That news comes from Dendreon, the company that makes Provenge.

“We believe this is truly a breakthrough for the prostate cancer community and a testament to the promise of the field of cancer immunotherapies,” Dendreon’s president and chief executive officer Mitchell Gold, MD, said in a conference call today.

Provenge is a biologic drug given by infusion to spur the immune system to fight advanced prostate cancer that doesn’t respond to anti-androgen treatment.

In 2007, an FDA advisory panel recommended that the FDA approve Provenge. But instead, the FDA requested more information about whether Provenge prolongs survival.

That request led to a new study of 512 men with advanced prostate cancer. Those men had metastatic, androgen-independent prostate cancer, meaning their cancer had spread and wasn’t responding to anti-androgen treatment.

In that study, overall survival was significantly better for men taking Provenge than those taking a placebo.

The study’s results were “unambiguous” and “very consistent” with previous Provenge trials, Gold says.

Dendreon plans to submit the study’s results to the FDA in the fourth quarter of 2009; after that, the FDA will have six months to review the material, Gold says.

“This data supports Provenge being used as front-line treatment in men with metastatic, androgen-independent prostate cancer,” says Gold, who notes that no new side effects from Provenge stood out in the study. In previous trials, the most common side effects in men taking Provenge were chills, fever, headache, fatigue, shortness of breath, vomiting, and tremor, mainly at a low level and for one to two days following infusion.

Gold says that those men would first have surgery or some form of local therapy, then anti-androgen therapy if their cancer recurred, and if their PSA levels rose after that, “Provenge would come into play as a potential treatment option for them.”

In men with prostate cancer, PSA (prostate-specific androgen) levels are used to gauge the success of prostate cancer treatment.

Dendreon isn’t releasing any further details of the study until April 28, when the findings will be presented at the American Urological Association’s annual meeting in Chicago.

The technology used to make Provenge may also prove useful against other forms of cancer, Gold says.

Prostate Cancer Vaccine Meets Goal

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Other than skin cancer, prostate cancer is the most commonly diagnosed cancer in U.S. men. In 2008 there were expected to be more than 186,000 new diagnoses of prostate cancer and more than 28,000 deaths from the disease. Previous studies suggested the risk of developing prostate cancer was reduced among men receiving selenium supplements or vitamin E supplements.

To further explore the relationship between selenium and vitamin E supplementation and prostate cancer risk, researchers conducted two large randomized trials.

The first trial, known as SELECT (the Selenium and Vitamin E Cancer Prevention Trial), enrolled more than 35,000 men from the United States, Canada, and Puerto Rico. Eligible participants were African American men age 50 or older and other males aged 55 or older. At the start of the study (2001-2004), all the men had normal prostate-specific antigen (PSA) levels and a normal digital rectal examination.

Study participants were assigned to one of four groups:

1. Selenium supplementation
2. Vitamin E supplementation
3. Selenium and vitamin E supplementation
4. Placebo

Study participants have now been followed for over five years, and men in the selenium and/or vitamin E groups do not have lower rates of prostate cancer than men in the placebo group. The hazard ratios (HRs) were as follows:

1. Selenium: 1.04
2. Vitamin E:1.13
3. Selenium and Vitamin E:1.05
4. Placebo:1.00

The second trial, the Physicians’ Health Study II (PHS II), enrolled more than 14,000 U.S. male physicians 50 years of age or older. These data were also presented at the American Association for Cancer Research’s Seventh Annual International Conference in Washington, D.C. on November 16, 2008. This trial assessed vitamin E and vitamin C supplementation, as well as supplementation with a multivitamin and beta-carotene. The current analysis focuses on the vitamin E and vitamin C results.

Study participants in PHS II have now been followed for an average of eight years, during which 1,008 prostate cancers were detected. Almost 2,000 total cancers were detected during the study period. Neither vitamin E nor vitamin C influenced the risk of prostate cancer. The incidences of prostate cancer for the various groups were observed:

1. Placebo: 17.8 cases per 1,000 person years
2. Vitamin E:17.3 cases per 1,000 person years
3. Vitamin C:17.6 cases per 1,000 person years

These authors also reported that vitamin C and vitamin E had no effect on colorectal, lung, or other cancers.

Comments: These results confirm other studies suggesting that vitamin E does not prevent cancer. (In fact, some studies have suggested harm from vitamin E supplementation). The SELECT trial is the first to document the ineffectiveness of selenium in preventing prostate cancer. The Physicians’ Health Study II is the first to document the ineffectiveness of vitamin E and C in preventing prostate cancer. These data are at odds with studies showing that lower serum levels of vitamin E and selenium are associated with an increased risk for some cancers. One possible explanation is that artificial supplementation is not as effective as consuming antioxidants in food.

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The addition of radiotherapy kept patients healthy much longer, the Swedish research team concluded. In fact, by adding radiotherapy, men’s overall survival was increased by 10 percent with only a modest increase in the risk of radiation-related side effects.

“The study will change practice in the treatment of locally advanced or local aggressive prostate cancer,” said lead researcher Dr. Anders Widmark, from the department of radiation sciences and oncology at Ume&#229 University. “These patients should be offered the addition of local radiation treatment.”

At least one American expert agreed. “This study just proves what we have suspected for a long time — namely, that both treatments are needed to get the best results,” said Dr. Anthony D’Amico, chief of radiation oncology at Brigham and Women’s Hospital in Boston.

The report is published in the Dec. 16 online edition of The Lancet.

In this trial, 875 men with locally advanced prostate cancer were randomly assigned to receive either the drug flutamide (Eulexin), to block androgens (male hormones), or hormone therapy along with radiation. Androgens are thought to encourage the spread of prostate cancer, so blocking their effect is a common prostate cancer treatment.

Over an average follow-up of almost eight years, 79 men who received hormone treatment alone died, compared with 37 men who received hormone treatment plus radiation, Widmark’s group found.

After 10 years, 23.9 percent of the men in the hormone therapy-only group had died from prostate cancer compared with 11.9 percent of the men in the combined treatment group. In addition, death from any cause was higher in the hormone therapy-only group, (39.4 percent) than in the combined treatment group (29.6 percent), the researchers found.

Moreover, fewer men in the combined treatment group saw a return of their cancer (26 percent) than did men in the hormone-only group (75 percent).

The addition of local treatment with radiotherapy improves survival, Widmark concluded. “These patients are highly curable — only 10 percent will die of prostate cancer within 10 years,” he said. “They should not give up.”

Dr. Chris Parker, from the Institute of Cancer Research in Sutton, Surrey, UK, and author of an accompanying editorial in the journal, said that combined radiation and hormone therapy should become standard treatment for men with locally advanced prostate cancer.

“This is a pivotal trial that for the first time demonstrates that radiotherapy improves survival of men with high-risk localized and locally advanced prostate cancer,” Parker said. “It is no longer acceptable to regard hormone therapy alone as standard of care.”

D’Amico agreed, noting that most U.S. doctors already provide combo therapy as standard treatment for men with locally advanced prostate cancer.

“Combined treatment with radiation and hormonal therapy is necessary to get the best overall survival in men with locally advanced prostate cancer,” he said. “The study nails that home.”

US News and World Report

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In findings that were released early because of the public health implications, the results of two large randomized, controlled clinical trials showed the supplements failed to provide a cancer-prevention benefit, despite past findings that seemed to indicate great promise — particularly for selenium. Both studies were expected to be published in the Jan. 7 print issue of the Journal of the American Medical Association.
“Our results showed no evidence of benefit from selenium and vitamin E on prostate cancer and other cancers,” said the lead author of one of the studies, Dr. Scott Lippman, a professor of medicine in the division of cancer medicine at M.D. Anderson Cancer Center, in Houston.

Lippman’s study, known as the SELECT trial, included more than 35,000 men. Black men included in the study were all over 50, and men from other races were all over 55. (Blacks have a higher risk of developing prostate cancer than do men of other races, according to the American Cancer Society.)

The men were randomly assigned to one of four groups: selenium; vitamin E; selenium and vitamin E; or a placebo. The average follow-up time was more than five years.

The researchers found no statistically significant difference between the groups, and the trial was ended early, because there was no convincing evidence of efficacy.

The second study, done by Harvard researchers, included almost 15,000 male physicians over 50 who were randomly assigned to receive vitamin E, vitamin C, or a placebo. The average follow-up time for this trial was eight years.

Again, no statistically significant benefits were found from either vitamin C or E when it came to preventing prostate and other cancers.

These studies are just the latest in a long list of recent research that’s been discounting the use of individual vitamins and supplements for chemoprevention. Other recent studies have suggested that vitamins, B, C, D, E, folic acid and calcium taken alone, or in various combinations, aren’t effective for cancer prevention.

“Single-agent interventions, even in combinations, may be an ineffective approach to primary prevention in average-risk populations,” wrote Dr. Peter Gann, the author of an accompanying editorial in the same issue of the journal.

Andrew Shao, vice president of scientific and regulatory affairs for the Center for Responsible Nutrition in Washington, D.C., said he thought researchers need to “redefine our expectations for nutrients. They’re not magic bullets, though they do have tangible effects.”

Shao said studies that look at vitamins and cancer prevention tend to treat vitamins the same way they would a targeted pharmaceutical agent. But, he said, “the whole body is affected by nutrients, while pharmaceuticals are highly specialized and targeted to specific cells.”

“It would be a mistake to look at one trial that answers a very specific question and say these nutrients don’t work at all,” said Shao.

Lippman, however, said he doesn’t recommend the use of supplements for cancer prevention. “There’s no evidence to support taking these,” he said.

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The findings indicate that a simple blood test may identify men at high risk for the most dangerous prostate tumors, and there already are drugs available that cut calcium levels in the bloodstream, the researchers said.

They tracked 2,814 men in a government health survey in which they gave blood samples that revealed calcium levels.

The men in the top third of blood calcium levels had 2.68 times the risk of developing fatal prostate cancer later in life compared to those in the bottom third, the study found.

"If serum calcium really does increase your risk for fatal prostate cancer, that’s wonderfully exciting because serum calcium levels can be changed," Gary Schwartz of Wake Forest University School of Medicine, who helped lead the study, said in a telephone interview.

"One way to think of it is to think of the tremendous advances in the control of cardiovascular disease that occur from understanding that things like serum cholesterol predict heart attack," Schwartz added.

Doctors have struggled to find ways to predict if a man who gets prostate cancer will have a tumor that poses little danger, as is often the case, or one that is a killer.

Blood calcium was not very predictive of whether a man would get nonlethal prostate cancer, but was highly predictive of whether a man would get a fatal case, the researchers wrote in the American Association for Cancer Research’s journal Cancer Epidemiology, Biomarkers & Prevention.

The blood samples on average were given a decade before the cancer appeared, the researchers said.

A common cancer

Prostate cancer is the second most commonly diagnosed form of cancer in men worldwide, with about 780,000 men diagnosed per year, and the sixth mostly deadly form in men, with about 250,000 deaths per year, the American Cancer Society said.

Schwartz said it is unclear whether it is the actual calcium or blood levels of parathyroid hormone, which is supposed to keep calcium levels at normal levels in the bloodstream, that is raising the risk.

Either way, he said there are drugs that can lower them, including Fontus Pharmaceuticals Inc’s Rocaltrol, also called calcitriol; Genzyme Corp’s Hectorol (doxercalciferol); Abbott Laboratories’ Zemplar (paricalcitol); and Amgen Inc’s Sensipar (cinacalcet).

People treated for high blood calcium usually have chronic kidney disease, which is associated with low vitamin D levels. Low vitamin D levels elevate parathyroid hormone levels, Schwartz said.

Halcyon Skinner of the University of Wisconsin, who also worked on the study, said there is little relationship between calcium in the diet and blood calcium levels, so these men would not benefit from eating less food rich in calcium.

Previous research had suggested a role for calcium in prostate cancer. In laboratory studies, parathyroid hormone and calcium promote the growth of prostate cancer cells.

Blood calcium tied to lethal prostate cancer – Cancer- msnbc.com

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"The risk of second cancer after irradiation, although probably small, needs nevertheless to be carefully monitored," the study team advises.

Dr. Christine Bouchardy from the University of Geneva, Switzerland and colleagues analyzed data on 1,134 men diagnosed with prostate cancer between 1980 and 1998 who survived for at least 5 years after diagnosis. Of these, 264 were treated with external radiation.

During follow-up through the end of 2003, 19 men out of the total group developed colorectal cancer.

The risk of colorectal cancer among the men who did not have radiation therapy was not increased compared to the general population, but it was 3.4-times higher than normal among the men who did have radiation, the team reports in the International Journal of Cancer.

On further analysis, the risk was significantly increased for colon cancer specifically but not for rectal cancer.

The risk of colon cancer was mainly elevated in the 5- to 9-year period after diagnosis, according to Bouchardy and colleagues.

They say "this serious long-term side effect should be discussed" with patients in weighing the pros and cons of radiation therapy for treating prostate cancer.

SOURCE: International Journal of Cancer, September 1, 2008.

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This study, led by researchers at that National Cancer Institute (NCI), part of the National Institutes of Health, was published in the August 15, 2008, issue of Clinical Cancer Research.

The vaccine used in this study is designed to stimulate an immune response against prostate-specific antigen (PSA), a protein produced by the prostate that is often found at elevated levels in the blood of men who have prostate cancer and some non-cancerous prostate conditions. In the study, researchers examined the side effects and immune responses of patients treated with a three-pronged approach: the vaccine, radiation therapy, and an alternative dosing regimen of an immune system booster, interleukin-2 (IL-2). The patients all had localized prostate cancer, had not undergone surgery to remove the prostate, and were candidates for radiation therapy as their primary form of treatment.

"Developing an alternative method of administering vaccine therapy that is well tolerated by most patients and produces similar immune responses to standard methods may help further the development of vaccine therapies for prostate cancer," said James L. Gulley, M.D., Ph.D., of NCI’s Center for Cancer Research.

Therapeutic cancer vaccines are designed to treat cancer by stimulating the immune system to attack tumor cells without harming normal cells. Several proteins, including PSA, are overexpressed, or produced in excess amounts, by cancer cells and have shown potential to serve as triggers in initiating immune responses. These findings have led to the development of cancer vaccines that target these proteins. The proteins are also known as tumor-associated antigens. To heighten the body’s natural defenses, immune system boosters, such as IL-2, are often given with the vaccines. IL-2 administration, however, is frequently associated with substantial side effects, including fatigue and high blood sugar.

In a previous study involving the same prostate cancer vaccine, IL-2 was given to 19 patients daily for five days during each 28-day vaccine treatment cycle, and a large majority of the patients had to have the dose of IL-2 reduced or discontinued, primarily because of fatigue.

In this new study, the researchers sought to decrease the side effects associated with IL-2. To do this, the team treated 18 patients with the vaccine and radiation therapy, but with lower doses of IL-2 given over a longer period of time. The patients received the same total amount of IL-2 as in the previous study, but it was administered in smaller daily doses for 14 days of each 28-day treatment cycle.

With metronomic dosing, less than a quarter of the patients had side effects that required their dose of IL-2 to be reduced.

The research team also found that metronomic dosing of IL-2 produced effects on immune cell populations and immune responses that were similar to those observed previously with the standard dosing method. Five of eight evaluated patients had at least a three-fold increase in immune cells that were directed against PSA. The researchers also noted that, similar to the standard dosing method, metronomic dosing of IL-2 induced immune responses against other prostate cancer antigens in some patients.

"Based on safety and feasibility, metronomic dosing appears to be superior to standard dosing and administration," said Gulley. "More research is needed to evaluate the efficacy of this dosing method in treating prostate cancer."

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