Healthcare Prof:

Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced additional positive results from its Phase III program for NEBIDO (testosterone undecanoate), a long-acting injectable testosterone therapy under development for the treatment of male hypogonadism. The trial data announced has been filed with the U.S. Food and Drug Administration (FDA) as an addition to information contained in the Company’s existing New Drug Application (NDA) that was originally filed on August 28, 2007. Based on recent conversations with the FDA, the Company anticipates that the FDA Prescription Drug User Fee Act (PDUFA) target action date for NEBIDO will remain June 27, 2008.

The dosing regimen for NEBIDO submitted within the original NDA was 1000 mg given every 12 weeks, and as announced previously, achieved all of the primary endpoints according to the FDA criteria for approvability. The Company has been exploring additional dosage regimens to determine if it is possible to achieve a a lot more rapid onset of steady state testosterone pharmacokinetics and still satisfy each with the FDA pre-specified criteria for approvability. This recently completed Phase III trial, announced today, studied a new remedy regimen in which hypogonadal guys were given an initial injection of 750 mg of NEBIDO, followed 4-weeks later by an additional 750 mg loading injection and then 750 mg injections every 10-weeks thereafter.

The data from this recently completed Phase III trial demonstrated a highly effective therapy regimen. In the trial, NEBIDO demonstrated a rapid achievement of steady state testosterone levels, minimal excursions outside with the normal range, and an extremely high percentage of patients maintaining a eugonadal (normal) testosterone range. NEBIDO met its primary endpoints, a responder analysis based on average testosterone concentrations throughout the steady state dosing interval and an outlier analysis based on the maximum testosterone concentrations during the steady state dosing interval. As using the original dosing regimen, treatment with NEBIDO was properly tolerated with this new dosing regimen.

“As we have previously stated, we have been evaluating dosing regimens that we believe optimize the replacement of testosterone in men with hypogonadism. I am extremely pleased that the dosing regimen evaluated in this study accomplishes this objective,” stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. “The results of our trial demonstrate a rapid achievement of steady-state testosterone levels, the maintenance of levels within the eugonadal range, and reductions in excursions above the normal range. Steady state testosterone pharmacokinetics had been achieved within just weeks under the new regimen, whereas the 1000 mg regimen, while successfully achieving all primary objectives, reached steady state pharmacokinetics after several months of therapy.”

Dr. Cooper continued, “We intend to ask for approval of this new 750 mg regimen, rather than the 1000 mg regimen, as we believe this new regimen distinguishes itself by providing physicians using the optimal long-term dosing solution for treating their male patients with hypogonadism. Importantly, we are extremely pleased using the feedback we lately received from the FDA that the PDUFA target action date was most likely to remain unchanged.”

Study Design

The most recent Phase III pharmacokinetic trial was an open-label (unblinded) study that evaluated remedy with an initial 750 mg of NEBIDO given via intramuscular injection, followed 4-weeks later by an additional 750 mg loading injection and then 750 mg every 10 weeks thereafter. Patients eligible for pharmacokinetic assessment had been males with a diagnosis of either primary or secondary hypogonadism, a body weight >65 kg, and at least 18 years of age.

The primary endpoints included a responder analysis (based on guidelines provided from the FDA for average testosterone concentrations over the steady state dosing interval) and an outlier analysis (based on the maximum testosterone concentrations for the duration of the steady state dosing interval). Specifically, a responder was defined (per FDA approvability criteria) as a patient who, for the duration of steady state, had an average concentration of serum total testosterone (Cavg) within the normal range (300 to 1000 ng/dL). The primary response endpoint was met if at least 75% of patients achieved a Cavg within this normal range. FDA also provided guidelines related to maximum testosterone (Cmax) levels, including thresholds that no patient really should exceed a testosterone concentration of 2500 ng/dL, no more than 5% of patients really should exceed a concentration of 1800 ng/dL, and no more than 15% of patients must exceed a concentration of 1500 ng/dL.

In addition, secondary outcomes included measurements evaluating thegeneral health and well-being of the patients by physical examinations,clinical laboratory measurements, questionnaires, along with other assessments.

Study Findings

The trial enrolled a total of 130 male hypogonadal patients, with 117 (90%) patients completing their data collection for the assessment with the primary endpoints. Of these 117 patients, 94% had a Cavg within the normal range. None of these patients exceeded a testosterone level of either 2500 ng/dL or 1800 ng/dL, and only nine of 117 (7.7%) patients had a peak level exceeding 1500 ng/dL. For those few patients exceeding the 1500 ng/dL threshold, the duration of time above the threshold was brief. Patients also demonstrated improvements from baseline within the key secondary clinical outcome variables.

NEBIDO was well-tolerated as indicated by the analysis with the safety measurements collected and the persistence with study remedy. Further, the spectrum of adverse events reported had been comparable to other injectable hypogonadism treatments reported inside the literature. There were no substantial adverse changes in laboratory parameters with NEBIDO remedy.

About NEBIDO

NEBIDO(R) is really a long-acting depot preparation of testosterone undecanoate under development for the treatment of male hypogonadism. NEBIDO is expected to be the first long-acting testosterone preparation available in the U.S. inside the growing market for testosterone replacement therapies. Indevus acquired U.S. rights to NEBIDO from Bayer Schering Pharma AG, Germany in July 2005.

About Hypogonadism

Male hypogonadism is an increasingly recognized medical condition characterized by a reduced or absent secretion of testosterone from the testes. Reduced testosterone levels can lead to well being problems and significantly impair quality of life. Common effects of hypogonadism consist of decreased sexual desire, erectile dysfunction, fatigue, muscle loss and weakness, depression, too as an increased risk of osteoporosis. These days, you will find an estimated four to five million guys inside the U.S. who suffer from hypogonadism. Of this group, less than ten percent are currently receiving remedy with testosterone replacement therapy.

About Indevus

Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged inside the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company’s approved products consist of SANCTURA XR(TM) and SANCTURA(R) for overactive bladder, VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, and DELATESTRYL(R) to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company’s core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development consist of, VALSTAR(TM) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000 for the prevention of infection by HIV as well as other sexually-transmitted pathogens, octreotide for acromegaly, and pagoclone for stuttering.

Forward Searching Statements

Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company’s actual outcomes and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth inside the Company’s filings under the Securities Act of 1933 as well as the Securities Exchange Act of 1934 under “Risk Factors” and elsewhere, and incorporate, but are not limited to: dependence on the success of SANCTURA, SANCTURA XR, NEBIDO, VANTAS and SUPPRELIN LA; effectiveness of our sales force; competition and its effect on pricing, spending, third-party relationships and revenues; dependence on third parties for supplies, particularly for histrelin, manufacturing, marketing, and clinical trials; risks connected with being a manufacturer of some of our products; risks linked with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR and the manufacture of NEBIDO, VANTAS, SUPPRELIN LA and VALSTAR; reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity, changes in reimbursement policies and/or rates for SANCTURA, SANCTURA XR, VANTAS, SUPPRELIN LA, DELATESTRYL and any future products; acceptance by the healthcare community of our approved products and product candidates; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA XR, NEBIDO, and VALSTAR; product liability and insurance uncertainties; risks relating to the Redux-related litigation; need for additional funds and corporate partners, including for the development of our products; history of operating losses and expectation of future losses; uncertainties relating to controls over financial reporting; difficulties in managing our growth; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; common globally economic conditions and related uncertainties; as well as other risks. Indevus undertakes no obligation to publicly update any forward- searching statement, whether as a result of new data, future events or otherwise.

Indevus Pharmaceuticals, Inc.
http://www.icadmed.com

View drug details on Sanctura; Supprelin LA.

four.five (8 votes)

Healthcare Prof:

5 (1 votes)

Increased exercise capacity reduces the threat of death in African-American and Caucasian men, researchers reported in Circulation: Journal of the American Heart Association.

The government-supported Veterans Affairs study included 15,660 participants and could be the largest known to assess the link between fitness and mortality.

“It is important to emphasize that it takes relatively moderate levels of physical activity – like brisk walking – to attain the linked health benefits. Certainly, 1 does not need to be a marathon runner. This may be the message that we need to convey to the public,” said Peter Kokkinos, Ph.D., lead author with the study and director with the Exercise Testing and Research Lab in the cardiology department in the Veterans Affairs Medical Center in Washington, D.C.

Professor Kokkinos and colleagues investigated exercise capacity as an independent predictor of overall mortality for African-American guys (6,749) and Caucasian men (8,911) and also examined whether racial differences in exercise capacity influence the danger of death. Veterans had been tested by a standardized treadmill test to assess exercise capacity among May 1983 and December 2006 at Veterans Affairs medical centers in Washington, D.C., and Palo Alto, Calif. The males were encouraged to exercise until fatigued unless they developed symptoms or other indicators of ischemia. These individuals had been then followed for an average of 7.five years and death rates were recorded.

Researchers classified the subjects into fitness categories based on their treadmill performance, expressed as peak metabolic equivalents (METs) achieved. Technically, a MET is equivalent to oxygen consumption of three.five milliliters per kilograms of body weight per minute. 1 MET represents the amount of oxygen the person uses at rest. Anything above 1 MET represents work. The higher the MET level achieved, the far more fit the individual.

Based on this concept, the researchers divided the participants into four categories:

* three,170 males had been “low fit,” achieving less than five METs;
* five,153 guys had been “moderately fit,” achieving five to 7 METs;
* five,075 were “highly fit,” achieving 7.1 to ten METs; and
* 2,261 were “very highly fit,” achieving more than ten METs.

The study discovered that “highly fit” males had half the danger of death compared to “low fit” men. Males who achieved “very highly fit” levels had a 70 percent lower risk of death compared to those within the “low fit” category. For every 1-MET increase in exercise capacity (fitness), the threat for death from all causes was 13 percent for both African Americans and Caucasians.

Kokkinos stated, “These findings are important for several reasons: First, we had been able to quantify the health benefits per unit increase in exercise capacity. Second, this is the first study to provide data on physical activity and mortality in African Americans, details lacking until now. Keep in mind that death rates in African Americans are much higher when compared with Caucasians, in portion since race and income negatively influence access to healthcare.”

“The Veterans Affairs’ wellness system is unique in that it ensures equal access to care regardless of a patient’s financial status,” he added. “Thus, it provides us with a unique opportunity to assess the impact of exercise or physical activity on death with out the influence of healthcare differences.”

According to Kokkinos, most middle-age and older individuals can attain fitness levels with a brisk walk, 30 minutes per day, five to six days each week. “I do not advocate that everyone can start with 30 minutes of physical activity. In reality, 30 minutes may be too much for some men and women. If this is the case, split the routine into 10-15 minutes in the morning and another 10-15 minutes inside the evening. The benefits will probably be comparable if the exercise volume accumulated is comparable,” he stated.

“Our findings show that the threat of death is cut in half with an exercise capacity that can easily be achieved by a brisk walk of about 30 minutes per session 5-6 days per week,” he added. “Physicians should encourage individuals to initiate and maintain a physically active lifestyle, which is probably to enhance fitness and lower the risk of death. Individuals must also discuss exercise with their physician before embarking on an exercise program.”

###

Co-authors are: Jonathan Myers, Ph.D.; John Peter Kokkinos; Andreas Pittaras, M.D.; Puneet Narayan, M.D.; Athanasios Manolis, M.D.; Pamela Karasik, M.D.; Michael Greenberg, M.D.; Vasilios Papademetriou, M.D.; and Steven Singh, M.D.

Start! will be the American Heart Association’s national movement that calls on all Americans and their employers to create a culture of physical activity and well being through walking. Lately, the Army National Guard Readiness Center in Arlington, VA was named a Start! Fit Friendly workplace — component with the alliance among the American Heart Association and also the Army National Guard. For more details about Start! visit heart.org/start.

Statements and conclusions of study authors that are published within the American Heart Association scientific journals are solely those with the study authors and do not necessarily reflect association policy or position. The American Heart Association makes no representation or warranty as to their accuracy or reliability.

Source: Karen Astle
American Heart Association

3 (4 votes)

Healthcare Prof:

5 (1 votes)

Gay rights advocates and opponents recently responded to study that links a drug-resistant strain of methicillin-resistant staphylococcus aureus, or MRSA, to men who have sex with males in Boston and San Francisco, the New York Times reports. The study was published online recently in the journal Annals of Internal Medicine, the Times reports (McKinley, New York Times, 1/20).

For the study, Binh Diep, a researcher at the University of California-San Francisco, and colleagues reviewed the charts of 183 men and women treated for MRSA at San Francisco Common Hospital’s Positive Well being Plan, an outpatient plan for HIV-positive people. They also reviewed the charts of an additional 130 folks at Fenway Community Wellness clinic in Boston. The review discovered that MSM ages 18 to 35 were the most most likely to have the infection. According to a statistical analysis based on ZIP codes, one in 588 folks in San Francisco’s Castro neighborhood, which has the highest number of MSM residents nationwide, is living with MRSA, compared with one in 3,800 folks across San Francisco. The study also located that MSM in San Francisco were 13 times much more likely than other city residents to contract MRSA.

The study located MRSA spreads most often through anal intercourse but also may be spread by means of casual skin-to-skin contact or by touching contaminated surfaces. MRSA can cause abscesses and skin ulcers and can produce necrotizing facsiitis, or flesh-eating bacteria. The infection also can cause pneumonia, heart damage and blood infections. Among MSM inside the study, MRSA was spread through skin-to-skin contact and caused abscesses and infection in the buttocks and genitals. The most effective method to prevent skin-to-skin transmission of MRSA is to wash with soap and water, particularly after sex, the researchers mentioned (Kaiser Day-to-day HIV/AIDS Report, 1/15).

According to the Times, the study “seemed to cast an unfair, and all too familiar, stigma” on MSM and “inadvertently offered ammunition” for gay rights opponents, including Concerned Women for America and Americans for Truth About Homosexuality. CWA on Wednesday issued a release that stated the “sexual deviancy” of MSM has led to HIV/AIDS, syphilis and gonorrhea. The group added that the “medical community has known for years that homosexual conduct, especially amongst males, creates a breeding ground for often deadly diseases.” National gay rights groups in response labeled the reaction as “hysteria,” and also the study’s authors on Friday issued an apology that said their press release “contained some data that could be interpreted as misleading.”

Henry Chambers, 1 with the study’s authors and a professor of medicine at UCSF, said, “We deplore negative targeting of specific populations in association with MRSA infections or other public well being concerns.” He added that the researchers had been “looking at this from a scientific point of view and not projecting any political impact.” Diep on Friday stated he regrets not being a lot more thorough in communicating the study’s findings to reporters, adding that the term “general population” employed in the study didn’t translate properly. “It’s really meant to be used to mean all inclusive, including the MSM population,” he stated.

CDC on Wednesday in a statement mentioned that MRSA is not sexually transmitted or limited to a certain population. Based on the statement, MRSA is transmitted by skin-to-skin contact and is widespread in hospitals and amongst hospital workers (New York Times, 1/20).

Reprinted with type permission from http://www.kaisernetwork.org. It is possible to view the whole Kaiser Everyday Health Policy Report, search the archives, or sign up for e-mail delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Every day Well being Policy Report is published for kaisernetwork.org, a free of charge service with the Henry J. Kaiser Loved ones Foundation? 2005 Advisory Board Company and Kaiser Loved ones Foundation. All rights reserved.

three.56 (9 votes)

Healthcare Prof:

The sports culture surrounding football and wrestling may be fueling aggressive and violent behavior not only among teen male players but also among their male friends and peers on and off the field, according to a Penn State study.

“Sports such as football, basketball, and baseball provide players with a certain status in society,” stated Derek Kreager, assistant professor of sociology in the Crime, Law, and Justice plan. “But football and wrestling are linked with violent behavior since each sports involve some physical domination with the opponent, which is rewarded by the fans, coaches and other players.”

Using a national database of 6397 male students from across 120 schools, Kreager analyzed the effects of team sports – football, basketball, and baseball – and individual sports – wrestling and tennis – on male interpersonal violence. The study looked at factors such as self-esteem, reports of prior fights, and popularity with the various sports.

The researcher located that, compared with non-athletes, football players and wrestlers face higher risks of getting into a serious fight by over 40 per cent. High-contact sports that are related with aggression and masculinity increase the danger of violence, he concluded.

“Players are encouraged to be violent outside the sport because they are rewarded for being violent inside it,” Kreager stated.

However, the violent behavior is not restricted to players alone. The Penn State researcher also located that the threat of getting involved in fights increases using the proportion of friends who play football.

“Males with all-football friends are expected to have a 45 per cent probability of getting into a serious fight, a lot more than 8 percentage points higher than similar individuals with no football friends and almost 20 percentage points higher than males with all-tennis friends,” Kreager stated in a recent issue of the journal American Sociological Review.

As for individual sports, wrestlers are 45 percent far more most likely to get into a fight than non-wrestlers, while tennis players are 35 per cent less likely to be involved in fights. The team sports, basketball and baseball, on the other hand, do not lead to fights.

The findings run contrary to a belief that participation in sports discourages anti-social behavior among boys since with the emphasis on teamwork, discipline and practice, and good sportsmanship and fair play.

“My outcomes suggest that high-contact sports fail to protect males from interpersonal violence,” Kreager stated. “Players might be getting cues from parents, peers, coaches, and also the local community, who assistance violence as a way of attaining ‘battlefield’ victories, becoming a lot more popular, and asserting ‘warrior’ identities.”

Pressure on teams to win games may be contributing towards the problem, due to the fact it makes coaches want to build a stronger team by selecting aggressive players and encouraging a ‘win at all costs’ attitude each on and off the field.

A compromise solution, Kreager adds, is to break the cycle of aggression.

“There is definitely a gate-keeping role for the coach,” he explained. “You would want to not select those kids you are already aware are uncontrollably aggressive, due to the fact they are going to be a problem for others inside the team. And that is also going to encourage other kids who are hanging out with them to be violent.”

The same also goes for players who start becoming far more violent, Kreager added. “You want to sanction them somehow and make sure they are not rewarded, else other kids might get a wrong message and that might perpetuate the violence off the field.”

###

Source: Amitabh Avasthi
Penn State

four.67 (3 votes)

Healthcare Prof:

4.5 (2 votes)

Defective sperm cells do not pass via the body unnoticed. A new University of Missouri study provides evidence that the body recognizes and tags defective sperm cells while they undergo maturation inside the epididymis, a sperm storage gland attached to the testis. According to researchers, only the best sperm that have the highest chance of succeeding in fertilization will survive the production process without having a “tag.”

A small protein called ubiquitin marks abnormal sperm cells, including cells that have two heads, two tails or are otherwise misshaped. This “recycling tag” on the sperm cell tells the body which cells need to be broken back down into amino acids. This provides evidence that there is an active removal process or marking of defective sperm for the duration of the epididymal passage.

“Fertilization is, in a way, a numbers game,” said Peter Sutovsky, associate professor of animal sciences, clinical obstetrics and gynecology in the MU College of Agriculture, Food and Natural Resources. “You need a certain number of normal sperm cells to reach the egg. If too many are tagged with ubiquitin, there may be not enough to fertilize an egg.”

This study suggests that the male reproductive method must be able to evaluate and control the quality with the sperm to insure an optimal chance of fertilization. High levels of ubiquitin in the sperm can indicate low-sperm count or infertility. This process of quality control has been identified in each humans along with other mammals including bulls, boars and rats.

“In many circumstances, the cells that are tagged with ubiquitin are obviously abnormal with two tails or two heads, but many of them look like they don’t have defects,” Sutovsky stated. “Oftentimes, these cells may look normal but lack proteins that are important to fertility.”

Once sperm cells are tagged as defective, it’s unlikely that the process may be reversed. Sutovsky stresses the importance of a healthy lifestyle to reduce the likelihood of abnormal sperm cells. He suggests avoiding exposure to toxic chemicals, abstaining from smoking and maintaining a healthy diet. He suggests individuals who work with toxins on a everyday basis should minimize their exposure by wearing protective clothing and respirators.

###

The study was published inside the Journal of Cellular Physiology.

Source: Jennifer Faddis
University of Missouri-Columbia

4 (1 votes)

Healthcare Prof:

The New York Times on Tuesday published letters to the editor in response to a recent Times editorial about HIV/AIDS among males who have sex with guys within the U.S. and New York City. Summaries appear below.

three (1 votes)

Healthcare Prof:

UroToday.com – Prior analyses identified overexpression with the transcriptional repressor EZH2 as a substantial predictor of poor outcome in organ-confined prostate cancer. Utilizing multiple information sources of cancer gene expression, the authors identify ADRB2 as a potential target of the Polycomb group protein complex PRC2 that includes EZH2. Data supporting this association was drawn from in vitro and in vivo studies and further supported by gene expression analyses of patient tumor samples.

The underexpression of ADRB2, connected in vivo with transcriptional repression through EZH2 overexpression, was related with 5-fold increased invasion of benign prostate epithelial cells. Furthermore, DU145 prostate cancer cells in which EZH2 was knocked-down resulting in elevated ADRB2 didn’t form tumors in nude mice, while control DU145 cells grew as a xenograft. Similarly, DU145 prostate cancer xenografts grew significantly less when treated with the ADRB2 agonist isoproterenol when compared to vehicle treated controls (p=0.006).

The prospective of ADRB2 as a biomarker of PCA aggressiveness was tested by immunohistochemistical analysis of 140 patient samples including benign, localized and metastatic tumor samples. The staining intensity was significantly lower in metastatic vs. localized vs. benign samples and suggested the ability of ADRB2 underexpression to predict poor outcomes in prostate cancer.

The clinical and pathological characteristics of 82 patients with organ-confined prostate cancer with 29 recurrence episodes had been analyzed along with ADRB2 staining intensity. Low ADRB2 staining predicted biochemical recurrence independent of Gleason score, preoperative PSA, tumor diameter, and surgical margin status (p=0.002). When compared using the 5yr post-surgical Kattan nomogram, ADRB2 status provided independent and substantial prediction of recurrence (p=0.015, RR =2.7, 95% CI 1.2-6.0).

In conclusion, this work highlights the prospective of genetic or molecular biomarkers to stratify threat based on tumor specific biology in addition to histologic appearance. Furthermore, molecules that can promote or inhibit tumor growth are potential candidates for developing targeted therapies.

Written by

David S Morris, MD, Jindan Yu, MD, and Arul M Chinnaiyan, MD, as part of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc… of their study by referencing the published abstract.

Link to Full Abstract

UroToday – the only urology web site with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:www.urotoday.com

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four.two (five votes)

Healthcare Prof:

Article Opinions:1 posts
UroToday.com – Treating Prostate Cancer as a Chronic Disease is becoming increasingly popular amongst physicians who recognize that up to a third of all prostate cancer treatments are unnecessary. The late, William Fair, M.D. (former Chairman of the Departments of Urology and Surgery at Memorial Sloan-Kettering) popularized the concept when he stated in 2000, “Based on everything we know about prostate cancer, I am not certain that it should not be treated as a chronic disease.” What seemed like a condemnation of radical prostatectomy was based on his frustration or inability to predictably cure guys with prostate cancer. His commentary energized a segment with the academic medical world that believed radical prostatectomy was over utilized. He also validated my analysis, which was in its infancy. To be sure, I have shown men can live with prostate within the majority of instances without having the need for definitive therapy. I am motivated to do for the disease what is required and nothing a lot more. My investigation shows that it really is not necessary to cure prostate cancer when it’s possible. Considering that 1999, males with favorable prostate cancer characteristics happen to be able to participate in a prospective chronic disease management (CDM) study, employing an academic strategy versus the cancer. While diet, nutrition, exercise, stress reduction and education are the pillars of this protocol, what sets this study apart from others may be the attention to prostatitis resolution using a patented all natural formula.

To date, 28 guys with a mean age of 63 years (median 64 years) happen to be followed for an average of 48.five months (median – 46 months). A review of the updated data confirms the stability and integrity of a protocol that allows males to excel clinically with prostate cancer. All guys in the study had been believed to have had organ confined disease, while 71% had a clinical stage T1c and 29% of guys noted clinical stages of T2a-T2c. 86% of the guys had a Gleason score (GS) of 5 or 6 while the most aggressive cancer monitored was a GS of 7 (4+3). 93% of men had reduced their PSA by 55% noting a mean PSA entry of 6.6 ng/ml (range: 2.1-14.4), while overall a 48% reduction in PSA was seen. The International Prostate Symptom Score Index (IPSS-Index) noted a 63% reduction in voiding symptoms while the Expressed Prostatic Secretion (EPS) noted a 77.2% reduction in the white blood cell count (a standardized measure of prostate inflammation).

Based upon a preponderance of information, the American Association of Cancer Analysis (AACR) and independent experts like David Bostwick, M.D., pathologists have expressed a major role for inflammation towards the evolution of prostate cancer. The reduction in prostate inflammation noted in this study as measured by the EPS may be the most sentinel finding that supports their belief. While further studies are encouraged, it truly is my belief that the resolution of prostatitis may be the key piece of data to allow us to formulate a prevention trial for prostate cancer. Minimally, an improvement in voiding symptoms, a reduction in prostate inflammation and a lower PSA value have validated a conservative approach for the majority of patients with prostate cancer.

References Barry MJ, PSA screening for prostate cancer: The current controversy a viewpoint. Annals of Oncology, 9: 1279-1282, 1998

Albertson PC, Hanley JA, Gleason DF, Barry MJ. A competing danger analysis of males age 55-74 years at diagnosis managed conservatively for clinically localized prostate cancer. JAMA, 280: 975-980, 1998

Ornish D, Weidner G, Fair WR, Marlin R. Intensive lifestyle changes may affect the progression of prostate cancer. Journal of Urology, Vol. 174, 1065-1070, 2005

Soloway MS, Soloway CT, Williams S, etal.: Active surveillance; a reasonable management alternative for patients with prostate cancer; the Miami experience

Written by

Ronald E. Wheeler, MD, as portion of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc… of their analysis by referencing the published abstract.

Link to Full Abstract

UroToday – the only urology site with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:www.urotoday.com

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Healthcare Prof:

1 (1 votes)

UroToday.com – Our study, lately reported inside the BJC, demonstrates for the first time that testicular microlithiasis (TM) is significantly more frequent in unaffected male relatives of testicular germ cell tumour (TGCT) circumstances than in healthy male controls. It also reveals that TM aggregates in families and there is significant concordance of TM in a variety of relative pairs. These observations generate the hypothesis that TM is an alternative manifestation of TGCT susceptibility alleles.

The clinical management of TM remains unclear with many previous studies documenting TM recommending some degree of follow-up. A recent survey of urologists based inside the UK and Ireland indicated that 70% carry out regular follow-up testicular ultrasounds on their patients diagnosed with incidental TM1. Our data would suggest that between 6 and 18% of all males, depending whether all TM or only classical TM (>5 microliths) are included, would require follow-up with regular testicular ultrasound if this policy had been to be widely adopted. Interestingly in this study, 38% with the consultants who perform follow-up for TM did not feel that it would affect overall patient survival. A a lot more targeted follow-up strategy may be far more appropriate.

Studies have demonstrated that the risk of tumour in patients with TM is increased if you’ll find additional TGCT risk elements also present, such as past history of TGCT2 or infertility3. In patients with a history of infertility, bilateral TM has been linked with the presence of pre-invasive carcinoma in situ (CIS), a lesion that is believed often to progress to an invasive cancer5. Twenty percent (6/30) of men with bilateral TM had CIS on biopsy, significantly higher than for infertile patients with unilateral TM (0/23) or no microlithiasis (1/210)three. These findings suggest that bilateral TM is strongly connected with TGCT and that inside the presence of other danger variables such as infertility a malignancy really should be considered. It may therefore be warranted to offer a small group of high-risk individuals a biopsy to exclude CIS/TGCT following screening ultrasound.

The increased frequency of TM in relatives of TGCT circumstances and the inherited component to TM demonstrated in this study suggests that TM associated with household history of TGCT might indicate an additional tumour risk factor warranting surveillance.

Our observation of aggregation of TM in families may have implications for mapping and identification of TGCT genes but may also have clinical implications. Guidelines for the follow-up of TM would be helpful. Before a coherent surveillance policy may be advised additional larger longitudinal studies are required to evaluate the magnitude of risk and to investigate the role of ultrasound and/or biopsy in various groups of patients. Such longitudinal studies are underway in our centre.

1. References Ravichandran, S., et al., Surveillance of testicular microlithiasis? Results of an UK based national questionnaire survey. BMC Urol, 2006. 6: p. 8.

2. Bach, A.M., et al., Is there an increased incidence of contralateral testicular cancer in patients with intratesticular microlithiasis? AJR Am J Roentgenol, 2003. 180(2): p. 497-500.

3. de Gouveia Brazao, C.A., et al., Bilateral testicular microlithiasis predicts the presence of the precursor of testicular germ cell tumors in subfertile guys. J Urol, 2004. 171(1): p. 158-60.

4. Skakkebaek, N.E., Possible carcinoma-in-situ with the testis. Lancet, 1972. 2(7776): p. 516-7.

Written by

Fiona McDonald, MD, Jerome Coffey, MD, Robert A. Huddart, MD, and Elizabeth A. Rapley, MD, as portion of Beyond the Abstract on UroToday.com. This initiative offers a method of publishing for the professional urology community. Authors are given an opportunity to expand on the circumstances, limitations etc… of their research by referencing the published abstract.

Link to Full Abstract

UroToday – the only urology web site with original content written by global urology key opinion leaders actively engaged in clinical practice.

To access the latest urology news releases from UroToday, go to:www.urotoday.com

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Reproduced for Medical News Today with permission of UroToday.
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