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 AZURE Shade of Blue

BY MARK SCHOLZ, MD

Patients frequently ask their physicians, “Am I stage A, B, C or D,” without realizing that the original purpose of a lettering system was simply to guide urologists in the selection of candidates for surgery. While stage matters, a combination of PSA level and the Gleason grade is a better way to assess disease status. So rather than using stage, it’s best to incorporate all three factors together—PSA, Gleason and stage—to divide prostate cancer into five broad categories or Shades of Blue.

Using standard doctor terminology, the AZURE Shade of Blue is essentially the same thing as “High-Risk” prostate cancer. “Risk” refers to a higher probability of relapse after surgery or radiation compared to men in SKY or TEAL shades. Therefore, men in AZURE are usually treated with combination therapy consisting of IMRT, a seed implant and testosterone inactivating pharmaceuticals (TIP) for 18 months.

 

Here are the specific factors that define AZURE. 

1.     No previous treatment with surgery or radiation.

2.     Bone and body scans without metastasis.

3.     One or more of the following three factors:

a.     PSA above 20 and less than 100, or

b.    Gleason score above 7, or

c.     A prostate tumor felt by digital rectal exam extending across the midline of the gland or outside the capsule.

Men with two or three of these factors are still classified as AZURE. Men with spread to pelvic nodes are classified as INDIGO.  Men with metastasis that has spread to bones or to nodes outside the pelvis are ROYAL. Radiation—rather than surgery—is the preferred treatment for AZURE because of the risk for cancer infiltration outside the prostate. Safe surgical removal is next to impossible when the disease extends into surrounding organs.  Incomplete cancer removal means radiation will be required to “mop up” the residual cancer anyway. Therefore, most experts recommend radiation because the risk of needing both surgery and radiation is so much lower.

Within the AZURE category exist subcategories of men who have a relatively more advanced type of AZURE. For example, some men have larger tumors, higher PSA levels above 40 and Gleason grade 9 or 10.  Men in this situation might want to try to further enhance their cure rates by adding a more potent form of TIP such as Xtandi or Zytiga to their therapeutic plan.  Also, a short course of Taxotere chemotherapy can be considered.

My last blog (about TEAL) reviewed potential side effects from surgery and radiation.  The side effects of TIP become more severe when treatment duration is prolonged. The three most troublesome TIP-related problems are low libido, weight gain and fatigue. However, libido recovers after TIP is stopped.  Weight gain and fatigue can be reduced with diet and exercise. Yet as we all know, maintaining a consistently good diet and getting adequate exercise over long periods of time can be very challenging.  Obtaining professional support from a trainer or a physical therapist is one way to sustain a disciplined program on an ongoing basis. 

 

Other common TIP side effects can be controlled with medications.  Hot flashes regress with a low-dose estrogen patch. Calcium loss from the bones can be prevented with an injection of Prolia every six months, a Fosamax pill weekly or with an Actonel or Boniva pill monthly. Mood swings can be reduced with low-doses of an antidepressant called Effexor.  Effexor also has salutary effects on hot flashes. Breast growth can be prevented with an estrogen-blocking pill called Femara.  When libido is chronically low, men tend not to care about getting erections, so taking daily Cialis should be considered standard for men receiving TIP.

Unfortunately, many doctors have limited knowledge about how to prevent TIP side effects. Patients, therefore, need to protect themselves by getting as much education as possible. Certain side effects, such as breast growth, erectile atrophy and osteoporosis, are preventable with appropriate intervention.  However, once they are allowed to occur, these effects can be permanent.

While side effects are an important consideration, men in the AZURE group have a relatively more dangerous type of prostate cancer compared to men with SKY or TEAL.  The appropriate treatment stance, therefore, is to be aggressive—to get cured.

The good news is that the majority of men with the AZURE stage of prostate cancer will be cured with the treatment approach outlined above.  Studies have shown that the best results come from using IMRT, radioactive seed implantation and testosterone inactivating pharmaceuticals (TIP) in combination with each other. 

So if you do find yourself in the AZURE zone, don’t despair: There is good reason for hope.

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. 

Hormone Blockade for Early-Stage Prostate Cancer

MARK SCHOLZ, MD

Being medical oncologists rather than surgeons—and being more impressed by the toxicity of surgery than by its effectiveness—my partners and I hypothesized back in the early 1990s that since testosterone inactivating pharmaceuticals (TIP) are powerful enough to reverse metastatic disease, they should be even more effective against early-stage disease.

Clinical Experience with TIP for Early Stage
In 2011, we published a scientific article in the Clinical Genitourinary Cancer detailing the twelve-year outcome for 73 men who embarked on TIP as primary therapy. In this group of men the average PSA was 9 and the average Gleason score was 7 (intermediate grade). Most of the men had tumors in their prostate large enough to be felt by digital rectal examination. Twenty-one of them maintained a low PSA indefinitely with a single course of TIP—they never needed a second cycle.

Another group of 24 men required periodic repeat cycles of TIP to keep their PSA less than five. In the remaining 28 men, after one or more cycles of TIP, the decision was made to undergo treatment with surgery, seeds or radiation.  However, the average time to treatment was 6.2 years after the first cycle of TIP. Only three of those 28 men ever relapsed after treatment. In summary, this study showed that initial remissions with TIP were universal and that even if the remission was not permanent, treatment with more radical therapy was delayed many years.

In 2012, we published another scientific study in The Prostate, in which we evaluated the effect of 12 months of TIP in 102 men. Twenty-two men were in the Low-Risk category, 30 were Intermediate-Risk and 50 were High-Risk. The median PSA was 7.8 and the median Gleason score was 3 + 4 = 7. The attainment of a clear biopsy after TIP followed by a sustained 7- year remission occurred in forty-five men. The likelihood of durable remission was dependent on the risk category: 82% of Low-Risk, 47% of Intermediate-Risk and 25% of men with High-Risk required no further treatment.

Monitoring TIP’s Effectiveness
One of the beauties of TIP is how easily its anti-cancer effects can be monitored with PSA. Although there is much debate about using PSA for cancer screening, PSA is an amazingly accurate tool for monitoring treatment response. In a study we published in Urology in 2007, we showed that more than 95% of men with newly-diagnosed disease drop their PSA to less than 0.05 within eight months of starting therapy. It’s a rare for cancers to continue producing PSAs above a threshold of 0.05 after six months of TIP therapy.  However, when these rare cancers occur, i.e. when an elevated PSA nadir occurs, it is a flashing sign that aggressive multi-modality therapy should be instituted.

What about Side Effects?
So what is the catch?  To this point TIP sounds like a very logical way to initiate treatment. Even if the disease is not arrested altogether, it delays progression for many years. And men who select TIP as initial therapy can always “jump ship” and undergo radiation or surgery. Delaying surgery or radiation with their potentially irreversible side effects makes sense considering the acclerating pace of medical progress. In this rapidly changing environment, postponing irreversible treatment for even five years is unquestionably an attractive proposition.

The catch is that while TIP side-effects are manageable, they are not trivial. Without attention to diet, notable weight gain occurs. Without regular resistance training and weight lifting, significant muscle weakness will ensue. While on treatment, the majority men lose their sex drive. A loss of sex drive is, however, different than impotence. With medications such as Viagra and Cialis most men on TIP can have erections sufficient for intercourse. Sex can be enjoyed, but it is not sought after with the usual male verve. There is also the potential for additional side effects such as breast enlargement, osteoporosis and hot flashes. As dire as these sound, they are preventable with common medications such as Femara, Prolia and progesterone. However, the side effects are cumulative and become more prominent the longer TIP treatment is continued.

Final Thoughts
Some men are concerned that their cancer will progress if “real treatment” like surgery or radiation is delayed. They forget that surgery and radiation only eradicate the “friendly types” of prostate cancer, the ones that remain contained in the gland. The real danger lies in the possibility of microscopic metastasis. Radiation and surgery have no effect whatsoever on cancer that has already spread. Only TIP circulates throughout the entire body attacking early-stage micro-metastasis in the lymph nodes or bones.

In my next blog, I will be discussing a new, more powerful type of TIP that has recently been approved by the FDA. The enhanced effectiveness of this new drug may enable a shorter course of treatment. And since testosterone levels in the blood remain normal throughout, the risk of lingering side effects should be eliminated.   

Revisiting TIP (Testosterone Inactivating Pharmaceuticals)

BY RALPH BLUM

Why Does TIP Work?
Testosterone is the hormone that causes boys to become men at puberty. Prior to puberty, the prostate gland is roughly the size of a small marble. Then, when the teenage surge of testosterone occurs, the gland expands to walnut size and begins producing semen. This transformation occurs because the cells of the prostate gland are uniquely sensitive to the presence, or absence, of testosterone. Lowering the level of testosterone in the blood causes the cancer cells to shrivel up a die because the cancer cells are derived from prostate gland cells and retain the same dependence on testosterone for survival.

Long Term Results
One downside to TIP is that while it shrinks the cancer, it does not, ultimately, kill every last cell. However, it has been my treatment of choice for the past ten years. Studies done at Prostate Oncology Specialists, Inc. show that after twelve months of TIP the amount of residual cancer is usually too small to be detected with a lesion-directed biopsy using color Doppler ultrasound. In most cases PSA drops to near undetectable levels (mine dropped to 0.125), and TIP has the added benefit of having anti-cancer effects throughout the body.

When TIP is stopped, testosterone levels gradually return to normal, and a number of men require no further treatment. Some men require periodic treatment with TIP to keep their PSA levels under 5.  And other men, rather than continuing with intermittent TIP, decide to go for surgery, seeds or IMRT. However, even this latter group has bought themselves on average of five plus years before risking the intimidating potential side effects of more radical treatments.

Side Effects of TIP
Although no prostate cancer treatment is free of undesirable side effects, most of the side effects of TIP (weight gain, muscle loss, loss of libido)   are preventable with proper management. And loss of libido, unlike impotence, is reversible when TIP is stopped. Meanwhile, although some of the magic may be gone while on TIP, most men find that they can still enjoy sex (and give pleasure to their partners) with a little help from Big Pharma. Viva Viagra!

Final Thoughts
I can think of only three reasons why this non-invasive alternative to surgery and radiation is not more often the treatment of choice for men with Intermediate-Risk prostate cancer:

1)  Patients never hear that it is an option: Urologists usually don’t suggest TIP to men with Intermediate-Risk cancer as a viable alternative to their preferred treatments—surgery and radiation.

2)  Doctors are unfamiliar with the TIP option.  Finding an oncologist with experience in state-of-the-art methods of administering TIP is still a challenge.

3)  Most men are shocked and fearful when they are first diagnosed with prostate cancer, and it’s hard to resist the emotional appeal of “Just cutting it out”—especially when the risks of more radical treatment are sometimes glossed over.

Thankfully, in 2002, when I learned that my PSA had bumped up to 18.3, my fear of being sliced open, or fried by radiation led me to Mark Scholz, and TIP. And although I would not describe my experience as “a day at the beach,” I am deeply grateful that I chose TIP, and, more importantly, ten years later, I am still here!

A Question of Blood Flow?

BY RALPH BLUM

Have you been watching the TV commercials for drugs that combat erectile dysfunction?  I don’t know about you but I’ve been conditioned PR wise—only in the wrong direction. I mean, I’ve become like one of Pavlov’s dogs gone bonkers - every time the bell rings, instead of salivating, I tend to piss on the bell-ringer’s leg. It’s gotten to the point where I grab the mute button whenever I hear any one of the brand names, or see a shot of a couple lying in his-and-hers bathtubs on a cliff overlooking the Promised Land. “A question of blood flow,” my keester! Still, in case you’re still in the “Help me get it up” market, let’s review a few of the offerings.

In addition to Viagra, Cialis, and Levitra, I found 12 other erectile dysfunction drugs listed; drugs with names like Staxyn, Yohimbe, Erex and Testomar . . . Compared with the big three, the others received very few, if any, reviews. However, ED commercials are ubiquitous on the Internet. When I last looked, I found over 300 “male enhancement” products on the market, each of them promising “bigger and better erections.” But what if you’re just not interested? What if one’s desire for sex is totally absent?

We know certain things for sure about prostate cancer and one of them is that it is, to various degrees, testosterone driven. Unfortunately, so is sexual desire. So what controls the cancer—a radically diminished testosterone level in the blood, aka TIP, as Mark has christened, it is a part of the formula for staying alive.

Attending Support Groups over the past two decades, I’ve heard a lot of discussion about erections and the absence of same. I’d bet that 96% of the complaints concerning the ED resulting from hormone therapy (and the resulting suspension of intercourse) do not come from our partners. It’s a guy thing. As one woman summed it up at a Support Group at the PCRI Conference last year, “If it’s a choice, believe me, we would rather have you alive than have sex.” So we’re talking ego versus reality.   

Yet all is not lost. Some couples, like my old Ojai friends, J and L, have replaced coitus with massage and cuddling and exploring touch, only to find that they actually have greater intimacy. As they have told one another, “I can’t see you too well, and I can’t hear you . . . But it feels really good.”

With all the horror stories, stories of fear and shame, of loss and self doubt, I find it heartening to see the lighter side. So when it comes to a catalogue of all the possible unpleasant side effects of erectile dysfunction drugs—ranging from dizziness and stuffy nose to seizure or sudden decrease or loss of hearing or vision—my favorite warning concerns priapism: “To avoid long term injury, seek immediate medical help for an erection lasting more than four hours.” By all means, call your doctor. In fact, you could make two calls, one toThe Guinness Book of Records!

In Chapter 16 of Invasion of the Prostate Snatchers, Mark talks about the effects of testosterone reduction and how to minimize its negative impact. While Viagra would permit most men to attain a workable erection, the problem proved to be more basic. When he was conducting a study, Mark found that many men simply “forgot” to take their Viagra. He wrote:  “To complete the study I had to resort to phoning them at home to remind them to take their pill.” While helping to preserve their lives, TIP had actually sapped all their interest in sex.

I have ridden the edge for what is now approaching a quarter of a century.  I have undergone no invasive treatment. Only hormone blockade.  There are no guarantees. Things may change, making treatment advisable at some point in my future. But so far so good.  For me my low libido has been a small price to pay to keep my show on the road.  

Confessions of an Anxious Man

BY RALPH BLUM

Like every man I know who is living with prostate cancer, I’ve had my bad moments. But right at the start, during the phase known as “newly-diagnosed,” I knew the odds were in my favor; knew I could die with it not from it. Now, after more than two decades of successfully and peacefully co-existing with this disease, I am once again feeling anxious and at risk.

I have succeeded in one area: the treatment I have undergone has been minimally invasive: no surgery, zero radiation, no chemo. Only a stint of hormone blockade, aka androgen deprivation therapy, and/or Testosterone Inactivating Pharmaceuticals (TIP). And even then, instead of the conventional triple medication—Proscar, Casodex and Lupron—being a minimalist rather than a fan of saturation bombing, I took only Lupron. Still, since there is no question about prostate cancer being testosterone driven, it was appropriate to choose TIP as the least invasive treatment option and, in my case, reduce my testosterone level to that of a pre-pubescent boy.

           

What else did I do to “fight” the cancer? I confess that my behavior as a prostate cancer patient does not receive high marks:  slovenly attention to weight (I’m 5’9” and weigh 218). Diet? Despite my wife Jeanne’s best efforts, I was only part time successful. Exercise? A stationary bike at my neighborhood YMCA, 20 minutes twice a week; no weights work. I am not proud of my record.

Prostate cancer specialists are now rethinking the validity of PSA monitoring. Still, as it was general practice with the option known as “Watchful Waiting,” I was regular in getting my PSA recorded. And until about six weeks ago, my levels were reasonable for a 79-year-old semi-careful patient of a conscientious, competent oncologist, my writing partner, Mark Scholz.

Then, in what might be called “overnight” after two decades of stability, my PSA doubled, vaulted up to 23 and change. And I confess, my sleep is being riven with anxious thoughts. The all but forgotten  “What  if . . .” assault has begin again earnest, with its companion stomach acidity, staring into the darkness, a renewed sense of urgency and, most upsetting, the writing on the wall has become the mirror image of my mantra: Die with it not from it.

However, since my last PSA test, I did undergo a form of heavy duty stress: two surgical procedures for kidney stones. And since surgery—together with heavy lifting, bike riding and recent sexual activity—is known to drive PSA to unrealistic levels, following any of these stressors, you are advised not to be re-tested for a good month or more.

Furthermore, although I was unaware of it for several months, I have been host to a nasty infection known as Proteus Mirabilis (More about that rabid puppy later!). Remembering a previous scare when my PSA suddenly jumped to an alarming level due to infection, I need to undergo a course of antibiotics—in my case Cipro—and then get another PSA test, and a rectal probe with analysis of prostatic fluid to determine whether the infection was actually the cause of my elevated PSA.

Then I will want two essential consults.

First, I need to see Duke Bahn, MD, radiation oncologist, and for my money, the world grand master of the Transrectal Color Doppler Ultrasound for Diagnosis, monitoring with Active Surveillance, and the management of Recurrent Disease.

           

And finally, I will consult with Lisa Chaiken, MD, radiation oncologist at St. John’s Medical Center in Santa Monica, and herself a grand master in the forefront technique of Intensity Modulated Radiation Therapy (IMRT), the only radiation procedure I would feel even provisionally comfortable undergoing.

So first things first: I just came back from my neighborhood CVS Pharmacy with 39 tablets of 500mg Ciprofloxacin HCL. Took the first tab in the parking lot. I’ll complete the two-a-day course of antibiotics; then redo the PSA and get the opinions of the prostate mavens I trust. But whatever the case, I have decided that it is time for definitive treatment—aka cure. Living with low testosterone is downright debilitating.

Enough is enough.

In Praise of Life in the Libido Free Zone

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Hormone Blockade Effectively Controls Prostate Cancer

BY MARK SCHOLZ

Ralph Blum, my coauthor of Invasion of the Prostate Snatchers, monitored his prostate cancer for 14 years before starting treatment in 2004.  Prior to meeting me, Ralph had been living in Hawaii and managing his own case.  However, when his PSA rose above 10 he came to Marina del Rey for a consult. I advised him to start treatment with either IMRT or Testosterone Inactivating Pharmaceuticals (TIP).  Ralph, after considerable uncertainty and discussion, embarked on TIP for 12 months.  So far he has required no additional therapy.

At Prostate Oncology Specialists, back in the 1990s, when radiation was more prone to burn than cure, we commonly treated men with TIP followed by active surveillance. Our first published report on the feasibility of intermittent TIP was presented at the annual meeting of the American Society of Clinical Oncology in 1997¹ and later published in The Oncologist in 2000.² In 2006 we updated our experience with intermittent TIP in the Journal of Urology and reported that Proscar (finasteride) extends the time-off period” after TIP is stopped.³

This December Clinical Genitourinary Cancer will publish our long-term outcome of 73 men treated at Prostate Oncology Specialists with TIP and monitored for a median of 12 years after treatment. A preprint of the article is available on our "publication" webpage found at prostateoncology.com. Here are the take-home messages we reported in the article about using TIP as first line treatment:

1.     Almost a third, 21 men, have not required any further treatment.

2.     One third, 24 men, have kept their PSA less than 5 with further cycles of TIP. 

3.     After an average of 5.5 years, slightly more than a third, 28 men, underwent delayed local therapy (surgery, seeds, IMRT or cryotherapy). After an additional six years observation, three men have developed a rising PSA (PSA relapse).

4.     Local treatment was administered much more frequently to younger men (whose testosterone recovered more quickly when TIP was stopped)—and to men with D’Amico High-Risk category disease (PSA > 20 or Gleason 8,9,10)—compared to older men and to men who were in the D’Amico Low-Risk or Intermediate-Risk categories.

5.     Mortality from prostate cancer was low.  After twelve years only three men (4%) died of prostate cancer, and none of the remaining 70 men developed metastatic disease. This result compares favorably to a group of 350 men with similar-stage prostate cancer treated with immediate surgery whose ten-year outcome was reported in the New England Journal of Medicine in 2005.⁴ In this group fifteen percent developed metastases and an additional ten percent died of prostate cancer. 

Unfortunately TIP, like all forms of prostate cancer treatment, is associated with a number of undesirable side effects including weight gain, muscle weakness, absent sex drive and hot flashes. However, for most men these side effects are either treatable⁵ or reversible.  Even so, as we have reported in the summary above, many men treated with TIP will, at some point, require further treatment, either with additional TIP or some form of local therapy.

All this not withstanding, in my mind there is no doubt that Testosterone Inactivating Pharmaceuticals (TIP), when appropriate and applied in a timely manner, acts effectively to control prostate cancer.

References:  Copies of all the articles referenced in this blog are available at our webpage  http://prostateoncology.com/education/publications

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