INDIGO: Relapsed Prostate Cancer

MARK SCHOLZ, MD

Those dreaded words, “relapsed cancer,” shake you to the core. They mean that surgery or radiation has failed to “get it all.”  However, while with most cancers “relapse” is a fatal pronouncement.  However, prostate cancer has its own distinct reality. Most men who relapse don’t die from the disease.  The outlook is good because relapses are usually detected by a rising PSA when the cancer is still microscopic. Visible, scan-detected metastases may not appear for ten or more years after the PSA relapse occurs.

Multiple Treatment Options for a Rising PSA
The list of potential treatment options for INDIGO is extensive: observation, radiation, hormone therapy with Lupron and Casodex, salvage seed implant, salvage cryotherapy, Zytiga, Xtandi and Taxotere. However, combinations of these treatments are most commonly employed. Some of these combinations are listed below in order of increasing treatment intensity:  

1.     Observation

2.     Mild hormone therapy consisting of continuous or intermittent Casodex

3.     Monotherapy with fossa radiation, seed implant or cryotherapy for persistent local disease

4.     Combination hormone therapy with Lupron and Casodex given intermittently

5.     Same as #4 but with the addition of pelvic radiation and 4 months of hormone therapy

6.     Same as #5 but with hormone therapy extended for 18 months

7.     Same as #6 but with the addition of Taxotere or Zytiga or Xtandi

Defining Different Types of Relapses
Just as PSA, cancer grade, scan findings and stage were instrumental for assigning a SHADE in newly-diagnosed men; SHADES are important for putting a relapsed in perspective. Ultimately, how to treat INDIGO is guided by a combination of four factors— the SHADE before treatment, the PSA doubling time, individual patient factors such as age, sexual functionality and urinary control, and last, but not least, the cancer location.

The Original Shade before Treatment
In general, treatment should be more aggressive (combined therapy with Lupron and pelvic lymph node radiation) if the original SHADE was unfavorable (AZURE for example).  Treatment should lean toward a less aggressive approach—cryotherapy alone, seed implant alone or Casodex alone—if the original SHADE was SKY.

The PSA Doubling Time
Treatment is heavily influenced by the rate of PSA rise. For example, if the PSA is doubling in less than six months, aggressive combination treatment with Lupron and Casodex plus radiation (or cryosurgery in men previously treated with radiation) is probably required.  If the PSA doubling rate is between six and twelve months, a less aggressive treatment approach with radiation alone, cryosurgery alone or intermittent Lupron and Casodex is reasonable.  When more than a year is required for the PSA to double, observation without immediate treatment may be considered.

Patient Factors that Affect Treatment Selection
A patient’s age needs to be factored into the treatment decision-making process. Men who are more elderly can “step down” the intensity of their treatment by temporizing with milder hormone therapy such as Casodex with Avodart. Younger men, who, prior to relapse, were in the High-Risk (AZURE) category may want to consider upgrading the intensity of treatment by using prophylactic pelvic lymph node radiation plus a more intensive hormone therapy such as Zytiga or Xtandi and/or chemotherapy with Taxotere.

Searching for the Location of the Cancer
Men with rising PSA should undergo standard imaging studies (listed below) in an attempt to determine the location of the cancer. Unfortunately, these scans are often unable detect recurrent cancer unless the PSA is over 20. However, improved PET scans that utilize C11 choline or acetate have the potential to detect recurrent disease with much lower PSA levels. Unfortunately, the PET scans are so new that insurance coverage is often limited.

Sometime even the best scans can’t detect where the cancer is. When this occurs after surgery, particularly when the PSA doubling time is slow, residual cancer in prostate fossa is often suspected and radiation to the prostate fosse is often administered. Cure rates are better when radiation is initiated at a lower level of PSA. 

Standard Imaging Studies for INDIGO

• Color Doppler Ultrasound or Multiparametric 3 Tesla MRI can be used to look for residual cancer in the surgical fossa or in the prostate gland in men previously treated with radiation. 
• Pelvic MRI or CT scans are used to check for spread to pelvic lymph nodes. (Carbon 11 acetate PET scan, however, is far more accurate than CT or MRI but some centers still consider them investigational/experimental)
• Technetium bone scans are standard. New F18 PET bone scans, however, are preferable because they can detect much smaller cancers than technetium bone scans.

Apparent Locally Recurrent Disease

Scans done in a man with a rising PSA after radiation that indicate a recurrence localized inside the prostate, may be curable with cryosurgery alone or possibly with a seed implant alone.  Similarly, an isolated local relapse in the prostate fossa after surgery may be curable with radiation alone. Even though scans show no metastases outside the prostate or the fossa, microscopic metastases in the pelvic nodes may be present, especially in men who have fast PSA doubling times or whose SHADE was originally AZURE.  In these higher risk situations, the addition of prophylactic pelvic lymph node radiation with intensity modulated radiation (IMRT) combined with hormone therapy may be advisable.

Regional Spread to Lymph Nodes

When cancerous nodes are detected in the pelvis, the idea of doing node-directed IMRT is even more compelling. Since overt cancer in the lymph nodes is an indication of potentially life threatening disease, an extended course of hormone therapy, possibly with the addition of second generation hormones such as Zytiga or Xtandi, can be contemplated. Taxotere chemotherapy is an additional consideration.

Hormone Therapy Alone

When the location of the relapse is unclear, or if the risks of side effects from radiation appear too high, relapsed disease can be effectively suppressed for many years with hormone therapy alone. The side effects of hormone therapy tend to increase with longer use so intermittent therapy is very popular. A typical intermittent protocol is to begin with an initial course of treatment for six to twelve month followed by treatment holiday. After hormone therapy is stopped, testosterone starts to recover and the PSA begins to rise. Treatment is restarted when the PSA rises back to the original PSA baseline, or up to five, whichever is lower.

Putting It All Together

Treatment selection for INDIGO can be complex. Constructing a cancer “profile” using the original SHADE, the PSA doubling time, and scan finding, is the first step. Unfortunately, the location of the recurrent cancer may remain uncertain, even after doing the best scans.  When this is the case the extent of disease may require a professional “guesstimate” based on the PSA doubling time and the original SHADE.  Despite all these difficulties and uncertainties, the good news is that a wide variety of treatment options are available and treatment is usually very effective. For the majority of men the disease can be controlled on a long-term basis, and some cases it can even cured. 

CALENDAR ALERT TO THOSE WHO LIVE AROUND LONG BEACH, CA Learn more about prostate cancer treatments as Mark Scholz, MD, discusses treating PSA relapsed disease at UsTOO Long Beach Prostate Cancer Support Group July 22, 2014 - 6:30 PM to 8:30 PM, at Long Beach Memorial Medical Center. For more information follow this link: http://goo.gl/HMojNV

 

The INDIGO Shade of Blue

BY MARK SCHOLZ, MD

Prostate cancer is a vast and complicated field. To make it more manageable, PCRI breaks it down into five separate Shades of Blue. Men with recurrent disease after surgery or radiation are in the INDIGO shade. The outlook for men with INDIGO is optimistic.  Some men can still be cured. For those who can’t, the vast majority will be able to keep their disease in check with treatment.

A rising PSA confirmed on sequential measurements is the most common sign of a relapse.

Less common signs of relapse are:

a.     A positive biopsy from the prostate fossa. The “fossa” is where the prostate gland used to be prior to surgery (also, a nodule may or may not be felt on digital rectal examination)

b.    Persistent prostate cancer detected in the gland after radiation by needle biopsy, or by scans or by digital rectal examination

c.     Prostate cancer that has been detected in the pelvic lymph nodes by a scan.

 

People need to be aware that a PSA elevation after surgery or radiation can occur for noncancerous reasons, including incomplete removal of the prostate gland after surgery, prostate tissue “left behind” in the fossa, results in low but persistent levels of detectable PSA.

After radiation, the prostate gland remains in place. Therefore, in men who have been recently treated with radiation combined with testosterone inactivating pharmaceuticals (TIP), discontinuing TIP will lead to testosterone recovery which causes PSA levels to rise. Also, radiation-induced inflammatory reactions can occur in residual prostate gland cause a PSA rise. This rather common phenomenon is called the “PSA Bump.”  It’s essential to be aware of the noncancerous causes of PSA elevation so that well-intentioned but unnecessary treatment can be avoided.  

INDIGO men will require imaging studies to determine the extent of the disease.

1.     Color Doppler or MRI is used to look for residual cancer located in the surgical fossa or in the prostate gland in men previously treated with radiation. 

2.     Pelvic MRI or CT scans are used to look for spread to pelvic lymph nodes. (Carbon 11 acetate PET scan is more accurate than CT or MRI but is still considered to be under investigation)

3.     CT or MRI of the abdomen and bone scans are used to detect the presence of more distant spread to lymph nodes outside the pelvis or to the bones. Scan-detected disease outside the pelvis or in the bones changes the shade to ROYAL. 

Treatment for INDIGO

Treatment options include observation, radiation, TIP, cryotherapy, or combinations of TIP with radiation or cryotherapy. Treatment selection is guided by four factors—the cancer location, the original Shade, the PSA doubling time and a patient’s age. By incorporating all four factors into the treatment selection process, the risk over-treating, i.e., incurring unnecessary side effects from treatment, is reduced.  Awareness of all four of the factors also helps to avoid another common mistake—under-treating—which reduces the likelihood of achieving durable remission.

An isolated “local” relapse is one that appears to be localized inside the prostate after radiation. Local relapse may be curable with cryosurgery alone.  An isolated “local” relapse in the prostate fossa after surgery may be curable with radiation alone.

When no local disease can be detected and when all the scans are clear—termed a “pure” PSA relapse—treatment selection will be influenced primarily by the rate of PSA rise. For example, if the PSA is doubling in less than six months, aggressive combination treatment with TIP plus radiation or TIP plus cryosurgery may be best.  If the PSA doubling rates is between six and twelve months, a less aggressive treatment approach with radiation alone, cryosurgery alone or intermittent TIP alone, is reasonable.  When the doubling time is greater than 12 months, observation without immediate treatment may be considered.

A patient’s age and the original shade at the time of diagnosis also need to be factored into the treatment decision-making process. Men who are more elderly can “step down” the intensity of their treatment plan by temporizing with mild forms of TIP, such as low-dose Casodex. Younger men, who prior to relapse, were in the High-Risk (AZURE) category may want to consider prophylactic pelvic lymph node radiation, a more intensive type of TIP with Zytiga or Xtandi or even chemotherapy with Taxotere.    

Side Effects of Treatment—INDIGO

The residual prostate gland after radiation is anatomically close to the rectum, urinary bladder, and the nerves that control erections. Therefore treatment with salvage radiation or cryotherapy increases the risk of additional long-term sexual, urinary or rectal dysfunction beyond what has already caused by the original surgery or radiation.

Men who are already struggling with incontinence problems from previous surgery may experience further decline in their urinary control when they undergo radiation directed at the fossa. Men who have cryosurgery for a relapse after radiation almost always become impotent. Incontinence can also occur. Surgery to remove a previously radiated prostate causes very high rates of impotence and incontinence.

Radiation to the pelvic lymph nodes can cause damage to the surrounding intestines with symptoms of cramping, diarrhea or loss of rectal control. Since the advent of intensity modulated radiation (IMRT), however, bowel damage from pelvic radiation is a much less common event.

TIP is a common component of the treatment plan for men in the INDIGO category. The severity of side effects from TIP increases when it is continued for a longer duration. As a result, intermittent TIP is very popular. The intermittent TIP protocol is to continue treatment for six to twelve month after which TIP is stopped and a treatment “holiday” is ensues—assuming the PSA drops below the 0.1/ng threshold. The next cycle of TIP is resumed when the PSA rises back to the original PSA baseline, or up to five, whichever is lower.

The most troublesome side effects from TIP are weight gain and fatigue. Maintaining a careful diet and doing regular exercise is very helpful in offsetting these problems. Low libido, however, only responds to a treatment holiday. Daily Cialis is necessary to reduce the risk of permanent erectile atrophy.

Other side effects of TIP typically respond well to the following medications:  Low-dose estrogen controls hot flashes. Osteoporosis can be prevented by Prolia, Boniva or Actonel. Mood swings stabilize with antidepressants. Breast growth is prevented with nipple radiation or Femara.  Erectile dysfunction can be counteracted with Viagra.

Finding the right type of treatment for men in INDIGO is achieved when the benefit of treatment is weighed carefully against the potential for treatment-related side effects. Fortunately, a wide variety of effective treatment is available for men with INDIGO and the majority will have their disease controlled on a long term basis.

So much for getting “the Blues” when you have prostate cancer!

The TEAL Shade of Blue

BY MARK SCHOLZ, MD

People assume that the differences in the way prostate cancer behaves—one man develops symptoms and another doesn’t—is because they are seeing different stages of the same illness.  What’s overlooked, often with disastrous consequences, is that these differences are also due to the fact that distinct varieties of prostate cancer exist.

Receiving optimal therapy depends on matching an appropriate treatment with both the correct stage and the correct type of prostate cancer.  Since blue is the color for prostate cancer, as pink is the color for breast cancer, the PCRI has subdivided prostate cancer into five major Shades of Blue. These shades incorporate both the stage and the type of disease. The five shades are SKY, TEAL, AZURE, INDIGO and ROYAL.

The first three shades, SKY, TEAL and AZURE, represent men who have had no previous surgery or radiation. TEAL is what medical professionals call “Intermediate-Risk.” Men in the TEAL shade have identical characteristics to SKY—PSA under 10, Gleason under 7 and a small nodule (or no nodule) on digital rectal examination. However, in addition, men in TEAL have one of the following: PSA between 10 and 20, or, Gleason of 7, or digital rectal exam with a “biggish” nodule confined to one side of the gland.

Since men in TEAL have a small but real chance of cancer spread, staging scans of the bone and body are needed.  In addition, a multiparametric MRI or a Color Doppler Ultrasound should be done to check for spread around the gland just outside the capsule. If extra-capsular disease is seen, the shade changes from TEAL to AZURE.

Treatment for TEAL
The list of treatment options for TEAL is long.  While occasionally men are candidates for active surveillance— particularly those who are older—one of the following treatments is usually administered: Robotic surgery, open surgery, intensity modulated radiation, temporary high-dose seed radiation, permanent seed radiation, a combination of seed radiation and IMRT, proton therapy, Cyberknife, focal therapy or testosterone inactivating pharmaceuticals (TIP).  Sometimes a short course of TIP is combined with radiation.

Focal therapy “focuses” treatment on the cancer itself rather than the whole gland.  Typical tools used for focal therapy are cryotherapy, HIFU or laser. In general, skillfully administered focal therapy is thought to be associated with a lower risk for side effects and only slightly higher risk of future cancer relapse. However, focal therapy is very new and there are relatively few studies accurately describing long-term results.

Another option is to use TIP. TIP causes the cancer to shrivel up.  Typically TIP is continued for six to twelve months after which men are placed on active surveillance.

One general principle is that treatment success depends just as much on the skill of the administering doctor as it does on the type of treatment selected.

The second general principle is that cure rates with most of the different treatments are so close that for comparison purposes, they should be considered identical. Of course, the truth of this principle is predicated on the assumption that all treatments are administered by equally skilled experts.

Side Effects of Treatment
The prostate gland is so close to other critical organs it becomes very difficult to target the gland without damaging surrounding structures. The most common side effects, therefore, are persistent difficulties with sexual, urinary or rectal function.  For example, after radiation in an average 65-year-old, about 75% of men will recover back to their normal pretreatment level of urinary function. About 50% will recover back to their normal pretreatment level of sexual function. After surgery, about 50% of men have urinary function that is restored but only 20% describe their sexual function as recovering back to baseline.

Predictions about the incidence of side effects after focal treatment are less than certain because this technology is so new. Overall, assuming that the treating physicians are skillful, one would expect somewhat better potency rates and somewhat lower cure rates compared to standard surgery or radiation.

Comparing TIP with others options is even more difficult.  Cure rates are certainly much lower. However, the good news is that permanent side effects are rare.  The three most troublesome side effects during therapy are low libido, weight gain and fatigue. Weight gain and fatigue are partially counteracted with diligent diet and exercise. Low libido only resolves after TIP is stopped. Other common side effects such as hot flashes, calcium loss from the bones, mood swings, breast growth and erectile dysfunction can be prevented with medication.

Final Thoughts
Men in the TEAL Shade of Blue, compared to men in the other shades, face the biggest challenge—making a therapeutic choice.  First, there are so many options. Second, none of the options are attractive.  The “best” choice is only relatively better than the others; it’s never something you want to do. Making the best choice for yourself requires good comparison shopping skills, and that requires extensive homework. There are no shortcuts. Third, the biggest differences between the options are not related to the cure rates, it’s the concern about permanent side effects that needs the most attention.

Therefore, my recommendation for selecting treatment is to create a list of all the reasonable choices and study them closely, especially in term of the potential long-term side effects.  The “worst” choices should be eliminated one by one. The last option left on the list will probably be the best treatment for you. 

The SKY Shade of Blue

BY MARK SCHOLZ, MD

The worst mistakes are to believe that prostate cancer is just one disease and that it will always need treatment. The entire physician community has stumbled into this terrible blunder by assuming that every tiny little spec of cancer being found through needle biopsy is equivalent to the long-familiar, deadly metastatic variety.  It was the invention of the spring-loaded needle biopsy gun, not just the discovery of PSA that launched the modern prostate cancer industry as we know it today.

Tragically, over the last twenty years, millions of men have had their sex lives ruined by unnecessary surgery or radiation. Only recently has it come to light that the Gleason six type of prostate cancer is harmless, that it never metastasizes.

Yet to this day, practically all men with Gleason six are still being treated. Justification is that since it’s called “cancer” we need to be safe and remove the gland. While many men and their doctors continue making this tragic mistake, now that we know how to differentiate between the harmless and dangerous types of prostate cancer, you can be spared.

Blue is the color for prostate cancer as pink is the color for breast cancer. So the PCRI has labeled the major subtypes of prostate cancer with different Shades of Blue. The five shades are Sky, Teal, Azure, Indigo and Royal.

Sky is the first and most favorable shade of blue, the type that can be safely monitored without treatment. Men in the Sky shade category are defined by having the following four characteristics:

1.       A PSA less than 10

2.       A Gleason score under 7

3.       A tiny nodule on digital rectal or no nodule at all

4.       Color Doppler ultrasound or multiparametric MRI scans showing no extra-capsular extension

Treatment for Sky

Studies show that initial observation, termed Active Surveillance, is a safe way to manage favorable forms of prostate cancer like Sky. In a ten-year observational study at Johns Hopkins out of1,000 carefully selected men it was reported that not a single man died of prostate cancer.  In fact there was not even a single case of metastasis.

Observation is preferred because even with the most skilled doctors, standard therapy with surgery or radiation is frequently associated with permanent impotence and incontinence.

A typical Active Surveillance program consists of PSA testing three or four times a year, a digital rectal examination once or twice a year, and periodic random prostate biopsy every one to three years. Bone scanning is not recommended.

Recently, the policy of performing routine random biopsies is being reconsidered. Biopsy is unpleasant and can occasionally be dangerous. Certain centers, those with access to quality imaging, are substituting an annual multi-parametric MRI or color Doppler ultrasound.  Biopsy is reserved only for the men whose imaging shows a new or growing lesion in the prostate. And rather than doing 12-core random biopsy, one to two targeted cores are used.       

|+| Dr. Scholz will be periodically emailing regarding the topics of Imaging, Active Surveillance, the dangers of prostate biopsy and the existence of safe alternatives.

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The 2013 PCRI Conference, How to Handle So Much New Information

MARK SCHOLZ, MD

Every year, it seems, the enthusiasm and excitement at the conference grows. Why?  Certainly Dr. Mark Moyad who moderates the conference, and the PCRI staff and I, who organize it, have grown from our experiences over the years. We are fine tuning and improving the agenda over time. But this isn’t the primary reason.

The prostate cancer world is changing, and changing quickly.  In the early years of putting a conference agenda together, I used to spend a lot of time “scrounging around the basement” to find content with high enough quality for presentation.  Back then the main treatments for early and advanced prostate cancer were surgery and chemotherapy respectively. Now for these same stages we have active surveillance and immunotherapy.

So the problem now – it is insufficient to do justice to all the new information in a two day conference. Nathan Roundy, one of our helpline volunteers, who recently returned to the PCRI from sabbatical, came up to me after the conference and said, “I can’t believe how much things have changed in just the last six months!”

The introductory comments I wrote in the conference syllabus convey some of these same thoughts about how the PCRI handles the massive overload of new information:

“Knowledge is power. And what you don’t know can indeed hurt you.  However, in this modern information age, the deluge of unfiltered data can be completely overwhelming. How can patients without professional training sort through it all out and distil a sensible plan of action?” 

No one can offer an easy solution.  The prostate cancer world is complex, and there are too many behind-the-scenes conflicts of interest to simply trust the first smiling doctor you encounter.  Although you can’t escape from the responsibility of doing your homework, you can make sure that you are registered ‘in the right classroom.’ 

The field of prostate cancer is vast, so the PCRI breaks the disease down into different categories, which we have termed Shades of Blue.  Failing to recognize the different Shades of prostate cancer is like wandering randomly between classrooms teaching totally different subjects. Is it any wonder there is so much confusion? Patients don’t need more information. They need personalized information—unbiased resources that are tailored to their specific disease category.”

Even though cancer is a serious subject, we had a lot of fun as well.  Ryan O’Neal came and shared his personal experience of having undergone focal cryotherapy with Dr. Duke Bahn. Dr. Mark Moyad and Ryan had a hilarious exchange culminating with Ryan giving Mark a kiss on the cheek.  Jerry Peters, our Grammy Award winning board member, along with his twelve-piece band, hosted a rocking evening at our Gala dinner Saturday night. Dr. David Hung, the CEO of Medivation, the manufacturer of Xtandi, gave a strikingly inspirational presentation concerning the acceleration of new drug development in the pharmaceutical world.

What a wonderful problem to have - with so many brand new treatments it’s hard to do justice to them in a two day conference.  The key is to recognize your shade of prostate cancer, identify the treatment options available based on that shade, and follow up with more research about those options.  The PCRI website is presently going through a major upgrade and will go live in the next week or so.  Check out www.pcri.org when you get a chance.

A Breakthrough Study in Prostate Cancer

BY MARK SCHOLZ, MD

Ten years ago everyone agreed that surgery was the “Gold Standard” to which every other kind of treatment should be compared.  Now as we approach 2013, you rarely encounter the Gold Standard argument to bolster surgery as the preferred treatment approach.  What has led to the change in perspective and why has it taken so long for this change to come about?

Good Science Finally Leads to a Clear Answer

The primary cause for the changed perspective about surgery is the result of a well-performed scientific study published this year by Dr. Timothy Wilt in the New England Journal of Medicine.  The study has been a long time coming.  It was first conceived way back in the early 1990s when Dr. Wilt and others designed a definitive trial to test whether or not radical prostate surgery improves survival compared to observation. Even back then, researchers knew that prostate cancer can often behave benignly and were questioning the benefits of radical surgery.  Therefore, between 1994 and 2002 over five-thousand men were invited to participate in a study comparing immediate surgery with no treatment.  To make the comparison totally fair, individuals volunteering for the study had to be willing to have either surgery or observation based on the flip of a coin.  Most of the more than five thousand men who were invited to participate in the study refused. Ultimately, however, 731 men agreed to participate.

Modest Benefits for “Bad” Cancer, No Benefit for “Good” Cancer

At the start of the study the average age of the men participating was 67 and the median PSA was 7.8. After ten years the difference in prostate cancer mortality was essentially the same in both groups, i.e., within the expected range of statistical variation: 5.8% died in the surgery group and 8.4% died in the observation group.  However, subgroup analysis of the 251 men in the study who started off with PSA levels above 10 showed a modest improvement in survival for the men undergoing surgery: 5.5% died in the surgery group and 12.8% died in the observation group.

Validation of the Right Way to Look at Prostate Cancer

This picture of how different types of prostate cancer behave over long periods of time (having a high PSA for example versus having a low PSA) has been slowly forming in the minds of the prostate cancer experts over the years.  Dr. Anthony V. D’Amico, MD, PhD, Professor of Radiation Oncology at Harvard Medical School, is credited with developing the modern staging system that divides men into Low, Intermediate and High-Risk categories (At the PCRI we call them Shades of Blue, i.e., Sky, Teal and Azure).  Dr. Wilt’s study conclusively validates the fact that favorable prostate cancer—termed Low-Risk—can be safely monitored without immediate treatment, whereas men with High-Risk disease derive a modest benefit from immediate treatment.  His study also reported an intermediate outcome for the men with Intermediate-Risk disease: After 10 years, men in the Intermediate category showed no improvement in cancer survival with surgery.  However, there was a 10% lower incidence of metastases in the men with Intermediate-Risk who had surgery.   

Conclusion

Dr. Wilt’s study is an important breakthrough because it is the first modern, large, long-term, prospective, randomized study comparing treatment versus no treatment in men with relatively early-stage disease, i.e. diagnosed via PSA screening.  This study provides critically important scientific confirmation validating the policy of withholding radical treatment in men with Low-Risk disease.  The study also validates the predictive accuracy of the D’Amico staging system which functions by dividing men into Low, Intermediate and High-Risk categories.  Lastly, Dr. Wilt’s study provides a quantifiable measure of the degree of benefit associated with immediate surgery in men with Intermediate-Risk and High-Risk disease.  Using this information, individuals with High-Risk disease can better understand the rather modest survival advantages of surgery, and weigh them against the probable deleterious side effects, enabling them to determine for themselves whether or not they want to proceed with radical treatment.

Managing Too Much Information—The PCRI’s Approach

BY MARK SCHOLZ, MD

Knowledge is power. And what you don’t know can indeed hurt you.  However, in this modern information age, the deluge of unfiltered data can be completely overwhelming. How can patients without professional training sort it all out and distil for themselves a sensible plan of action?

No one can offer a quick fix.  Prostate cancer is too complex and there are too many behind-the-scene conflicts-of-interest simply to trust the first smiling doctor you encounter.  Although you can’t escape from the responsibility of doing your homework, you had better make sure you’re in the right classroom.

Because prostate cancer is so varied in how it affects men, PCRI has divided the disease into five major categories, which we have called Shades of Blue.  This division emphasizes the extreme diversity of this infirmity we call prostate cancer, a condition that ranges from totally innocuous to fatal.

In the process of learning about prostate cancer, failing to stick to the domain of a single Shade is like wandering randomly between five classrooms that are teaching five different subjects. Is it any wonder there is so much confusion? Patients don’t need more information. They need unbiased information that is tailored to their specific needs, i.e. their Shade of prostate cancer.

When you think about it, it’s obvious why we need a new approach to information management. In the old days, new discoveries came slowly. The doctors who were thought leaders had plenty of time to attend medical conferences to discuss disease management in a leisurely fashion to achieve broad consensus. Those days are gone forever. In this era of rapidly changing technology, consensus about a treatment probably means the treatment is out of date. These days, new treatments are vetted by experts on primetime news. Unfortunately, breaking news, due to its fundamental need to be controversial and attract an audience, tends to emphasize fringe thinking.

Relying on traditional university centers to define a sensible, middle-of-the-road plan of action is also no longer possible.  Prostate cancer is big business and most large treatment centers specialize in one form of therapy such as radiation or surgery to the exclusion of all the others. Studies show that large specialty centers do indeed yield better quality than centers treating fewer numbers of patients. However, the large centers are understandably biased toward recommending their specific form of therapy. Their advice about which treatment to select is all too often tainted by their financial conflict of interest.

The PCRI’s mission is to fill the cavernous need for unbiased information that has been created by the accelerated rate of technological discovery. Rapidly exploding technology and new treatments are a great blessing as long as these powerful tools are applied selectively and appropriately to individuals who can benefit, while withholding potentially toxic treatments from those who won’t benefit or may actually be done some harm.

With the annual PCRI conference rapidly approaching, PCRI will continue striving to fulfill its mission to provide up-to-date and scientifically-based information that helps patients and their families sort through the ever expanding number of treatment options.