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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: |
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What is prostate cancer? |
| A: |
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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
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| Q: |
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What are the signs and symptoms of prostate cancer? |
| A: |
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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
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| Q: |
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How quickly does prostate cancer spread? |
| A: |
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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
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| Q: |
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Is prostate cancer a terminal illness? |
| A: |
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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
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| Q: |
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What are the risk factors associated with prostate
cancer? |
| A: |
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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
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| Q: |
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How is prostate cancer diagnosed? |
| A: |
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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
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| Q: |
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What happens if prostate cancer is found in the biopsy? |
| A: |
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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
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| Q: |
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Can a doctor tell how fast the cancer will grow? |
| A: |
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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
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| Q: |
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How does prostate cancer affect a mans spouse/partner/family? |
| A: |
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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.
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| Q: |
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What are the treatment options for prostate cancer? |
| A: |
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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
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| Q: |
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What is the role of hormones in prostate cancer? |
| A: |
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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
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| References are available at www.viadur.com |
About
Viadur
| Q: |
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What is Viadur? |
| A: |
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Viadur is a leuprolide acetate implant that is placed under the
skin of the patients 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.
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| Q: |
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How does Viadur work? |
| A: |
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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.
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| Q: |
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Does Viadur cure prostate cancer? |
| A: |
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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.
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| Q: |
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Why is testosterone reduction important in the treatment
of prostate cancer? |
| A: |
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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 bodys 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.
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| Q: |
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What are the benefits of Viadur? |
| A: |
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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
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Viadur
Safety and Efficacy
| Q: |
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How effective is Viadur? |
| A: |
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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.
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| Q: |
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What were the most common side effects during treatment
with Viadur? |
| A: |
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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.
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| Q: |
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Who should NOT use Viadur? |
| A: |
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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.
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Viadur
Implant Insertion and Removal
| Q: |
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How is Viadur inserted? |
| A: |
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The Viadur implant is about the size of a matchstick and is inserted
under the skin of a patients 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.
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| Q: |
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Where is the procedure done and how long does it
take? |
| A: |
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The implant procedure is conducted in the physicians office
and usually takes about five minutes.*
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| Q: |
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How frequently will I need to visit the doctor after
Viadur is implanted? |
| A: |
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While Viadur eliminates the need for doctors 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 patients
treatment needs.
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| Q: |
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How often must the Viadur implant be replaced? |
| A: |
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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.
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* Journal of Urology, September 2000. Urology
55 (5), 2000.
Viadur is indicated in the palliative treatment of advanced
prostate cancer.
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