Healthcare Prof:

Brief stress management sessions prior to and immediately after surgery may have both short- and long-term benefit for guys undergoing a radical prostatectomy for early-stage prostate cancer, according to research from The University of Texas M. D. Anderson Cancer Center.

The study, inside the current issue of the Journal of Clinical Oncology, is the first to examine the benefits of psychosocial intervention for prostate cancer patients prior to surgery. It found that guys who participated inside the sessions experienced less short-term mood disturbance and better long-term quality of life, compared to patients who had the procedure but did not have any behavioral intervention.

Most psychosocial interventions in cancer of any type have been studied after patients have completed surgery, explained Lorenzo Cohen, Ph.D., the study’s senior author and professor in M. D. Anderson’s Departments of Behavioral Science and General Oncology, and director with the Integrative Medicine Program.

“We know that for males with early-stage prostate cancer, the time when they are making treatment decisions is very stressful,” stated Cohen. “A radical prostatectomy is not without possible, very personal, consequences, including urinary incontinence and erectile dysfunction. Patients may also be worried about the uncertainty that the surgery will cure their cancer.

“From other areas of research, we know that going into a surgical setting overly stressed may increase a patient’s recovery time. With this study, we wanted to intervene inside the pre- and post-surgical setting and try to help relieve stress and minimize mood disturbance, such as depression, anxiety and distress, both inside the short- and long-term.”

For the randomized study, 159 early stage prostate cancer, radical prostatectomy patients were assigned to receive either: two 60-90 minute sessions of pre-surgical stress management intervention and brief booster sessions the morning of, and 48 hours following surgery; two 60-90 minute individual supportive attention sessions and boosters similar towards the stress management group; or standard care.

Assessments occurred before the sessions, one month before, one week before, and the morning of surgery, as well as six weeks, six and 12 months following surgery.

The stress management was based on aspects of cognitive behavioral therapy. Males in the stress management group met with a clinical psychologist and were taught simple behavioral techniques, including diaphragmatic breathing and relaxing guided imagery and cognitive therapy. Those within the supportive attention groups met with the same psychologist, but sessions were more general, and centered around open discussions. Patients in the standard care group did not receive any behavioral therapy.

For the stress management group, the guys were exposed to an imagery experience of the day of surgery – all the sounds and sensations from pre-op, to the recovery room, to coming out of anesthesia – although they were in a relaxed state. They were then taught cognitive skills to work with negative thinking and realistic expectations – so that patients could better manage any unexpected side effects throughout their recovery or difficulty healing.

The researchers found that in terms of short-term effects, assessed at one week before and the morning of surgery, men inside the stress management group had the lowest levels of mood disturbance followed by those within the supportive attention group, with patients inside the no therapy group having the highest level, using the difference between the stress management and standard care groups being statistically significant.

During the long-term follow-up, assessed at six weeks, six and 12 months, patients in the stress management group reported a higher level of physical functioning and aspects of quality of life than patients within the other two cohorts; the difference between the stress management and standard care groups was statistically significant.

The largest difference between the groups was at the 12-month follow-up, when the standard care group reported lower levels for physical functioning than those who received the stress management intervention. It’s also interesting to note that at no point was there any statistical difference between the supportive attention and the other two groups, stated Cohen.

Cohen and his team were surprised to see this level of difference in physical functioning for the duration of the long-term follow-up because the interventions in the pre- and peri-operative settings were so brief and mainly focused on aspects of stress management.

“We’re trying to understand what is potentially associated with a patient’s long-term quality of life and what was it that happened within the stress management group that resulted in a much better quality of life within the year post-surgery,” Cohen said.

“Before we can suggest that stress management is useful prior to surgery for all males undergoing a radical prostatectomy, we need to better understand the mechanism behind our findings, as well as understand for whom this type of intervention will be the most useful,” Cohen said. “However, that said, all diagnosed with cancer treatment should be encouraged to participate in any stress management plan – be it mind-body, or cognitive in nature. We know that they are safe and may improve patients’ well-being and help them adjust to a cancer diagnosis.”

As a follow up, Cohen and his team are currently analyzing immune function and stress hormone levels from collected blood samples.

Prostate cancer is the leading cause of cancer in males. Based on the American Cancer Society, in 2008, 186,320 were diagnosed with, and 28,660 died from the disease.

The research was supported, in part, by funds from the National Cancer Institute.

In addition to Cohen, other authors on the study include, from M. D. Anderson: Patricia Parker, Ph.D., Adoneca Fortier, Danielle Carr, Ph.D., all with the Department of Behavioral Science; Curtis Pettaway, M.D., Richard Babian, M.D., and Louis Pisters, M.D., all of the Department of Urology; Qi Wei, Department of Palliative Care and Rehabilitation Medicine; and from Baylor College of Medicine, Brian Miles, M.D., of the Department of Urology.

About M. D. Anderson

The University of Texas M. D. Anderson Cancer Center in Houston ranks as 1 with the world’s most respected centers focused on cancer patient care, research, education and prevention. M. D. Anderson is one of only 40 comprehensive cancer centers designated by the National Cancer Institute. For four of the past six years, including 2008, M. D. Anderson has ranked No. 1 in cancer care in “America’s Best Hospitals,” a survey published annually in U.S. News & World Report.

Source: University of Texas M. D. Anderson Cancer Center

Healthcare Prof:

Article Opinions:1 posts
The prostate cancer education and advocacy community has come together to collaborate on and develop a shared agenda within the interests of the hundreds of thousands of American guys who are at risk for a diagnosis of prostate cancer every year.

The leadership from eight leading prostate cancer organizations met on April 2, in Washington, DC, to explore how to effectively work together on specific policy initiatives to advocate for early detection and appropriate treatment of clinically significant prostate cancer, particularly among those males at high risk for this disease leading towards the deaths of over 28,000 American guys every year.

First, the eight organizations reached consensus that:

— We will continue to work with other cancer groups in support of increased federal funding for cancer research through the annual appropriations process to support the National Institutes of Well being, the National Cancer Institute, and the Centers for Disease Control

— We will continue to call upon Congress to increase funding for the Prostate Cancer Research Program at the Department of Defense

Second, the eight organizations will work closely together in support of four specific initiatives:

— Passage of a Bill to create an Office of Men’s Health within the Department of Well being and Human Services (HHS); this Office will mirror the fine work of the Office on Women’s Health

— Passage of a Congressional resolution that there is a prostate cancer epidemic among the African-American community, and that appropriate research and educational initiatives are needed to combat this epidemic

— Passage with the Thomas J. Manton Early Detection and Treatment Act, which is focused on the provision of funds to support the early detection and appropriate treatment of clinically significant prostate cancer in underprivileged and underserved communities

— Elimination of “least costly alternative” (LCA) policies for Medicare beneficiaries

Finally, the eight organizations agreed to work closely with other relevant cancer and consumer organizations to ensure that healthcare reform includes provisions for the early detection and appropriate treatment of clinically significant prostate cancer across all sectors.

Source: Men’s Health Network

Healthcare Prof:

5 (1 votes)

The Palm Springs, Calif.-based Desert AIDS Project has launched an Internet-based education and prevention program aimed at men who’ve sex with guys, the Desert Sun reports. The program was launched ahead with the area’s White Party Easter weekend, based on the Sun. “With the White Party literally in our backyard, we feel a responsibility every year to get out the message about safer sex even though not throwing the proverbial wet blanket on the enjoyable individuals are here for,” David Brinkman, AIDS Project executive director, mentioned.

The plan, known as “I-Connect,” makes it possible for project staff to distribute data about safer sex, HIV testing, mental wellness and substance abuse counseling on several Net web sites, according to a release. In addition, some staff program to be in the lobby with the host hotel for the White Party all through the weekend, based on Brinkman. The AIDS Project aims to reach about 3,000 individuals throughout the program’s 1st year. MSM are the primary attendees with the White Party, and Palm Springs has one of the largest MSM populations per capita inside the U.S., based on the Sun (Brambila, Desert Sun, 4/3).

Reprinted with kind permission from http://www.kaisernetwork.org. You’ll be able to view the whole Kaiser Day-to-day Well being Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Wellness Policy Report is published for kaisernetwork.org, a free of charge service of the Henry J. Kaiser Loved ones Foundation.

? 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Healthcare Prof:

The Miami Herald on Monday examined issues that some HIV-positive men who have sex with men face when determining when to reveal their status to potential partners. Based on the Herald, a recent study from the Gay Men’s Well being Crisis found that half of U.S. residents surveyed stated they believe that HIV/AIDS contributes to discrimination against MSM. In addition, discrimination inside the MSM community toward HIV-positive MSM is not discussed widely, based on the Herald. This stigma often leads to a fear of disclosure among HIV-positive MSM, which can contribute to high-risk sexual activity and the spread of HIV.

Spencer Lieb, senior epidemiologist in the Florida Department of Health Bureau of HIV/AIDS, stated, “Non-disclosure is one with the challenges of HIV prevention.” Reports in Florida show a 48% increase in newly recorded HIV cases in Miami-Dade County from 2006 to 2008, as well as a 74% increase in Broward County. Lieb said these figures could point to an enhanced reporting method. Even so, the Herald reports that the increase in new cases also could be in part because of increased HIV/AIDS complacency. Linda Simon, a psychotherapist with the Miami Beach Community Wellness Center, stated that among some MSM, disclosing their HIV-positive status is a “struggle,” because “on the one hand they want to be responsible, but on the other they want to protect themselves from breaching confidentiality and rejection” (Roth, Miami Herald, 4/6).

The Gay Men’s Health Crisis study is available online.

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Wellness Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Well being Policy Report is published for kaisernetwork.org, a free service with the Henry J. Kaiser Family Foundation.

? 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Healthcare Prof:

A new multi-center study shows that an experimental drug lowers prostate specific antigen (PSA) levels a marker for tumor growth in men with advanced prostate cancer for whom traditional therapy options have failed. The study, led by researchers at Memorial Sloan-Kettering Cancer Center (MSKCC), is published in Science Express, the online version of the journal Science.

Most men with metastatic prostate cancer eventually build up resistance to the drugs that lower or block male hormones and develop a far more aggressive form of the illness called castration-resistant prostate cancer (CRPC), or hormone-refractory disease. According to the study’s findings, investigators studied two novel compounds, RD162 and MDV3100, and not only gained an understanding of their novel mechanism of action, but discovered that these agents showed activity in CRPC cells in culture and in mice.

The study also reports on a Phase 1/2 trial of MDV3100 in 30 patients with advanced CRPC and discovered that 22 out of 30 men showed declining PSA levels, and 13 out of 30 men (43 percent) had PSA levels fall by more than half.

Several years ago, the senior author of the study, Charles Sawyers, MD, and his colleagues in the University of California, Los Angeles (UCLA), uncovered a potential reason why metastatic prostate cancer patients eventually relapse with CRPC. This insight was used to discover RD162 and MDV3100.

“It’s gratifying to know that our hypotheses about why men develop resistance to currently available treatments are confirmed and, most importantly, that there are already patients who are benefiting from our investigation,” stated Dr. Sawyers, Chair with the Human Oncology and Pathogenesis Program at MSKCC as well as a Howard Hughes Medical Institute investigator.

Current treatments for men who have advanced prostate cancers inhibit the activity of male hormones that help drive tumor growth. Many of these drugs disrupt the androgen (male hormone) receptor, which helps regulate cell proliferation, but tumors eventually become resistant to the drugs by expressing higher levels of the receptor. Preclinical studies by Dr. Sawyers and others have demonstrated that CRPC cells have increased expression of the androgen receptor and that overexpression of this receptor could contribute to the progression of disease.

Based on this information, Dr. Sawyers initiated a collaboration with Michael Jung, PhD, Professor of Chemistry at UCLA, that led to the discovery of a number of nonsteroidal, small molecule antiandrogen compounds, including MDV3100, which has been shown to retain its anticancer activity, even when the receptor’s expression is elevated.

“The discovery and initial development of this drug was a collaborative effort all done within the academic setting, without reliance on the engine with the pharmaceutical industry that typically drives drug development,” stated Dr. Sawyers. Dr. Jung’s group synthesized the compounds, which Dr. Sawyers’ team then evaluated using prostate cancer mouse models engineered to highly express the androgen receptor, mimic progression to castration-resistant disease, and reflect the biology of clinical drug resistance.

According to the new study, the team of researchers tested various compounds to block the androgen receptor in CRPC cells. They chose to further evaluate the drug RD162 as well as a closely related compound, MDV3100. According to their findings, both drugs inhibit the androgen receptor function by impairing the receptor’s ability to enter a CRPC cell’s nucleus (called nuclear translocation), blocking it from binding to the DNA of its target genes, and preventing the cell from growing. They identified that both compounds worked well in cells in culture, shrank tumors in mice, maintained tumor shrinkage for months, and prevented the androgen receptor from activating additional genes later in the process, or “downstream.” Other currently approved drugs cannot disable the receptor in such a way.

The biopharmaceutical company Medivation, Inc., licensed RD162 and MDV3100 from UCLA in 2006 and has already completed enrollment in the first human trial of oral MDV3100 a Phase 1/2 clinical trial, which was led by investigators at MSKCC and conducted through the Prostate Cancer Clinical Trials Consortium. The Consortium is sponsored by the Department of Defense and the Prostate Cancer Foundation. The trial enrolled men with metastatic, castration-resistant prostate cancer who relapsed after therapy with conventional hormone therapy and demonstrated anti-prostate cancer effects beginning with the first patient treated with MDV3100 in the lowest dose. Further positive results from an additional 110 patients who received the drug at higher doses had been recently reported in the ASCO Genitourinary Cancers Symposium in February 2009

Source: Memorial Sloan Kettering Cancer Center

Healthcare Prof:

IRIN/PlusNews on Monday examined a peer education program in Laos directed toward “hidden” men who have sex with men, a group that is “difficult to identify in HIV prevention and surveillance” despite being “probably the largest group of MSM within the country.” Anan Bouapha — a former coordinator for the project, which is run by the Australian medical research facility the Burnet Institute — stated, “Unlike transsexuals or openly gay men, hidden MSM can be homosexual, bisexual or straight. They might not want to be identified as MSM but we require to get the safe-sex message to them, no matter how difficult this is.” IRIN/PlusNews reports that the program’s peer educators visit places young men are most likely to gather, such as beer shacks, saunas or video shops. Bouapha said that the peer educators are trained to discuss HIV and other sexually transmitted infection prevention, as well as how to method MSM so that they feel comfortable asking questions.

However, IRIN/PlusNews reports that interventions like this “may not be enough to stem an HIV/AIDS epidemic” in the country, where programs for HIV prevention, therapy and care aimed at MSM have not yet been rolled out nationwide. Establishing contact with Lao MSM, especially hidden MSM, is vital to the fight against HIV/AIDS in Laos, which has a prevalence of 5.6% among MSM compared with 0.1% among the general population, according to a 2007 study conducted by the Burnet Institute and the Ministry of Health. The study’s findings “represent a worrying trend” in Laos because ignorance of HIV/AIDS among some MSM, especially those with female partners, “could potentially lead to an epidemic in the broader community, something which the country has so far been able to avoid,” IRIN/PlusNews reports (IRIN/PlusNews, 4/6).

Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of the Henry J. Kaiser Family Foundation.

? 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Healthcare Prof:

1 (1 votes)

University of Nevada School of Medicine scientists within the Department of Physiology and Cell Biology have discovered insight into the reproductive workings of the male sex chromosome that may possibly have significant implications for male infertility and contraception.

This important discovery has been published in Nature Genetics, one with the highest-ranking journals within the field of biomedical analysis based upon the impact factor.

The study findings indicate that the X chromosome in developing sperm cells encodes numerous tiny ribonucleic acids called microRNAs despite the fact that that most of genes on the X chromosomes are suppressed. This unprecedented observation implies that these small RNAs have critical roles in chromosome inactivation and also in sperm formation.

“The sex chromosome silencing in meiotic male germ cells is a well-known phenomenon, which has been termed meiotic sex chromosome inactivation. I was surprised when we first observed that numerous microRNAs had been highly expressed in these cells,” mentioned Wei Yan, M.D., Ph.D., principal investigator for the study and associate professor of physiology and cell biology in the School of Medicine.

Working in collaboration with Dr. John McCarrey, professor of molecular biology and reproductive biology in the University of Texas, San Antonio, Yan’s investigation group further investigated all the known X-linked microRNAs. Their information confirm that these X chromosome-derived microRNAs indeed escape the silencing effects and mange to be expressed.

“This finding opens a new avenue towards understanding the role of these small RNA species inside the control of sperm production. Worldwide, one in nine couples in their reproductive age experience infertility. On the other hand, the number of unintended pregnancy is rising yearly. Since these small RNAs are involved in the control of sperm formation, they can be causative factors in male infertility and also can be used as non-hormonal male contraceptive targets,” added Yan.

Yan’s analysis is focused on mammalian sperm and egg production and is funded by grants from the National Institutes of Well being. Rui Song, a third year graduate student and Seungil Ro, Ph.D., an assistant professor of physiology and cell biology, co-first authored this paper. Other contributing authors include Jason D. Michaels, a third year medical student, and Chanjae Park, Ph.D., a post-doctoral researcher.

Notes:

As the state’s only public medical school, the University of Nevada School of Medicine has been a leader in healthcare, medical education and study in Nevada since 1969. The School of Medicine contains 16 clinical departments including family medicine, pediatrics, obstetrics and gynecology, internal medicine, surgery, and psychiatry and behavioral sciences, and five nationally recognized departments in basic science including microbiology and biomedical engineering. The a lot more than 185 doctors of University Health System, the school’s clinical practice, offer care in much more than 40 medical specialties and subspecialties with eight physician offices inside the Reno/Sparks area and seven in Las Vegas. The school is committed to a best practices approach to medicine and is dedicated to exceptional healthcare for Nevada now and inside the future.

Source:
Anne McMillin
University of Nevada, Reno

Healthcare Prof:

In a potential advance toward a male contraceptive pill and new treatments for infertility, researchers are reporting the identification of key biochemical changes that put sperm “in the mood” for fertilization. Their study, which addresses a long-standing biological mystery, appears in ACS’ Journal of Proteome Research, a monthly publication.

Mark Platt and colleagues note within the new study that sperm cannot fertilize an egg immediately after entering the female reproductive tract. Sperm must acquire this ability after undergoing an activation process called “capacitation.” Scientists have known for years that this process involves phosphorylation. That common biological modification causes cellular activities to be turned “on” by the addition of phosphate molecules to certain amino acids within proteins. Nevertheless, the specific biochemical details have been a deep mystery.

Using laboratory mice, the researchers compared the extent of phosphorylation in both capacitated and noncapacitated sperm samples. They identified 44 peptides exhibiting differential phosphorylation, on 59 specific amino acids, suggesting that modification of these particular sites is essential for the capacitation process. The relative ratio of phosphorylation between the capacitated and noncapacitated samples had been also reported, providing the first biochemical description of what puts sperm “in the mood.”

“Use of Differential Isotopic Labeling and Mass Spectrometry To Analyze Capacitation-Associated Changes within the Phosphorylation Status of Mouse Sperm Proteins”

American Chemical Society

The American Chemical Society is a nonprofit organization chartered by the U.S. Congress. With far more than 154,000 members, ACS could be the world’s largest scientific society and a global leader in providing access to chemistry-related investigation by means of its multiple databases, peer-reviewed journals and scientific conferences. Its main offices are in Washington, D.C., and Columbus, Ohio.

Source
American Chemical Society

Healthcare Prof:

5 (2 votes)

Dendreon Corporation (Nasdaq: DNDN) announced that the pivotal Phase 3 IMPACT study of PROVENGE(R) (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted within the study successfully achieving the pre-specified level of statistical significance defined by the study’s design. The safety profile of PROVENGE appeared to be consistent with prior trials.

The 512-patient, multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Remedy) study enrolled men with metastatic androgen-independent prostate cancer was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).

PROVENGE is Dendreon’s investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies specifically developed to engage the patient’s own immune method against cancer.

Detailed results from the IMPACT study will be presented during a plenary session in the American Urological Association’s Annual Meeting in Chicago on Tues., Apr. 28 at 2:20 pm CT.

“Survival may be the gold standard outcome for oncology clinical trials, and overall survival was the primary endpoint with the IMPACT trial. The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with PROVENGE could prolong survival,” mentioned Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. “We are immensely grateful to our clinical investigators and the much more than 1,000 men with advanced prostate cancer who have participated in our studies over the last decade and whose courage and contribution have significantly advanced the understanding and treatment of prostate cancer and the potential role of cancer immunotherapies.”

“The successful outcome from the Phase 3 IMPACT study provides validation with the long-pursued goal of harnessing the human immune technique against a patient’s own cancer,” continued Dr. Gold.

Because the data meet the criteria and specifications outlined in its Special Protocol Assessment (SPA) agreement with the FDA, Dendreon intends to file an amendment to its existing Biologic License Application (BLA) inside the fourth quarter of this year to gain licensure of PROVENGE.

Prostate cancer will be the most common non-skin cancer in the United States and the third most common cancer worldwide. A lot more than one million men in the United States have prostate cancer, with an estimated 186,320 new cases and approximately 28,660 men who were expected to die from the disease in 2008. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.

About PROVENGE

PROVENGE (R) (sipuleucel-T), an investigational product in development for men with androgen-independent prostate cancer, may represent the first product in a new class of active cellular immunotherapies (ACIs). PROVENGE and other ACIs are uniquely created to make use of live human cells to engage the patient’s own immune method with the goal of eliciting a specific long-lasting response against cancer. In controlled clinical trials, the most common adverse events were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade with a short duration of 1-2 days following infusion.

About Dendreon

Dendreon Corporation is a biotechnology company whose mission would be to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates created to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN.

Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of information to the FDA and approval of product applications by the FDA and risks and uncertainties inherent inside the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that could cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret information differently than we do or require much more information or a more rigorous analysis of information than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product could not be indicative of results obtained in a later clinical trial, risks that we could lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property.

Source: Dendreon Corporation

View drug information on Provenge.

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