• 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 for someone with more aggressive HRPC this may be an attractive option.
Question 6: What is “early/expanded access” or “compassionate use,” and why is it important to some men with HRPC?
Answer: Individuals with few or no remaining treatment options or those who are no longer responding to any of the currently available treatment options for HRPC may be given access to phase-3 drugs at little to no cost. Efforts are currently underway to expand the number of drugs available to patients through this valuable program. Always be sure to ask to see if a drug is available for an interesting new treatment if you have limited options or do not qualify for the study. The potential downside is that just because a drug becomes available for EAP or Compassionate Use does not mean that it will be effective.
IMAGING TESTS USED IN PROSTATE CANCER
A variety of imaging tests are used to give physicians a reliable analysis of the location and possible spread of your cancer. Many of these tests are used to provide a baseline when compared to the same test at a later date. For example, comparing a recent bone scan to a bone scan from months or years ago can help determine if bone metastasis or further spread of the cancer has occurred. These tests may lead to further tests or treatments, such as a biopsy, the removal of a lymph node, or the treatment of an area of the body to eliminate tumor cells. Most of these imaging procedures are painless, with the possible exception of a needle stick to inject dye to improve readability of results.
Bone Scan
Advantage A bone scan, also called a “radionuclide bone scan” or “bone scintigraphy,” is the gold standard test for determining if a patient has prostate cancer that has spread to any of the bones.
The catch The test exposes the patient to radiation and may not be able to pick up very tiny bone metastasis. It can appear falsely positive for cancer if the patient has arthritis, degenerative bone disease, infection, or fracture.
Computed Tomography (CT scan)
Advantage A CT scan can find cancer in the regional and non-regional lymph nodes, especially when the nodes become large in size because the test detects this size change. It is a good complementary test to investigate a suspicious region found on bone scan or plain X-ray.
The catch The test exposes the patient to radiation and until the lymph node becomes larger in size it cannot detect a possible cancer in that location.
Intravenous Pyelogram (IVP)
Advantage An IVP is used to provide an image of the kidneys, ureters, and bladder.
The catch The test exposes the patient to radiation. It is rarely used any more because newer devices are preferred.
Magnetic Resonance Imaging (MRI)
Advantage An MRI does not involve exposure to radiation. It may be able to find cancer in and around the prostate, such as the seminal vesicles or regional lymph nodes (stage N1). MRI can even find tumors in the spine, especially some high-grade tumors. The catch MRI is not good at detecting cancer in the lymph nodes unless a special iron oxide dye is used. It is not as useful as a bone scan for finding cancer in bony areas. Because the test utilizes a strong magnet, it cannot be used on individuals with metal in their bodies, such as from past medical procedures.
PET/CT Scan
Advantage This technology is rapidly developing. It may be able to pick up cancer in the organs, bone, or non-regional and regional lymph node metastasis very early when the nodes are still not large enough to be picked up by CT scan or MRI. It can sometimes detect cancer when a bone scan did not find cancer in the bones because it relies on a tracer compound to find even tiny tumors.
