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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:
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T Refers
to the Tumor and its stage |
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N describes how
far the cancer has spread to nearby lymph Nodes |
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M
shows whether the cancer has spread (Metastasized)
to other organs of the body13 |
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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
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Surgery The two most common
operations for prostate cancer are radical prostatectomy
and transurethral resection of the prostate. |
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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 |
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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 |
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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 |
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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. Side effects may include nausea, fatigue, and impotence.20 |
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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 |
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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 |
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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 inner 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.
View
an Image of the Implant
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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:
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Once-yearly dosing provides an
alternative to one-, three-, or four-, or six-month injection
schedules. |
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Viadur may be appropriate for any
patient who requires at least 12 months of LH-RH therapy. |
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Viadur
Safety and Effectiveness
| 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 burning, 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 in clinical trials, the average time
for the implant procedure (from incision to close) was four to six
minutes (range: one to 15 minutes, not including patient preparation
or recovery time. Preparation includes identifying the insertion site, preparing the sterile field, loading the implanter, and anesthetizing the area).
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| Q: |
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How frequently will the patient 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 removed 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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References

Clinical
Trial Information
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