a higher TNM stage have a worse prognosis than patients with a low TNM stage.
Testosterone Levels There is some preliminary research to suggest that a patient who had an abnormally low testosterone level before receiving an LHRH medication or surgical removal of the testicles could have a more aggressive prostate cancer, and that it may be more difficult to treat. This is preliminary, but it does make some sense that such a cancer would be able to grow with less testosterone available, making LHRH medication possibly less effective. In other words, some of these cells may have found a way to survive without much testosterone.
Time from Initial Treatment to CRPC Diagnosis If you were treated for localized prostate cancer, and then it rapidly progressed to become HRPC, this could indicate a more aggressive cancer. However, if you were diagnosed and treated for localized prostate cancer, and many years later the disease came back, and several years after that it became HRPC, it would imply a slow, steady cancer that may have a better prognosis.
PELVIC NODES
The pelvic lymph nodes are the first set of nodes in the human body where prostate cancer usually goes after growing beyond the prostate area.
Visceral Disease or Soft-Tissue Disease The literal meaning of visceral is “of the internal organs,” and this has come to mean cancer that has spread to locations apart from the prostate or bones, such as the liver, lungs, or other areas far from the prostate. Individuals who have visceral disease or cancer in multiple areas of the body and around the prostate tend to have a worse prognosis than those without disease in these areas. This is because the disease has advanced further. The situation is similar with what is called “soft-tissue disease,” where the cancer has gone to non-bony areas such as organs and/or regional or non-regional lymph nodes.
ABDOMINAL NODES
The abdominal pelvic lymph nodes are the second set of nodes where cancer may typically spread.
Volume or Amount of Cancer In general, the greater the amount of cancer in your body, the more aggressive the tumor, and the more serious the situation. For example, someone with cancer in the lymph nodes, in some organs, and in many bones tends to have a more aggressive cancer as compared to someone with just a few tumors located on a single bone. This is why working with your doctor to find the location of your tumor sites as early as possible is an important tool in planning treatment.
PERI HILAR/SUPRACLAVICULAR NODES
The Peri Hilar/Supraclavicular lymph nodes, located generally speaking in the chest and neck area, are usually the third set of nodes where prostate cancer spreads.
Weight Loss When the cancer itself is impacting a variety of areas of the body and causing extreme weight loss, this usually means that the cancer has become more aggressive and occupies more of the body as compared to someone without weight loss. In general, when men have castrate levels of testosterone because of LHRH treatment or surgery, there is usually some weight gain, or it is at least difficult to lose a lot of weight, even with exercise and diet. Therefore, when a patient begins to lose weight, this is often associated with a worse prognosis. Exceptions include when a chemotherapy drug causes nausea, resulting in weight loss due to a lack of appetite and not because the cancer is progressing. Weight loss due to cancer spread is more troubling.
Question 5: What treatments are available for my HRPC right now?
Many options currently exist, including:
• Anti-androgen addition or withdrawal
• Secondary hormonal therapies
• FDA-approved therapies
• “Off-Label” use of a drug already approved for a different type of cancer
• Enrolling in a phase-1, -2, -3, or -4 research study
• Find a drug in a phase-3 clinical trial that is available for an Early/Expanded Access Program (EAP) or Compassionate Use Program
As this book was being written, it became apparent that we would need to do a quick review of the process that drugs go through before they are readily available for use on patients. After some initial laboratory testing, it may be determined that a drug is ready for human testing. Before it receives a final approval from the FDA, it will go through several phases of testing. In the following section you’ll find more information on what happens in each phase of testing and who is eligible to participate. In considering any trials, first check to see if you will be required to pay for anything for the trial. One advantage of being in such a trial, in addition to receiving a potentially exciting new treatment and contributing to research knowledge that could help you and others, is that there should be little to no cost for you. Patients also participate in clinical trials to try therapies for which they do not technically qualify under FDA guidelines. For example, a patient who does not have metastatic disease may join a trial for a drug only FDA-approved for metastatic patients thus far. Here, quickly, are the differences among phase-1, -2, -3, and -4 trials:
Phase-1 Clinical Trial
Who are the best candidates? Individuals with limited, minimal, or no treatment options.
Description:
• Generally enroll fewer than 100 patients.
• May test different types of cancers or a single type of cancer.
• Enroll a small number of participants to generally determine how a new treatment should be delivered in terms of the most effective maximum dosage, safest dosage, how often the drug should be given, and in what form the drug should be given (IV, pill, injection, patch, gel). It is not unusual for a new drug to be tested at several doses, monitoring efficacy and all side effects.
What is the catch? Drugs that have not gone beyond phase-1 testing still have many years of testing before they may be approved. The exception to this rule is a drug being tested in phase 1 that is already approved for another cancer. It then is possible to get it off-label, meaning you may have access to this drug immediately if you qualify (for financial reasons, clinical reasons, specific doctor choice, etc.), so you do not need to be in a clinical trial.
Phase-2 Clinical Trial
Who are the best candidates? Individuals who have minimal to moderate options, but who want to test a new and exciting emerging treatment.
