Physician Support
Patient FAQs
 
 

Viadur is indicated in the palliative treatment of advanced prostate cancer.

The following frequently asked questions were developed to help answer common patient questions about prostate cancer and the palliative treatment of advanced prostate cancer with Viadur.


About Prostate Cancer

Q:   What is prostate cancer?
A: Most cancers are named after the part of the body where the cancer first starts. Prostate cancer starts in the prostate gland, which is found only in men. The prostate is about the size of a walnut and is located just below the bladder, in front of the rectum. The prostate gland makes a fluid that is part of semen.1

 

Q: What are the signs and symptoms of prostate cancer?
A: Most cases of early prostate cancer cause no symptoms and are found by a prostate specific antigen blood test and/or digital rectal exam by a doctor. Symptoms of advanced prostate cancer include hematuria (blood in the urine), impotence (difficulty having an erection), and pain in the pelvis, spine, hips or ribs. It is important to remember that these symptoms may also be present with other diseases.2

 

Q: How quickly does prostate cancer spread?
A: Most prostate cancers grow very slowly. But sometimes this form of cancer can grow quickly, spreading to other parts of the body. Cancer cells may enter the lymph system and spread to lymph nodes (small, bean-shaped collections of cells that help in fighting infections). If cancer is in the lymph nodes, it is more likely to have spread to other organs of the body as well.3

 

Q: Is prostate cancer a terminal illness?
A: When treated by a doctor, many patients with prostate cancer continue to live and lead active lives. Ninety-three percent of men with prostate cancer live at least five years, and 72 percent survive at least 10 years. If the cancer is found before it has spread outside the prostate and is treated at that point, the five-year relative survival rate is 100 percent. If the cancer has spread to tissues near the prostate, the survival rate is 94 percent. And if the cancer has spread to distant parts of the body when it is found, about 33 percent will live at least five years.4

 

Q: What are the risk factors associated with prostate cancer?
A: While the causes of prostate cancer are not yet completely understood, researchers have found several factors that may be associated with the disease. These include:

Age: The chance of having prostate cancer increases rapidly after age 50. More than 80 percent of all prostate cancers are diagnosed in men age of 65 or older.5

Race: Prostate cancer is about twice as common among African-American men as it is among white American men.6

Nationality: Prostate cancer is most common in North America and northwestern Europe and less common in Asia, Africa, and South America.7

Diet: Many studies have shown eating a high-fat diet leads to a greater chance of developing prostate cancer. According to some research, eating fruits and vegetables with high levels of lycopenes or selenium appears to lower prostate cancer risk.8

Physical activity: Regular physical activity and maintaining a healthy weight may help reduce prostate cancer risk.9

Family history: Prostate cancer seems to run in some families, suggesting an inherited or genetic factor. Having a father or brother with prostate cancer doubles a man's risk of developing this disease. The risk is even higher for men with several affected relatives, particularly if the relatives were young at the time of diagnosis.10

 

Q: How is prostate cancer diagnosed?
A: If certain symptoms or the results of early detection tests have raised the possibility of prostate cancer, the doctor will use other tests to decide whether the disease is present. A prostate biopsy is a surgical procedure in which a sample of tissue is removed for examination under a microscope. Under transrectal ultrasound guidance a doctor inserts a narrow needle through the wall of the rectum into the area of the prostate gland that appears abnormal or suspicious. The needle then removes a cylinder of tissue, which is sent to the laboratory to see if cancer is present. The procedure is usually done in the doctor's office and takes about half an hour. Though the procedure sounds painful, it typically causes little discomfort because a special instrument inserts and removes the needle in a fraction of a second.11

 

Q: What happens if prostate cancer is found in the biopsy?
A: If the prostate biopsy finds a cancer, more tests are done to find out whether the cancer has spread and if so, how far.12 This process is called staging. Staging is very important because your treatment and the outlook for recovery depend on the stage of the cancer.

There is more than one system for staging prostate cancer. The TNM system, the one used most often, gives three key pieces of information:

  • T – Refers to the Tumor and its stage
  • N describes how far the cancer has spread to nearby lymph Modes
  • M shows whether the cancer has spread (Metastasized) to other organs of the body13

Letters or numbers after the T, N, and M give more details about each of these factors. The TNM descriptions can be grouped together into a simple set of stages, labeled stage 0 through stage IV (0-4). In general, the lower the number, the less the cancer has spread. A higher number, such as stage IV (4), means a more serious cancer.14

 

Q: Can a doctor tell how fast the cancer will grow?
A: In addition to staging, if cancer is found in a prostate biopsy specimen it will be graded to estimate how fast it is likely to grow and spread. Grading is done by the pathologist examining the prostate biopsy tissue sample. Prostate cancers are graded according to how closely they look like normal prostate tissue when viewed under a microscope.

The Gleason system is used most often for grading. Under this system a lower number like 2-4 means a slower growing tumor. A higher number such as 8-10 means the cancer cells are likely to grow more quickly. Scores of 5-6 are considered in between.15

 

Q: How does prostate cancer affect a man’s spouse/partner/family?
A: The diagnosis of cancer can be overwhelming not only to the patient, but also to the patient's family and friends. People often don't know what to say. They may feel sad and fearful of upsetting the patient, or they may be afraid. It is sometimes easier for people to stay away. Some people find it easier to talk, and still others may become overly considerate. There are no absolute rights and wrongs when dealing with people, because everyone copes differently and has a unique personality.

 

Q: What are the treatment options for prostate cancer?
A: There are many treatments for prostate cancer. The choice depends on several factors, including patient age, overall health, and the stage and grade of the cancer. Each type of treatment has benefits and drawbacks. Some of these treatments include:16
  • Surgery – The two most common operations for prostate cancer are radical prostatectomy and transurethral resection of the prostate.

    • Radical prostatectomy removes the entire prostate gland and some tissue around it. This surgery is done only if it appears that the cancer has not spread outside the prostate. The operation lasts up to four hours and is followed by an average hospital stay of three days and average time away from work of three to five weeks. The main side effects are lack of bladder control (incontinence) and not being able to get an erection (impotence).17

    • Transurethral resection of the prostate is used for men who can't have a radical prostatectomy for some reason. It may be done to relieve symptoms before other treatments begin, but is not done to cure the disease or to remove all the cancer. A tool with a small loop of wire on the end is placed inside the prostate through the urethra. The wire is heated and it cuts out the cancer tissue. The operation takes about one hour, and patients usually can leave the hospital after a couple of days and return to work in one to two weeks. After effects may include some trouble with bladder control, but permanent loss of control is rare.18

  • Cryosurgery – Involves placing a small metal tool into the tumor and killing the cancer by freezing it. The probe is placed through an incision between the anus and scrotum. Spinal or epidural anesthesia is used during this procedure, and a hospital stay of one or two days is common. After the procedure, there will be some bruising and soreness of the area where the probe was inserted. Freezing can damage nerves near the prostate and cause impotence and incontinence. In addition, freezing may damage the bladder and intestines, leading to pain, a burning sensation, and the need to empty the bladder and bowels often.19

  • Radiation therapy – High-energy x-rays are used to kill cancer cells via radiation. This form of treatment is used most often for cancer that has not spread outside the prostate gland, or has spread only to nearby tissue. If the disease is more advanced, radiation may be used to shrink the tumor and provide pain relief.20

  • Chemotherapy – Patients whose prostate cancer has spread outside of the prostate gland and for whom hormone therapy has failed may turn to chemotherapy. It will not destroy all the cancer cells, but it may slow tumor growth and reduce pain. Chemotherapy uses drugs in the form of injections or pills to kill cancer cells. Side effects may include nausea and vomiting, loss of appetite, loss of hair, and mouth sores. Because chemotherapy can damage the blood-producing cells of the bone marrow, patients may have low blood cell counts, which can increase the chance of infection, and cause bleeding or bruising after minor cuts or injuries, as well as tiredness. Most side effects go away once treatment is over.21

  • Hormone Therapy – Hormone therapy is often used for men whose cancer has spread to other parts of the body or has come back after earlier treatment. While hormone therapy does not cure the cancer, it can provide relief from symptoms. There are several methods used for hormone therapy. Most involve the release of drugs to lower the amount of testosterone or to block the body's ability to use androgens. Hormone treatment can have serious side effects, which may vary depending on the kind of treatment, hormone, or drug taken. Side effects may include reduced sexual desire or impotence, temporary hot flashes, breast tenderness and growth of breast tissue, and infertility.22

 

Q: What is the role of hormones in prostate cancer?
A:

Male hormones or androgens (which include testosterone) are produced mostly in the testicles. Androgens cause prostate cancer cells to grow. Lowering androgen levels can make prostate cancer shrink or grow more slowly. Therefore the goal of hormone therapy is to lower the levels of androgens.23

 

References are available at www.viadur.com

About Viadur

Q:   What is Viadur?
A:

Viadur is a leuprolide acetate implant that is placed under the skin of the patient’s upper arm. The implant releases leuprolide acetate, which reduces the amount of testosterone produced by the testicles and circulated in the body. Viadur releases leuprolide acetate for 12 months. After 12 months, the implant must be removed and may be replaced with a new implant. Viadur treats the symptoms of advanced prostate cancer, but is not a cure for cancer.

 

Q: How does Viadur work?
A:

By lowering the amount of testosterone in the body, Viadur may help relieve the pain, urinary problems, and other symptoms of prostate cancer. However, Viadur is not a cure for prostate cancer. Once Viadur is removed by your doctor, your body will start producing testosterone again.

Leuprolide, the active medication in Viadur, works by reducing the testosterone produced by the testicles. This lowers the amount of testosterone in the body. Testosterone appears to be needed by prostate cancer cells. Usually prostate cancer shrinks or stops growing when the body's supply of testosterone is lowered.

The DUROS technology used for Viadur is osmotically driven. Following surgical implantation of the Viadur implant, water from surrounding tissue enters one end of the cylinder through a semipermeable membrane. This causes the osmotic engine to swell, which in turn pushes the piston toward the drug compartment, causing a release rate controlled by the inflow of water. The drug is delivered from an exit port opposite the semipermeable membrane. This controlled release process takes place at rates less than 1/100th of a drop of water over 24 hours.

 

Q: Does Viadur cure prostate cancer?
A:

Viadur is a palliative treatment for advanced prostate cancer, which means it provides temporary relief of the symptoms of a disease but does not cure the disease.

 

Q: Why is testosterone reduction important in the treatment of prostate cancer?
A:

Prostate cancer cells seem to need testosterone (the natural male hormone produced by the testicles) for their growth. Usually prostate cancer shrinks or stops growing when the body’s supply of testosterone is lowered. Testosterone reduction therapy is usually administered to prostate cancer patients for many months or a few years, and is considered an important treatment of the symptoms of advanced prostate cancer.

 

Q: What are the benefits of Viadur?
A: Viadur brings 12-month convenience to long-term therapy:
  • Once-yearly dosing provides an alternative to one-, three-, or four-month injection schedules.
  • May meet the varied needs and busy lifestyles of many patients today, including:
    • "Snowbirds" and other frequent travelers
    • Patients who are employed
    • Patients who live in rural areas
    • Elderly patients and those in long-term care

 

Viadur Safety and Efficacy

Q:   How effective is Viadur?
A: In clinical studies, after surgical insertion of one Viadur implant, testosterone concentrations fell to castrate levels within four weeks in 99% of patients following the expected initial increase in serum testosterone. The one remaining patient achieved continuous testosterone reduction after 28 weeks of treatment. Once reduced, testosterone remained well below the castrate threshold for the duration of treatment. In addition, no patient had a clinically significant increase in testosterone levels when the original implant was removed and a new one was inserted.

Q: What were the most common side effects during treatment with Viadur?
A:

The most common side effects related to Viadur were hot flashes, lack of energy, depression, sweating, headache, bruising, and breast enlargement.

Prostate cancer-related symptoms may become worse during the first few weeks of treatment.

Like other similar treatment options, Viadur may cause impotence.

There may be some pain and discomfort during and after Viadur insertion and removal. Bruising may occur. Reactions, such as itching and redness, are usually mild and heal without treatment within two weeks. If they do not heal, contact your doctor.

There is a chance that your bones may become thinner if you use this type of drug for long periods of time. Ask your doctor if this is a risk for you.

This list is not a complete list of all the possible side effects. If you need more information, or are worried about these or other side effects, talk to your doctor or pharmacist.

Click here for detailed clinical trial information.

Q: Who should NOT use Viadur?
A:

Viadur should not be used by anyone who is allergic to the drug leuprolide or any of the components in Viadur. Viadur is not approved for use in women of any age. Use by a woman who may be pregnant may cause harm to the baby or cause a miscarriage. Viadur has not been studied in children and should not be used in them.

 

Viadur Implant Insertion and Removal

Q:   How is Viadur inserted?
A:

The Viadur implant is about the size of a matchstick and is inserted under the skin of a patient’s upper inner arm. The doctor numbs the arm, makes a small incision and then places the Viadur implant under the skin. The incision is closed with special surgical tape and covered with a bandage. After Viadur is inserted, the patient should keep the site clean and dry for 24 hours and avoid heavy lifting and physical activity for 48 hours. After the cut has healed, the patient should be able to go back to his normal activities.

 

Q: Where is the procedure done and how long does it take?
A:

The implant procedure is conducted in the physician’s office and usually takes about five minutes.*

 

Q: How frequently will I need to visit the doctor after Viadur is implanted?
A:

While Viadur eliminates the need for doctor’s office visits solely to administer hormone treatment, it is still important for patients to meet with their doctor regularly to determine treatment effectiveness and run various tests at different times over the course of the year, which may include the prostate specific antigen test (PSA) and digital rectal examination. The doctor will be able to advise the patient on the frequency of visits based on the patient’s treatment needs.

 

Q: How often must the Viadur implant be replaced?
A:

The Viadur implant must be replaced 12 months after insertion. At the one-year mark, the doctor will remove the previous implant and may replace it with a new Viadur implant.

 

* Journal of Urology, September 2000. Urology 55 (5), 2000.

Viadur is indicated in the palliative treatment of advanced prostate cancer.

 

Important Safety Considerations
Viadur should not be used by patients who are allergic to the drug leuprolide. Viadur should not be used by women or children and was not studied in women or children. Viadur, like other similar medications, causes a temporary increase of testosterone in the blood during the first week of treatment. During this initial period, patients may experience worsening of symptoms or onset of new symptoms including bone pain, nervous system distribances, blood in the urine, difficulty urinating, and spinal cord compression. During treatment, the most common side effects reported throughout the body were hot flashes, lack of energy, breast enlargement, depression, and sweating. The most common side effects reported where the implant was inserted in the arm were bruising and burning.

See Your Healthcare Provider
Remember, your doctor or health care provider is the single best source of information regarding you and your health. Please consult your doctor if you have any questions about your health, your symptoms, or your medication.

This information does not take the place of your doctor’s advice or instructions but should help answer some of the questions you might have about prostate cancer therapies.

Distributed and Marketed by: Manufactured by:

Bayer HealthCare Pharmaceuticals
6 West Belt, Wayne, NJ 07470 USA

© Copyright 2007 Bayer HealthCare Pharmaceuticals. Viadur is a trademark of ALZA Corporation under license to Bayer HealthCare Pharmaceuticals. DUROS® is a registered trademark of ALZA Corporation.

The information provided on Bayer products is only intended for the United States audience. Regulatory requirements, regulations, laws, and distribution of information about drug products may vary from country to country. Product names and indications (product uses) also may be different in different countries. The prescribing information provided here is based on United States labeling and may not be appropriate outside of the United States.