The medical device expands Sicel Technologies’ portfolio, because the DVS-HFT dosimeter is specifically calibrated for use with radiation therapy protocols that give patients higher single doses of radiation over a shorter period of time compared to conventional radiation therapy. Also, known as hypo-fractionated therapy, treatment with higher radiation doses over fewer treatments has been highly effective in treating some tumors and is becoming more popular. However, it is critical that physicians confirm that the actual intended dose reaches the target tumor to maximize the therapeutic benefit as well as to avoid damaging healthy tissue.

“The DVS-HFT is an important advance in hypo-fractionated therapy, because physicians can now confidently determine the prescribed dose has been accurately delivered throughout the course of treatment, which is a key determinant in the long-term successful treatment of a tumor,” said Arnold Malcolm, MD, Associate Professor Vanderbilt Center for Radiation Oncology. “This device may actually accelerate the use of hypo-fractionated protocols, like those being adopted for treatment of prostate cancer, which may offer benefits across the healthcare spectrum.”

Recent changes by the Centers for Medicaid & Medicare Services in the 2009 Hospital Outpatient reimbursement policy for Medicare patients will make DVS accessible to more patients undergoing radiation therapy treatment in hospital outpatient facilities. The change, effective January 1, significantly increases reimbursement to facilities implanting the sensors.

“We are very pleased that CMS has acknowledged the importance of breakthrough technologies like DVS in cancer treatment and we continue to work with professional organizations like ASTRO, AAPM, and the AUA to ensure that all patients have access to innovative treatment options,” said Michael Riddle, President and CEO, Sicel Technologies, Inc.

For more information about DVS-HFT or Sicel Technologies, Inc., please call 1-888-DVS-6697 or visit http://www.dvssmartmarker.com.

About Sicel Technologies

Founded in 1999 and headquartered in Morrisville, North Carolina, Sicel Technologies, Inc. is a privately held, specialty device company focused on the development of revolutionary therapies that significantly impact the treatment of cancer-a leading cause of death in the U.S., second only to heart disease.

Sicel Technologies, Inc. developed the Dose Verification System®, the first U.S. Food & Drug Administration approved wireless implantable sensors designed to assist clinicians in determining the actual dose of radiation being delivered to the tumor. The company also makes and markets OneDose™, patient dosimetry verification systems specifically designed for radiation oncology therapy.

In 2008, Sicel Technologies, Inc. was named “Company of The Year” in the Life Science, Biotech, Medtech category by the North Carolina Technology Association.

The disciplines represented in the institute include urologic oncology, medical oncology, diagnostic and interventional radiology, pathology, nursing, basic sciences and clinical trials. The new institute will allow experts from these areas to collaborate more efficiently and effectively, bringing to patients the most promising advances in medical and surgical treatments, including targeted therapies, chemotherapy, immunotherapy, radiation therapy and minimally invasive and ablative surgery.

“This is a one-stop shop for patients. All the experts will be involved in their care, all working together,” said Dr. Arie Belldegrun, a professor of urology, a researcher at UCLA’s Jonsson Comprehensive Cancer Center and director of the new Institute of Urologic Oncology at UCLA. “Our goal is to bring all our resources to the patient, rather than the patient going from office to office to see everyone they need to see.”

That multi-disciplinary, translational approach to care and targeted therapies was pioneered at UCLA. The molecularly targeted drugs Herceptin for breast cancer and Gleevec for chronic myeloid leukemia, among others, were developed based on research conducted in Jonsson Cancer Center laboratories. Such leading-edge work will be done within the institute to develop new, more effective, less toxic therapies for urologic cancers.

Dr. Dennis Slamon, director of Clinical/Translational Research at UCLA’s Jonsson Comprehensive Cancer Center, called the Institute’s research and clinical model “outstanding.”

“It’s an excellent idea to bring people together from different disciplines that overlap around a disease,” said Slamon, whose laboratory and clinical research led to the development of Herceptin. “It creates a synergy that allows us to do things more quickly and efficiently.”

Dr. Jean DeKernion, chairman of the UCLA Department of Urology, agrees.

“With this approach, we’ll be able to get leading-edge therapies to the patient faster, taking them out of the lab and into practice in much less time,” he said.

Patients also will benefit from the institute’s top diagnostic tools, expertise in robotic and minimally-invasive surgery and the combined experience of the experts, who often treat the most complicated urologic cancer cases. In addition, a joint, multi-disciplinary board across all genitourinary specialties will meet at the institute to discuss complicated and challenging tumor cases referred to UCLA.

“This unique institute, blending both academic and clinical pursuits, will offer the patient the latest treatments as well as allow researchers and clinicians the opportunity to collaborate in moving cancer therapies forward,” said Dr. Gerald Levey, vice chancellor of UCLA Medical Sciences and dean of the David Geffen School of Medicine.

An educational symposium will be held at UCLA on March 3, 2009 to celebrate the launch of the institute. The symposium will feature top oncologists and researchers discussing translational research, advances in personalized medicine for prostate cancer, targeted treatments for kidney cancer and the latest in therapies for bladder cancer. Slamon will discuss the lessons learned from the development of Herceptin and how they may apply to prostate cancers. Keynote speakers include Michael Milken, chairman of the Milken Institute, and Dr. Andrew C. von Eschenbach, former director of the National Cancer Institute and a former commissioner for the U.S. Food & Drug Administration.

The Institute will be housed in temporary space until a permanent, state-of-the-art facility can be built.

About 390,000 Americans were diagnosed with kidney, bladder, testicular and prostate cancer last year, resulting in about 56,000 deaths. The Institute’s goal is to dramatically lower the death rates for urologic cancers.

“Our mission is to offer patients outstanding, individualized surgical and medical care and access to leading-edge experimental therapies with the overall goal to cure urologic cancers,” Belldegrun said.

Main Category: Urology / Nephrology
Also Included In: Prostate / Prostate Cancer; Cancer / Oncology

Cancer harms the body when damaged cells divide uncontrollably to form lumps or masses of tissue called tumors (except in the case of leukemia where cancer prohibits normal blood function by abnormal cell division in the blood stream). Tumors can grow and interfere with the digestive, nervous, and circulatory systems, and they can release hormones that alter body function. Tumors that stay in one spot and demonstrate limited growth are generally considered to be benign.

More dangerous, or malignant, tumors form when two things occur:

1. a cancerous cell manages to move throughout the body using the blood or lymph systems, destroying healthy tissue in a process called invasion
2. that cell manages to divide and grow, making new blood vessels to feed itself in a process called angiogenesis.

When a tumor successfully spreads to other parts of the body and grows, invading and destroying other healthy tissues, it is said to have metastasized. This process itself is called metastasis, and the result is a serious condition that is very difficult to treat.

In 2007, cancer claimed the lives of about 7.6 million people in the world. Physicians and researchers who specialize in the study, diagnosis, treatment, and prevention of cancer are called oncologists.

What causes cancer?

Cancer is ultimately the result of cells that uncontrollably grow and do not die. Normal cells in the body follow an orderly path of growth, division, and death. Programmed cell death is called apoptosis, and when this process breaks down, cancer begins to form. Unlike regular cells, cancer cells do not experience programmatic death and instead continue to grow and divide. This leads to a mass of abnormal cells that grows out of control.

What is cancer? – Video

A short, 3D, animated introduction to cancer. This was originally created by BioDigital Systems and used in the Stand Up 2 Cancer telethon.

3D Medical Animation – What is Cancer?

Genes – the DNA type

Cells can experience uncontrolled growth if there are damages or mutations to DNA, and therefore, damage to the genes involved in cell division. Four key types of gene are responsible for the cell division process: oncogenes tell cells when to divide, tumor suppressor genes tell cells when not to divide, suicide genes control apoptosis and tell the cell to kill itself if something goes wrong, and DNA-repair genes instruct a cell to repair damaged DNA.

Cancer occurs when a cell’s gene mutations make the cell unable to correct DNA damage and unable to commit suicide. Similarly, cancer is a result of mutations that inhibit oncogene and tumor suppressor gene function, leading to uncontrollable cell growth.

Carcinogens

Carcinogens are a class of substances that are directly responsible for damaging DNA, promoting or aiding cancer. Tobacco, asbestos, arsenic, radiation such as gamma and x-rays, the sun, and compounds in car exhaust fumes are all examples of carcinogens. When our bodies are exposed to carcinogens, free radicals are formed that try to steal electrons from other molecules in the body. Theses free radicals damage cells and affect their ability to function normally.

Genes – the family type

Cancer can be the result of a genetic predisposition that is inherited from family members. It is possible to be born with certain genetic mutations or a fault in a gene that makes one statistically more likely to develop cancer later in life.

Other medical factors
As we age, there is an increase in the number of possible cancer-causing mutations in our DNA. This makes age an important risk factor for cancer. Several viruses have also been linked to cancer such as: human papillomavirus (a cause of cervical cancer), hepatitis B and C (causes of liver cancer), and Epstein-Barr virus (a cause of some childhood cancers). Human immunodeficiency virus (HIV) – and anything else that suppresses or weakens the immune system – inhibits the body’s ability to fight infections and increases the chance of developing cancer.

What are the symptoms of cancer?

Cancer symptoms are quite varied and depend on where the cancer is located, where it has spread, and how big the tumor is. Some cancers can be felt or seen through the skin – a lump on the breast or testicle can be an indicator of cancer in those locations. Skin cancer (melanoma) is often noted by a change in a wart or mole on the skin. Some oral cancers present white patches inside the mouth or white spots on the tongue.

Other cancers have symptoms that are less physically apparent. Some brain tumors tend to present symptoms early in the disease as they affect important cognitive functions. Pancreas cancers are usually too small to cause symptoms until they cause pain by pushing against nearby nerves or interfere with liver function to cause a yellowing of the skin and eyes called jaundice. Symptoms also can be created as a tumor grows and pushes against organs and blood vessels. For example, colon cancers lead to symptoms such as constipation, diarrhea, and changes in stool size. Bladder or prostate cancers cause changes in bladder function such as more frequent or infrequent urination.

As cancer cells use the body’s energy and interfere with normal hormone function, it is possible to present symptoms such as fever, fatigue, excessive sweating, anemia, and unexplained weight loss. However, these symptoms are common in several other maladies as well. For example, coughing and hoarseness can point to lung or throat cancer as well as several other conditions.

When cancer spreads, or metastasizes, additional symptoms can present themselves in the newly affected area. Swollen or enlarged lymph nodes are common and likely to be present early. If cancer spreads to the brain, patients may experience vertigo, headaches, or seizures. Spreading to the lungs may cause coughing and shortness of breath. In addition, the liver may become enlarged and cause jaundice and bones can become painful, brittle, and break easily. Symptoms of metastasis ultimately depend on the location to which the cancer has spread.

How is cancer classified?

There are five broad groups that are used to classify cancer.

1. Carcinomas are characterized by cells that cover internal and external parts of the body such as lung, breast, and colon cancer.
2. Sarcomas are characterized by cells that are located in bone, cartilage, fat, connective tissue, muscle, and other supportive tissues.
3. Lymphomas are cancers that begin in the lymph nodes and immune system tissues.
4. Leukemias are cancers that begin in the bone marrow and often accumulate in the bloodstream.
5. Adenomas are cancers that arise in the thyroid, the pituitary gland, the adrenal gland, and other glandular tissues.

Cancers are often referred to by terms that contain a prefix related to the cell type in which the cancer originated and a suffix such as -sarcoma, -carcinoma, or just -oma. Common prefixes include:

* Adeno- = gland
* Chondro- = cartilage
* Erythro- = red blood cell
* Hemangio- = blood vessels
* Hepato- = liver
* Lipo- = fat
* Lympho- = white blood cell
* Melano- = pigment cell
* Myelo- = bone marrow
* Myo- = muscle
* Osteo- = bone
* Uro- = bladder
* Retino- = eye
* Neuro- = brain

How is cancer diagnosed and staged?

Early detection of cancer can greatly improve the odds of successful treatment and survival. Physicians use information from symptoms and several other procedures to diagnose cancer. Imaging techniques such as X-rays, CT scans, MRI scans, PET scans, and ultrasound scans are used regularly in order to detect where a tumor is located and what organs may be affected by it. Doctors may also conduct an endoscopy, which is a procedure that uses a thin tube with a camera and light at one end, to look for abnormalities inside the body.

Extracting cancer cells and looking at them under a microscope is the only absolute way to diagnose cancer. This procedure is called a biopsy. Other types of molecular diagnostic tests are frequently employed as well. Physicians will analyze your body’s sugars, fats, proteins, and DNA at the molecular level. For example, cancerous prostate cells release a higher level of a chemical called PSA (prostate-specific antigen) into the bloodstream that can be detected by a blood test. Molecular diagnostics, biopsies, and imaging techniques are all used together to diagnose cancer.

After a diagnosis is made, doctors find out how far the cancer has spread and determine the stage of the cancer. The stage determines which choices will be available for treatment and informs prognoses. The most common cancer staging method is called the TNM system. T (1-4) indicates the size and direct extent of the primary tumor, N (0-3) indicates the degree to which the cancer has spread to nearby lymph nodes, and M (0-1) indicates whether the cancer has metastasized to other organs in the body. A small tumor that has not spread to lymph nodes or distant organs may be staged as (T1, N0, M0), for example.

TNM descriptions then lead to a simpler categorization of stages, from 0 to 4, where lower numbers indicate that the cancer has spread less. While most Stage 1 tumors are curable, most Stage 4 tumors are inoperable or untreatable.

How is cancer treated?

Cancer treatment depends on the type of cancer, the stage of the cancer (how much it has spread), age, health status, and additional personal characteristics. There is no single treatment for cancer, and patients often receive a combination of therapies and palliative care. Treatments usually fall into one of the following categories: surgery, radiation, chemotherapy, immunotherapy, hormone therapy, or gene therapy.

Surgery

Surgery is the oldest known treatment for cancer. If a cancer has not metastasized, it is possible to completely cure a patient by surgically removing the cancer from the body. This is often seen in the removal of the prostate or a breast or testicle. After the disease has spread, however, it is nearly impossible to remove all of the cancer cells. Surgery may also be instrumental in helping to control symptoms such as bowel obstruction or spinal cord compression.

Radiation
Radiation treatment, also known as radiotherapy, destroys cancer by focusing high-energy rays on the cancer cells. This causes damage to the molecules that make up the cancer cells and leads them to commit suicide. Radiotherapy utilizes high-energy gamma-rays that are emitted from metals such as radium or high-energy x-rays that are created in a special machine. Early radiation treatments caused severe side-effects because the energy beams would damage normal, healthy tissue, but technologies have improved so that beams can be more accurately targeted. Radiotherapy is used as a standalone treatment to shrink a tumor or destroy cancer cells (including those associated with leukemia and lymphoma), and it is also used in combination with other cancer treatments.

Chemotherapy

Chemotherapy utilizes chemicals that interfere with the cell division process – damaging proteins or DNA – so that cancer cells will commit suicide. These treatments target any rapidly dividing cells (not necessarily just cancer cells), but normal cells usually can recover from any chemical-induced damage while cancer cells cannot. Chemotherapy is generally used to treat cancer that has spread or metastasized because the medicines travel throughout the entire body. It is a necessary treatment for some forms of leukemia and lymphoma. Chemotherapy treatment occurs in cycles so the body has time to heal between doses. However, there are still common side effects such as hair loss, nausea, fatigue, and vomiting. Combination therapies often include multiple types of chemotherapy or chemotherapy combined with other treatment options.

Immunotherapy

Immunotherapy aims to get the body’s immune system to fight the tumor. Local immunotherapy injects a treatment into an affected area, for example, to cause inflammation that causes a tumor to shrink. Systemic immunotherapy treats the whole body by administering an agent such as the protein interferon alpha that can shrink tumors. Immunotherapy can also be considered non-specific if it improves cancer-fighting abilities by stimulating the entire immune system, and it can be considered targeted if the treatment specifically tells the immune system to destroy cancer cells. These therapies are relatively young, but researchers have had success with treatments that introduce antibodies to the body that inhibit the growth of breast cancer cells. Bone marrow transplantation (hematopoetic stem cell transplantation) can also be considered immunotherapy because the donor’s immune cells will often attack the tumor or cancer cells that are present in the host.

Hormone therapy

Several cancers have been linked to some types of hormones, most notably breast and prostate cancer. Hormone therapy is designed to alter hormone production in the body so that cancer cells stop growing or are killed completely. Breast cancer hormone therapies often focus on reducing estrogen levels (a common drug for this is tamoxifen) and prostate cancer hormone therapies often focus on reducing testosterone levels. In addition, some leukemia and lymphoma cases can be treated with the hormone cortisone.

Gene therapy

The goal of gene therapy is to replace damaged genes with ones that work to address a root cause of cancer: damage to DNA. For example, researchers are trying to replace the damaged gene that signals cells to stop dividing (the p53 gene) with a copy of a working gene. Other gene-based therapies focus on further damaging cancer cell DNA to the point where the cell commits suicide. Gene therapy is a very young field and has not yet resulted in any successful treatments.

How can cancer be prevented?

Cancers that are closely linked to certain behaviors are the easiest to prevent. For example, choosing not to smoke tobacco or drink alcohol significantly lower the risk of several types of cancer – most notably lung, throat, mouth, and liver cancer. Even if you are a current tobacco user, quitting can still greatly reduce your chances of getting cancer.

Skin cancer can be prevented by staying in the shade, protecting yourself with a hat and shirt when in the sun, and using sunscreen. Diet is also an important part of cancer prevention since what we eat has been linked to the disease. Physicians recommend diets that are low in fat and rich in fresh fruits and vegetables and whole grains.

Certain vaccinations have been associated with the prevention of some cancers. For example, many women receive a vaccination for the human papillomavirus because of the virus’s relationship with cervical cancer. Hepatitis B vaccines prevent the hepatitis B virus, which can cause liver cancer.

Some cancer prevention is based on systematic screening in order to detect small irregularities or tumors as early as possible even if there are no clear symptoms present. Breast self-examination, mammograms, testicular self-examination, and Pap smears are common screening methods for various cancers.

How to eat to prevent cancer – Video

A guide to some everyday foods that contain nutrients that may help reduce your risk of getting cancer. Video by Howcast.

How To Eat To Prevent Cancer

Cancer / Oncology news

Medical News Today is a leading resource for the latest headlines on Cancer and Oncology. So, check out our cancer news section. You can also sign up to daily medical news alerts or our weekly digest medical newsletters to ensure that you stay up-to-date with the latest news.

Expression of the gene, Ataxia Telangiectasia Group D Complementing gene, called ATDC, is on average 20 times higher in pancreatic cancer cells than in cells from a normal pancreas. What’s more, the gene appears to make pancreatic cancer cells resistant to current therapies.

“One of the challenges in pancreatic cancer is that it is biologically aggressive and it does not respond well to chemotherapy or radiation. We found that ATDC not only causes the cancer cells to grow faster and be more aggressive, but it also makes the cancer cells particularly resistant to chemotherapy and radiation. By targeting this gene, we may be able to make cancer cells more sensitive to the therapies we already have in hand,” says senior study author Diane Simeone, M.D., director of the Multidisciplinary Pancreatic Cancer Clinic at the U-M Comprehensive Cancer Center.

Results of the study appear in the March issue of Cancer Cell.

The researchers injected into mice tumor cells expressing ATDC and compared that to a separate group of mice injected with tumor cells in which ATDC was suppressed. In the ATDC-expressing group, tumors grew in all the samples and were significantly larger and starting to metastasize, or spread. In the group in which ATDC was not expressed, only minimal signs of tumor growth were seen after 60 days.

“This particular gene promotes the biologic aggressiveness of the cancer,” says Simeone, who is also Lazar J. Greenfield Professor of Surgery and Molecular & Integrative Physiology at the U-M Medical School.

In addition, the researchers found that ATDC is most highly expressed at the point when pre-cancerous cells become malignant. ATDC was also linked to increased levels of a signaling protein called beta-catenin, which is known to play a key role in cancer development.

Researchers believe ATDC has potential as a target for developing future therapies. It could also help doctors determine when a patient has pancreatic cancer and when it’s chronic pancreatitis, a diagnosis that’s often difficult to make without surgery. In some cases, this may allow patients to avoid an operation.

ATDC also appears to be involved in other cancer types, including bladder cancer and lung cancer. Researchers are continuing to investigate its role. This research was done in the laboratory. No tests or therapies related to ATDC are available at this time.

Pancreatic cancer statistics: 37,680 Americans will be diagnosed with pancreatic cancer this year and 34,290 will die from the disease, according to the American Cancer Society

Additional authors: Lidong Wang, David G. Heidt, Cheong J. Lee, Huibin Yang, Eric R. Fearon and Mats Ljungman from U-M; Craig D. Logsdon from M.D. Anderson Cancer Center; and Lizhi Zhang from the Mayo Clinic.

Funding: National Institutes of Health, Lustgarten Foundation

People across the UK are still unaware that men living with prostate cancer – the most common cancer in men – continue to have to deal with the ‘historical legacy of neglect’ surrounding the disease.

It is a little known fact that men diagnosed with the disease report the worst NHS experience of all common cancers. A recent survey carried out for The Prostate Cancer Charity, in the run up to its first ever awareness month, showed that 80% of people remained unaware of the inequality of care for men with prostate cancer.

The Prostate Cancer Charity is using the month of March to raise awareness, not just of prostate cancer, but of some of the inequities surrounding the disease, under the banner, ‘it matters’.

John Neate, Chief Executive of The Prostate Cancer Charity, said: “People are not aware of some of the injustice around prostate cancer, which has suffered from a historical legacy of neglect. Long term underfunding of prostate cancer research, for example, has resulted in many unanswered questions about testing, treatments and care. We also know that men with prostate cancer report the worst NHS experience of all common cancers, often missing out on access to reliable support and information.

“The Government and NHS have placed an increased focus on prostate cancer, but urgent action is needed to implement its planned new programme to measure patient satisfaction, introduced through the Cancer Reform Strategy. Only then, can we see whether this increased focus is feeding through to convincing improvements in men’s experience.

“Progress on reducing deaths from prostate cancer is firmly linked to the research agenda. Critically important is the need to develop a new generation test capable of distinguishing between aggressive and slow-growing forms of prostate cancer. This could form the basis for a national screening programme and would enable treatment to be focussed on those men for whom prostate cancer presents a serious risk to health. The Charity will undertake a number of actions to progress this, including lobbying for increased research into a new diagnostic test and prostate cancer prevention, as well as investing more in its own research programme.”

PR Consultant, Max Clifford, who was diagnosed with prostate cancer himself, is supporting the awareness month. He said: “My own battle with prostate cancer, which is the most common cancer in men, showed me that much needs to be done to raise awareness of the prevalence and impact of the disease and its potential signs and symptoms, so that men can seek help early. It is also critical that more is invested in research, that credible information is made available for the 35,000 men diagnosed with prostate cancer every year and that their experience of treatment improves. This type of cancer affects more men in Britain than any other and that is why Prostate Cancer Awareness Month is so important.”

The survey, carried out by Tickbox.net on behalf of the Charity, also underlined men’s attitude to their health, with only 50% of British men saying they would visit the doctor if they were experiencing symptoms affecting an intimate part of their body. More than one in ten would prefer to sit tight, worry, and hope the symptoms will just go away. Responses also revealed that one in five men are more likely to confide in a partner or a close friend about an intimate illness than visit their doctor. Worryingly, 13% of British men will only visit a doctor after they’ve been coerced into it by their partners, friends or family.

John Neate explained: “The good news is that more people are becoming aware of just how common prostate cancer is. We have been trying to raise awareness of how many men and their families are affected – one in eleven men will develop prostate cancer in their lifetime – and it looks as though that message is hitting home.

“We want to mobilise a movement for change in the UK in tackling prostate cancer. We can only do this when everyone is prepared to take some form of action – to donate their time, skills, support campaigns, raise funds and help raise awareness. I hope people will take the facts on board and do what they can to support Prostate Cancer Awareness Month,” added Neate.

The theme of injustice is rooted in the Charity’s newly-released strategy, ‘Transforming the future for prostate cancer’. The strategy outlines five key goals, which the Charity believes will bring about the vital changes we must see for people affected by prostate cancer by 2020.

INTERVIEWS are available with John Neate and Max Clifford on request.

Prostate Cancer Awareness Month: Fact Box

- The Prostate Cancer Charity is staging its first ever Prostate Cancer Awareness Month, in March 2009. Extending the well-established Awareness Week to a month is an exciting development for The Prostate Cancer Charity, and reflects significant growth within the Charity and the event, which has grown year on year.

- Prostate Cancer is the most common cancer in men in the UK. The 2005 National Audit Office report, “Tackling cancer: improving the patient journey”, showed that men living with prostate cancer report the worst NHS experience of all common cancers. During Prostate Cancer Awareness Month, The Prostate Cancer Charity is urging people to show ‘it matters’ to them.

- The Prostate Cancer Charity aims to reduce the death rate from prostate cancer by 30 per cent, from 25 per 100,000 to 18 per 100,000, by 2020. This would save the lives of around 3,000 men every year. Progress on reducing the mortality rate is firmly linked to the research agenda and the need to develop a new generation test capable of distinguishing between aggressive and slow-growing forms of prostate cancer.

- Thousands of individuals and groups across the UK will join forces to show that raising awareness of prostate cancer matters to them. There are numerous ways to get involved, from staging an information day to participating in a pub quiz, to raising funds.

- Anyone wanting to participate in Prostate Cancer Awareness Month can request an information pack from prostatecancermatters@prostate-cancer.org.uk or by calling 0208 222 7141

Notes

- Prostate cancer is the most common cancer diagnosed in men in the UK. Every year in the UK, 35,000 men are diagnosed with prostate cancer. One man dies every hour of prostate cancer in the UK.

- African Caribbean men are three times more likely to develop prostate cancer than white men.

- The Prostate Cancer Charity is striving for a world where lives are no longer limited by prostate cancer. The Charity is fighting prostate cancer on every front – through research, support, information and campaigning.

- If you have any queries about prostate cancer, call The Prostate Cancer Charity’s confidential Helpline 0800 074 8383 which is staffed by specialist nurses and open from 10am to 4pm Monday to Friday and Wednesdays from 7 – 9pm or visit http://www.prostate-cancer.org.uk

“This is the first report of several we plan to present this year from a large and growing data set demonstrating the broad therapeutic potential of AT-101,” said Mel Sorensen, MD, CEO of Ascenta Therapeutics. “The evidence of resistance reversal from this refractory population supplements the earlier clinical data demonstrating robust activity with the same regimen in docetaxel-naive patients.”

Initial findings from the ongoing open-label, multi-center study demonstrates that AT-101 can be administered safely with D/P in these patients. Investigators also observed clinical responses, based on both PSA and RECIST criteria, including four patients with a confirmed PR (partial response, defined as a PSA decline of 50 percent or greater).

“This first look at the data is very encouraging, particularly since all of these patients were truly refractory to docetaxel, having not simply failed to respond but actually experienced disease progression during prior therapy,” said James Reeves, MD, principal investigator, Florida Cancer Specialists. “Our results to date suggest that stimulating cancer cell apoptosis through Bcl-2 pathways with AT-101 may in fact extend the clinical utility of docetaxel in this cohort of highly treatment-resistant patients.”

The analysis included data from 37 men with docetaxel-refractory CRPC who were treated with D (75 mg/m(2) q3 weeks), P (5 mg b.i.d. on days 1-21) and AT-101 (40 mg b.i.d. on days 1-3 of each 21-day cycle). Safety and efficacy were assessed at three-week intervals, with radiological assessments performed at 6-week intervals for patients with soft tissue disease and bone scans performed after cycle 6 and at completion of therapy. Ten of the 37 patients remain on study.

Thirty-eight percent (14/37) of patients treated had at least a 30 percent decrease in PSA level and 19 percent (7/37) achieved a confirmed PR. Twenty patients had measurable disease, five of whom (25 percent) had a PR by RECIST criteria, with additional patients eligible to achieve a response. Four patients have been on therapy for 6 months or more.

Safety data was available for 22 patients. The most common (10 percent or greater) adverse events included fatigue (50 percent), diarrhea (27 percent), nausea, anorexia, and neutropenia (all 23 percent), vomiting and dizziness (18 percent). The most common Grade 3/4 toxicity was neutropenia (23 percent) and was the only Grade 3/4 adverse event that occurred in more than two patients (5 patients). These adverse events were considered manageable and consistent with the safety profile of D/P.

Facts About Prostate Cancer

The American Cancer Society estimates that more than 186,000 new cases of prostate cancer were diagnosed in the United States and that more than 26,000 men died of the disease in 2008, making it the second leading cause of cancer deaths among American men after lung cancer. Approximately half of all patients with prostate cancer suffer recurrent, advanced disease after definitive local therapy with radiation or prostatectomy and systemic treatment. One process by which prostate cancers may develop resistance to systemic treatment is by increasing the expression of proteins that inhibit apoptosis (programmed cell death). The most recognized group of such proteins are the antiapoptotic members of the Bcl-2 family, including Bcl-2, Bcl-XL, and Mcl-1. Overexpression of Bcl-2 family proteins in human tumor specimens has been reported by several groups to be associated with recurrence, more advanced stage, treatment resistance, the development of hormone-resistance, and shortened survival in prostate cancer.

About AT-101

AT-101 is an orally-active, pan-Bcl-2 inhibitor (including Bcl-2, Bcl-xL, Bcl-w, and Mcl-1 inhibition), that has been shown to directly induce apoptosis by operating as a BH3 mimetic and indirectly as an independent upregulator of Noxa and Puma. By blocking the binding of Bcl-2 family members with proapoptotic proteins and upregulating specific proapoptotic factors, AT-101 lowers the threshold for cancer cells to undergo apoptosis in various tumor types. In Phase I and Phase II trials, AT-101 has demonstrated single-agent cytoreductive activity in chronic lymphocytic leukemia (CLL), non-Hodgkins lymphoma (NHL), and prostate cancer. Phase II combination trials are ongoing in hormone-refractory prostate cancer and non-small cell lung cancer (with Taxotere(R) [docetaxel]), B-cell malignancies (with Rituxan(R) [rituximab]), small cell lung cancer (with Hycamtin(R) [topotecan]), glioma (with Temodar(R) [temozolomide], +/- chemoradiotherapy [XRT]) and in esophageal cancer (with docetaxel, 5-fluorouracil and XRT). Recently, two double-blinded, randomized, controlled trials of the docetaxel + AT-101 combination were opened in hormone-refractory prostate cancer and non-small cell lung cancer, both indications in which docetaxel is approved as a single agent.

About Ascenta Therapeutics

Ascenta Therapeutics, Inc. is a privately-held, clinical-stage biopharmaceutical company that discovers and develops new medicines for the treatment of cancer. The company is headquartered in Malvern, Pennsylvania, and has a preclinical research facility in Shanghai, China. Its technology, licensed from both the National Institutes of Health and the laboratory of Dr. Shaomeng Wang at the University of Michigan, is focused on discovering molecules that target proteins that prolong cell survival.

For additional information on Ascenta Therapeutics, including information on ongoing clinical trials with AT-101, please visit the company’s website at http://www.ascenta.com.

Men with advanced prostate cancer may receive initially effective treatment with hormonal therapies to which the majority of prostate cancers can later become resistant. This is known as hormone refractory, androgen resistant or castration (medical or surgical) resistant prostate cancer. The Phase II EPOC (Endothelin A Proof Of Concept) data published today show that HRPC patients who were asymptomatic or mildly symptomatic for pain and received ZD4054 10mg once-daily experienced a 45% reduction in the risk of death compared to placebo (HR 0.55; 80% CI 0.41, 0.73). [1]

The Phase II EPOC data show an increase in overall survival (OS) (the secondary endpoint of the study) though they do not show a statistically significant difference in Progression-Free Survival (PFS) between ZD4054 and placebo treatment arms (the primary endpoint of the study). [1]

Nick James, Professor of Clinical Oncology, Institute for Cancer Studies, Birmingham, UK, and principal investigator of the EPOC study said: “Currently, the only licensed treatment option for metastatic patients shown to improve survival in men with HRPC is docetaxel chemotherapy. These data demonstrate that ZD4054 may offer hope to men with the most severe form of prostate cancer who no longer respond to hormone therapies.”

To further evaluate the potential of ZD4054 in men with HRPC, a Phase III trial programme ENTHUSE (ENDOTHELIN A USE) is underway. The ENTHUSE programme consists of three studies. The first of these trials is aimed at investigating the efficacy of ZD4054 in metastatic HRPC, while the second will look at its role in non-metastatic HRPC patients. A third trial will study ZD4054 in combination with docetaxel chemotherapy (Taxotere TM) for the treatment of metastatic HRPC.

EPOC Phase II Clinical findings

Results from the EPOC study, which originally presented at the 14th European Congress of Clinical Oncology (ECCO, 23-27 September, Barcelona) in which all men received study treatment in addition to best supportive care (palliative measures that help control cancer symptoms and treatment side effects), suggest that patients who received ZD4054 10mg once-daily experienced a 45 per cent reduction in the risk of death compared to placebo (HR 0.55; 80% CI 0.41, 0.73). Patients who received ZD4054 15mg once-daily experienced a 35% reduction in risk of death (HR 0.65; 80% CI 0.49, 0.86), translating into an improved median OS of 23.5 months compared with 17.3 months in the placebo arm. [1]

The primary endpoint of PFS data did not show a statistically significant difference between ZD4054 and placebo treatment arms. PFS in this study was measured through clinical progression or radiological evidence of disease worsening, or worsening of disease-related pain. However, patients with metastatic HRPC can typically have multiple bone metastases, making assessments of further changes in bone metastases difficult.

Professor Nick James commented: “There is no established definition for progression in HRPC and as such it can be difficult to measure accurately; however, overall survival represents a clear endpoint in this disease stage.”

ZD4054 taken as an oral tablet was seen to be convenient and well tolerated, with a side-effect profile consistent with that seen in previous ZD4054 studies, which included headache, oedema and nasal congestion. [1] Further assessment of the safety of ZD4054 will continue throughout the ENTHUSE clinical trials.

More information on the ZD4054 ENTHUSE programme in the UK can be found on . http://www.astrazenecaclinicaltrials.com/ and http://astrazeneca.citeline.com.

Mode of action – specific ETA receptor antagonism

ZD4054 works by specifically blocking the ETA receptor. This may lead to the inhibition of multiple processes that drive tumour growth and spread, including tumour cell proliferation, tumour cell survival, angiogenesis and the formation of bone metastases. It does so without blocking the ETB receptor, which may provide beneficial biological effects in terms of encouraging apoptosis, the death of unhealthy cells.[2]

About the EPOC study

-The EPOC study is a Phase II, randomised, double-blind, placebo-controlled study of ZD4054

-A total of 312 pain-free or mildly symptomatic patients with metastatic hormone-resistant prostate cancer were enrolled in the study

-Participants were from Australia, Belgium, Canada, Denmark, Finland, France, Indonesia, Netherlands, Norway, Poland, Sweden, Switzerland, UK and the USA

About Prostate Cancer in the UK

Prostate cancer is the most common cancer to be found in elderly men in the UK. Over 34,000 men in the UK alone are diagnosed with prostate cancer each year and prostate cancer has overtaken lung cancer to become the most common cancer for men in the UK. Prostate cancer is the second biggest cause of death from cancer in men in the UK with around 10,000 deaths each year. More than 60 percent of cases occur in men over 70 years old and the largest number of cases is diagnosed in those aged 70-79. [3]

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world’s leading pharmaceutical companies with healthcare sales of $26.475 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.

References

[1] James ND, et al. Safety and Efficacy of the Specific Endothelin-A Receptor Antagonist ZD4054 in Patients with Hormone-Resistant Prostate Cancer, Eur Urol (2008), doi:10.1016/j.eururo.2008.11.002

[2] Morris, C.D. et al. Specific inhibition of the endothelin A receptor with ZD4054: clinical and pre-clinical evidence. British Journal of Cancer. 2005: 92

[3] Cancer Research UK. http://info.cancerresearchuk.org/cancerstats/types/prostate/ accessed November 200

The presentations, accompanied by presenter voiceovers, can be reviewed by going to: http://www.prostatecancerfoundation.org/scientificretreat. Free Adobe™ Flash and Adobe Reader™ downloads are provided on the site.

“The Prostate Cancer Foundation’s Annual Scientific Retreat is a unique conference. It provides a collaborative environment to share new data that might accelerate solutions for prostate cancer,” explained Dr. Howard Soule, executive vice president and chief scientist for the Prostate Cancer Foundation. “It is the most sought-after invitation in the world for prostate cancer scientists. Each year we receive more requests for an invitation than we can accommodate.

“We are pleased to make the meeting presentations available to a broader audience and hope that this online distribution will support our mission to accelerate scientific exchange, discovery and development,” added Soule.

About the Prostate Cancer Foundation

The Prostate Cancer Foundation is the world’s largest philanthropic source of support for prostate cancer research focused on discovering better treatments and a cure for recurrent prostate cancer. Founded in 1993, the PCF has raised more than $370 million and provided funding to more than 1,500 researchers at nearly 200 institutions worldwide. The PCF also advocates for greater awareness of prostate cancer and more governmental resources, resulting in a 20-fold increase in government funding for prostate cancer. More information about the PCF can be found at http://www.allcancercure.com.org.

In addition, the researchers, led by Marja Nevalainen, M.D., Ph.D., associate professor of Cancer Biology at Jefferson Medical College of Thomas Jefferson University, also showed that the convergence of two biological pathways could be responsible for making such hormone-resistant prostate cancers especially dangerous. They have found that a synergy between Stat5 and hormone receptors in recurrent prostate cancer cells helps each maintain its activity. Dr. Nevalainen and her co-workers report their findings January 1, 2008 in the journal Cancer Research.

“These findings validate Stat5 as a potential drug target in prostate cancer, and in particular, in a form of prostate cancer for which there are no effective therapies,” Dr. Nevalainen says.

Men with primary prostate cancer usually have either surgery or radiation, whereas subsequent disease is frequently treated by hormone therapy. But if the cancer recurs again, years later, it can be more aggressive and typically fails to respond to hormone treatment. In previous work, the researchers showed that when Stat5 is turned on in primary prostate cancer, men are more likely to have recurrent disease.

In the current study, the team examined human prostate cancer cells of 198 patients with prostate cancer recurrence. They found that Stat5 was active in 74 percent of all recurrent prostate cancers. Of these patients, 127 had been treated with androgen deprivation therapy. The researchers found Stat5 was active in 95 percent of these hormone resistant tumors, meaning it was more likely to be active if the patient had been treated with hormone deprivation therapy.

Dr. Nevalainen shows that Stat5 interacts with the androgen receptors and keeps them “transcriptionally active.” Next, the scientists would like to conduct tests in animal models to see if this synergy promotes androgen-independent prostate tumor growth, and whether or not Stat5 synergizes with androgen receptors activated by adrenal androgens, which are present in the absence of testicular androgens during the hormone therapy of prostate cancer in patients.

Thomas Jefferson University

Hypogonadism occurs in 50-80% of men age 80 years or older and is associated with decreased bone mineral density, decreased muscle mass, increased risk of falls, and increased risk of impaired static balance. ADT is an immediate and extreme form of hypogonadism and thus the authors point out has the same associations. They reviewed the 5 criteria for frailty and whether evidence demonstrates that ADT meets the criteria.

Regarding weight loss (lean), ADT actually results in weight increase but this is due to gaining fat and losing lean muscle mass. Numerous studies support this finding and while increased inflammatory biomarkers are reported following ADT in laboratory studies, no correlative data in clinical trials is provided in this paper. Weakness is also documented in clinical studies of aging men and those undergoing ADT. While the authors cite references that biomarkers are elevated in the elderly they do not present citations of elevated biomarkers for men undergoing ADT although it seems to be a reasonable assumption. Objective measures of mobility and falls in CaP patients receiving ADT have not been reported. There is good evidence that ADT is clinically associated with patient self-reported fatigue and low physical activity.

While there is actually evidence to support that ADT adversely affects most of the criteria consistent with frailty, good level I or II evidence for mobility or biomarkers is lacking. The authors present a paper that raises the awareness of ADT as accelerating the properties of frailty. It is hypothesis generating that biomarkers may be a useful marker for following these adverse events.

Bylow K, Mohile SG, Stadler WM, Dale W

Cancer. ePub: October 24, 2007

DOI: 10.1002/cncr.23084

Reported by UroToday.com Contributing Editor Christopher P. Evans, M.D

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