Combined Androgen Blockade: Pro And Con
Pro:
Crawford ED, Eisenberger MA, McLeod DG, et al. A Controlled Trial of Leuprolide With and Without Flutamide in Prostatic Carcinoma. New England Journal of Medicine 1989 321:41924. PMID: 2503724.
Con:
Eisenberger MA, Blumenstein BA, Crawford ED, et al. Bilateral Orchiectomy With or Without Flutamide for Metastatic Prostate Cancer. New England Journal of Medicine 1998 339:103642. PMID: 9761805.
Two large meta-analyses that reviewed many studies comparing combined androgen blockade to monotherapy concluded that the combination offered only a small survival advantage and even that finding was inconsistent between the two analyses. One analysis, which reviewed 27 randomized studies involving 8,275 men, estimated that combined androgen blockade improved five-year survival by only 2% to 3%, at most. However, an advantage of only 2% to 3%, when applied to thousands of men undergoing treatment, translates into hundreds of lives extended obviously an important benefit to the men who gain months and even years of life as a result. That is why I use combined therapy for all of my patients who undergo hormone treatments.
How Does It Work
The class of drugs to which Lupron belongs speaks a lot about its mechanism of action. Leuprolide acetate works to suppress gonadotrope secretion of follicle-stimulating and luteinizing hormone . This action eventually inhibits gonadal sex steroid production.
A more detailed explanation would be the following.
At first, administration of Lupron stimulates pituitary gland gonadotropins luteinizing hormone, and follicle-stimulating hormone .
As a result, steroidogenesis in a mans testicles increases.
When that happens, men may have elevated serum testosterone and dihydrotestosterone levels.
This is called tumor flare when the initial stages of treatment worsen symptoms of the disease.
That said, continuous administration of Lupron decreases gonadotropins and gonadal steroids.
With time, consistent administration of leuprolide acetate lowers the concentration of serum testosterone levels by inhibiting LH and FSH.
When Is It Given
How often you receive a Lupron Depot dose depends on the condition its being used to treat:
- For endometriosis or uterine fibroids, Lupron Depot is given either every month or every 3 months.
- For advanced prostate cancer, Lupron Depot is given every 1, 3, 4, or 6 month.
- For central precocious puberty in children, Lupron Depot-Ped is given either every month or every 3 months.
Your doctors office will work with you to make sure the injection appointments fit your schedule. To help make sure you dont miss an appointment, try setting a reminder on your phone.
The Lupron Depot dosage your doctor prescribes will depend on several factors. These include:
- the type and severity of the condition youre using Lupron Depot to treat
- the dose of Lupron Depot you take
- other medical conditions you may have
The following information describes dosages that are commonly used or recommended. However, your doctor will determine the best dosage to fit your needs.
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How Often Should I Receive Lupron Depot
Lupron Depot is given as an intramuscular injection into the muscle in your upper arm, buttock or thigh. Lupron Depot is available as single dose kits that contain a prefilled injection syringe of:
- 7.5 mg
- 22.5 mg
- 30 mg
- 45 mg
Depot formulations continuously release medicine into your body over a certain period of time after injection. This means you may not need to get a shot every day, or even every month. Your healthcare provider will give you Lupron Depot injection, and together you can decide which treatment dose and schedule might work best for you.
How Does The Doctor Know I Have Prostate Cancer
Prostate cancer tends to grow slowly over many years. Most men with early prostate cancer dont have changes that they notice. Signs of prostate cancer most often show up later, as the cancer grows.
Some signs of prostate cancer are trouble peeing, blood in the pee , trouble getting an erection, and pain in the back, hips, ribs, or other bones.
If signs are pointing to prostate cancer, tests will be done. Most men will not need all of them, but here are some of the tests you may need:
PSA blood test: PSA is a protein thats made by the prostate gland and can be found in the blood. Prostate cancer can make PSA levels go up. Blood tests will be done to see what your PSA level is and how it changes over time.
Transrectal ultrasound : For this test, a small wand is put into your rectum. It gives off sound waves and picks up the echoes as they bounce off the prostate gland. The echoes are made into a picture on a computer screen.
MRI: This test uses radio waves and strong magnets to make detailed pictures of the body. MRI scans can be used to look at the prostate and can show if the cancer has spread outside the prostate to nearby organs.
Prostate biopsy: For a prostate biopsy, the doctor uses a long, hollow needle to take out small pieces of the prostate where the cancer might be. This is often done while using TRUS or MRI to look at the prostate. The prostate pieces are then checked for cancer cells. Ask the doctor what kind of biopsy you need and how its done.
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When To Consider Hormone Therapy
Hormone therapy is a treatment option for men with prostate cancer in any of the following situations:
- when cancer has metastasized beyond the prostate
- when cancer is confined to the prostate, but hormone therapy is used to boost the effectiveness of radiation therapy or to shrink the size of a tumor before brachytherapy
- when PSA begins to rise sometime after initial treatment with surgery or radiation therapy, indicating the cancer may have recurred.
Not all doctors agree on when to use hormone therapy, or how to administer it. Indeed, this is an area that requires a physician to exercise as much art as science in clinical practice. You should also be aware that side effects can be daunting, although most men tolerate treatment reasonably well .
Lupron Depot Side Effects
Lupron Depot can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Lupron Depot. These lists do not include all possible side effects.
For more information on the possible side effects of Lupron Depot, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.
Note: The Food and Drug Administration tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect youve had with Lupron Depot, you can do so through MedWatch.
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What Should You Ask Your Doctor About Treatments
The American Cancer Society recommends that you ask questions like these:
- What treatment might be best for me?
- What are the possible benefits of getting it?
- How soon would I need to start treatment?
- Will I need to get surgery as part of my treatment? If so, what will it be like and who will do it?
- Will I need other treatments, too? If so, how might they benefit me?
- What side effects could my treatments cause? And what should I do if I get them?
- Is there a clinical trial that might be a good option for me?
- Can you review any vitamins or diet Iâm on to make sure it wonât interfere with my cancer treatment?
Evidence For Combining Hormone Therapy And Radiation Treatment
Bolla M, Collette L, Blank L, et al. Long-Term Results with Immediate Androgen Suppression and External Irradiation in Patients with Locally Advanced Prostate Cancer : A Phase III Randomised Trial. Lancet 2002 360:1036. PMID: 12126818.
Bolla M, Gonzalez D, Warde P, et al. Improved Survival in Patients with Locally Advanced Prostate Cancer Treated with Radiotherapy and Goserelin. New England Journal of Medicine 1997 337:295300. PMID: 9233866.
DAmico AV, Schultz D, Loffredo M, et al. Biochemical Outcome Following External Beam Radiation Therapy With or Without Androgen Suppression Therapy for Clinically Localized Prostate Cancer. Journal of the American Medical Association 2000 284:12803. PMID: 10979115.
DAmico AV, Manola J, Loffredo M, et al. Six-Month Androgen Suppression Plus Radiation Therapy Versus Radiation Therapy Alone for Patients with Clinically Localized Prostate Cancer: A Randomized Controlled Trial. Journal of the American Medical Association 2004 292:8217. PMID: 15315996.
Denham JW, Steigler A, Lamb DS, et al. Short-Term Androgen Deprivation and Radiotherapy for Locally Advanced Prostate Cancer: Results from the Trans-Tasman Radiation Oncology Group 96.01 Randomised Controlled Trial. Lancet Oncology 2005 6:84150. PMID: 16257791.
Nesslinger NJ, Sahota RA, Stone B, et al. Standard Treatments Induce Antigen-Specific Immune Responses in Prostate Cancer. Clinical Cancer Research 2007 13:1493502. PMID: 17332294.
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Where Prostate Cancer Spreads In The Body Affects Survival Time
EMBARGOED FOR RELEASE until 4 p.m. on Monday, March 7, 2016
DURHAM, N.C. Patients with lymph-only metastasis have the longest overall survival, while those with liver involvement fare worst. Lung and bone metastasis fall in the middle.
Smaller studies had given doctors and patients indications that the site of metastasis in prostate cancer affects survival, but prevalence rates in organ sites were small, so it was difficult to provide good guidance, said Susan Halabi, Ph.D., professor of biostatistics at Duke and lead author of the study published online March 7 in the Journal of Clinical Oncology.
With the large numbers we analyzed in our study, we were able to compare all of these different sites and provide information that could be helpful in conveying prognosis to patients, Halabi said. This information could also be used to help guide treatment approaches using either hormonal therapy or chemotherapy.
Halabi and colleagues from leading U.S. and international cancer research centers pulled data from nine large, phase III clinical trials to analyze outcomes of 8,736 men with metastatic prostate cancer. The patients had all undergone standard treatment with the chemotherapy drug docetaxel.
Site of metastases was categorized into four groups: lung, liver , lymph nodes only, bone with or without lymph nodes and no other organ metastases.
Halabi said more research is needed to understand how and why prostate cancer spreads to different organs.
The Initial Causes Prostate Cancer Spread To Organs
One of the first symptoms of prostate issues is pain or tenderness in the groin or lower back. This can be the result of a noncancerous condition called enlarged prostatic tissue, or it could be an infection of the bladder. In either case, its important to see a doctor as soon as possible. If youre suffering from prostate pain, you may want to consider reducing your caffeine intake.
Another symptom of a potentially enlarged prostate is difficulty starting a stream of urine, leaking, or dribbling. These symptoms are not serious, but theyre still alarming. Most men put up with an enlarged prostate for years before seeking medical attention, but they typically seek treatment as soon as they notice symptoms. Even if you dont have symptoms, its worth getting checked to determine if you have any prostate issues.
If you experience nightly bathroom runs, you may be experiencing an enlarged prostate. You may be having difficulty starting a stream of urine, or you may even be dribbling or leaking during the day. These problems arent life-threatening, but can become a nuisance. You should not ignore these signs and seek treatment as soon as you notice them. If you feel any of these symptoms, you should consult a doctor.
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How Effective Is It For Treating Prostate Cancer
Although Lupron for prostate cancer is not a novel idea, studies on this subject are scarce. Current evidence confirms administration of leuprolide acetate can, indeed, suppress the production of testosterone, i.e., it is effective for androgen deprivation.
Not only is leuprolide effective in suppressing testosterone, but it is also well-tolerated.
Not every patient with prostate cancer will need to take Lupron. Doctors recommend and prescribe leuprolide acetate to men with late-stage prostate cancer.
Its highly unlikely for most doctors to start treating early-stage prostate cancer with hormonal therapies, including Lupron.
Doctors may prescribe Lupron for cases when cancer comes back after surgery or radiation therapy.
Hormone therapy such as Lupron may be recommended to patients whose cancers spread too much for radiation therapy and surgery to cure it.
Patients who cant have surgery or radiation therapy could benefit from Lupron and other hormone therapy approaches to treat prostate cancer.
Doctors may also recommend Lupron to shrink cancer before employing radiation therapy.
Prostate cancer patients undergoing radiation therapy and having a high risk of cancer returning may also get a prescription for Lupron therapy.
Now youre probably wondering why doctors cant start with hormonal therapy such as Lupron at early prostate cancer stages? Whats stopping them?
However, cancer may become resistant to the medication and stop responding to the treatment.
Stages Of Prostate Cancer
In order to determine the stage of a patients prostate cancer, most doctors start by using the TNM staging system, which helps describe different aspects of the cancers growth.
- T the T category measures the size and extent of the Tumor
- N the N category measures whether and how far the cancer has spread to the Lymph Nodes
- M the M category whether the cancer has spread to other organs in the body (a process called Metastasis
The score for each of these categories is determined based on a pre-determined set of criteria. Your doctor cannot feel or see the tumor with a score of T1. A score of T3 means that the tumor has begun to grow outside of the prostate.
After calculating the TNM categories, doctors will combine the TNM score with the patients Gleason score and PSA levels assigning of a specific stage to the patients cancer.
Prostate cancer prognosis and survival rates can help give patients an idea of their chances of surviving the disease based on the stage and time of diagnosis. While some patients may find this information helpful, others may not want to know.
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Controversies In Hormone Therapy
The use of hormone therapy requires as much art as science. Physicians do not always agree about when it is best to start treatment, whether it needs to be continuous or can be stopped and started up again periodically, and whether monotherapy or combination therapy is best. Here are the salient issues, what the studies say and what I believe and follow in my own practice.
Lupron Depot And Lab Tests
You may have reduced levels of certain hormones in your body during your treatment with Lupron Depot. If you have any lab tests that look for hormones, the results of the tests may be incorrect.
Its recommended that you wait 3 months until after youre done with Lupron Depot treatment before having these tests. This way, the results are less likely to be incorrect. Talk with your doctor about any tests you have scheduled while taking Lupron Depot to ensure your lab results will be accurate.
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How Serious Is My Cancer
If you have prostate cancer, the doctor will want to find out how far it has spread. This is called the stage of the cancer. You may have heard other people say that their cancer was stage 1 or stage 2. Your doctor will want to find out the stage of your cancer to help decide what types of treatment might be best for you.
The stage is based on the growth or spread of the cancer through the prostate, and if it has spread to other parts of your body. It also includes your blood PSA level and the grade of the cancer. The prostate cancer cells are given a grade, based on how they look under a microscope. Those that look very different from normal cells are given a higher grade and are likely to grow faster. The grade of your cancer might be given as a Gleason score or a Grade Group . Ask your doctor to explain the grade of your cancer. The grade also can helpdecide which treatments might be best for you.
Your cancer can be stage 1, 2, 3, or 4. The lower the number, the less the cancer has spread. A higher number, like stage 4, means a more serious cancer that has spread outside the prostate.
If your cancer hasnt spread to other parts of the body, it might also be given a risk group. The risk group is based on the extent of the cancer in the prostate, your PSA level, and the results of the prostate biopsy. The risk group can help tell if other tests should be done, and what the best treatment options might be.
How Lupron Depot Works
Lupron Depot contains the drug leuprolide acetate, which belongs to a class of drugs called gonadotropin releasing hormone agonists. It works by blocking your body from creating certain hormones, like estrogen and testosterone.
These hormones play key roles in many of our bodily functions. However, when the hormones are out of balance, they can cause negative side effects. For example, testosterone signals prostate cancer cells to grow. Lupron Depot works by stopping the production of testosterone in your body. This can help stop prostate cancer cells from growing.
With endometriosis, estrogen affects lesions by stimulating them to bleed like uterine tissue. This is often uncomfortable and painful.
Estrogen also can cause uterine fibroids to develop and grow. By blocking estrogen production, Lupron Depot helps reduce pain and can shrink or get rid of lesions and uterine fibroids.
Lupron Depot-Ped is used for central precocious puberty, a condition in which a child experiences the effects of puberty earlier than usual. Lupron Depot-Ped works by blocking certain hormones that make childrens bodies undergo puberty. This delays puberty as long as the child uses the medication.
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