CaP Update 2018: When to Pull the ”Ripcord”?

 In Men's Health

Docere

Phranq D. Tamburri, NMD

This article will:

  • Explain why prostate cancer (CaP) treatment objectives are more important than specific treatments
  • Outline the objectives for Active Surveillance
  • Clarify how to determine when, specifically, a patient should abandon natural treatments and/or Active Surveillance and instead pursue conventional treatments. This is a critical determination for both patient safety and physician liability.

Part 1: Prepare Your Patient for Responsible Active Surveillance

Defining Goals & Strategy

The experienced physician will know that throwing treatments at a patient who has initially been diagnosed with CaP may both satisfy his initial expectation in seeking a naturopathic doctor and reduce his initial anxiety by immediately “doing something.” Anxious patients with a new cancer diagnosis are more than willing, especially with less scrupulous practitioners, to throw money at their problem to make it “go away.” They often present with a list of treatments that they or their wives studiously found online, often including the typical vitamin C IVs, ketogenic diets, prostate herbal products, expensive 2-week retreats of IVs, and juicing in Mexico, etc. They yearn for an expert to confidently proclaim which of these treatments are the “best” so that they can immediately get started. However, this approach will only be an expensive Band-aid – not that different from the conventional medical model – if a forward-reaching treatment strategy and goals are not first defined. In other words, rather than focus on what treatments to follow, instead answer the following questions: What are we treating? What are the specific goals of treatment? and, most importantly: When will their (potentially expensive) treatments end? These are the questions that define a proper Active Surveillance protocol.

Admittedly, some patients are confounded by a physician who does not immediately sell them supplements and a “1-size fits all” anti-cancer protocol. When they present with an elevated PSA and a legal diagnosis of CaP on a piece of paper from their urologist, they sincerely don’t understand what more there is to discuss. Why discuss long-term goals when they’ve just been handed a scary CaP diagnosis? It took years of experience to finally learn to avoid this reactionary approach (“saw palmetto and vitamin C IVs to the rescue!”) when considering the long-term welfare and finances of my patient. Remember that most men with CaP die with it, not from it. Active Surveillance must be viewed as a marathon, not a sprint. If your patient is overly anxious, or if his CaP is at a high risk of metastasis, then he is likely not a good candidate for Active Surveillance in the first place.

What Are We Treating & What Are the Goals?

Slow down the interview to ask your patient, “What are we treating?” and “What are your goals?” Your patient may reply, “I told you already, Doc! My urologist said I have prostate cancer, and my goal is to kill it! What else is there to talk about? Let’s not wait! If we delay in ‘analyzing’ my problem, I am worried the prostate cancer will ‘get me.’”

Although my prior contributions to NDNR have detailed these initial questions, for the better understanding of this article let us review an actual case study to refresh the importance of refining the diagnosis before a torrent of CaP treatments begin.

Case Study

A 60-year-old patient with 10 years of PSA values under 1.0 ng/mL takes a 2-week motorcycle sojourn that leads to sudden and complete urinary retention secondary to a prostate spasm from the extended sitting and vibration. The ER inadvertently injures the prostate further during an aggressive catheterization. This is followed by a PSA that is now at 16 ng/mL. A reflex biopsy is automatically performed, revealing a small, indolent CaP (1 out of 12 cores positive, Gleason 6(3+3), <5% of the core).

Superficially, this patient is warned that he has “prostate cancer” with a very hIgh PSA and that it should be treated immediately. However, assuming that we have random cancer in us all the time, this latent CaP was discovered accidentally because of a recently injured prostate. The small CaP had likely been present in this patient not just during the 2 weeks of the trip, but for years and while the PSA was under 1.0 ng/mL. Considering this, should we really be treating this “legally confirmed” CaP, or should we instead be treating the cause of the elevated PSA?

Although this example emphasizes the need to critically refine the diagnosis, for the remainder of this article, we will discuss scenarios in which PSA contributors such as urinary tract infection, prostatitis, and benign prostatic hypertrophy (BPH) have each been accounted for and the nominal PSA levels have been linked directly to CaP activity.

Guiding Your Patient from Anxiety to Empowerment

When CaP is initially confirmed on a biopsy, many questions arise for the anxious patient and his partner. I have found that they generally evolve into 3 levels of questions that represent the patient’s evolution from initial anxiety, to understanding his diagnosis through education and, finally, self-empowerment.

Level 1: Defining the Problem

A newly diagnosed CaP patient is typically very anxious. Common patient questions include: Do I really have cancer? Is it aggressive? What does the prostate do, anyway? Was the biopsy accurate? Am I going to die soon? Do I need surgery? What are the side effects of surgery and radiation? Are there any natural treatments that will make this go away? These questions must initially be addressed on the patient’s terms; however, the substantive answers they truly seek come next.

Level 2: Analysis of the Problem

After the patient weeds through his initial shock, he often begins to ask more pragmatic and analytical questions, typically fueled by internet investigation. For example, the reactionary Level-1 How did I get this cancer? evolves into: Don’t we have cancer in us all of the time, anyway? The immediacy of his elevated PSA recedes when he learns that all sort of things can make the PSA go up. Other examples include: What does “aggressive” really mean, anyway? and the important How much will natural treatments cost me? The evolution into this Level-2 analysis will often change how your patient pursues his treatment. Unfortunately, it is also a time that can become rife with over-saturation of often-conflicting information as he inquires into more and more sources.

Level 3: Synthesis of the Problem – Empowerment

Your anxious patient will (almost) never initially articulate the following questions as written. However, as with the saying from antiquity, “All roads lead to Rome,” so too will your patient’s treatment journey inevitably lead to the following questions:

  1. If I decide against surgery in lieu of natural options, when am I done? (aka, When is the cancer “gone”?)

…followed by the most important question:

  1. If my prostate cancer worsens, when should I “pull the ripcord” and finally have my urologist remove or radiate the gland?

Importantly, responsible, long-term Active Surveillance cannot be followed without these Level-3 questions and goals in place. Some patients will intuitively understand them immediately. Some will understand them from prior experience, such as watching a loved one’s long battle with cancer. I have found that many refuse to acknowledge these for fear that they are “giving power over to the CaP” or that I will not vigilantly fight for them with natural means if they confront a possibility for conventional treatments. However, even if your patient is initially too anxious or inexperienced to have this Level-3 discussion and he demands that you immediately “throw the kitchen sink” treatments at him, you can proverbially “set your watch” that he will eventually come around. Typically, this occurs after the patient spends a year or more of time and money taking countless supplements while waiting for some doctor to declare that his “cancer is gone!” This is because he eventually learns that a lowered PSA or a second biopsy found to be “negative” will not legally confirm absence of the disease. Frustration at this realization is common. The patient has to mentally transition from the concept of “killing the CaP” to “outliving the CaP.” At this point your patient is mentally and emotionally ready for the CaP marathon of Active Surveillance, regardless of the treatments selected.

Part 2: Defining Goals & Limits of Responsible Active Surveillance

Here we discuss each of the Level-3 questions from above. Note that the first one is from the patient’s perspective and is more qualitative, whereas the second one – the physician’s perspective – is rooted in a specific quantitative triangulation (“3 canary” model). We will discuss both perspectives and then how they each contribute 50% to the final (patient-empowered / “physician liability”) decision to, if absolutely necessary, abandon Active Surveillance.

  1. Pulling the Ripcord – The Patient’s Perspective

If I decide against surgery in lieu of natural options, when am I done? (aka, When is the cancer “gone”?)

This Level-3 question was discussed in detail in my 2017 NDNR article, “A Prostate Cancer Discussion: Just What is ‘Aggression’?”1 The short answer is that a contained CaP is never officially “gone” without removing one’s prostate, and, even still, the cumulative incidence of PSA recurrence (PSA-R) after radical prostatectomy is still 13.6% at 5 years and 19.9% at 10 years, as revealed by the 2014 CaPSURE study.2 Furthermore, a low PSA or subsequent negative biopsy will no more mean the CaP is gone, as an elevated PSA or positive biopsy means that the patient has a “real” CaP that is capable of killing him.

A patient will next often ask, therefore, if his cancer is “aggressive.” Although legal CaP aggression is technically a function of Gleason Score on biopsy, I use a more pragmatic, qualitative interpretation when defining it for patients and within this article. I define qualitative “aggression” as an amalgam of the personality of the cancer (based upon numerous physical factors: PSA kinetics, family history, prostate ultrasound/MRI imaging, new genetic molecular testing, etc) with the personality of the patient (ie, his preference for longevity of life vs quality of life, his current general health, life expectancy, and even the money he has to spend on it). One can easily realize how individualized and personal each CaP case is. Histological oncologists have now identified over 50 variants (personalities) of CaP that combine with the infinite but individual personality of the patient.

If the patient is too anxious to live with the disease, is hemorrhaging his financial nest egg on treatments, or simply does not have the lifelong commitment to CaP-tracking and lifestyle changes, then I would recommend definitive conventional treatment. Otherwise, the patient is “done” with Active Surveillance when the physical risk that the patient’s CaP will become metastatic (discussed below in the physician’s perspective) outmatches his emotional and philosophical risk tolerance.

For example, if the CaP personality is a low-aggressive “poodle,” but the patient’s personality is an affluent, quality-of-life-seeking, high-risk “pitbull,” then he is a perfect candidate for Active Surveillance. However, if it is the other way around – eg, a high-metastasis-risk CaP in an anxious patient, perhaps on Medicare, with a priority to watch his grandchildren marry, then conventional treatments might be a better option.

The CaP patient should consider the following facts when assessing his risk tolerance (as discussed in prior NDNR November issues):

  • One in 9 men will be diagnosed with CaP during his lifetime.3 However, the 5-year survival rate is almost 100% for diagnosed men, and even the 10-year survival is 98%.4 Early detection is obviously important.
  • Most PSA elevations between 2.0 ng/mL and 10.0 ng/mL are more often linked to BPH and/or prostatitis than to CaP,5 even in cases where CaP has been confirmed on biopsy.6 In my experience, sharp increases in PSA are particularly suggestive of non-cancer causes such as prostatitis.
  • CaP mortality does not even begin to occur until the cancer starts to metastasize7
  • Although survival rates for metastatic CaP will vary depending on the site of metastasis,7 metastatic CaP still typically takes many years – typically over a decade – before reaching the point of mortality. An important point, and one not reflected in available survival tables, is that it takes 5 or so years before a CaP becomes large enough to detect. For a patient to decide how many years he may have, this 5-year buffer should be taken into account.

This last point bears repeating, since it is critical when answering the question, “Should I treat my CaP?” Even if CaP does escape the gland, the patient typically still has 10 to 15+ years to live, and most of that time is with high-to-reasonable quality of life.

Consider the influence of these points for a sexually active 68-year-old CaP patient with other health problems (most commonly cardiac) and limited funds. If the CaP is assumed to be currently contained, then not only does risking lifelong suffering from surgically imposed side effects (erectile dysfunction, incontinence, etc) seem foolish, so TOO could following expensive naturopathic treatments.

Side Note About Natural CaP Treatments:

Although treatment is not the theme of this article, I want to be clear that I am not stating that natural treatments are not warranted. Diet, nutrition, water, hormone-modulating botanicals, lymphagogues, immune stimulation, pelvic-opening exercises, and other treatments are highly recommended for prostate health, as they encourage the immune system to manage the CaP. These should be recommended in almost every case.

However, when a patient asks, “When do I stop?” he is essentially asking, “When is the cancer gone?” This question infers, “What natural treatments will ‘kill’ the cancer?” What most patients do not initially realize is that natural treatments, with a few exceptions, do not directly “kill” the CaP. Rather, they create a proper milieu for the body to heal and facilitate its own immune response geared toward neutralizing the CaP threat. With this in mind, the goal stops being “When is the CaP gone?” and instead becomes, “How can I outlast the CaP?” This is a very important point that I recommend reinforcing to your patient.

In summary, besides diet and lifestyle changes, the ideal goal of the patient with stable lab values might be to track the CaP rather than engage in active treatments such as weekly IVs, short-term intense diets, etc. Again, manage CaP as a realistic marathon, not an unrealistic, never-ending sprint.

  1. Pulling the Ripcord – The Physician’s Perspective

When are my natural treatment protocols “not working well enough” and I need to send my patient to a urologist for surgery/radiation? 

Skydiving is an excellent metaphor for initially explaining Active Surveillance principles to your patient. Like a tandem skydiver team, however, deciding when to pull their ripcord is a question caught between the longevity-biased urologist who warns, “Pull it now!” and the quality of life-biased alternative practitioner who argues “CaP rarely kills men, so keep free-falling!” [sexual function usually being top of mind]

Evaluating a patient’s initial mortality risk (initial altitude) is the first step. This involves determining how far “off the ground” he is, starting from what is represented by his initial CaP biopsy report (ie, number of cores, Gleason aggression value), his current PSA, and his family history. The next step is to evaluate his PSA momentum (ie, PSA velocity, PSA density, PSA pattern), color Doppler flow, and molecular qualitative testing, which dictate their “falling velocity.” Sometimes the patient is plummeting fast (eg, quick PSA Doubling Time) while another might be “floating like a seagull on updrafts” with mildly vacillating lab work over the years. Of course, the patient’s risk tolerance is akin to the skydiver’s experience (patient’s assessment discussed above). What is finally required to pull the ripcord is the exact “altitude” limit, reflecting the patient’s current metastatic risk.

Three Critical Factors for Determining Metastasis Risk

How do we decide when a prostate cancer is nearing the threshold probability for eventual or current early-stage metastasis? There are 3 critical metrics to assess. I categorize each metric as Green (the official “normal” per the lab), Yellow (intermediate risk that is common with Active Surveillance patients), or Red (findings often concomitant with aggressive or early metastatic CaP).

  1. PSA Density (PSAD)1: This is the only metric utilizing the questionable PSA, since it reflects the PSA that is specific to the patient, as opposed to a lab standard. It is the nominal serum value relative to the gland volume. Since PSA is specific to the prostate gland (not to prostate cancer), the more cells contained in a man’s prostate, the more PSA can be produced. In other words, despite a lab’s “normal” PSA cut-off of 4.0 ng/mL, the larger the gland, the higher the acceptable PSA value. Therefore, a PSA of 7.0 ng/mL would be considered too high in a normal-sized gland of 30 mL but perfectly average for a larger (BPH) gland of 80 mL. Prostate imaging, through ultrasound or MRI, is required to generate this accurate volume. Divide the PSA by this measurement to calculate the PSAD. An acceptable “green zone” is 0-0.15. I consider the “yellow zone” to be 0.15-0.30, which could imply an early CaP or an active prostatitis. [Note: prostatitis typically causes urinary symptoms.] The “red zone” is thus 0.30+, over double the normal value and indicative of risk of early metastasis. In theory, a density this high suggests metastasis because the maximum PSA per volume limit has been maxed out, thus suggesting that PSA-producing cells are outside the prostate.
  2. Prostatic Acid Phosphatase (PAP)1: This serum test was in use prior to the PSA, but is still available through most labs. The PAP was originally used after an unspecified metastatic cancer was diagnosed, in order to determine whether it was prostate cancer in origin. This determination allowed for focused treatment – typically hormone ablation via orchidectomy. Of course, since the test was positive only after the cancer had already metastasized, it was not useful as a screening tool. Because imaging, such as CT bone scans, typically don’t pick up very early prostate cancer metastasis, some urologists today still use this test, often when a PSA is over 10.0 ng/mL, before advising a radical prostatectomy. The PAP, however, could help a doctor advise against prostate removal, and related side effects, if the cancer possibly had already escaped the gland. The “green zone” is 0-2.0 ng/mL; the “yellow zone” is 2.0-3.0 ng/mL; and the “red zone” is 3.0+ ng/mL or if the PAP is quickly accelerating toward 3.0 ng/mL. Understand that a nominal value slightly over 3.0 ng/mL does not necessarily mean that the cancer has metastasized; however, this amount of positive combined with its acceleration, concomitant with an accelerating PSA, is highly worrisome. Note: Each lab has a slightly different reference range for “normal.” I use an average 3.0 ng/mL for teaching purposes.
  3. T Status8: This is a common conventional nomenclature for classifying the location and prevalence of a prostate cancer being close to or at the edge, or pushing outside of the gland. (“T” refers to “tumor.”) This determination may be initially deceptive for a naturopathic physician, but can be inferred from an imaging report or sometimes found in the biopsy report. T1 represents the “green zone” and suggests a minimal cancer, often not palpable, contained within the gland, and with clear (negative) margins. T2 is the “yellow zone” and suggests a cancer at the capsule wall without noted extensions. T3 is the “red zone,” indicating that the cancer has a defined extension noted on prostate ultrasound, MRI, DRE, or on the biopsy itself, and accompanied by phrases such as “perineural invasion“ or “extra-capsular extension.” There is also a T4 classification, which suggests overt metastasis.

3 Caged Canaries in the Coal Mine

Now let’s (finally!) put this all together. Although skydiving is a good analogy for explaining the larger concepts of Active Surveillance strategies (initial starting risk and acceleration), I find “descending into a mine shaft” a more apropos analogy to help determine when to consider abandoning primary natural treatments for conventional ones.

Imagine you are descending a mineshaft, looking for gold. Anxious about noxious gases, you bring along a cage containing 3 canaries (each representing 1 of the 3 critical indicators discussed above). The birds initially are singing (representing the “green zone”). However, as you continue to descend, the birds may become sick. When do you turn back? When the first canary begins to cough (“yellow zone”)? If you are anxious or you value longevity over quality of life, then you should turn back at this first warning. Or, do you perhaps continue until 2 of the birds are coughing? If quality of life is your absolute priority, then perhaps you wait until 2 birds are deceased (“red zone”) and the third is coughing (“yellow zone”).

Most patients appreciate this example and find their risk sustainable when each value is in the green or yellow zone. A reassessment of the goals and life expectancy should be made when a value first enters the “red zone.” However, many patients who lean towards quality of life are comfortable with a low, stable “red zone” value when the other 2 are “yellow” and “green,” respectively.

Personally, I’ve found this “3 canary” risk assessment system highly effective in giving a patient understandable and hard values representing their quantitative metastatic risk – values that they can track with me. A conventional nominal PSA value or routine biopsy finding is often not enough to explain or convince a skeptical patient the risk of a CaP problem that is relative to them.

Conclusion: A 50/50 Shared Determination

After 18 years in practice, this article represents the most succinct and distilled summary of how I determine when an integrative-medicine-minded patient, who is understandably resisting a urologist, should consider conventional treatments. Keep in mind that most naturopathic patients are not truly opposed to drugs, biopsy, or surgery if these options are used after all other less-invasive options have been tried. In actuality, patients are usually only opposed if they are not used as a last resort. This article has taught you to advise them about when that point is reached.

If longevity of life is the patient’s clear goal, or the physician is being pressured to take a liability risk on behalf of the patient, then use the static line common to many urologists that pulls the parachute when first out of the plane! But if the patient is educated and comfortable with the specific treatment goals discussed in this article, and the quantitative “canary” markers (PAP, PSA Density, and T-Status) are generally stable around the “yellow zone,” then the naturopathic doctor should have enough information to keep the patient safe as he continues his natural treatments, thoroughly researches conventional options (just in case), or simply tracks it as he enjoys his years to come. This is the physician’s 50% obligation when advising responsible Active Surveillance.

The patient, however, although expected to be open and honest with his physician, is obligated to be honest first to himself. A patient may need time, after an initial CaP diagnosis, to delve within. He may become initially frustrated that you are not taking his case seriously by immediately throwing the kitchen sink of internet-endorsed natural treatments at him. He may not understand at first why you want him to speak to other CaP survivors, read books, talk with loved ones, and determine their priority in terms of longevity vs quality of life. But once he does, encourage him to grasp that the ultimate answer of when, or if, to undergo conventional treatment comes almost always from within. At the end of the day, the responsible Active Surveillance physician is not treating a CaP patient with supplements and protocols, but rather treating him through empowerment.

Now… go protect a man’s (quality of) life.

References:

  1. Tamburri PD. A Prostate Cancer Discussion: Just What is “Aggression”? Naturopathic Doctor News & Review. 2017;13(11):1,3-5.
  2. Xia J, Trock BJ, Gulati R, et al. Overdetection of recurrence after radical prostatectomy: estimates based on patient and tumor characteristics. Clin Cancer Res. 2014;20(20):5302-5310.
  3. American Cancer Society. Key Statistics for Prostate Cancer. Last revised January 4, 2018. Available at: https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html. Accessed October 4, 2018.
  4. ZERO — The End of Prostate Cancer. Facts and Statistics. 2018. Available at: https://zerocancer.org/learn/about-prostate-cancer/facts-statistics/. Accessed October 4, 2018.
  5. National Cancer Institute. Understanding Prostate Changes: A Health Guide for Men. Available at: https://www.cancer.gov/types/prostate/understanding-prostate-changes. Accessed October 5, 2018.
  6. Nickel JC. When Men with Prostate Cancer Get Prostatitis. April 18, 2018. Prostate Cancer Research Institute Web site. https://pcri.org/insights-blog/2018/4/4/when-men-with-prostate-cancer-get-prostatitis. Accessed October 5, 2018.
  7. Pascale M, Azinwi CN, Marongiu B, et al. The outcome of prostate cancer patients treated with curative intent strongly depends on survival after metastatic progression. BMC Cancer. 2017;17(1):651.
  8. American Society of Clinical Oncology. Prostate Cancer: Stages and Grades. Approved March 2018. ASCO Web site. https://www.cancer.net/cancer-types/prostate-cancer/stages-and-grades. Accessed October 5, 2018.

Photo by Maria Fernanda Gonzalez on Unsplash


Phranq D. Tamburri, NMD, is founder of Prostate Second Opinions, with an international patient clientele in Phoenix, Scottsdale, and Seattle. Dr Tamburri has been Professor of Urology at his alma mater, Southwest College of Naturopathic Medicine (SCNM), for 17 years, and educates in all media forums for both patients and physicians on pragmatic approaches to refining the diagnosis and tracking of prostate cancer. He was uniquely cross-trained, from western Mayo Clinic surgeons to Buddhist monks, while graduating from Kansai Gaidai, Japan. When not conducting digital exams, Dr Tamburri loves Arizona desert rides on his green Kawai while blaring Tangerine Dream.

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