UCSF Urologic Medical Oncology Program
Advanced Prostate Cancer and its Treatment
An Information Handout Written for our Patients with Advanced Prostate Cancer
Version Date: May 11, 2011
This sheet has been developed to provide you with general information on the different treatments available for advanced prostate cancer at UCSF. Many of the terms describe the disease in relation to whether or not hormonal therapy (see below) has been administered. For example, a person who is responding to hormonal therapy is considered to have hormone sensitive prostate cancer, whereas a person who has prostate cancer that is growing despite hormone therapy is considered to have hormone refractory prostate cancer (although despite the term hormone refractory it is important to realize that further hormonal treatments are still a big part of treatment – this is detailed below). We define advanced prostate cancer as prostate cancer that requires additional therapy beyond surgery and/or radiation. The treatment options available to you will depend on what kind of treatment you have already had and what your current condition is.
Many (but not all) of the following treatments are options for patients with metastatic prostate cancer. The term metastatic means that the prostate cancer has spread (or metastasized) outside of the prostate to a distant site, such as bone or lymph nodes. Patients who have no evidence of disease at distant sites but whose PSA (prostate specific antigen: a blood test which measures a protein that is secreted by prostate cancer cells) is climbing may also be candidates for some of the treatments described. The term most commonly used for this condition is rising PSA, or “PSA-only� prostate cancer.
Throughout this handout we discuss both standard and experimental treatments for prostate cancer. At the UCSF Urologic Oncology Program, we have a strong commitment to delivering state of the art care for patients with all stages of prostate cancer, improving the effectiveness of existing therapies and developing entirely new therapies for this disease. We have an extensive and very active research clinical trials program that applies to virtually all patients. While we may discuss participation in clinical trials with you, not all patients treated at UCSF participate in these trials and participation in a clinical trial is not necessary to receive care at UCSF. Please note that this is only a very general information sheet, and that new treatments are continuously added to our list. We will be providing you with considerably more information as we discuss your specific treatment options.
I. Hormonal Therapy for Prostate Cancer
Hormone therapy is frequently the first treatment offered for patients with metastatic disease, for some patients who choose not to have radiation or surgery, and for some patients with a rising PSA after radiation or surgery. The male hormone testosterone causes the growth of prostate cancer, and elimination of testosterone with hormonal treatments can kill prostate cancer cells. Testosterone is mostly produced by the testicles, and a smaller supply comes from the adrenal glands (glands that sit on top of the kidneys). “Hormonal therapy� refers to treatments designed to reduce the amount of testosterone that feeds the prostate cancer. Another term for “hormonal therapy� is “androgen deprivation therapy� (ADT).
There are two treatments that reduce the supply of testosterone from the testicles to the prostate tumor. One method is the surgical removal of the testicles, known as “orchiectomy�. The other is an injection of leuprolide (Lupron), goserelin (Zoladex), degarelix (Firmagon), implantable leuprolide (Viadur), or subcutaneous leuprolide (Eligard) which are medications that stop the production of testosterone. These injections are available in 1, 3, 4, 6 month(s) and 1 year preparations. These injections are as effective as orchiectomy in controlling prostate cancer. Side effects of both orchiectomy and the injections can include hot flashes, and, in virtually all patients, low sexual desire and impotence (inability to have an erection). There can be fatigue, muscle loss, weight gain, anemia (a lowering of the red blood cells which can contribute to fatigue), diabetes, and in some patients on long-term therapy, thinning of the bone, also known as osteoporosis. There are some medications that may help decrease hot flashes. Medications also exist to treat anemia and osteoporosis. We generally recommend that all patients on hormonal therapy take calcium (500–1000 mg/day) and vitamin D (400 IU/day) in order to prevent bone loss If bone loss progresses despite calcium and vitamin D we will often add a 3rd medication: i.e. Fosamax (also known as Alendronate, a bisphosphonate) or Xgeva (also known as Denosumab, an antibody that strengthens bone). In addition, weight-bearing exercise is helpful in maintaining muscle tone, reducing fatigue and possibly slowing bone loss. The impact that hormone treatments have on an individual's sex life is equally as important as other side effects, and we hope to provide an
open, supportive environment for you to discuss this if you wish. If desired, we can refer you to our urology program for treatment of erectile dysfunction.
In addition to the injections or surgery, you may also be started on an oral medication called an antiandrogen, which includes flutamide (Eulexin), bicalutamide (Casodex), or nilutamide (Nilandron). These medicines block the effects of the male hormone testosterone from making prostate cancer cells grow, regardless of where the testosterone is produced (testicles or adrenal glands). Most physicians who treat prostate cancer feel that Eulexin, Casodex, and Nilandron are equivalent. These drugs may also be used sequentially (e.g., nilutamide after bicalutamide) if one drug becomes ineffective.
The side effects from Eulexin may include mild stomach distress and diarrhea. Eulexin, Casodex, and Nilandron can make blood tests that measure liver function (liver enzymes) abnormally high, and, on rare occasion, the drug may need to be stopped because of this. The liver enzymes return to normal (in the vast majority of patients) once the drug is discontinued. Because of this, we recommend checking blood tests that measure the liver enzymes one month after starting Eulexin, Casodex or Nilandron, and then at least once every 3 months. Diarrhea and abnormalities in liver enzymes occur in less than 5–10% of patients. Nilandron will very rarely result in shortness of breath (if you experience this, stop the drug at once and call us) or decreased ability of the eyes to adjust to changes in light (i.e., going from daylight into a tunnel).
Although many patients stay on androgen deprivation therapy continuously, some patients are treated with intermittent therapy. This involves taking a shot (Lupron, Zoladex or Eligard) every 3 months plus a daily pill (Eulexin, Nilandron or Casodex) until the PSA falls to its lowest point and for a total of 9 to 12 months. The drugs are then stopped, followed by careful PSA monitoring (usually once every 1 or 2 months). When the PSA starts to climb and reaches about
half of the previous highest PSA level, the medications are started again for 9-12 months at which point they are stopped and the PSA allowed to rise again, and so on. The benefit to this approach is that you will be off hormone therapy for a period of time, and it may slow the time to when the cancer becomes resistant to hormones.
Alternative ways of administering hormonal therapy are also utilized. When Casodex is given at a high dose (3 pills per day instead of 1), some studies have shown that it may be equivalent to the use of a Lupron shot plus low-dose Casodex. These studies suggest that there may be fewer side-effects with this approach, although confirmatory studies are needed. The combination of Eulexin or Casodex plus finasteride (Proscar) has also been shown to be very effective in lowering PSA in patients without the use of Lupron, Zoladex, or Eligard. These approaches may be used in patients with localized disease, but are generally not used in patients with metastatic prostate cancer.
II. The Next Step After Hormonal Therapy: Eulexin/Casodex/Nilandron
Discontinuation
If the PSA rises despite the combined use of a shot plus an antiandrogen pill, the next approach is to stop the pill (Eulexin, Casodex or Nilandron). Although Eulexin, Casodex or Nilandron may be effective initially in slowing tumor growth by blocking the action of testosterone on the tumor, after a period of time (usually more than 6–8 months) the Eulexin, Casodex or Nilandron may add fuel to the fire and feed the cancer. For this reason, approximately 10-15% of patients will have an improvement in their disease when the Eulexin, Casodex, or Nilandron is stopped. However, Lupron, Zoladex, or Eligard injections should never be stopped. Improvement in the disease is usually manifested as a decrease in PSA, usually within 4 to 8 weeks of discontinuation of Eulexin, Nilandron or Casodex. In order to determine if you are having a response, a PSA will be drawn around the time you stop taking Eulexin, Nilandron or Casodex, and then every 3–4 weeks. If your PSA declines or remains stable, no further treatment is undertaken until the PSA starts to climb. PSA levels are usually checked monthly. Responses to Eulexin, Nilandron or Casodex discontinuation last an average of 5 months, but in some patients responses last for several years.
III. Options After Stopping Eulexin/Casodex/Nilandron
If the PSA continues to rise and/or tumors continue to grow after stopping Casodex, Eulexin, or Nilandron, treatment options again depend on certain characteristics of the disease. Three general categories of treatment can be considered: 1) additional hormonal therapies, 2) investigational therapy, and 3) chemotherapy. Some of the therapies available are described in this handout. We will discuss with you the relative benefits and side effects of each therapy, and provide you with additional written information about
the therapies you are interested in pursuing. Which therapy is best for you will depend on your wishes and the therapies medically best suited for you. In addition, since some of our therapies are investigational in nature, there may be restrictions placed by the National Cancer Institute, the FDA, or the sponsor of the trial, on situations in which a given treatment can and cannot be used.
1. Additional Hormone Therapy (including Investigational Hormone Therapy)
A) Androgen Synthesis Inhibitors:
A significant amount of recent research (much of it done at UCSF) has shown that prostate cancer can be stimulated by androgens (testosterone like hormones) that are made in the adrenal glands or in the cancer cells themselves. As a result a significant amount of research into the development of new therapies that target this has been done and is ongoing. Abiraterone, Ketoconazole and TAK-700 are three drugs that block enzymes responsible for the production of androgens in these various sites.
1. Ketoconazole (Nizoral) is another form of hormonal therapy, which is ideal for patients who may be unable to tolerate more aggressive treatment, who have minimal symptoms, or who wish to be treated first with less aggressive treatment. Ketoconazole works by shutting down hormone production by the adrenal glands. This therapy is relatively easy to take (pills) and has modest side effects. about
15% of patients have nausea, and 5% will have abnormalities of blood tests that measure the liver’s function (liver enzymes), although both resolve if the drug is discontinued. Rarely, patients will develop rashes. Many patients on ketoconazole notice a sensation of sticky skin, and a mild increase in fatigue is common. In addition to making testosterone, the adrenal glands serve to balance minerals and fluids in the body by producing the hormone hydrocortisone. For this reason, all patients on ketoconazole also receive hydrocortisone (two pills in the morning and one pill at night) to replace what the body normally produces. There are usually no side effects from the hydrocortisone. While taking ketoconazole, patients must not take certain “statin� cholesterol drugs (e.g., Lipitor or Zocor) since there can be serious adverse drug interactions of these medications with ketoconazole. If you are on a cholesterol medication, please talk with your healthcare provider prior to starting ketoconazole because there are alternative cholesterol medications such as fluvastatin (Lescol), rosuvastatin (Crestor), or ezetemibe (Zetia) which do not interact with ketoconazole.
We also have a clinical trial combining dexamethasone with ketoconazole. In this study, when the ketoconazole stops working, the hydrocortisone (the steroid that patients normally take with ketoconazole) is stopped and patients begin taking an alternative and more powerful steroid called dexamethasone. We think the dexamethasone may then be able to stop testosterone production from the adrenal gland, making this combination (ketoconazole/dexamethasone) effective.
2. Abiraterone Acetate : This drug is similar to ketoconazole in that it shuts down hormone production by the adrenal gland. This drug is likely more potent and better tolerated than ketoconazole (it can increase the blood pressure, but it causes less nausea and rashes). This drug is given in conjunction with prednisone (5 mg 2x/day). Multiple clinical trials with this drug have been conducted at UCSF and UCSF played a key role leading up to the its approval by the FDA in April 2011. It is typically given to patients who have already had chemotherapy but may be useful for patients who have not had chemotherapy in certain circumstances and in ongoing clinical trials.
3. TAK-700 (Investigational Hormonal Agent): This drug is similar to abiraterone acetate and to ketoconazole in that it shuts down hormone production by the adrenal gland. The side effects include fatigue, poor appetite, nausea, vomiting, and constipation. This drug is taken twice daily. Here at UCSF it is being tested in men both with and without metastatic disease, who have not previously received ketoconazole, abiraterone, or chemotherapy.
B) Androgen Receptor Antagonists.
This appproach involves taking drugs that directly block the androgen receptor which is the molecule in the cancer cells that receives hormone stimulation and drives growth of the tumor. Casodex is the most widely used of these drugs currently however newer drugs and approaches to targeting the androgen receptor are under way.
1. Sequential Use of Eulexin, Casodex or Nilandron: Around 20–40% of patients whose disease has worsened on one of these medications may benefit from trying another one of these drugs. These approaches are best used when the PSA is rising slowly. Results, if any, are generally seen within 1–2 months. While changing from one type of antiandrogen pill to another may be of benefit, once one antiandrogen pill is stopped, it should not be re-initiated.
2. Medivation: MDV3100 (Investigational Hormonal Agent). This drug, like Casodex, is an new type of antiandrogen which may work even in patients who have developed resistance to Casodex. This drug is taken daily by mouth and appears to be well tolerated. This drug may become available 2012 depending on the results on large ongoing studies.
3. ARN-509: (Investigational Hormonal Agent) This drug is also like Casodex and MDV3100, and may work in patients who have developed resistance to Casodex. This drug is also taken by mouth. It is being evaluated in men who have not previously received ketoconazole, abiraterone, or chemotherapy.
C) Diethylstilbesterol (DES):
DES is an estrogen pill that has been found to be effective in treating prostate cancer after conventional hormones have stopped working. While it is generally well tolerated, breast enlargement and nipple tenderness are common. Because a small percentage of patients (5–10%) develop blood clots while receiving DES, a low dose of Coumadin (a blood thinner) is usually administered as a pill along with DES in order to prevent this. DES is not available at pharmacies and requires a special mail order. It is not recommended for patients with prior blood clots, strokes, or heart attacks.
D) Steroids:
Steroids (also known as “corticosteroids�) such as prednisone and dexamethasone are active against prostate cancer for some individuals. They are especially useful for patients with bone pain or weight loss, and are also used as part of chemotherapy combinations.
2. Chemotherapy
Chemotherapy refers to drugs that directly kill prostate cancer cells. Chemotherapy can consist of conventional FDA approved drugs, as well as new investigational drugs.
A) Docetaxel (Taxotere) is a standard chemotherapy drug given by vein in the outpatient setting once every 3 weeks. Prednisone is an oral steroid which is taken twice daily. The combination of Docetaxel and prednisone has received FDA approval for the treatment of metastatic hormone refractory prostate cancer, as it has been shown to prolong survival in these patients. Approximately 50–60% of patients will have a significant lowering of PSA with this therapy, and 20–40% of patients will have shrinkage of measurable tumors (e.g., enlarged lymph nodes).
Patients treated with Docetaxel are at risk of developing nerve damage (neuropathy). This neuropathy is generally described by patients as numbness and/or tingling in the fingers and toes. Neuropathy usually occurs only after many doses of the medication. Some patients need to stop treatment with Docetaxel due to neuropathy. There are also medications to treat neuropathy, which your provider can discuss with you. Docetaxel can also cause fluid retention leading to swelling of the legs, but this is usually prevented by a steroid (dexamethasone) given before and after the administration of Docetaxel. In addition, some patients treated with Docetaxel develop other side effects, such as fatigue and changes in their fingernails.
B) Intermittent Chemotherapy (Standard Chemotherapy Being Tested in an Investigational Fashion)
The current standard method of treating patients with Docetaxel is to treat continuously (usually with every three week infusions) until the drug stops working or until side effects require that we stop. We are studying whether it is more beneficial to stop the chemotherapy when a response has been achieved (and re-starting the therapy later, when needed) or whether continuous therapy is best. In addition, we will be looking to see whether the addition of GM-CSF (an immune stimulant described above) during periods off chemotherapy can delay the time until the chemotherapy needs to be restarted.
C) Docetaxel +/- Alpharadin (Investigational Combination of Chemotherapy and Radiation therapy)
Alpharadin is a type of radiation therapy given by vein which targets prostate cancer lesions in the bones. In this study patients will receive either standard docetaxel chemotherapy, or docetaxel + alpharadin. In this study the treatments are given every 3 weeks. The side effects of alpharadin includes impairment of the immune system and fatigue.
D) Tesataxel (Investigational chemotherapy)
Tesataxel is similar to docetaxel however it is a pill and is given by mouth. While docetaxel is given with prednisone, tesataxel is not. It appears to be well tolerated and does not cause neuropathy. You doctor will follow your blood tests closely if you are taking tesataxel to monitor its effects on your body.
E) Cabazitaxel plus Abiraterone (Investigational Combination of Chemotherapy and Hormonal Therapy)
Cabazitaxel is a new chemotherapy which is approved for patients who have already received docetaxel (see “Chemotherapy after Docetaxel� below). This study will test whether the combination of cabazitaxel plus abiraterone is effective for patients who have never received chemotherapy or abiraterone before. The side effects of this treatment may include low blood counts, impairment of the immune system, high blood pressure, and swelling of the limbs.
F) Cabazitaxel plus Mitoxantrone and Prednisone (“CaMP� – Investigational Chemotherapy combination)
Cabazitaxel and Mitoxantrone are chemotherapies which are approved for patients who have already received docetaxel (see “Chemotherapy after Docetaxel� below). This study will test whether the combination of cabazitaxel + mitoxantrone is more effective than standard docetaxel for patients who have never received chemotherapy before. The side effects of this treatment may include low blood counts, impairment of the immune system, and shortness of breath
G) Chemotherapy after Docetaxel
1. Cabazitaxel (Jevtana) is a new chemotherapy given by vein in the outpatient setting once every three weeks. Like docetaxel, cabazitaxel is given with prednisone which is taken orally twice daily. The combination of cabazitaxel plus prednisone has received FDA approval for the treatment of metastatic hormone refractory prostate cancer in patients who have already received docetaxel, as it has been shown to prolong survival in these patients. The major side effects of cabazitaxel are low blood counts and impairment of the immune system. Should this occur there are treatments that can “boost� the immune system to prevent serious infections from occurring.
2. Mitoxantrone (Novantrone)
Mitoxantrone is given by IV injection over 30 minutes in the outpatient infusion center every 3 weeks. This drug has received FDA approval for the treatment of prostate cancer. Its primary role is in controlling pain. It is often combined with prednisone, similar to the manner in which prednisone is added to docetaxel. We will occasionally combine it with Navelbine, discussed below.
3. Vinorelbine (Navelbine)
Vinorelbine is given by IV injection in the outpatient infusion center, and is usually given weekly. It is often combined with mitoxantrone. Major side effects of vinorelbine include hair loss, fatigue, neuropathy, and decreased blood counts.
4. Oral Cyclophosphamide (Cytoxan)
Cytoxan is given as an oral tablet daily. Major side effects of cytoxan include hair loss, nausea and vomiting, blood in urine, and decreased blood counts.
5. Adriamycin/ Cyclophosphamide
Adriamycin (Doxorubicin) and Cyclophosphamide (Cytoxan) are given by IV injection every 3 weeks. Major side effects of adriamycin include fatigue, nausea and vomiting, and decrease in the ability of the heart to pump. Major side effects of cytoxan are described above.
6. Carboplatin +/- Docetaxel
Carboplatin has modest activity when used as a single agent in advanced prostate cancer. Its efficacy increases when this drug is given in combination with docetaxel (some patients continue to have a response with the combination even after they have progressed on single agent; this combination regimen is also the first choice for patients with the “anaplastic� or very aggressive variant of prostate cancer). When used as a single agent, this drug is given intravenously every 3 weeks. Side effects include fatigue, nausea, and suppression of the blood counts.
7. Satraplatin (Investigational Chemotherapy)
Satraplatin is a new type of chemotherapy which is given as a tablet by mouth for 5 days every month. The major side effects of satraplatin are low blood counts, impairment of the immune system, and diarrhea.
3. Other Therapies (non hormonal and non chemotherapy)
There are many options for participation in clinical trials at UCSF. In general, most clinical trials require that there be progression of your cancer to be eligible. If you are responding to a given treatment (e.g. hormonal therapy) participation in a trial may not be possible at the present time, but may be more appropriate at a later time.
A) Immune Therapy:
There are several agents that have the potential of stimulating your immune system to fight cancer. These treatments are usually well tolerated, however may not work for everyone.
1. Provenge (sipuleucel-T): Provenge is a vaccine that stimulates your own immune system to fight against prostate cancer. Unlike most vaccines, Provenge is used not to prevent illness but to treat an already existing condition. This vaccine must be custom made for each patient. First, patients have their blood run through a machine in an infusion center for two or three hours in order to extract certain immune system cells. These cells are then mixed with a protein that is commonly found on most prostate tumors. The protein is fused with another immune-stimulating substance called GM-CSF. The mixture is then returned to the patient in a one-hour infusion, given two days after the first blood draw. This process is repeated a total of 3 times over the course of a month. The basic idea is to alert
the immune system that prostate cancer cells should now be attacked as if they were a foreign invader.
This drug has been tested in patients who never received chemotherapy, and in a small number of men who have already received chemotherapy. In these trials, men who received Provenge lived an average of 4 months longer than those that did not; and a fraction of these patients were still alive 3 years later. Interestingly, men who lived longer with after receiving Provenge did not have reductions in their PSA nor shrinkage of their tumors. This drug received FDA approval in 2010 and is the first anti-cancer therapy vaccine ever to be approved. Side effects of this vaccine are mild, consisting mainly of flu-like symptoms that tend to resolve within a few days, and rarely, allergic reactions at the time of infusion. In order to receive Provenge you must have metastatic prostate cancer that has progressed despite Lupron or other treatments that lower testosterone. You must also not be taking or have recently received corticosteroids (prednisone, dexamethasone, or others) or chemotherapy, as it is thought that these will prevent Provenge from working. Most insurance companies cover the cost of Provenge, however, as it is expensive, it is important to discuss this with your physician.
Currently at UCSF we have a study evaluating the use of Provenge in men who are newly diagnosed with high-risk prostate cancer, and planning to undergo a prostatectomy. In this study patients receive 3 “doses� of Provenge over 9 weeks, then have their surgery. A certain number of men will then have an additional “booster� dose of Provenge after they have recovered from surgery. It is hoped that giving Provenge earlier in the course of the disease will result in better responses.
2. GM-CSF: Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF, or Leukine) has been shown to stimulate an anti-cancer immune response in patients with prostate cancer. GM-CSF is a growth factor for immune cells and white blood cells, and is identical to a protein your body naturally makes in smaller quantities. GM-CSF is injected under the skin using a small insulin syringe daily for 14 days, followed by a 2-week break. Side effects can include back pain and reactions like welts at the site of injection, both of which last only a few days.
3. DNA Vaccine (Investigational agent): This is a treatment which involves receiving an injection into the skin every two weeks of a vaccine made from the DNA genetic material from prostate cells, which is given together with GMCSF. The study aims to see whether this type of vaccine can generate a long-lived immune response against the cancer. Side effects may include redness, swelling, or bruising at the injection site
B) XL-184 (Cabozantanib, Investigational Agent):
XL-184 is a new type of treatment which blocks processes inside the cancer that are necessary for tumor growth. It is a pill taken once daily by mouth, and is being tested in men who have metastatic disease and have previously received chemotherapy. Side effects include loss of appetite, weight loss, rashes, diarrhea, and low blood counts.
C) Histone Deacetylase Inhibitors (HDACI, Investigational Agent):
Panobinostat (LBH-589) inhibits the enzyme histone deacetylase which eventually leads to cell death. We plan on using this oral drug in combination with Casodex. Side effects from this drug include fatigue, nausea, a decrease in blood counts, and a potential change in the electrical activity of the heart (which, if monitored, is not life threatening).
4. Phase I Clinical Trials
UCSF has a very active and growing Phase I Clinical Trials program headed by an experienced team of doctors and nurses. In general, phase I trials evaluate the safety of new pharmaceutical compounds in the body, as well as methods for safely administering these drugs, including dosage and delivery (such as oral, injection, and intravenous). These trials involve a small number of patients. If you participate in a phase I trial, you will see an oncologist that specializes in phase I trials in conjunction with your current team of oncologists. These trials quickly accrue patients (including patients with other types of tumors besides prostate cancer) and thus
open and close quickly. At any given time, we have 3-7
open phase I trials and we will discuss them with you on a case by case scenario.
A. Hyperpolarized (C13) Pyruvate (Investigational Imaging Study):
Many men with newly diagnosed prostate cancer will follow a course of active surveillance before having radiation therapy or having their prostate removed. The best type of imaging (ultrasound, MRI, CT scan) to follow the growth of these early cancers, however, is not known. A new type of scan called MRI spectroscopy has recently generated much interest, and it is thought that an injection by vein of C13-pyruvate, which comes from the breakdown of sugar, may improve the quality of the MRI in detecting and evaluating the growth of the cancer. This study is limited to men with recently diagnosed prostate cancer who have not had surgery or radiation therapy to the prostate, and who are not taking any hormonal therapy. A one-time dose of C13-pyruvate is given at the time of the MRI spectroscopy.
5. Other Therapies
Zoledronic Acid (Zometa) is a type of medication called a bisphosphonate that is used to prevent thinning of the bones. Zometa has also been shown to reduce the rate of bone-related events (fractures, worsening bony pain, and new lesions on bone scan) in patients with hormone resistant prostate cancer who have bone metastases. We are currently investigating the role of Zometa in patients with earlier stages of prostate cancer, most notably in patients who are about
to start or have just started hormone therapy for metastatic prostate cancer to bone. Zometa is given by vein every 3 to 4 weeks by a 15-20 minute infusion. There is a small risk of kidney damage, although this is minimized by checking kidney function before giving each Zometa dose. Also, 10–20% of patients develop a flu-like syndrome (muscle aches, fever, bone pain, extreme fatigue) beginning 24 to 48 hours after a Zometa infusion, which usually last 24 to 48 hours. This syndrome usually gets milder with each subsequent treatment and can be effectively treated with ibuprofen (Motrin, Advil) or acetaminophen (Tylenol). This therapy should be taken in combination with a calcium and vitamin D supplement. Rarely, Zometa has caused bone damage in the jaw when patients undergo dental extractions. If you are currently undergoing dental work (routine cleaning is fine) or have such work planned, please discuss this with your physician prior to starting Zometa.
Denosumab (Xgeva, Prolia) a new type of medication which reduces the rate of bone-related events (fractures, worsening bony pain, and new lesions on bone scan) in patients with hormone resistant prostate cancer who have bone metastases. It is a therapy given by vein every 4 weeks and appears to work as well as or better than Zometa. Unlike Zometa, it is an antibody (a type of immune protein). Its side effects are similar to those of Zometa (see above) and it can cause bone damage in the jaw when patients undergo dental extractions. If you are currently undergoing dental work (routine cleaning is fine) or have such work planned, please discuss this with your physician prior to starting Denosumab
Samarium (Quadramet) and Strontium: These are forms of radiation therapy that can be administered by a one-time intravenous injection. They can be used very effectively to reduce pain in the bones in patients who have cancer that has spread to the bones. The procedure is very similar to undergoing a bone scan. While usually an outpatient procedure, rarely it may require an overnight hospital stay.
Please note that this is only a very general information sheet, and that new treatments are continuously added to our list. We will be providing you with considerably more information as we discuss your treatment options. Our primary commitment is to your well being. Please let us know if there is more information that you need. Should you have additional questions, please feel free to contact us at 415-353-7171. Our web page has updated listings of protocols and other material of interest, and can be accessed at
http://cc.ucsf.edu/trials (type in keyword prostate cancer).
Please note that this is only a very general information sheet, and that new treatments are continuously added to our list. We will be providing you with considerably more information as we discuss your treatment options. Our primary commitment is to your well being. Please let us know if there is more information that you need. Should you have additional questions, please feel free to contact us at 415-353-7171. Our web page has updated listings of protocols and other material of interest, and can be accessed at
http://cc.ucsf.edu/trials (type in keyword prostate cancer).