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.
Description:
• May enroll fewer than 100 to several hundred patients.
• Enroll a higher number of patients to begin to test the safety and efficacy of a specific dosage.
• These trials usually enroll participants with a specific type of cancer and generally test against the standard of care for an experimental treatment.
What is the catch? Drugs that have not gone beyond phase-2 testing still have several years of testing before they may be approved. The exception to this rule is a drug being tested in phase 2 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-3 Clinical Trial
Who are the best candidates? All types of HRPC patients may qualify because they should (make sure you check) get the standard currently available approved treatment or one of the most promising treatments available (but not approved), involving a drug that has already done so well in phase-1 and -2 testing that it is ready to be tested in phase 3.
Description:
• Determines whether or not the promising drug will get FDA approval.
• Generally enrolls hundreds to over a thousand patients at many different locations.
• A participant is randomly assigned to the current approved treatment or the new potential treatment (a process called randomization). In other words, every participant gets the standard-of-care/approved treatment for this condition, or else gets the new and emerging potential treatment.
• “Crossover” is also usually available in a phase-3 trial. This means if you stop responding to the treatment that you are initially assigned (either the standard of care or potential drug), then you will be allowed to get the other treatment in the trial if you want it. Ask about this possibility in any clinical trial.
What is the catch? Drugs that have not completed phase-3 testing still have at least one to a few more years to be tested before they can get approved. The exception to this rule is a drug being tested in phase 3 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 (financial reasons, clinical reasons, specific doctor choice, etc.), so you do not need to be in a clinical trial.
Phase-4 Clinical Trial
Who are the best candidates? All type of HRPC patients who qualify because they should receive an approved treatment for HRPC.
Description: Involves further testing of a treatment after it has been approved in order to further investigate how best to continue to use this treatment.
What is the catch? Drugs that have completed successful phase-3 testing and are entering phase-4 testing have been approved, so why enter a clinical trial for a drug that is already available and probably covered by insurance? A few possible reasons are that the drug may be provided at a lower cost to you in terms of out-of-pocket expense, or that you may want to continue to support research and knowledge on an available drug, or because the new protocol with the drug being tested is one that may have a better response potential as compared to the standard of care. There are some phase-4 tests that involve getting more frequent treatments or more potentially potent dosages, and