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FDA: Prostate Cancer Risk From BPH, Hair Loss Drugs

June 9, 2011 -- The prostate drugs Proscar, Avodart, and Jalyn and the hair-loss drug Propecia add to the risk of high-grade prostate cancer, the FDA warns.

All of the drugs must change their labels to warn of the risk, which unexpectedly appeared in two different large-scale clinical trials.

Ironically, Proscar and Avodart appear to reduce the risk of low-grade prostate cancer, which is less aggressive than high-grade prostate cancer. But the increased risk of high-grade prostate cancer means the drugs can't claim to lower overall prostate cancer risk.?

The FDA ruling follows the December 2010 vote of an FDA advisory panel, which rejected requests from Merck (for Proscar) and GlaxoSmithKline (for Avodart) to claim that the drugs prevent prostate cancer.

The male hair-loss drug Propecia has the same active ingredient as Proscar, although at one-fifth the dose. But the FDA says Propecia should carry the same prostate cancer warning as Proscar.

Even though the drugs are linked to prostate cancer, the risk is small. Men who are taking Proscar, Avodart, or Jalyn for benign prostatic hyperplasia (BPH) should not stop taking their medications, but should consult their doctors about their prostate cancer risk.

Proscar, Avodart, and Propecia are in the same class of drugs, known as 5-alpha-reductase inhibitors or 5-ARIs. Jalyn has the same active ingredient as Avodart, together with a drug called tamsulosin (Flomax). The FDA warning does not include Flomax, which is in a different class of prostate drugs called alpha blockers.

Other alpha blockers include Cardura, Hytrin, Uroxatral, and Rapaflow. Unlike the 5-ARI drugs, the alpha blockers are effective in treating the symptoms of BPH but have not been shown to reduce the risk of urinary retention due to an enlarged prostate.

Minoxidil is an alternative over-the-counter drug used to treat male pattern baldness.

Do you know all you need to know about prostate enlargement/BPH and Prostatisis? Get the health information you need to manage your health from your trusted health source.

日期:2011年6月10日 - 来自[Health News]栏目
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Prostate Cancer Drug Zytiga May Extend Life

May 25, 2011 -- The newly approved prostate cancer pill Zytiga (abiraterone acetate) may extend life by up to four months in men with spreading cancer who have already been treated with chemotherapy, a study shows.

This survival gain "means quite a bit," says study researcher Howard I. Scher, MD, chief of the genitourinary oncology service at Memorial Sloan-Kettering Cancer Center in New York City. "These are a group of patients for whom there is no standard of care and it is particularly gratifying to see these results, to say the least."

The new study is published in the New England Journal of Medicine.

Prostate cancer is the most common cancer diagnosed in men besides skin cancer, according to the American Cancer Society. One out of every six men will be diagnosed with prostate cancer during his lifetime.

The new drug, which was approved by the FDA in April, inhibits a protein that helps form male hormones. The findings may help reshape the way doctors view and treat advanced prostate cancer.

The new study included 1,195 men with metastatic prostate cancer whose disease had progressed after chemotherapy. Those men who received steroid therapy along with the new pill survived for 14.8 months, on average, compared with 10.9 months seen among those who received a placebo along with steroids. This translated into a 34% reduction in risk of dying, the study shows.

This survival edge was considered so significant that men who received the placebo were permitted to switch to the new drug before the study was completed.

Men who took the new pill also saw greater responses in levels of prostate-specific antigen (PSA) than men who received placebo. Elevated levels of PSA may be a marker for prostate cancer.

The men who took Zytiga also showed improvements in disease-related symptoms and prostate cancer progression on imaging tests compared with men who received the placebo.

Zytiga side effects included fluid retention, high blood pressure, and a drop in blood potassium levels.

日期:2011年5月26日 - 来自[Health News]栏目

Brisk Walking May Help Keep Prostate Cancer in Check

May 24, 2011 -- Brisk walking may help men diagnosed with early-stage prostate cancer reduce their risk of progression of the disease, according to a new study.

Researchers at the University of California, San Francisco and the Harvard School of Public Health followed 1,455 men who had been diagnosed with early-stage prostate cancer.

The study shows that survivors who walk at a pace of at least 3 miles per hour for three hours or more per week were 57% less likely to develop the biochemical markers of cancer recurrence or to need a second round of treatment for their disease.

"The important point was the intensity of the activity," Erin Richman, ScD, a post-doctoral fellow at University of California, San Francisco, says in a news release. "The walking had to be brisk for men to experience a benefit."

She says the results of the study suggest a way for men who have prostate cancer to do something to improve their prognosis and stay well.

The study is published in the June 1 edition of Cancer Research.

Another study published earlier this year by June Chan, ScD, of University of California, San Francisco, along with researchers at Harvard, also showed that physical activity after diagnosis seemed to reduce disease-related death in a distinct group of men with prostate cancer.

The new study supports that finding and was the first to focus on the effect of exercise after diagnosis on early indications of progression of the disease, such as a rise in prostate-specific antigen (PSA) blood levels.

"Our work suggests that vigorous physical activity or brisk walking can have a benefit at the earlier stages of the disease," says Chan in the news release.

The participants in the study were a subset of a larger group of 14,000 men with prostate cancer enrolled in a long-term, nationwide prostate cancer registry project, known as the Cancer of the Prostate Strategic Urologic Research Endeavor. It's led by Peter Carroll, MD, MPH, chair of the urology department at University of California, San Francisco and one of the study's authors.

Benefits of Physical Activity

The researchers also report that the benefit of physical activity in their study was independent of the participants' age at diagnosis, type of treatment, and clinical features of their disease when first detected.

Chan says she would recommend walking for all men with prostate cancer, but stresses the walking must be brisk and not leisurely.

"Our results suggest that it is important to engage in exercise that gets your heart rate up a bit," she says.

The 1,455 men observed by the researchers had been diagnosed with prostate cancer that had not spread beyond the prostate gland. They reported their physical activity by questionnaire about 27 months after their original diagnosis and before evidence suggested the cancer had recurred or that there may be a need for additional treatment.

日期:2011年5月25日 - 来自[Health News]栏目
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Coffee May Lower Prostate Cancer Risk

May 17, 2011 -- Men who drink coffee regularly appear to lower their risk of prostate cancer, especially the lethal form, new research suggests.

When the researchers looked at all forms of prostate cancer, ''the highest coffee drinkers had about a 20% lower risk of developing prostate cancer during the follow-up," says researcher Lorelei Mucci, ScD, MPH, associate professor of epidemiology at the Harvard School of Public Health.

The 20% lower risk was found in those drinking six or more cups daily compared to none, she tells WebMD.

Coffee protected even more against the most lethal form of prostate cancer. Among those drinking one to three cups a day, the risk of lethal prostate cancer declined 29%, compared to that of nondrinkers. Among those drinking six or more cups daily, the risk for deadly prostate cancer was reduced 60% compared to that of nondrinkers.

The surprise: the risk reduction held for both regular coffee and decaf, leading the researchers to speculate it's not the caffeine providing the protection.

The study is published online in the Journal of the National Cancer Institute.

Other research has found coffee can lower the risk of Parkinson's disease, type 2 diabetes, gallstones, and liver cancer.

About 217,730 new cases of prostate cancer were diagnosed in 2010, according to the American Cancer Society. About 32,000 men died of the disease in 2010.

Checking for Health Benefits of Coffee

Mucci and her colleagues tracked more 47,911 men who participated in the Health Professionals Follow-up Study. The men reported their intake of coffee, both regular and decaf, in 1986, and every four years after that.

From 1986 to 2006, 5,035 men developed prostate cancer. This included 642 with lethal forms of the cancer. Lethal forms were either fatal or were cancers that spread.

The researchers evaluated whether there was a coffee and prostate cancer link. They found it held after accounting for such factors as obesity and smoking.

"We're not exactly sure what the mechanism is," Mucci says. It could be the antioxidants in coffee.

Or it could be substances that reduce inflammation, which has also been linked with higher prostate cancer risk.

It might be compounds that help regulate insulin, she tells WebMD. Higher insulin levels have been linked to higher risk of prostate cancer, she says.

"I think it's probably too early to tell men to start drinking coffee to lower their risks of lethal prostate cancer," she tells WebMD.

However, she adds, it's probably good news for men who already enjoy a cup or more.

More Studies Needed

The study evaluates participants from a long-running, well-regarded study, says Mark Kawachi, MD, director of the Prostate Cancer Center at the City of Hope Comprehensive Cancer Center, Duarte, Calif.

He reviewed the study findings for WebMD. ''Coffee is a very complex beverage, in that there are so many known and unknown chemicals in coffee," he says.

For those advised not to drink caffeinated coffee for other health reasons, he says, the study still holds some good news. "Some of the concerns about drinking so much coffee may be mitigated by the fact they found decaf had the same benefits."

The findings, he tells WebMD, need to be validated in another, independent study.

Likewise, Eric Jacobs, PhD, of the American Cancer Society urged caution in interpreting the findings. "This is a large, well-designed study," he tells WebMD, ''but it is the only study to show a link between coffee consumption and lower risk of fatal prostate cancer."? More research is needed to duplicate the finding, he says.

Smoking and being obese are linked with a higher risk of fatal prostate cancer, he says.? "So it is fine to enjoy a nice cup of coffee, but avoiding smoking and maintaining a healthy weight are among the surest ways to stay healthy."

Are you getting all the information you need to manage your prostate cancer? Get the health information you need from WebMD, your trusted health source.

日期:2011年5月18日 - 来自[Health News]栏目

Prostate Cancer: Early Surgery or Watchful Waiting?

May 4, 2011 -- Fifteen-year results from a Swedish study show that early prostate surgery cuts deaths in under-65 men with "low-risk" prostate tumors -- but for today's men, the definition of "low risk" has changed.

The study of 695 men with early prostate cancer assigned half the men to immediate surgery -- prostatectomy -- and half to watchful waiting. The first results, reported in 2002, showed that early surgery improved survival.

In watchful waiting, patients are not treated but monitored closely to see if there is any progression of the disease.

Now, 15 years after the study began, it's clear that men who underwent early surgery cut their risk of death from prostate cancer by 38%.

However, only men under age 65 saw this benefit. Early surgery did not significantly improve survival in men diagnosed with prostate cancer after age 65, notes Anna Bill-Axelson, MD, PhD, lead author of the report in the May 5 issue of the New England Journal of Medicine.

"What we see is that surgery reduces prostate cancer deaths, but that not all patients need to undergo surgery," Bill-Axelson tells WebMD. "It depends on age, on the presence of other medical conditions, on patient preference, and on how the tumor looks. You cannot generalize and say everybody needs to undergo surgery."

The study showed that:

  • Overall, 15 men had to undergo prostate surgery to save one death from prostate cancer. For men under age 65, seven had to be treated to prevent one prostate cancer death.
  • Men whose tumors had broken through the prostate capsule had a much higher risk of death than did those with tumors that remained inside the capsule.
  • 63% of the men assigned to watchful waiting and 40% of the men assigned to prostatectomy needed androgen-deprivation therapy, which has serious side effects that include sexual dysfunction, fatigue, and risk factors for diabetes and heart disease.
  • More men in the watchful waiting group than in the prostate surgery group died from causes other than prostate cancer but with spreading prostate cancer that would likely have been fatal.

?

Prostatectomy for Low-Risk Prostate Cancer?

Possibly the most important study finding is that among these younger men, surgery improved survival even in those with prostate tumors considered to be low risk -- by the standards of the decade 1989-1999.

"When we say the low-risk group benefits from surgery, it is not as we would define a low-risk group by today's standards," Bill-Axelson says. "It is important that people don't panic and all go for surgery. It is important to have people closely watched and to undergo surgery when necessary."

There are degrees of "low risk" for prostate tumors, says prostate cancer expert Matthew R. Smith, MD, PhD, director of the genitourinary malignancies program at Massachusetts General Hospital. Smith's editorial accompanies the Bill-Axelson study in the New England Journal of Medicine.

日期:2011年5月5日 - 来自[Health News]栏目
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FDA Approves Prostate Cancer Drug

April 28, 2011 -- The FDA has approved the Johnson & Johnson pill Zytiga for use in combination with the steroid prednisone to treat a certain type of late-stage prostate cancer in men who have already been treated with chemotherapy.

The medication is to be used to treat patients with metastatic, castration-resistant prostate cancer.

In men with prostate cancer, ?the male sex hormone testosterone stimulates the tumor to grow.

The FDA says in a statement that drugs or surgery are used to reduce testosterone production or block the effects of testosterone, but that prostate cancer sometimes continues to grow, even when testosterone levels are low. Men with such cancers are said to have castration-resistant prostate cancer.

What Zytiga Does

Zytiga (abiraterone acetate) targets a protein called CYP17A1, which the FDA says plays a key role in the production of testosterone.

The agency says the drug works by decreasing the production of testosterone that stimulates cancer cells to keep growing.

The application for approval of the pill, made by the Johnson & Johnson unit Centocor Ortho Biotech, was considered under the FDA’s priority review process. The FDA says that process provides for an expedited six-month review for drugs that are believed to offer major advances in treatment or which provide a treatment when no adequate therapy exists.

Zytiga Prolongs Life

“Zytiga prolonged the lives of men with late-stage prostate cancer who had received prior treatments and had few available therapeutic options,” Richard Pazdur, MD, director of the FDA’s Office of Oncology Drug Products, says in the agency’s news release.

The FDA says the drug’s safety and effectiveness were established in a clinical study involving 1,195 patients with late-stage castration-resistant prostate cancer who had received treatment with docetaxel chemotherapy.

Patients in the study received either Zytiga once daily in combination with prednisone two times per day, or a placebo twice daily in combination with prednisone.

Patients who received the Zytiga and prednisone combo had a median overall survival of 14.8 months, compared to 10.9 months for those in the group taking the placebo-prednisone combination.

Side Effects

Commonly reported side effects of Zytiga included joint swelling or discomfort, low levels of potassium in the blood, fluid retention, usually in the legs and feet, muscle discomfort, hot flashes, diarrhea, and urinary tract infection.

Other side effects included cough, high blood pressure, heartbeat disorders, urinary frequency, increased nighttime urination, upset stomach or indigestion, and upper respiratory tract infection.

Centocor, based in Horsham, Pa., says in a statement that the FDA’s approval of Zytiga represents a step forward in the treatment of metastatic prostate cancer.

“As a clinician, I believe the efficacy and safety profile of abiraterone acetate, as well as its oral, once-daily formulation, will help address the important need for additional therapeutic choices for men living with this serious disease,” Howard Scher, MD, of Memorial Sloan-Kettering Cancer Center in New York, says in the company’s news release.

日期:2011年4月30日 - 来自[Health News]栏目

New Doubts on Value of Prostate Cancer Screening

March 31, 2011 -- A study from Sweden raises new questions about the value of screening average-risk men for prostate cancer.

In the study, screening did not significantly reduce prostate cancer deaths over two decades of follow-up, but it did result in the detection of more cases of the cancer and more treatment.

The study is not as large as several other recent trials suggesting that routine screening leads to the over-detection and overtreatment of prostate cancer, but it is the longest.

Starting in 1987, some study participants received routine screening for prostate cancer while others did not. Twenty years later, the two groups had similar prostate cancer death rates.

“We found no survival advantage for screening, but this may have been influenced by the fact that the screening test we used when the trial started is not as sensitive as the tests we use today,” study researcher Gabriel Sandblom, MD, of Stockholm’s Karolinska Institute, tells WebMD.

PSA Screening Debate

The men in the screening study group did not receive prostate specific antigen (PSA) blood testing until their third or fourth screenings.

PSA is now the screening method of choice, but it remains controversial.

The American Cancer Society stopped recommending routine PSA screening more than a decade ago. Last year the group came out even more strongly against routine testing, stating that men should not be screened without first discussing the risks and limitations of screening with their doctors.

Two major studies published in 2009, one from the U.S. and another from Europe, added to the concerns about the PSA screening.

The U.S. trial, supported by the National Cancer Institute, failed to show a reduction in prostate cancer deaths associated with PSA screening over an average of seven years of follow-up.

The European study showed a modest reduction in prostate cancer deaths associated with screening, but the researchers concluded that an estimated 1,400 men would have to be screened and 48 men would have to be treated to prevent one death from prostate cancer.

A separate analysis involving Swedish participants in the European trial lowered that number to 293 men screened and 12 men treated to prevent one death.

“The 48 number is probably an overestimate and it is not clear if the 12 is an underestimate,” ACS Director of Prostate and Colorectal Cancers Durado Brooks, MD, MPH, tells WebMD. “What we can say is that there is significant over-diagnosis and overtreatment associated with screening.”

Prostate cancer is most often treated with surgery and radiation, which can result in erectile dysfunction and bladder and bowel incontinence.

Screening for Prostate Cancer

The newly published study included close to 1,500 Swedish men randomly selected for prostate cancer screening every three years from 1987 to 1999 and about 7,500 men who were not screened.

日期:2011年4月1日 - 来自[Health News]栏目
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No-Scalpel Treatment for Enlarged Prostate

March 29, 2011 -- A minimally invasive procedure that cuts off the blood supply to an enlarged prostate may help when medications fail, and it appears to provide good symptom control without sexual dysfunction, a new study shows.

The procedure involves using a tiny catheter that is threaded through arteries near the groin to reach the vessels that supply the prostate with blood. These vessels are then blocked with particles the size of a grain of sand.

A similar procedure is sometimes used to treat another kind of benign growth, uterine fibroids, in women.

“It was my inspiration -- uterine fibroids. It’s the same kind of growth,” says study researcher Joao Martins Pisco, MD, chief radiologist at Hospital Pulido Valente and director of interventional radiology at St. Louis Hospital, both in Lisbon, Portugal. “The results are excellent.”

In a small pilot study, most men were able to leave the hospital four to eight hours after the procedure, which is called prostatic artery embolization (PAE), researchers report.

PAE reduced the symptoms of frequency and urgency of urination without causing side effects like incontinence, sexual dysfunction, retrograde ejaculation (ejaculation into the bladder), or bleeding.

Despite the promising results of this small trial, experts said it was far too early to recommend PAE to patients.

“There are a lot of questions. We really don’t know what the short- and long-term success or complication rates are,” says Anthony Malizia Jr., MD, president and director of the Malizia Clinic, a nonprofit urology specialty center in Atlanta. “We don’t know how well these particles are localized to the prostate or if they’re going to the pelvis or other parts of the body.”

Malizia notes that in one serious complication reported in the study, the particles appeared to migrate and kill a small part of the bladder wall. The authors report that the dead tissue required surgical removal.

The study was presented at the Society of Interventional Radiology annual meeting in Chicago.

日期:2011年3月30日 - 来自[Health News]栏目
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