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SECTION III
THE TEAL
STAGE OF BLUE
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Chapter 16
OVERVIEW OF TEAL
Mark Scholz, MD
Sometimes you have to choose between a bunch of wrong choices and no right ones. You just have to choose which wrong choice feels the least wrong.
COLLEEN HOOVER
TEAL IS VERY CHALLENGING FROM the treatment-selection point of view. The list of treatment options is long (see below). Accurate staging is the key. Teal splits into three subtypes: Low-Teal, Basic-Teal and High-Teal. Treatment is different for each subtype.
THREE SUBTYPES OF TEAL
āLowā-Teal has only one intermediate risk factor, such as a Gleason score of 3+4=7, with all the remaining factors being like those of Sky. (PSA less than 10, no nodule or a very small nodule). Men with Low-Teal also have favorable biopsy findings: They have Gleason 3+4=7 in no more than two biopsy cores and less than 20 percent of the cancer in the biopsy core is grade 4. In addition, if imaging with multiparametric MRI shows a tumor, it should be relatively small. Since Low-Teal behaves like Sky, active surveillance becomes a reasonable consideration, a topic that was covered thoroughly in Section II. A blog posted on the PCRI website discusses active surveillance for Low-Teal as well.
Men with Basic-Teal have somewhat more extensive disease in their 12-core random biopsy specimen. Up to 50 percent of their biopsy cores may be involved with Gleason 3+4=7. All their other features are like Sky. Basic-Teal is usually treated rather than monitored.
High-Teal is characterized by one of the following:
- Two or more intermediate-risk characteristics such as a PSA over 10 plus a nodule involving more than two quadrants of the prostate (stage T2b), or
- A Gleason grade of 4+3=7 (rather than 3+4=7), or
- Gleason 7 in more than 50 percent of the cores from a 12-core random biopsy.
High-Teal is more likely to metastasize, so staging scans are needed before starting any treatment, especially before starting testosterone inactivating pharmaceuticals (TIP). TIP causes cancer regression and can rapidly erase spots of cancer from the scan, which can lead to misinterpretation of the cancerās actual stage.
The types of scans used for staging are:
- Bone scan (Chapter 6)
- CT scan or MRI of the abdomen and pelvis to rule out enlarged lymph nodes
- A multiparametric MRI (MP-MRI) or color Doppler ultrasound (CDU) of the prostate gland to check for the possibility of extra-capsular disease (Chapters 4 and 5). If unequivocal extra-capsular disease is detected, Teal becomes Azure.
THE CHALLENGE OF PICKING THE RIGHT TREATMENT
The biggest challenge for Teal is sorting through the multiplicity of treatment alternatives. While I have listed 10 choices below, saying there are only 10 choices understates the situation. There are variations within each of these 10 options. For example, for option #1 there are three different types of permanent seeds: iodine, palladium and cesium. When you consider the possibility of varying the dosage and the duration of treatment, the number of options becomes almost infinite.
- Brachytherapy, permanent low-dose seed radiation
- High-dose-rate brachytherapy, (i.e., temporary seed radiation)
- Intensity modulated radiation (IMRT), a type of external beam radiation (EBRT)
- Brachytherapy combined with IMRT
- Proton therapy
- Cyberknife or stereotactic body radiation therapy (SBRT)
- Focal therapy (in its many forms: Cryo, HIFU, laser, radiation, electroporation)
- Testosterone inactivating pharmaceuticals (TIP) as a standalone treatment
- Robotic or open surgery
- TIP administered for a variable period in combination with radiation
USING SCIENTIFIC STUDIES TO COMPARE TREATMENT OPTIONS
Scientific studies are the main basis for evaluating a treatmentās effectiveness. Patients naturally tend to rely on their doctor to sort through the studies and determine which are reliable. One generally hopes that the doctors are sophisticated, truth-based scientists, objectively selecting the most accurate studies to guide them in their treatment recommendations. Unfortunately, doctors fall prey to the temptation of quoting the studies that support their preexisting point of view. A study can be found that supports almost any point of view.
The aim of this chapter is to convey one important messageānot all scientific studies are created equal. Unfortunately, few people are schooled in how a studyās veracity is determined. While there are many potential pitfalls, there are common methods for determining which studies can be trusted. To protect themselves from being misled, patients need to learn how to assess the quality of a study.
An experienced and unbiased expert scrutinizes the value of a study by first looking at its scientific method. Did the researchers doing the study ask the right question in the first place? Second, is to consider the relevance of the study: Was the study performed with patients with an age and stage of disease like yours? Third, how does the integrity and the reputation of the researchers who wrote the study stack up? This criterion is often reflected by the prestige of the journal in which the study is published. Lastly, the type of study must be considered.
SCIENTIFIC STUDIESāGOOD, BAD, AND UGLY
Please forgive me if you feel that the logic behind this paragraph is so obvious that I am insulting your intelligence. However, after talking with thousands of patients I have learned that some fail to think things through. Treatment results from studies performed in Petri dishes or on animals have only preliminary value and can be used only for designing future human studies. Over and over, it has been shown that the findings from nonhuman studies are poor predictors of what will happen when that same type of treatment is finally tested in humans. Please donāt confuse yourself by considering any nonhuman study in your quest to find optimal treatment.
Another type of untrustworthy study relies on retrospective database queries. The advent of electronic records has opened the door to the possibility of doing all kinds of computerized data searches. One popular methodology relies on searching through the billing records of men treated for prostate cancer to estimate the incidence survival and quality-of-life events in the long-term. Recently, one such study received wide press coverage by claiming hormone therapy causes Alzheimerās disease.1 Unfortunately, there was no press coverage of the backlash from the scientific community, which severely criticized the studyās methodology and conclusions.2,3,4,5
Prospective studies that compare outcomes by randomly allocating patients into separate treatment groups are by far the best. However, such studies are few and far between because they are so expensive. Retrospective studies easily outnumber the randomized studies by more than 100 to 1. As we progress through this section of the book, we will be faced with the need to interpret and compare numerous studies from many different treatment centers, most of them retrospective. Here are a few of the difficulties this presents:
- All retrospective studies are self-reported, so the people writing the study have a major conflict of interest. Who would want to report bad results from their own treatment center?
- In retrospective studies, patients are not of comparable age. Men undergoing surgery are consistently younger than the men who undergo radiation. It is a well-known medical fact that younger patients have better treatment outcomes and fewer side effects than older ones. So how do you accurately compare surgery versus radiation if the patients are different ages?
- The definition of what constitutes a cancer relapse is not uniform between radiation and surgery. Relapses with radiation are detected later. The low levels of PSA from a recurring cancer after radiation are obscured by the background PSA being produced by the prostate gland.
- A time lag occurs with all prostate cancer studies. Cure rates are not finalized until five to 10 years after the treatment. Over this extended waiting period, technology advances. This is important because radiation technology has greatly improved, whereas cure rates from surgery, even robotic surgery, have remained about the same. Therefore, older radiation studies understate the results obtainable with modern techniques.
COMPARING CURE RATES
Despite these difficulties, a broad overview of many studies ever performed can provide a comparative sense of how these different treatments perform. By examining multiple studies, some of the biases and variations between the studies may be averaged out. Reviewing all the retrospec...
