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.
The catch The patient is exposed to radiation. Finding the right tracer marker (carbon-11, choline, glucose, NaF) to be used with the test is challenging because the technology is developing so quickly. In some cases, patients have problems with insurance coverage for this test.
ProstaScint Scan
Advantage The ProstaScint scan can suggest whether or not cancer has returned after localized treatment for prostate cancer, especially in the areas around the prostate.
The catch This test is of little value for a man with HRPC. Also, the accuracy of this test has been questioned.
Transrectal Ultrasonography (TRUS)
Advantage A TRUS involves no radiation exposure. It is the gold standard device to obtain prostate tissue biopsy samples.
The catch The TRUS is not a good test by itself for detecting a tumor in or near the prostate.
X-ray
Advantage In traditional X-ray procedures, the patient receives a low amount of radiation exposure. The tests can be done quickly.
The catch X-rays only show something when it is more obvious and takes up a lot of space, such as an infection, fracture, or cancer in the lungs or the ribs. They are not as good at finding small-to-moderate amounts of cancer or bone loss.
In upcoming chapters, we’ll consider a number of currently recognized FDA-approved treatments for HRPC and drugs that are in phase-3 testing. As you read those chapters, you will get more detailed information on the full scope of possible therapies to discuss with your physician to determine the best course of action for your individual situation. Following the sections on treatment, we’ll spend some time discussing side effects and offer suggestions on preventing and mitigating them. Remember, an informed patient can better weigh his options and make an educated choice on treatment plans.
Notes
Three Minimal Treatment Options
Here is one quick tip—you may want to be SURE that you have HRPC. You can elect to get a total testosterone test, preferably with the blood drawn in the morning when testosterone levels are generally highest. For HRPC, your blood testosterone should be less than 50 ng/dL (1.7 nmol/L). In a very small number of situations (fewer than 5 percent), a rise in PSA is not due to HRPC, but rather due to an actual rise in testosterone. In such a case, the patient is considered to have HRPC even though he did not really have it. Rather, the therapy used to reduce testosterone levels was not able to completely get into the blood and effectively reduce testosterone to castration levels.
After establishing that you do, indeed, have HRPC, there are many options you should consider, along with your physician.
Three Minimal Treatment Options for Early HRPC When the PSA rises several times while a man has castrate levels of testosterone (less than 50 ng/dL [1.7 nmol/L]), there are a few quick options that need to be considered for some patients before other options come into play.
Some men have a rising PSA on ADT, but no signs or symptoms of metastatic disease. These men have non-metastatic HRPC (PSA-only relapse), and they have a higher risk of developing cancer in the bones in the future. However, this can take many years to occur. Thus, these men do not truly qualify yet for the FDA-approved metastatic HRPC treatments. So, what to do? Treat this disease with the FDA-approved drugs, something else, or not at all? A couple of minimal approach treatment options to HRPC may be attempted before other drug treatments, namely observation (rarely used) and, more commonly, the use of a low-dose anti-androgen, followed by anti-androgen withdrawal (AAWD). At some point, more aggressive treatments, such as secondary hormonal therapies, become a better option. Keep in mind that several different secondary hormonal treatments involve multiple options that can be used by themselves, one at a time (sequentially),