The most commonly used tool for detecting prostate cancer, routine PSA screening, has become “a hugely expensive public health disaster,” its discoverer said on Wednesday.

Dr. Richard Ablin of the University of Arizona joined the ongoing debate over the blood test, saying the screening procedure is too costly and ineffective.

“I never dreamed that my discovery four decades ago would lead to such a profit-driven public health disaster,” Ablin wrote in a commentary for The New York Times.

Ablin said that as Congress searches for ways to cut costs in the U.S. health care system, a significant savings could come from changing the way PSA is used.

“The test’s popularity has led to a hugely expensive public health disaster,” he wrote.

He said the annual bill for PSA screening is at least $3 billion, with much of it paid for by Medicare and the Veterans Administration.

“As I’ve been trying to make clear for many years now, PSA testing can’t detect prostate cancer and, more important, it can’t distinguish between the two types of prostate cancer — the one that will kill you and the one that won’t,” he wrote.

“Instead, the test simply reveals how much of the prostate antigen a man has in his blood.”

Prostate cancer is the second most common cancer in men worldwide after lung cancer, killing 254,000 men a year.

PSA is a protein made only by prostate cells, and levels can shoot up as a prostate tumor proliferates. But levels can also rise as the prostate naturally enlarges with age.

A high PSA reading is usually followed by a biopsy, which is a sample of the prostate tissue taken and examined for signs of a tumor.

SLOWLY TURNING AGAINST

Doctors have routinely recommended PSA tests to men over 50 in the belief that early diagnosis and aggressive treatment for any cancer is better than standing by and doing nothing.

But prostate cancer can often be a slow-growing tumor and men will often die of something else before the cancer becomes dangerous.

Prostate cancer treatments, including surgery or radiation, can cause incontinence and erectile dysfunction in about a third of patients. Many men also experience bowel problems.

Citing recent studies and reversals of some early screening proponents, Ablin said the medical community is slowly turning against PSA screening.

“So why is it still used? Because drug companies continue peddling the tests and advocacy groups push ‘prostate cancer awareness’ by encouraging men to get screened,” Ablin wrote.

Ablin said PSA testing does have a place, after treatment for prostate cancer and for men with a family history of prostate cancer.

“Testing should absolutely not be deployed to screen the entire population of men over the age of 50, the outcome pushed by those who stand to profit,” Ablin wrote.

He urged the medical community to “confront reality and stop the inappropriate use of PSA screening.”

Source: Reuters

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New research suggests that the type of specialist a prostate cancer patient sees — rather than the patient’s own preference — may determine the treatment he receives.

This is problematic, the study’s authors say, because none of the options now available for treating localized prostate cancer have been shown to be any better than the others.

“The different treatments for prostate cancer…entail different side effects, different recovery profiles, and they require different time commitments,” Dr. Thomas L. Jang of The Cancer Institute of New Jersey in New Brunswick, one of the study’s authors, told Reuters Health. For this reason, he and his colleagues say, it should be the patient’s preferences — rather than the physician’s specialty — that guides treatment decisions.

Current options available for treating prostate cancer that has not spread include watchful waiting, in which a patient receives no treatment but is monitored closely; hormone therapy; radiation therapy; or surgery to remove the prostate. Radiation and surgery both carry the risk of urinary incontinence and impotence; hormone therapy can cause hot flashes, breast tenderness, and loss of sex drive; while watchful waiting may lead to anxiety in men who fear their cancer will spread.

Surveys have suggested that specialists are more likely to recommend the type of treatment they provide; for example, radiation oncologists prefer radiation therapy, while urologists choose surgery.

To investigate whether the type of physician a prostate cancer saw would actually influence the type of treatment he got, Jang and his team looked at Medicare data on more than 85,000 men 65 and older diagnosed between 1994 and 2002 with localized prostate cancer. Within nine months of diagnosis, 21 percent had undergone prostate removal; 42 percent had radiation; 17 percent had hormone therapy; and 20 percent watchful waiting. Jang conducted the study, which is published in the Archives of Internal Medicine, while at Memorial-Sloan Kettering Cancer Center in New York City.

Half of the men had only seen a urologist, while 44 percent had seen a radiation oncologist and a urologist, 3 percent had seen a urologist and a medical oncologist, and 3 percent had seen all three specialists.

One-third of the men who had only seen a urologist underwent prostate surgery, and surgery was the most common treatment for the men who were 65 to 74 years old and only saw a urologist. However, among men of any age who saw a radiation oncologist as well as a urologist, radiation therapy was the most common treatment; 83 percent of these men received radiation therapy.

And men who had been seen by a urologist and a medical oncologist, or a urologist only, were more likely to receive watchful waiting or hormone therapy than men who had seen both urologists and radiation oncologists.

Only about one in five men saw their primary care physician after their diagnosis of prostate cancer and before they received treatment (or within nine months of diagnosis). Nearly 60 percent of these men received watchful waiting, compared to 7 percent of men who hadn’t seen their primary care doctor.

When the researchers looked at individual urologists who had cared for at least 10 of the study participants, they found sharp doctor-to-doctor differences in whether a patient was referred to a radiation oncologists; some urologists frequently made these referrals, while others did so much less often.

Men newly diagnosed with prostate cancer face “a lot of confusion,” Jang noted, because there are so many treatment options available. “The physician who is providing the counseling for these patients should go to great lengths to provide a balanced perspective, an unbiased perspective, on these treatment options.”

And if patients don’t feel they are getting unbiased advice, Jang added, they should get a second opinion. “It’s really our responsibility to provide these men with every single available treatment option.”

SOURCE: Archives of Internal Medicine, March 8, 2010.

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The American Cancer Society put out updated guidelines for prostate cancer screening today and they look, well, a lot like the current ones.

After reviewing the recent scientific literature, there’s still no evidence that routine screening for men of any age makes sense, according to the committee that issued the guidelines.

They continue to recommend that men of average risk receive information and weigh the “uncertainties, risks, and potential benefits” of screening starting at age 50. Higher-risk individuals — African-Americans or those with one relative diagnosed with prostate cancer before age 65 — should be presented with the information at age 45. Men with a strong family history should start thinking about screening at age 40.

The group also emphasizes the importance of joint decision-making between the patient and his doctor about whether to be screened for prostate cancer. Men don’t always get the information they need to make such decisions about prostate screening, according to the cancer society and findings from other studies.

“Men without access to regular care should not be tested unless high-quality informed decision-making as well as appropriate counseling and follow-up care for those who test positive can be assured,” Otis Brawley, chief medical officer of the American Cancer Society said in a statement. “Without those, community-based screening should not be initiated.”

Prostate cancer screening has long been debated. That’s because screening for slow-growing diseases, like prostate cancer tends to be, may lead to unnecessary treatment.

Source: The Wall Street Journal

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A mid-stage trial for abiraterone–an oral drug which inspired a billion-dollar buyout less than a year ago –has produced another set of promising results for men with advanced, treatment-resistant prostate cancer.

For most of the 47 men recruited for the Phase II trial, the cancer had already spread to the bone. All of the patients had received hormone therapy as well as chemotherapy but were no longer responding to standard treatment. About half of the men saw their PSA levels drop by half, a key biomarker for disease activity. And three out of four of the patients experienced a drop in the number of tumor cells circulating in the blood.

“Docetaxel is an important drug, but it extends life for an average of just two to three months, so there is a desperate need to improve treatment options for late-stage prostate cancer patients,” said chief investigator Dr. Johann de Bono. “In this trial, abiraterone shrank or stabilized men’s cancers for an average of almost six months, which is a very impressive result.”

Scientists at the UK’s Cancer Research UK and the Institute for Cancer Research at London’s Royal Marsden Hospital have been studying the drug closely. Two years ago researchers said that the therapy was responsible for shrinking tumors in 80 percent of the men taking it.  Johnson & Johnson acquired the drug when it bought out Cougar Biotechnology last year for $970 million. And Cougar had licensed the drug from BTG.

Source: FierceBiotech

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J.P. Morgan is hosting its big drug-industry conference this week in San Francisco. Here are a couple tidbits from the first few days:

Sales of the multiple sclerosis drug Tysabri topped $1 billion last year, Biogen Idec said today, and the number of patients taking the drug neared 50,000.

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On the one hand, that’s notable, given that the drug (which Biogen co-markets with Elan) was pulled from the market in 2005 because of safety concerns. On the other hand, Biogen recently said its CEO will step down later this year, a move that Dow Jones Newswires said was linked in part to concerns about Tysabri’s growth trajectory. The CEO, James Mullen, will be speaking at the conference at 4:30 Pacific time today. You can tune in online.

Dendreon now has about $600 million in cash, which came largely from a supplemental stock offering in December. Dendreon has had a long road trying to win FDA approval for Provenge, a vaccine intended to treat advanced prostate cancer; a decision from the FDA is expected by May 1.

The vaccine is tailored to each patient; manufacturing it is a complex chore that involves taking cells from the patient and shipping them to the company for processing. The company is using some of its cash to speed up its build-out of manufacturing facilities. Here’s the Dow Jones Newswires story on what the CEO said yesterday; here’s a Webcast of the presentation.

Source: The Wall Street Journal

Popularity: 2% [?]

One in eight men screened for prostate cancer will test positive when they do not have the disease, a major European trial has shown.

A positive result can mean undergoing invasive tests such as biopsy as well as potentially unnecessary treatment.

Screening with prostate specific antigen (PSA) is not routinely offered in the UK but government experts are reviewing evidence from the study.

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Cancer Research UK said men should talk about the pros and cons with their GP.

Early data from the European Randomised Study of Screening for Prostate Cancer, which is being conducted in seven countries, showed in March 2009 that deaths could be cut by 20%.

But other recent evidence has cast doubt on the long-term benefits of screening, suggesting some men may end up being “over-treated” for slow-growing disease that would never cause a problem in their lifetime.

Now data from the Finnish part of the European trial has shown that for every eight men screened – tests are being done on a four-yearly basis – one ended up with a false positive result, even with a fairly high PSA threshold.

Those men who tested positive but were later found not to have cancer were twice as likely not to agree to screening in the future even though they were at risk of developing the disease later, the British Journal of Cancer reported.

‘Adverse effects’

The researchers have said more research is needed to make screening more accurate and to help pick out those who are most likely to have a true positive result.

Study leader, Dr Tuomas Kilpelainen, said: “I don’t think routine screening should be advised until more is known on the adverse effects and costs of screening.

“If a man has urinary tract symptoms and is concerned he could have prostate cancer, the most important thing is to consult a GP or a urologist.”

There is currently no organised screening programme for prostate cancer in the UK but men can request a PSA test if they want and demand is increasing.

Professor Julietta Patnick, director of the NHS Cancer Screening Programmes, said: “While the European trial, of which this Finnish study is a part, showed for the first time that prostate screening with PSA can save lives, it also suggested that 48 men would have to be treated in order to save one life.

“False positives are an issue for any screening programme, and this Finnish paper is very helpful at gaining an understanding of how they might figure in the context of prostate screening.”

Results from both the European trial and a large study being carried out in the US are due this year, Cancer Research UK said.

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Professor Peter Johnson, Cancer Research UK’s chief clinician, said the paper showed there were “two sides” to using PSA for prostate cancer screening.

“Although for some men detecting prostate cancer early through screening can be life-saving, on the other hand the test will be abnormal for around one man in eight without cancer being detectable at that time.

“For this reason, it is important that men in their 50s and 60s can to talk to their doctor about the pros and cons of having a PSA test and only have the test if they feel it is right for them.”

Source: BBC NEWS

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Inhibiting TNF-receptor associated protein-1 (TRAP-1) may prevent cancer cell death, according to investigators at the University of Massachusetts Medical School. They also note that TRAP-1 is a marker of localized and metastatic prostate cancer and is required for prostate cancer cell viability.

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The report will appear in the January 2010 issue of the American Journal of Pathology in a paper titled “Cytoprotective Mitochondrial Chaperone TRAP-1 as a Novel Molecular Target in Localized and Metastatic Prostate Cancer.”

Since TRAP-1 is known to regulate cell death, the researchers decided to study its role in prostate cancer. They found that the protein was highly expressed in both high-grade human prostate cancer lesions and mouse models of prostate cancer but not in benign or normal prostate tissue.

In addition, TRAP-1 overexpression in noncancer prostate cells inhibited cell death, whereas TRAP-1-deficient prostate cancer cells had enhanced levels of cell death. Moreover, treatment with gamitrinibs, a class of small molecules that inhibit TRAP-1, resulted in prostate cancer cell death but not death of noncancerous prostate cells.

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Dario C. Altieri, M.D., who led this research, reported in February on the synthesis and properties of gamitrinib as a treatment for prostate cancer in The Journal of Clinical Investigation. He designed gamitrinibs to selectively target Hsp90 in human tumor mitochondria. TRAP-1 is a mitochondria-localized Hsp90 chaperone. Therefore, Dr. Altieri believes that based on his research, targeting TRAP-1 via gamitrinib may be a viable therapeutic strategy for patients with advanced prostate cancer.

Dr. Altieri’s experiments also found that TRAP-1 was differentially expressed in localized and metastatic prostate cancer compared with normal prostate.

A similar approach may be also suitable for other types of cancer, as TRAP-1 is broadly expressed in disparate human malignancies, Dr. Altieri continues. He plans to “further dissect the biology of TRAP-1 cytoprotection in cancer cells and test whether disabling its function may overcome drug resistance, the most common reason of treatment failure and dismal outcome in patients with advanced prostate cancer.”

Source: GEN News

Popularity: 2% [?]

Dendreon’s vaccine to treat prostate cancer has already been rejected once by the FDA. But the company recently re-applied for FDA approval, and it’s acting pretty confident while it waits to hear back from the agency.

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Earlier this week, Dendreon said it would sell 15 million new shares of stock and use a chunk of the proceeds to speed up construction of new manufacturing facilities. The sale will increase shares outstanding by at least 13%, Dow Jones Newswires said.

And today, the company said it had hired a new COO who will be responsible for “preparing for and leading the commercial launch” of the prostate cancer vaccine, which is called Provenge. The new guy is Hans Bishop, who previously ran the specialty medicines business at Bayer.

The moves are a reminder of the long run-up required to get sales and manufacturing going for a new treatment. Vaccine manufacturing is particularly complex; Dendreon said the manufacturing expansion it’s funding now won’t bear fruit until mid-2011. A decision from the FDA is expected next year.

Source: The Wall Street Journal

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In just the latest sign of just how hot new cancer drugs have become, San Francisco-based Medivation garnered a $110 million upfront payment and a milestone package of $655 million from Astellas for global rights to its experimental prostate cancer drug. The therapy, MDV3100, is currently being evaluated in the Phase III AFFIRM clinical trial in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.

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Medivation also gets a co-promotion deal in the U.S. market, a collaborator to help foot development costs and a partner who will provide royalties for sales outside the United States. “Astellas is the second major collaboration we have completed in the past year, and we are confident we have the right partners in place for each of our late-stage programs–Astellas for MDV3100 and Pfizer for Dimebon,”  said David Hung, M.D., president and chief executive officer of Medivation.

MDV3100 triggers cell death in bicalutamide-resistant cancers via three complementary actions: Blocking testosterone binding to the androgen receptor, impeding movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibiting binding to DNA.

Source: FierceBiotech

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For a few years now, researchers have been looking at what role a virus called XMRV plays in prostate cancer. A study published today in Science suggests the virus may also be linked to chronic fatigue syndrome. But the picture is still cloudy, and it’s not clear whether the virus actually causes prostate cancer or CFS.

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A series of studies in recent years have suggested XMRV may be linked to at least some cases of prostate cancer. One recent study found signs of XMRV in 23% of prostate-cancer samples, compared with 6% of tissue samples from men with benign prostate tissue.

Both CFS and XMRV-linked prostate cancer are associated with changes in a particular enzyme, which made scientists wonder if there was a connection between the virus and CFS. So they compared blood samples from 101 people with CFS against blood samples from 218 similar people who did not have CFS. The virus was present in the blood of 68% of the CFS patients, and only 4% of the control group.

What does all this mean? It’s not clear whether the virus causes either prostate cancer or CFS, notes a perspective piece that accompanies the study. At the same time, the piece says, “further study may reveal XMRV as a cause of more than one well-known ‘old’ disease, with potentially important implications for diagnosis, prevention, and therapy.”

Source: The Wall Street Journal

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