Tag Archive | "prostate cancer treatment"

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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Brisk Walking Slows Down Prostate Cancer Progression

A recent study at the University of California, San Francisco (UCSF) and the Harvard School of Public Health found that an association between brisk walking and lowered risk of prostate cancer progression in a study of 1,455 men in the U.S. diagnosed with early-stage prostate cancer.

The research team found that men who walked briskly at least at three miles per hour for at least three hours each week after diagnosis were about sixty percent less likely to develop biochemical markers of cancer recurrence or less likely to need a second round of prostate cancer treatment.  The study was published in the journal Cancer Research.

This new finding complements an earlier study published by UCSF’s June Chan, ScD, and collaborators at the Harvard School of Public Health showing that physical activity after diagnosis could reduce disease-related mortality in a distinct population of men with prostate cancer.  The recent study by Erin Richman, ScD, a postdoctoral fellow at UCSF is the first to focus on the effect of physical activity after diagnosis on early indications of disease progression, such as rise in prostate-specific antigen (PSA) blood levels.

An advantage of this study is the focus on early recurrence of prostate cancer, which occurs before men may experience painful symptoms of prostate cancer metastases, a frequent cause for men to decrease their usual physical activity. Additionally, the researchers reported that the benefit of physical activity was independent of the participants’ age at diagnosis, type of treatment and clinical features.  This work was funded by the Department of Defense, the Prostate Cancer Foundation, Abbott Labs, and through a National Institutes of Health training grant.

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Prostate Cancer Treatment Diligence Decreases with Age

As men age, their risk of prostate cancer increases; however, a recent U.S. study suggests that prostate cancer care declines as age increases.

The study shows that men with prostate cancer over 75 often receive less effective treatment than younger men with prostate cancer.

“It seems men in this age group are often undertreated, and that in turn may contribute to the higher mortality from prostate cancer among older men,” said Dr. Matthew Cooperberg of the University of California, San Francisco, who led the research.

Nearly 160 out of 100,000 men in the U.S. develop prostate cancer every year. And the cancer kills about one-sixth of them.

Cooperberg’s study involved data from 40 urology practices across the United States. The levels of care for nearly 12,000 patients with prostate cancer were reviewed.

The researchers found that 60 percent of those aged 75 and over received only hormone treatment for high-risk tumors. The significance of this finding is that sole hormone treatment is not considered a cure or to be an aggressive treatment of prostate cancer. Further, eight percent of those patients studied were followed by their doctors with no active treatment.

In comparison, only 18 to 26 percent of younger patients were given hormone treatment. Watchful waiting was practiced in a mere one percent of them.

“If you look at the national practice pattern, there is no question that older men are treated very differently,” Cooperberg said. “Age is a stronger driver of treatment pattern than risk, and I think that’s troubling.”

Non-aggressive treatment, such as watchful waiting, is often effective in men with low-risk disease. “Treatment really should be guided by disease risk, not by patients’ chronologic age,” notes Cooperberg.
Traditionally, physicians and researchers associated old age with death rates from prostate cancer: the older the patient, the less likely he will survive the cancer. But when the researchers adjusted their calculations based on the kind of treatment people got, age was no longer the main indicator of risk of death.

Among 629 men aged 70 and older with high-risk cancer, about one in five died of prostate cancer within six years of diagnosis. Those who had local treatment, such as prostate cancer surgery or radiation, were 46 percent less likely to die from their cancer than those who had hormone therapy or were put on watchful waiting.

“Elderly men are becoming healthier and healthier,” said Dr. Bob Djavan, who heads the urology department at the New York University School of Medicine and was not involved in the new study.

“A guy who is 70 today may become 85, so why should I not offer him curative treatment?” he said, adding that what actually matters is cancer stage and life expectancy. “You need to live 10 to 15 years to see a survival benefit.”

“Today we shouldn’t think like we did 20 or 30 years ago: let’s operate on the young guys and drop the old guys,” said Djaven. “If you have a guy with high-risk disease, no matter how old he is he may benefit from surgery.”

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