Dispatches from the PSA Front: What You Don’t Know May Be Good for You

RALPH BLUM

There is a growing sense that those who are medically challenged—in this case the challenge being prostate cancer—are just another population of “consumers” in Big Pharma’s drive to capture market share.

                                   

Boil it down and the issue here can be stated in just three words: overtreatment by doctors. It is ironic that the first serious warning came from Thomas Stamey, M.D., formerly Chief of Urology at Stanford University, the man who developed the PSA blood test. Stamey’s dire prediction should be part of the awareness of every urologist and every newly diagnosed man:

“I believe that when the final chapters of this disease are written, it will prove that never in the history of oncology, will so many men have been so over-treated for one disease.”

One rarely sees Stamey’s warning reprinted. Why not? “Bad for business,” one urologist admitted to us.

           

However, concern for this situation is expanding rapidly. An October 5, 2011 New York Times article by Shannon Brownlee and Jeanne Lenzer quoted one of the major figures in the field, Otis Brawley, currently Chief Medical and Scientific Officer of the American Cancer Society, who the authors describe as “the public face of the cancer establishment. Brawley has become the target for attacks because of “his blunt and very public skepticism about the routine use of the prostate-specific antigen, or PSA, to screen men for early prostate cancer.” Brawley’s position is unequivocal and disturbing to the medical establishment:

“I’m not against prostate-cancer screening. I’m against lying to men. I’m against exaggerating the evidence to get men to get screened. We should tell people what we know, what we don’t know and what we simply believe.”

Otis Brawley, who is also a professor of oncology and epidemiology at Emory University, is foremost among a growing number of urologists and oncologists who recognize the ethical obligation to make certain that men grasp the nature of the radical “downstream decisions” they might have to face as a result of early screening—or any screening at all.                                                       

The newly identified risk of knowing too much is redressed when men are given balanced information about both the pros and cons of P.S.A. testing. Studies have found that well-informed men are less likely to opt for screening than men who were merely offered the test. “If a man understands the risks and benefits and does not want to be screened, that decision should be supported,” Brawley says. “But just saying that gets you in trouble.”

Well, that is changing, and changing fast. Since we posted our blog, “Who’s Afraid of a PSA?” the word is out. As I write this blog, I am receiving calls referring me to the latest Oncology Today, and also suggesting I Google: “Breaking News: PSA tests no longer generally recommended. “

It appears that we are entering a time when PSA testing is no longer done automatically as part of a doctor visit or a check-up with your urologist. A time when men will receive explanations as to the necessity for testing—and ask for explanations if they are not forthcoming. A time when there will be more transparency regarding the possible adverse side effects of PSA testing, the most egregious side effect being unnecessary aggressive treatment.

And meanwhile, hats off to Tom Stamey and Otis Brawley!

Discontinue PSA Screening?

BY MARK SCHOLZ

The recent task force’s recommendation* to discontinue PSA screening has shocked the prostate cancer community.  Yet with radical prostatectomy rates up 50% over the last five years their desire to apply the brakes is understandable. 

No one disputes that PSA testing leads to earlier detection of prostate cancer. In fact, one could argue that the problem with PSA is that it works too well, diagnosing the disease years before we even need to know about it. Attention, therefore, needs to be refocused on how doctors respond to an elevated PSA rather than recommending the end of PSA testing altogether.

Presently, at the first sign of PSA elevation doctors urge immediate prostate biopsy, taking a dozen needle samples of the gland through the rectum. More than a million men undergo this unpleasant procedure annually, risking the possibility of serious infections, bleeding and temporary impotence.

Rather than triggering an immediate biopsy, an elevated PSA should prompt additional testing with urine tests and scans along with thorough patient education about the risks of biopsy. 

Moreover, this would be a good time to educate the medical community about how to judiciously use the information PSA provides. We can’t forget the fact that 30,000 men die annually from advanced prostate cancer, and that twice that many are living and suffering from advanced disease including metastatic disease in their bones. We also need to remain mindful that studies clearly show that early diagnosis leading to the selective use of appropriate treatment reduces mortality rates.

*The public may submit comments to the task force through November 8.

Support Groups: Pluses and Minuses

BY RALPH BLUM

Most men are uncomfortable talking openly about sensitive issues—painful emotional stuff like their fear of incontinence, or of never having another erection—and many feel that support groups, where such things are talked about, are not for them. However, my own experience in the medical minefield of prostate cancer taught me that finding the right support group is one of the best things you can do for yourself following a prostate cancer diagnosis.

                                                                       

A good support group provides you with an opportunity to discover how other men have resolved the challenges and coped with fears that you are currently facing—men who have actually lived through surgery, radiation, cryotherapy or hormone blockade. What’s more, your local support group is often your best resource for recommendations and referrals, for learning the names of the most experienced (and best liked) prostate specialists in your area.    

           

Often you will find that the volunteer leaders of support groups are unique individuals who, while waging their own battles against prostate cancer, have dedicated countless hours to research, and who willingly share their experiences with those just beginning the journey. Some groups have expert speakers—doctors, social workers, psychologists specializing in intimacy issues that impact both men and their spouses—who can offer helpful information and can answer questions from first hand experiences that relate directly to your problems and concerns.

                                                                                                           

However, not all support groups are created equal. A group’s effectiveness depends a great deal on its members. Are they mostly upbeat and willing to share their experiences? Do they mainly discuss possible solutions to problems? Do you feel that you can learn something from them? Or do the members mostly complain? Is there an atmosphere of doom-and-gloom? You don’t want to leave feeling more depressed than when you went into the meeting!

                                                           

Another thing to keep in mind is that every support groups has members in different stages of the disease, ranging from localized and curable, to very advanced. If you have never been to a support group before, you could become frightened or depressed by what you hear. If this is the case, either you are in the wrong group, or you may be simply be more comfortable with an internet site like Prostate Cancer Blue Community website http://www.prcibc.org/ that connects you with other men in your same category of prostate cancer.    

                                                                                                                                                   

In most states you can find support groups that provide treatment advice as well as emotional support. The American Cancer Society’s Man to Man chapters are nationwide; most of them welcome spouses, a few prefer that women and men meet separately. To locate the Man to Man chapter nearest you, contact the American Cancer Society at 800-227-2345. You can also go to http://www.cancer.org/ for their online prostate cancer support group. Other excellent resources include Male Care, “Men fighting prostate cancer together” (http://www.malecare.com/), Michael Milken’s Prostate Cancer Foundation (http://www.pcf.org/)  and USTOO International (http://www.ustoo.org/).

                                                           

So even if you are one of those guys who look down on support groups as crutches for sissies, I suggest that you at least give your local group a try. At the very least, you will be able to query a number of men about their experiences with doctors in your community. At best you may develop, as I did, very special prostate cancer friendships with men you can call at any time of the day or night, men who understand what you’re going through. And if you’re lucky, you might run across a uniquely knowledgeable group leader who can give you exactly the information you need to make the right treatment decision.                                                                                                                     

No doubt about it. There is strength in numbers.

FDA Roulette

BY MARK SCHOLZ

The notoriously stingy and demanding FDA gave the go ahead for two new treatments for prostate cancer in 2010.  New approvals are rare because of the hundreds of millions of dollars required to undertake the type of studies that the FDA requires. The FDA wants studies that randomly allocate men into two comparison groups. One group gets the new medicine. The other group gets an ineffective fake called a placebo. FDA approval comes when men getting the new medicine live longer than those given the placebo.

Finding volunteers willing to participate in these types of studies is difficult. The men know there is a 50% chance they will get an ineffective placebo. Who wants to take the chance of getting a sugar pill as their treatment? Even so, some men are so desperate, they sign up, hoping to be among the lucky ones who receive the real McCoy.

These studies often run for years because the study ends when the study participants die from progressive cancer.  To find men willing to participate, the supervising companies that organize and run these studies need contractual relationships with a hundred or more study centers. Just keeping track of all these different patients, at so many different locations, over a period of several years, is in itself very costly.

Provenge is the first FDA approved treatment for prostate cancer that works by strengthening the immune system. Dendreon is the name of the company that has patented a process of harvesting immune cells out of the blood by means of a technique known as “plasmapharesis.” Plasmapharesis is a three hour process similar to dialysis that extracts immune cells from the blood. The harvested cells are then taken to a special laboratory and mixed with substances that enhance their aggressiveness against cancer.  The cells are then re-infused back into the same patient. 

Provenge’s primary appeal is the low incidence of side effects. The treatment, which does not rely on chemotherapy, is so revolutionary that at first the FDA was very skeptical. They dragged their feet for years, forcing the company to run their studies over and over.  Lo and behold, additional studies again demonstrated that Provenge-treated men were 30% more likely to be three years after their treatment with Provenge compared to the men who received a placebo. Dendreon should be commended for patiently persevering time after time when the FDA kept turning them down. Now men with prostate cancer have access to an effective treatment that has very few side effects.

The other new treatment recently approved by the FDA, Jevtana, falls into the more familiar category of chemotherapy.  Jevtana was approved in July 2010 based on a randomized survival study evaluating Jevtana compared to an older, ineffective type of chemotherapy called Mitoxantrone. 755 men were treated with either Jevtana or Mitoxantrone. The survival of men receiving Jevtana was 30% better then the men treated with Mitoxantrone.  

This remarkable achievement took some industry experts by surprise because the participants in the trial had all been treated previously and become resistant to another type of chemotherapy called Taxotere.  Historically, resistance to Taxotere has been a bad sign predicting resistance to all types of chemotherapy. Jevtana, unlike Provenge has the traditional side effects of chemotherapy such as tiredness, hair loss and increased risk for infection. Even so, reversing cancer in men with Taxotere-resistant disease is quite an accomplishment. 

The FDA finally agrees that both Jevtana and Provenge are proven to make men live longer. Studies are ongoing with these newly-approved medicines to see if combining them with other drugs can further enhance their effectiveness. In the meantime, men with prostate cancer need to be aware that these new and effective tools are available.