PRODUCT INFORMATION
ProstaScint® is an imaging agent that can help locate and identify the extent of prostate cancer. It also helps identify previously diagnosed prostate cancer that has spread (metastasized) to other areas within the body, such as the lymph nodes, adjacent tissue and bone. ProstaScint is a single clone (monoclonal) antibody that is combined with a small amount of radioactive material called Indium 111. Given by injection into a vein, ProstaScint circulates throughout the body and attaches to an antigen called PSMA (Prostate Specific Membrane Antigen), which is located on prostate cancer cells. Pictures or images are then taken with a special device called a gamma camera that can detect radiation given off by the Indium 111. Using this technology, pictures or images will be produced showing prostate cancer. Click here for the ProstaScint Patient Instruction Guide.
ProstaScint can be used in newly-diagnosed prostate cancer patients with biopsy-proven prostate cancer, who are at high-risk for pelvic lymph node cancer growth. ProstaScint is also recommended for use in post-prostatectomy patients with a rising PSA (Prostate Specific Antigen) in whom there is a high medical suspicion of metastatic disease. Patient management should not be based on ProstaScint scan results without additional verification.
SAFETY INFORMATION
Indium 111 ProstaScint images should be interpreted only by physicians who have had specific training in Indium 111 ProstaScint image interpretation and proper patient preparation is mandatory to obtain optimal images for interpretation (see PRECAUTIONS, Imaging Precautions in the full prescribing information).
Indium 111 ProstaScint should not be used in patients who are hypersensitive to products of murine origin or Indium 111 chloride. Allergic reactions, including anaphylaxis, can occur in patients who receive murine antibodies. Although serious reactions of this type have not been observed in clinical trials after Indium 111 ProstaScint administration, medications for the treatment of hypersensitivity reactions should be available during administration of this agent. Indium 111 ProstaScint may induce human anti-mouse antibodies which can interfere with some immunoassays, including those used to assay PSA and digoxin. Patients should be advised to discuss prior use of murine-protein based products with their physicians.
In clinical trials, adverse reactions were observed in 4% of 529 patients. The most common adverse reactions are increased levels of bilirubin in the blood, elevated blood pressure or low blood pressure, which occurred in less than 1% of patients. Click here for Product Safety Q&A
ProstaScint Prescribing Information
Click here for ProstaScint full prescribing information
ProstaScint Product Safety Q&A
Why would my doctor recommend a ProstaScint scan?
Your doctor would recommend a ProstaScint scan if you had a biopsy of the prostate gland that showed you have prostate cancer and he/she feels that there is a risk the cancer may have spread (metastasized) to the lymph nodes or tissue that surrounds the prostate gland.
OR
If you have had your prostate gland removed and blood tests show a rise in your PSA (Prostate Specific Antigen) levels your doctor may order a ProstaScint scan to rule out the spread of prostate cancer.
Is there any reason why I should not have a ProstaScint scan?
You should not have a ProstaScint scan if you are allergic to murine antibodies or to the radio active material called Indium 111
Are there any side effects with ProstaScint?
Yes. Although uncommon, allergic reactions can occur including anaphylaxis ("shock"). Your doctor should have medication available for the treatment of these reactions during the administration of ProstaScint.
Other side effects that can occur are increase or decrease in blood pressure, effects on your liver and injection site reactions.
Some patients can develop a HAMA response, which is a human anti-mouse antibody response from ProstaScint. This can interfere with some other tests (immunoassays) including those used to measure PSA and digoxin. Patients need to tell their doctor that they have had an earlier ProstaScint injection before having any tests of this kind in the future.
Click here for ProstaScint full prescribing information
FREQUENTLY ASKED QUESTIONS
- Questions
- What is the prostate gland and where is it?
- What is prostate cancer?
- What are the symptoms of prostate cancer?
- How is prostate cancer diagnosed?
- What is a PSA test?
- What is the survival rate for prostate cancer?
- What treatments are available for prostate cancer?
- What age group is most at risk for prostate cancer?
- What can you do to prevent prostate cancer?
- What are some risk factors that increase a person's chances of developing prostate cancer?
- Do hereditary factors increase the likelihood of contracting prostate cancer?
- Should only older men be concerned about prostate cancer?
- Could a vasectomy cause prostate cancer?
- Does treatment for prostate cancer inevitably cause sexual dysfunction or impotence?
What is the prostate gland and where is it?
The prostate is a gland in the male reproductive system. The prostate makes and stores a component of semen and is located near the bladder and the rectum. The prostate surrounds part of the urethra, the tube that empties urine from the bladder. A healthy prostate is about the size of a walnut. If the prostate grows too large, the flow of urine can be slowed or stopped.
What is prostate cancer?
Prostate cancer is a disease in which malignant (cancer) cells form in the tissues of the prostate. The disease is found mainly in older men. As men age, the prostate may enlarge, blocking the urethra or bladder. This may cause difficulty in urination or can interfere with sexual function. These symptoms may indicate cancer, but they also are common to benign prostatic hyperplasia (BPH), a noncancerous enlargement of the gland. Therefore, it is important to discuss them with your doctor as soon as they occur.
What are the symptoms of prostate cancer?
Prostate cancer often does not cause symptoms for many years. By the time symptoms occur, the disease may have spread beyond the prostate. When symptoms do occur, they may include:
- Frequent urination, especially at night
- Inability to urinate
- Trouble starting or holding back urination
- A weak or interrupted flow of urine
- Painful or burning urination
- Blood in the urine or semen
- Painful ejaculation
- Frequent pain in the lower back, hips, or upper thighs
How is prostate cancer diagnosed?
The diagnosis of prostate cancer can be confirmed only by a biopsy. During a biopsy, a urologist (a doctor who specializes in diseases of urinary and sex organs in men, and urinary organs in women) removes tissue samples, usually with a needle. This is generally done in the doctor's office with local anesthesia. Then a pathologist (a doctor who identifies diseases by studying tissues under a microscope) checks for cancer cells.
What is a PSA test?
The PSA or prostate specific antigen test is a blood test used to measure the amount of a particular protein found in a person's blood. Prostate cells make this protein and normally the PSA level is usually low (less than 4.0 nanograms per milliliter).
Prostate cancer and certain other conditions can raise the PSA value because of an increase in the amount of prostate specific protein circulating in the blood. If the PSA value is higher than 4.0 nanograms per milliliter in a normal middle-aged male, the doctor may consider further testing to see whether prostate cancer could be the cause.
What is the survival rate for prostate cancer?
About 99 percent of men will survive five years and 92 percent will survive 10 years.
What treatments are available for prostate cancer?
- Radical prostatectomy is a surgery to completely remove the prostate gland.
- Radiation is a treatment option that may be less traumatic than a radical prostatectomy (RP). When used in early-stage patients, radiation can have similar results. About half of the patients receiving radiation experience side effects such as impotence. It can be applied through an external beam that directs the dose to the prostate from outside the body. FDA also has cleared low-dose radioactive "seeds," each about the size of a grain of rice, that are implanted within the prostate to kill cancer cells. This technique, called brachytherapy, can be used in conjunction with external-beam radiation for a more effective way of treating prostate cancer.
- Cryotherapy is a treatment that uses very cold gases to freeze and destroy prostate tissue. The doctor administers the therapy through needles and monitors the effects on images provided by transrectal ultrasound.
- Hormonal Therapy may be used in all phases of prostate cancer treatment. Drugs are often given to cease production or action of the male hormones that have been shown to encourage the growth and spread of prostate cancer. The testicles produce male hormones, and their removal can end hormone production.
- Chemotherapeutic drugs do not cure the disease, but they can be used to ease pain and other symptoms of advanced prostate cancer patients.
- Skeletal Targeted Radiopharmaceuticals - In cases of advanced disease, prostate cancer that has spread to the bones can result in significant pain. This pain is usually initially responsive to analgesic (pain killing) medications, however, as symptoms intensify sometimes other methods are required to treat the pain. One such method involves the injection of radioisotopes that seek out and bind to areas of the bone affected by cancer. These radioisotopes then provide a very high dose of radiation to the region, which can result in the relief of painful symptoms.
What age group is most at risk for prostate cancer?
About 70% of all diagnosed prostate cancers are found in men aged 65 years or older.
What can you do to prevent prostate cancer?
Some research suggests that lifestyle changes can reduce the risk of prostate cancer.
- Eat a low-fat diet: consume a diet rich in fresh fruits and vegetables and cut back on foods high in cholesterol.
- Quit smoking! Smoking has been associated with rapid growth of prostate tumors in some patients.
- Take good general care of your self with regular exercise, a good night's sleep and learning to manage stress.
What are some risk factors that increase a person's chances of developing prostate cancer?
- AGE - Simply growing older increases a man's risk for getting prostate cancer. More than 75 percent of prostate cancer cases are diagnosed in men ages 65 or older; just 7 percent of cases occur in men younger than age 60. The average age at diagnosis is 72.
- RACE - African-American men have the world's highest incidence of prostate cancer-a third higher than white Americans. By contrast, Asian immigrants to the United States have much lower rates.
- FAMILY HISTORY - Men whose father or brothers have prostate cancer have an increased risk of contracting the disease as well. The risk is more than 10 times higher for a man who has three relatives with the disease. Risk may also be increased for men whose from families with a high incidence of breast cancer. Researchers increasingly are looking at hormonal and hereditary factors and at diet, environmental exposures, and other lifestyle factors in relation to prostate cancer.
Do hereditary factors increase the likelihood of contracting prostate cancer?
As with breast and colon cancer, familial clustering of prostate cancer has been reported frequently. Genetic factors account for 5 to 10 percent of prostate cancer cases. Results from several large case-control studies and cohort studies representing various populations suggest that family history is a major risk factor in prostate cancer.
Should only older men be concerned about prostate cancer?
Prostate cancer is found mainly in older men. About 70 percent of all diagnosed prostate cancers are found in men aged 65 years or older. In some instances, prostate cancer can strike younger men in their 40s and 50s, especially if there is a family history of prostate cancer. All adult men need to learn about this cancer and pay attention to their bodies.
Could a vasectomy cause prostate cancer?
The results of research on the association between vasectomy and prostate cancer are not consistent. In addition, scientists have not found any convincing biological explanation for a link between vasectomy and an increased risk of prostate cancer. Scientists and researchers have concluded that even if having a vasectomy can increase a man's risk of developing prostate cancer, the increase in risk is relatively small.
Although a few studies have reported a link between vasectomy and prostate cancer, it is possible that other factors, including chance, may be responsible for the association suggested in these studies.
Does treatment for prostate cancer inevitably cause sexual dysfunction or impotence?
The National Cancer Institute reports surgery to remove the prostate may cause long-term problems. After surgery, some men are unable to control the flow of urine from the bladder, called urinary incontinence. If the rectum is injured, men may be unable to prevent the escape of stool from the body, called fecal incontinence.
Some men may become impotent. Nerve-sparing surgery is an attempt to avoid the problem of impotence. If the operation is fully successful, impotence may be only temporary. In some cases, however, even men who have this procedure remain impotent. Men can talk with their doctor about medicine and other ways to help manage the sexual effects of cancer treatment.
Men who have a prostatectomy no longer produce semen, so they have dry orgasms. Men who wish to father children may consider sperm banking or a sperm retrieval procedure.
Both internal and external radiation therapy can cause nerve damage that results in impotence. However, internal radiation therapy is not as likely to have this effect.
Internal radiation therapy may cause temporary incontinence. Long-term side effects from internal radiation therapy are uncommon.
