Xofigo compared to Xtandi means that men with prostate cancer have another treatment option to consider. The Food and Drug Administration (FDA) approved a new medication, Xofigo (radium-223 dichloride), for late stage castration-resistant prostate cancer on May 15, 2013.  With this new addition of medication on the market, prostate cancer patients will want to ask how it compares to other available medications they are taking or considering. Xtandi (enzalutamide), was approved by the FDA on August 31, 2012, so both medications are fairly new to the market.

 How Do Xofigo and Xtandi Work?

Both medications are used for hormone-resistant prostate cancers that have metastasized, or spread to other areas of the body.

Xofigo has an anti-tumor effect. The injectable medication contains radium (a heavy metal), which delivers radiation directly to bone tumors without significantly damaging surrounding tissues. This breaks up double-strand DNA, killing the prostate cancer cell at the site of cancer-induced increased bone turnover. Therapy consists of six injections given at four-week intervals.

Xtandi is an androgen receptor inhibitor that works against prostate cancer by causing cell death and decreasing tumor size. Studies show that Xtandi works by interfering with the testosterone and dihydrotestosterone receptors on prostate cancer cells. The drug also stops the hormone receptors from exchanging messages with prostate cancer cells, and this stops cancer growth. It is an oral medication taken at home. Treatment usually lasts eight months.

In studies, Xtandi had a 4.8-month survival benefit over a placebo, while Xofigo had a 3-month survival benefit over a placebo.

Xofigo Compared to Xtandi: Who Is Eligible?

Both drugs are used for advanced stages of castration-resistant prostate cancer that have spread despite hormone therapy.

Xofigo is only for cancers that have spread to the bones and not other organs. It cannot be used with chemotherapy.

Candidates for Xtandi have advanced prostate cancer that has spread or recurred after treatment with docetaxel (chemotherapy) in addition to hormone therapy.

Xofigo Compared to Xtandi: Side Effects

Common side effects of Xofigo may include:

• Nausea
• Diarrhea
• Vomiting
• Swelling of the leg, ankle, or foot

Common side effects of Xtandi may include:

• Anxiety
• Back pain
• Blood in the urine
• Diarrhea, dizziness
• Headache
• High blood pressure
• Hot flush
• Lower or upper respiratory infections
• Muscle weakness
• Sleep problems
• Spinal cord compression
• Tingling in the arms and legs

 Xofigo Compared to Xtandi: Cost

Xofigo costs $69,000 for the complete course of therapy. Because it is new, patients need to check with their insurance carrier for coverage. Bayer will have a patient assistant program to help with costs.

Xtandi costs $7,450 per month, and the average treatment course is eight months, so it is approximately $60,000 for a full course of treatment. Xtandi should be covered by Medicare and by most insurance companies, but men need to check with their insurance provider.

 Xofigo Compared to Xtandi: Which One for You?

Your physician can help you determine which medication is right for you based on your symptoms, metastases, and other treatments you are using. If your prostate cancer has spread beyond bones to other organs, then Xofigo is not the right treatment for you. If you have already had hormone therapy and chemotherapy, then Xtandi may be a choice. Ultimately, you are the one who will decide what is right for your health.

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In order to understand prostate cancer and immunotherapy treatment, you need to learn a little bit about the progression and standard treatment of prostate cancer.

In the United States, prostate cancer is the second leading cause of cancer death among men with more than 200,000 new cases and more than 27,000 deaths annually. In some men prostate cancer is diagnosed early with only localized disease, while others are diagnosed late after the disease has spread.

Immunotherapy and Prostate Cancer—Standard Therapy

Standard treatment for prostate therapy is hormone therapy or androgen deprivation therapy. The goal is to reduce levels of male hormones, called androgens, in the body, or to prevent them from reaching prostate cancer cells. The main androgen in men is testosterone.

Despite initial response rates in the 80 to 90% range, nearly all men eventually develop progressive disease. Immunotherapy for prostate cancer is indicated when patients develop symptoms and progressive disease following androgen deprivation therapy, also referred to as castration-resistant metastatic prostate cancer.

Immunotherapy and Prostate Cancer—Provenge Therapy

Sipuleucel-T (Provenge) is a relatively new therapy for the treatment of asymptomatic or minimally symptomatic, castrate resistant metastatic prostate cancer. This therapy is like a vaccine that stimulates your own immune system to attack and fight the spread of cancer.

In order to be considered a good candidate for this therapy you need to have a rising PSA level despite standard treatments. Additionally, the cancer needs to have spread outside of the prostate but not be significant enough to need narcotics for pain control.

Basically, your body’s immune cells are taken out of your body and treated to develop your Provenge infusion. In this sense, your treatment is tailored for you specifically.When your immune cells are given back to you as an infusion, your immune cells have been trained to find and attack the advanced prostate cancer cells in your body. Additionally, the Provenge infusion helps your body to continue to increase its immune response to your cancer.
One of  the advantages of this treatment is the relatively smaller number of side effects and tolerability of the treatment.

Immunotherapy and Prostate—Immune Therapy

PROSTVAC is another therapeutic cancer vaccine that is currently in clinical trials. This particular vaccine stimulates an immune response against prostate cancer by targeting the prostate specific antigen or PSA.

GVAX is a genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), an immunostimulant. It is currently being evaluated in a number of different combinations.

Immunotherapy and prostate cancer will continue to be linked in the near future with the development of novel therapies as well as sequencing and combinations of these new drugs.

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Lawrence Fong and Eric J. Small. Immunotherapy for Prostate Cancer. Semin Oncol. 2003, 30:649-658.

Rini BI, Small EJ. Immunotherapy for Prostate Cancer. Current Oncology Reports. 2001, 3:418–423

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Xofigo compared to Zytiga means that men with prostate cancer have another treatment option to consider. The Food and Drug Administration (FDA) approved a new medication, Xofigo (radium-223 dichloride), for late stage castration-resistant prostate cancer on May 15, 2013.

With this new addition of medication on the market, prostate cancer patients will want to ask how it compares to other available medications they are taking or considering taking. Zytiga (abiraterone acetate) is another medication for patients with late-stage (metastatic) castration-resistant prostate cancer. Zytiga was approved by the FDA for use in combination with a steroid, prednisone on April 29, 2011, as a hormone therapy for patients whose prostate cancer has spread after chemotherapy.

How Do Xofigo and Zytiga Work?

Both medications are used for hormone-resistant prostate cancers that have metastasized, or spread to other areas of the body.

Xofigo has an anti-tumor effect. The injectable medication contains radium (a heavy metal), which delivers radiation directly to bone tumors without significantly damaging surrounding tissues. This breaks up double-strand DNA, killing the prostate cancer cell at the site of cancer-induced increased bone turnover. Therapy consists of six injections given at four-week intervals.

Zytiga is an oral medication taken once per day, but the dose is accompanied by the steroid prednisone, which is taken twice a day. Zytiga works by targeting a protein called cytochrome P450 17A1 (CYP17A1). This plays a significant role in testosterone production. Zytiga differs from other hormone therapies for prostate cancer in that it is the only therapy able to reduce the production of testosterone from three sources: the adrenal glands, the testes, and the prostate tumor. The average length of treatment is eight months.

In studies, patients taking Zytiga had a 3.9-month survival benefit over a placebo, while Xofigo had a 3-month survival benefit over a placebo.

Xofigo Compared to Zytiga: Who Is Eligible?

Both drugs are used for advanced stages of castration-resistant prostate cancer that have spread despite hormone therapy.

Xofigo is only for cancers that have spread to the bones and not other organs. It cannot be used with chemotherapy.

Candidates for Zytiga have advanced prostate cancer that has spread or recurred after treatment with docetaxel (chemotherapy) in addition to hormone therapy.

 Xofigo Compared to Zytiga: Side Effects

Common side effects of Xofigo may include:

• Nausea
• Diarrhea
• Vomiting
• Swelling of the leg, ankle, or foot

Common side effects of Zytiga may include:

• Cough
• Diarrhea
• Fluid retention
• Heartbeat disorders
• High blood pressure
• Hot flashes
• Joint swelling
• Low potassium levels
• Muscle aches
• Upper respiratory tract infection
• Upset stomach
• Urinary frequency
• Urinary tract infection

Prednisone is taken along with Zytiga. Steroids may be associated with weakening of the immune system, making individuals susceptible to infection.

 Xofigo Compared to Zytiga: Cost

Xofogo costs $69,000 for the complete course of therapy. Because it is new, patients need to check with their insurance carrier for coverage. Bayer will have a patient assistant program to help with costs.

Zytiga costs $5,000 per month, and the average treatment course is eight months, so it is approximately $40,000 for a full course of treatment. Medicare and most insurance companies cover treatment. Patients may be eligible for financial assistance.

 Xofigo Compared to Zytiga: Which One for You?

Your physician can help you determine which medication is right for you based on your symptoms, metastases, and other treatments you are using. If your prostate cancer has spread beyond bones to other organs, then Xofigo is not the right treatment for you. If you have already had hormone therapy and chemotherapy, then Zytiga may be an option for you. You will need to weigh all the costs and benefits to make a decision that is right for you.

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There are several risk factors for prostate cancer. Some you may have heard about such as age, race, and family history, but there are also some unusual and lesser-known links, such as finger length and baldness, that could put men at higher risk. Here are eight signs that are associated with a risk for prostate cancer.

Being African American

Compared with white men, African-American have twice the risk of prostate cancer in their early 50s and are twice as likely to die from prostate cancer. What makes African American men more likely to get prostate cancer? The reasons could be genetic or environmental. African American men have a higher rate of prostate cancer than black men who live in Africa. Researchers think this may be due to diet, chemicals, or other factors.

Being Overweight

Studies show that obesity is linked to prostate cancer. Possible reasons for this connection are that obese men tend to have lower testosterone levels, higher estrogen levels, elevated levels of insulin-growth factor (which might spur the cancer on), and greater amounts of saturated fats in their diet. Additionally, men who are overweight are more likely to have type 2 diabetes or metabolic syndrome, both of which may put them at higher risk of prostate cancer.

 Index Finger Length

You could hold the link to prostate cancer in your hands. According to a British Study, having an index finger that is shorter than your ring finger or the same size as your ring finger could increase your prostate cancer risk. Finger length correlates to exposure to testosterone before birth, and that may affect risk of cancer later in life. This could be related to the genes HOXA and HOXD, which control both finger length and development of sex organs. The more testosterone a baby is exposed to, the shorter his index fingers will be.

“Our results show that relative finger length could be used as a simple test for prostate cancer risk, particularly in men aged under 60,” says joint senior author Professor Ros Eeles from the ICR and The Royal Marsden NHS Foundation Trust. “This exciting finding means that finger pattern could potentially be used to select at-risk men for ongoing screening, perhaps in combination with other factors such as family history or genetic testing.” Men whose index finger is longer than their ring finger were one-third less likely to develop prostate cancer than men with even fingers or a shorter index finger.

Hair Loss

Experts don’t know for sure what the connection is, but studies show that bald men have a higher risk for prostate cancer. A study in Cancer Epidemiology, Biomarkers & Prevention found that men with any type of baldness had a 69% greater risk of prostate cancer, and young men with frontal hair loss were six times as likely as those without such baldness to be diagnosed with advanced prostate cancer by age 60. Researchers suspect that it’s related to the male hormones known as androgens (such as testosterone), which can inhibit hair growth and trigger abnormal expansion of prostate cells. The good news is that early baldness was not associated with an earlier onset of prostate cancer or with more aggressive cancer.

 Having Daughters

Men who have only daughters may have 60 percent higher chance of being diagnosed with prostate cancer compared to men who father only boys. And the more sons a man has, the lower his risk of prostate cancer. These findings come from an Israeli study of almost 39,000 people. The reason may be chromosomal. Some men may be predisposed to having daughters because of certain characteristics on their Y chromosome, and this might also increase the risk for prostate cancer.

 Being Tall

In a couple of studies done in the United Kingdom and the United States, researchers studied men with or without prostate cancer and found that the tallest men had a 19 percent higher risk of developing prostate cancer than the shortest men. Men over six feet tall were at highest risks, and findings showed that men over 6’3” and under the age of sixty-five had an even higher risk of aggressive prostate cancer. This may be due to genetics or growth hormones.

 Sex Drive

The connection among hormones, sex drive, and prostate cancer is complicated and could change depending on age. The sex lives of 840 men were studied by researchers at Nottingham University in the United Kingdom. Findings showed that men who masturbated more and had more sex in their twenties and thirties had a higher incidence of prostate cancer. However, in the case of older men, they found the opposite. Men who masturbated more in their fifties showed a lower risk for prostate cancer.

 Living in the North

The Prostate Cancer Foundation found that men who live north of 40 degrees latitude (north of such cities as Philadelphia, Pennsylvania, Indianapolis, Indiana, and Denver, Colorado for example) have the highest risk for dying from prostate cancer compared to other men in the United States. There could be many reasons for this spike. It could be that men in colder places have lower vitamin D levels. Vitamin D is important to prostate health.

What Does This Mean?

Just because you are found to have any of these increased risk factors does not mean that you will get prostate cancer. These factors are meant to help you identify an increased risk so you can get screened regularly and take precautionary measures to prevent prostate cancer through diet, exercise, prostate supplements, and vitamin D.

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Sifferlin, Alexandra. 2013. The Link Between Early Baldness and Prostate Cancer.

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Because treatments for castration-resistant prostate cancer have only been studied individually, it is not definitively possible to answer the question “Does Provenge work better with Xtandi?”

Standard practice in oncology involves the use of multiple therapeutic drugs with different mechanisms of action. Because immunotherapy like Provenge (sipuleucel-T) offers a different mechanistic action from traditional treatments, there is potential for synergy of Provenge with other traditional treatments, such as chemotherapy, radiation, and hormonal therapy. A recently published case report describes one of the first experiences using Provenge and Xtandi (enzalutamide) together.

Few studies have examined combinations of any of the currently approved treatment options for advanced prostate cancer. Provenge is an immunotherapy—a novel treatment for advanced prostate cancer that utilizes the body’s own immune system to help fight advanced prostate cancer. Xtandi is an androgen receptor inhibitor that works against prostate cancer by causing cell death and decreasing tumor size. The case report describes a 69-year-old patient who, after a prolonged treatment, achieved a decrease in PSA with the combination of Provenge and Xtandi, a response not normally seen with just Provenge. Does Provenge work better with Xtandi? More studies are needed but this case points that it may be so.

This particular patient previously received and responded to granulocyte-macrophage colony stimulating factor (GM-CSF). The authors hypothesized that previous response to GM-CSF may predict future response to Provenge. Further, the authors discuss basic science studies that indicate Xtandi treatment may augment a patient’s response to Provenge. The authors go on to say that because Xtandi does not require use of steroids, an immune suppressant that can affect vaccine response, it may be an optimal choice for combination.

Research on Provenge with Other Prostate Cancer Treatments

Dendreon, the company that makes Provenge, has begun studying how Provenge acts with other prostate cancer treatments. In order to determine if Provenge does work better with Xtandi, the company has begun sequencing trials. These trials look at how the order and timing of cancer treatments affect clinical outcomes.

According to a press release at the 2013 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO), Dendreon has completed enrollment in a sequencing study of Provenge and ADT that demonstrated some improvements in immune response. Another study of Provenge sequencing with Zytiga (abiraterone acetate) has been completed with results to be presented later in 2013. Dendreon has formed a steering committee for a Phase II trial for sequencing PROVENGE with Xtandi and plans to begin enrolling patients in late 2013.

In a summary of Provenge research presented at this years ASCO meetings, Mark Frohlich, M.D., executive vice president of research and development and chief medical officer at Dendreon said “This year’s ASCO GU meeting is important for Dendreon because of the wide range of studies being presented that help us better understand Provenge. The studies that inform us about the potential use of Provenge in combination or sequenced with other advanced prostate cancer treatments are encouraging, and we look forward to additional data from these studies.”

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Sources for Does Provenge Work Better with Xtandi?

W. R. Gerritsen. The evolving role of immunotherapy in prostate cancer. Annals of Oncology. (2012) 23 (suppl 8): viii22-viii27.

Julie N. Graff, Charles G. Drake, and Tomasz M. Beer. Complete Biochemical (Prostate-specific Antigen) Response to Sipuleucel-T With Enzalutamide in Castration-resistant Prostate Cancer: A Case Report With Implications for Future Research. Urology 81: 381-383, 2013.

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Circumcision has been found to be a weapon in the fight against HIV and AIDS, following studies in Africa that indicate benefits for heterosexual men. The American Academy of Pediatrics (AAP) changed its position on the topic following the studies’ findings. Previously, the academy held a neutral position regarding the procedure, but their most recent statement indicates that male circumcision may protect heterosexual men against HIV. The AAP still contends that the decision to have the procedure performed is still a family choice.

Parents of male babies have struggled with the decision to or not to circumcise for decades. Long-standing American traditions have been to circumcise infant boys, religious rituals make the act a rite of initiation, but many people throughout the world pass on this procedure. They feel it to be unnecessary and traumatic for the infants. Are there benefits to circumcision other than cosmetic conformity?

The practice of circumcision in now looked at differently, and a recent article in the New York Times says, “The American Academy of Pediatrics has shifted its stance on infant male circumcision, announcing on Monday that new research, including studies in Africa suggesting that the procedure may protect heterosexual men against H.I.V., indicated that the health benefits outweighed the risks.” (Rabin)

A previous study conducted in New Zealand found that “uncircumcised males are at greater risk of acquiring sexually transmitted infection than circumcised males. Male circumcision may reduce the risk of sexually transmitted infection acquisition and transmission by up to one half.” (Fergusson) The data was gathered as a 25-year study of children in New Zealand.

In the past 10 years, circumcision has become a topic of debate among medical professionals. Since 2005, the AAP’s Task Force on Circumcision has explored the effects of circumcision on adult males who have had the procedure.  Advantages include lower incidence of urinary tract infections, transmission of sexually transmitted diseases (especially syphilis, herpes, HPV, and HIV) and cancers of the penis. Males who are circumcised also have a lower risk of prostate cancer.

The AAP policies greatly influence the recommendations of their members and other healthcare professionals,   however, individual families still make the final decision to or not to circumcise.

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[1] Circumcision Policy Statement, Policy Statement  from the American Academy of Pediatrics. In Pediatrics Accessed Apr 28, 2013.

[2] Fergusson, D.M., et al. Circumcision Status and Risk of Sexually Transmitted Infection in Young Adult Males: An Analysis of a Longitudinal Birth Cohort. In Pediatrics, Accessed Apr 28, 2013

[3] Nordqvist, Christian; Circumcision Benefits More Than Risks, AAP. In eMedical News Today, Accessed Apr 27, 2013.

[4] Rabin, R.C. Benefits of Circumcision Are Said to Outweigh Risks.

[5] Shepherd, R. Circumcision Linked To Lower Prostate Cancer Risk. In Medical News Today, Accessed Apr 28, 2013.

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Xofigo compared to Provenge is a factor that men with prostate cancer may have to consider. The Food and Drug Administration (FDA) approved a new medication, Xofigo (radium-223 dichloride), for late stage castration-resistant prostate cancer on May 15, 2013.

With this new addition of medication on the market, prostate cancer patients will want to ask how it compares to other available medications they are taking or considering. Provenge (sipuleucel-T) is an immunotherapy that was approved by the FDA April 29, 2010, for men with advanced stage prostate cancer.

How Do Xofigo and Provenge Work?

Both medications are used for prostate cancers that have metastasized, or spread to other areas of the body.

Xofigo in an injectable medication that has an anti-tumor effect. The medication contains radium (a heavy metal), which delivers radiation directly to bone tumors without significantly damaging surrounding tissues. This breaks up double-strand DNA, killing the prostate cancer cell at the site of cancer-induced increased bone turnover. Therapy consists of six injections given at four-week intervals.

Provenge uses immunotherapy, the body’s own immune system, to fight the cancer. Immunotherapy does not destroy or harm prostate cells in the body, whether they are cancer cells or healthy cells. This kind of therapy is considered a positive therapy. Treatment with Provenge usually takes three doses over five weeks. Each dose involves collecting a patient’s blood, harvesting certain cells, and then returning the remaining blood to the patient. The harvested cells are modified and then given back to the patient a few days later via an infusion. Patients like that they are using their body’s own cells to help them fight prostate cancer.

How Do Xofigo and Provenge Extend Life?

In clinical trials, men who took Provenge lived an average of 25.8 months compared with men who took a placebo, who lived on average 21.7 months. On average, Provenge extended life 4.1 months longer than the placebo.

Men on Xofigo survived a median of 14 months compared with men taking a placebo, who lived a little over 11 months. Xofigo extended life 3 months longer than the placebo.

 Xofigo Compared to Provenge: Who Is Eligible?

Both drugs are used for advanced stages of prostate cancer that have spread despite hormone therapy. Xofigo is only for cancers that have spread to the bones and not other organs. It cannot be used with chemotherapy.

Provenge can be used for cancers that have spread to the bones and other parts of the body as well. Patients who are candidates for Provenge have minimal symptoms and have no pain or pain that does not require narcotic medication. Because Provenge is an immunotherapy it can be used before other treatments such as chemotherapy.

 Xofigo Compared to Provenge: Side Effects

Both medications have mild common side effects.

Most Common side effects of Xofigo include:

• Nausea
• Diarrhea
• Vomiting
• Swelling of the leg, ankle, or foot

These Xofigo side effects are from the clinical trials so it is assumed that as the drug is used in practice, more side effects may become known.

Common side effects of Provenge include:

• Muscle aches and pains
• Joint pain
• Fatigue
• Fever
• Chills
• Headache
• Nausea

Contact your doctor right away if you experience breathing problems, chest pains, racing heart or irregular heartbeats, dizziness, nausea, or vomiting after getting Provenge because any of these may be signs of heart or lung problems.

 Xofigo Compared to Provenge: Cost

Xofigo costs $69,000 for the complete course of therapy. Because it is new, patients need to check with their insurance carrier for coverage. Bayer will have a patient assistant program to help with costs.

Provenge costs over $90,000, but is usually covered by most insurance plans and Medicare. The drug’s manufacturer, Dendreon, offers financial assistance. Provenge may be provided free for patients without insurance or who demonstrate a financial need. For patients who qualify, Dendreon may reimburse or offer financial assistance for copays, co-insurance, or deductibles.

 Xofigo Compared to Provenge: Which One for You?

Your physician can help you determine which medication is right for you based on your symptoms, metastases, and other treatments you are using. If your prostate cancer has spread beyond bones to other organs, then Xofigo is not the right treatment for you. Provenge has the advantage that it can be used in conjunction with other therapies. Ultimately, you and your loved ones will have to weigh the costs and benefits of treatment choices to make a decision that is right for you.

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A new drug for late stage prostate cancer is marketed by Bayer as Xofigo. Xofigo is a novel radiopharmaceutical called radium-223 dichloride. This drug for late stage prostate cancer is for use in men whose cancer has spread to the bones but no other organs. The medication is for patients with castration-resistant prostate cancer, which is prostate cancer that has spread even after surgery or other therapy to lower testosterone. Testosterone is a hormone that can stimulate prostate cancer growth.

The FDA approved Xofigo three months ahead of schedule. It was given an expedited review because the medication appears to provide a safe and effective therapy that does not exist in other products and because it may offer a significant improvement over existing products on the market. Patients in a clinical trial who took radium-223 lived three months longer than patients who used a placebo.

How Xofigo, a Drug for Late Stage Prostate Cancer, Works

Radium-223 dichloride has an anti-tumor effect. It “binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products at the FDA Center for Drug Evaluation and Research.

The medication is given once a month by intravenous injection. It contains radium (a heavy metal), which delivers radiation directly to bone tumors without significantly damaging surrounding tissues. This breaks up double-strand DNA, killing the prostate cancer cell at the site of cancer-induced increased bone turnover. The medication causes minimal bone marrow suppression and is tolerated pretty well. Studies show that it helps patients who were resistant to hormone treatment live longer.

Because Xofigo, a new drug for late stage prostate cancer, is targeted for bone metastases, it may be found useful for many different cancers that have spread to the bone, according to lead investigator Chris Parker, MD, consultant clinical oncologist at the Royal Marsden Hospital in London, United Kingdom. They studied prostate cancer patients first because in around 90% of advanced prostate cancer patients the cancer will spread to the bone. Plus, in many of these cases, the cancer does not spread elsewhere in the body.

Side Effects of Xofigo

Side effects include nausea, diarrhea, vomiting, and swelling of the leg, ankle, or foot. The most common abnormalities found during blood testing of this drug for late stage prostate cancer were low levels of red blood cells (anemia), lymphocytes, white blood cells, platelets, and infection-fighting white blood cells.

How Much Does Xofigo Cost?

The drug costs $69,000 for a complete course of therapy. Therapy consists of six injections given at four-week intervals. Bayer will have a patient assistance program to help cover the cost of treatment.

Who Does Xofigo Help?

This medication is for patients with late stage prostate cancer that is resistant to hormone therapies. Men whose prostate cancer has metastasized to the bones but not other organs after medical treatment or surgery to lower testosterone are candidates for this medication. Xofigo is not recommended in patients on chemotherapy due to the potential for additive myelosuppression.

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Chustecka, Zosia. Xofigo (Radium-223) Approved for Prostate Cancer With Bone Mets. MedScape Today. May 15, 2013.

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Precision Medicine involves tailoring medication to patients’ individual genes. While this may sound like science fiction, it is on the way to becoming scientific fact. In New York, top tier, nonprofit research facilities are building gene-pool exploration centers for what some call the latest “medical arms race.” The DNA combatants include Icahn School of Medicine at Mount Sinai, Weill Cornell Medical College and New York-Presbyterian Hospital/Weill Cornell Hospital, and the Memorial Sloan-Kettering Cancer Center. Advocates for precision medicine believe that the complete sequencing of patients’ gene-pools will become an every day proven necessity. Others are not so sure.

Having risky DNA sequences does not guarantee the development of diseases. Lifestyle and environment  have important effects on disease. To that end, Johns Hopkins is studying how toxic exposures in patients’ every day environments may trigger risky DNA sequences. Additionally, the US government’s research grants for precision medicine will fund worthiness studies.

What Is the Cost of Precision Medicine?

Some Harvard researchers are studying whether precision medicine can reasonably be considered practical, while  others are researching diseases where the method might be used. Until there is more definitive information, your health insurance company is unlikely to contribute much for precision medicine assessments. The cost to assess the entire sequence of a person’s DNA is between $5,000 and $10,000, and analysis of the sequence is extra. Also extra are some of the newer medications that the sequencing may select.  Some of these are significantly more expensive than standard therapies but have yet to prove significantly longer survival benefit.

Mainstream acceptance of precision medicine requires validation. Researchers must produce multiple, large-scale, human studies proving that precision medicine can correctly identify patients who will benefit from atypical medicines. Funding for these billion dollar projects will largely come from the government and from pharmaceutical companies (meaning they will own the human data and the results). Outreach needs to be done in order to gain participation from patients who have the target diseases and/or who are likely to have the disease markers in their DNA.

Handing over DNA has far-reaching implications for patients, their families, and all of their descendants.  Additionally, we need to develop new technology for tracking, trending, and analyzing human DNA. Most importantly, in order for precision medicine to be considered worthwhile, its application must result in the beneficial use of existing atypical medications or in the rapid production of such medicines. Otherwise, what is the point?

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Bekiempis, V. Mount Sinai Medical Center Opens New High-Tech Research Facility. DNAinfo.com New York Neighborhood News. Published 12/13/12.

Hartocollis, A. Cancer Centers Racing to Map Patients’ Genes. The New York Times: Health. Published 4/21/13.

Mirnezami, R., J. Jeremy Nicholson, and A. Ara Darzi. Preparing for Precision Medicine. The New England Journal of Medicine. 2012; 366:489-491. DOI: 10.1056/NEJMp111486

Zimmer, A. Medical Arms Race’ Spurs Massive Health Development on East Side. DNAinfo.com New York Neighborhood News. Published 1/18/12.

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Can Restless Legs Cause ED? A man’s restless legs that are keeping him up at night may prevent him from “getting it up.” A recent study shows that men with restless leg syndrome (RLS) have an increased risk for erectile dysfunction (ED). So how can restless legs cause ED, and what is the connection?

Restless Legs Syndrome and ED

Men with RLS have a 38% increased risk of ED compared with men without RLS. These results were found after adjusting for age, body mass, other sleep disorders, snoring, physical activity, and smoking status. Researchers led by Xiang Gao, MD, of the Channing Laboratory and Harvard Medical School in Boston also found that risk of ED also went up for a higher frequency of RLS symptoms. According to the results, men who experienced RLS 5–14 times per month had a 34% increased risk of ED (compared with men who did not have RLS), whereas men who had RLS 15 or more times per month had a 45% increased risk.

David Luterman, MD, medical director of the Sleep Center at Baylor University Medical Center in Dallas say this is a good starting point for researching how RLS and ED are connected. “Not everyone with restless legs has erectile dysfunction,” Dr. Luterman says. “But the occurrence is greater than in the general population.”

One possible connection could be dopamine. Dopamine (a neurotransmitter in the brain) has a role in both RLS and ED. Dopamine helps the muscles of the penis to relax and the arteries to widen, increasing blood flow, which leads to an erection. Researchers believe that the proper transmission of dopamine signals from the brain is important in avoiding RLS symptoms. Medications that increase dopamine in the brain are often effective at treating RLS.

Approximately 10 percent of adults suffer from RLS, which is a neurological sensorimotor disorder that causes uncomfortable or painful sensations in the legs. People who have RLS often feel as though they need to move their legs, by walking or stretching, in order to stop the uncomfortable sensations. The symptoms tend to get worse when sitting for a long time or even just relaxing. Because the symptoms usually get worse at night, they interfere with the ability to sleep.

How Does Sleep Affect ED?

While the RLS study does not say what exactly causes the link between RLS and ED, they did find that combinations of other sleep disorders with RLS further increased the risk of ED. Possibly disruption of sleep is partly to blame.  Other studies researched the effects of sleep on ED and other urinary health problems. “Sleep is a modifiable risk factor that precedes certain urologic conditions,” according to a study by researchers at New England Research Institutes Inc. in Watertown, Massachusetts.

American Urological Association spokesperson, Kevin T. McVary, MD, said, “We know that proper amounts of sleep and quality of sleep can impact a wide range of health conditions including erectile function and lower urinary tract symptoms…These data may help us better assess how helping patients modify their sleep patterns may help improve their health and overall quality of life.”

Can restless legs cause ED? Researchers cannot say for sure if RLS causes ED, but there is a strong link and risk factor. Whether the two conditions are related to dopamine or interrupted sleep or some other connection, the studies on “can restless legs cause ED” are sure to bring more understanding of and treatments for erectile dysfunction.

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Acosta Scott, Jennifer. 2013. Could Restless Legs Syndrome Be Linked to Erectile Dysfunction?

American Urological Association 2011. Studies Link Quality of Sleep to Erectile Dysfunction, Other Urologic Conditions.

Yanping Li, Salma Batool-Anwar, Sehee Kim, Eric B. Rimm, Alberto Ascherio, and Xiang Gao. 2013. Prospective Study of Restless Legs Syndrome and Risk of Erectile Dysfunction. American Journal of Epidemiology.

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