surgery experienced higher rates of urinary incontinence and erectile dysfunction two and five years later, men who received radiation therapy had higher rates of bowel urgency, or feeling like they had to pass stool but not being able to do so.

The study was published in the Jan. 31 issue of the New England Journal of Medicine.

"Our hope was that measuring patient-reported outcomes at a 15-year time point would provide patients and their physicians with a realistic picture of the prostate cancer survivorship experience," said study author Dr. Matthew Resnick, an instructor of urologic surgery at Vanderbilt University Medical Center in Nashville, Tenn.

Urinary, sexual and bowel problems are among the most common side effects of treatment for prostate cancer, Resnick added. Declines are probably due to a combination of the treatment and aging in general, and the side effects even out after 15 years.

However, the shorter-term differences could be enough to steer some men toward one treatment or the other.

"There isn't a one-size-fits-all approach. Different men feel differently about the possibility of benefits and risks of treatment," Resnick said. For example, men who were already experiencing urinary incontinence might want to choose a treatment like radiation therapy because it was associated with lower rates of urinary problems in the short-term.

Surgery to remove the entire prostate, called radical prostatectomy, and radiation therapy are both recommended treatments for low- and medium-risk prostate cancer, according to the National Comprehensive Cancer Network guidelines.

However, these guidelines state that, for men with low-risk prostate cancer, watchful waiting -- closely monitoring the disease and treating it only if it changes -- is the best option.

It remains to be seen how men who opt for watchful waiting will fare in terms of their urinary, sexual and bowel health, especially in the long-term, Resnick noted.

Previous research has found doing watchful waiting for one year after diagnosis was associated with lower rates of urinary incontinence and sexual dysfunction, but higher rates of urinary blockage seven years later, compared to men who were treated immediately.

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