Archive | Prostate Treatment

Testosterone Replacement Therapy—In Deodorant Form?

Recently, the US Food and Drug Administration (FDA) approved the first underarm testosterone replacement therapy. The treatment is a testosterone 2% topical solution and can be applied to the underarm, much like deodorant.

Results of the study showed that 84.1% of men with hypogonadism increased their testosterone blood levels to within the normal range of men, often after just two weeks of treatment. The treatment also significantly improved mood, sexual desire, sexual activity, and sexual performance.

“The post-treatment changes demonstrated positive responses in sexual desire, sexual activity, mood, and general well-being, underpinning the patient-reported benefits of this treatment. Patient compliance and acceptance of the unique no-touch axilla application technique was very good,” said lead investigator Christina Wang, MD, from the Los Angeles Biomedical Research Institute and professor of medicine at UCLA David Geffen School of Medicine, California.

Testosterone topical solution is found in a metered-dose pump with a no-touch applicator. The recommended initial dose is one pump of the applicator (30 mg) applied to each armpit once daily at the same time every morning. The efficacy of the solution is not affected by application of underarm deodorants or antiperspirants, and grooming such as shaving is not required. But to avoid contamination, deodorant or antiperspirant should be applied before the testosterone solution.

The dosage is determined by serum testosterone concentrations obtained from a blood draw two to eight hours after application after two weeks of the start of therapy.

Virilization in children with secondary exposure to the treated skin is a potential side-effect. Women who are pregnant or might become pregnant should avoid contact with the application site, due to the risk for fetal harm.

In order to avoid contamination, patients should wash their hands with soap and water immediately after applying the testosterone solution. Further, the application site should be covered with clothing after the solution has dried and remain covered until washed. Patients should not swim or wash the underarm area for two hours after application.

Side-effects include hematocrit, headache, diarrhea, vomiting, and serum prostate-specific antigen. Several patients have reported some form of transient application-site reaction during the initial four-month treatment phase, but all cases were mild and resolved quickly on their own.

Patients with benign prostatic hyperplasia should be monitored for worsening of associated signs and symptoms. All patients should be evaluated for prostate cancer at baseline and in accordance with screening practices.

Further, testosterone therapy can decrease blood glucose levels, which may alter insulin requirements in diabetic patients. For those on anticoagulant therapy, testosterone can cause changes in activity, so frequent monitoring is advised. Simultaneous use of corticosteroids can increase fluid retention and should also be monitored cautiously, especially in patients with cardiac, renal, or hepatic disease.

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New Prostate Cancer Treatment Criticized

The device called NanoKnife is undergoing scrutiny as a cancer killing machine throughout the United States.  NanoKnife uses electrical jolts to zap tumors, but a thorough analysis, including a large clinical trial to prove it is safe and effective in people, has not been conducted.

Currently, 13 United States hospitals including Baptist Health Medical Center in Little Rock, Arkansas, University of Louisville, and Shands Hospital/University of Florida in Gainesville, Florida are using the device.  Each machine costs $300,000.  And some of the hospitals are aggressively promoting the device in ads and media presentations.  In fact, a radio ad developed by the University of Miami’s Sylvester Comprehensive Cancer Center says NanoKnife offers “real hope” to patients with cancer with “almost no side effects.”

Although the NanoKnife has been tested on animals and a small number of human patients, a large, controlled clinical trial has not been conducted.  Jan Keltjens, the company executive of AngioDynamics, Inc. of Queensbury, N.Y., the manufacturer of the product, states, “We have not done randomized controlled clinical trials, the so-called gold-standard studies.  We think this is a very promising technology for treating cancer that is otherwise untreatable.”

“There is growing concern in the interventional oncology community that the NanoKnife is being widely adopted prior to having gone through the necessary rigors of controlled investigations and clinical trials,” says Riad Salem, chief of interventional oncology at Chicago’s Northwestern Memorial Hospital.  Salem says that Northwestern does not have a NanoKnife.

The reason NanoKnife has been allowed to take shortcuts through the ordinary long process of becoming FDA approved deals with a modification enacted in 1976 by Congress.  During that time, Congress enacted a change that allows for granting regulatory approval to certain medical devices quickly, often with little or no clinical evidence, if the device is similar enough to another already on the market.  This change was allowed in order to encourage innovation in the industry and to get improved products quickly to market.  Now, since August of this year, the FDA panel recommends that the regulation be tightened by requiring manufacturers to provide more safety data on new devices and more detail about the connection between new and previously approved devices.  Manufacturers have 60 days to comment.

But as a result of the 1976 enactment, the NanoKnife went from being tested in animals to being directly promoted as a cancer fighter.  Some fear a situation where the product has been approved by the FDA only to be later recalled due to major side effects.  These concerns are based on the Bausch & Lomb Inc.’s situation where its contact-lens solution Renu with MoistureLoc was removed from the world market in 2006 after being linked to cases of fungal eye infection that can cause blindness.  Bausch & Lomb was approved through the same shortcut that applied to NanoKnife and was allowed marketing without large clinical studies.

In 2008, NanoKnife was originally approved because it was shown capable of destroying tissue similar to other existing devises that are used in heart surgery.  This time around, the NanoKnife is being used to treat cancer by excising malignant tumors near arteries, airways, or other vulnerable tissues and thus difficult to remove.

The device works through disposable electrode needles, which are inserted into the tumor.  Powerful electrical jolts are emitted from one needle to the other, creating microscopic holes in the cell membranes of cancer cells.  This is what allegedly destroys the tumor, but the large electrical bursts are also what cause side effects such as fast heartbeats.

Tim Clark, director of interventional radiology at Penn Presbyterian Medical Center in Philadelphia, which does not have a NanoKnife, says the device “has potential to treat cancers next to delicate structures.”  But for the time being, he says, there is not enough clinical data to be certain of its safety and efficacy.

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Prostate Surgery Causing Problems for Sexual Function

A new long-term follow-up study indicates that many men continue to feel distressed about their reduced sexual function years after prostate surgery.  In fact, the study reveals that sexual function is so important to them that adapting to a lower level of functioning is much more difficult than adapting to temporary urinary problems, explains Dr. Walter R. Parker and colleagues from the University of Michigan Health System in the Ann Arbor report.

Of the 434 men in the study with localized prostate cancer, all underwent radical prostatectomy, which is the complete removal of the gland.  This type of surgery is creating controversy among urologists and surgeons because it is commonly used to treat early-stages of the disease.  Men with early-stage prostate cancer are at a low risk that the disease will be fatal, yet the impact of the surgery is quite negative on the men’s quality of life.

Long-term quality of life is extremely important in men when they have a high likelihood of survival from prostate cancer.  Parker’s team at the University of Michigan developed a survey called the Expanded Prostate Cancer Index Composite (EPIC), which is designed to assess various aspects of quality of life after prostate cancer treatment.  This study is the first to compare men’s scores before the surgery and five years after the surgery.

The study shows that 38 percent of the men who had undergone radical prostatectomy reached baseline levels of urinary function 12 months after the surgery (despite an instantaneous, but temporary, decrease in urinary function and incontinence right after the surgery).  But by four years the improvement declined.

The study revealed even less promising results in regards to sexual function of the men.  Although sexual function began to improve after the surgery, only 28 percent had actually returned to the level of sexual function they reported before the surgery.  After three years from the surgery, 37 percent reported the same level of sexual trouble they reported before undergoing the surgery.  Only 11 percent of the men returned to their pre-surgery sexual function after two years from when they underwent the surgery.  This means that about 63 percent of the men were experiencing low sexual function after undergoing prostatectomy surgery.

The recommended recovery program for sexual function after the surgery includes Kegel exercises and prescription drugs.  These are intended to restore erectile function.  Yet studies have shown that many prescription drugs for erectile dysfunction leave the patients feeling sick and with many side-effects.

Researchers are initiating a “structured early and long-term erectile rehabilitation program to augment sexual recovery as early as possible, yet also convince patients to maintain their erectile rehabilitation efforts long-term,” states Reuters.

But something different needs to be included in these rehabilitation programs.  Many men are searching for alternative treatments for their erectile dysfunction and sexual function problems.  Natural supplements offer safe, often effective, and clinically proven results.  If you have undergone prostatectomy surgery and are considering natural supplements, contact your urologist for further information.

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Prostatitis and Your Diet

Prostatitis is an inflammation or infection of the prostate gland. It can cause abnormal urinary frequency and urgency, painful urination and ejaculation and if left untreated, chronic, recurrent symptoms. This common disorder affects approximately 10% of men. In addition to medication and nutritional supplements, certain diet additions can help alleviate the symptoms of and prevent prostatitis.

These nutrients and foods are beneficial for prostate health:

Vitamin C – Found in spinach, citrus fruits, red berries, kiwi, red and green bell peppers, tomatoes, strawberries, cabbage, and broccoli.

Zinc – Good sources include high protein foods such as red meat, fish and shellfish, dairy products, nuts, whole wheat foods, and legumes.

Saw Palmetto Berry – Can be steeped into a tea, or found in nutritional supplements.

Lycopene – Found in tomatoes.

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Prostate Cancer Patients on ADT Not Affected by Provenge

A recent study, led by Tomasz Beer, MD, Professor of Medicine at Oregon Health & Science University (OHSU) in Portland, Oregon, found that prostate cancer (PCa) patients on androgen deprivation therapy (ADT) and receiving sipuleucel-T (Provenge) have no adverse outcomes in terms of quality of life.  These findings were presented at the 47th Annual Meeting of the American Society of Clinical Oncology.

The study involved 176 men who were placed on ADT for three to four months after experiencing PSA recurrence after radical prostatectomy.  Sipuleucel-T, which received FDA approval for the treatment of late-stage PCa last year, is not usually used in men with earlier states of prostate cancer.  This is the first study to explore the effect of the autologous cellular immunotherapy on quality of life.

After three to four months, ADT was stopped and all men were randomized to treatment with sipuleucel-T (117 patients) or control (59 patients). Using survey techniques, the researchers assessed quality of life at baseline (following ADT and prior to randomization) and at weeks 13 and 26 after treatment.  Ninety-eight percent of subjects completed baseline quality of life assessment and 92% had at least one post-treatment assessment.  During ADT in the three months before sipuleucel-T treatment, quality of life measures decreased comparably in both study arms.  After the start of the study treatment, there were no significant differences found in the quality of life between the two groups.

Dr. Beer emphasized that the results from the study suggest that a larger study in early disease patients is needed.

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Gene Test Effectively Predicts Presence of nearby Prostate Cancer

Data from a large group of tissue samples showed that gene expression in prostate stroma predicted the presence of nearby cancer with 97% overall accuracy.  Stroma adjacent to or near prostate tumors expressed genes significantly differently from normal stroma.

In a recent issue of Cancer Research, it was reported that the correlation between stromal gene expression and cancer increased with proximity to cancer.  The 144-gene panel had 98% sensitivity and 88% specificity for predicting the presence of cancer, whereas, a randomly selected 100-gene panel had no predictive value.  If replicated in additional studies, the gene test has multiple therapeutic implications.

The research team compared gene expression profiles in 13 prostate biopsy specimens containing stroma near tumor and in 15 biopsy specimens from men without prostate cancer and identified 3,800 significant changes in expression.

The authors developed a 114-gene stroma-specific classifier for nearby tumor after filtering for age-related genes and for genes known to be expressed at detectable levels in tumors.  They tested the classifier in 364 prostate specimens, consisting of 243 tumor-bearing samples and 121 normal specimens.  These 364 specimens included samples from normal prostate biopsies, normal prostate tissue obtained from autopsies, stroma remote to tumor, and stroma from within a few millimeters of tumor.  The gene panel correctly identified all but two of the 243 tumor-containing specimens. Analysis of the two misclassifications suggested the tissue might not have come from patients with prostate cancer.

The research team also compared expression patterns in stromal tissue near and far from the tumor and found a gradient of classification frequency values of 98%, 75%, and 36% for stromal samples adjacent to, close to, and remote (>15 mm) from the tumor.

These findings suggest several practical applications of the gene test, such as assessment of suspicious initial biopsies and possibly therapeutic targeting of stromal expression changes indicating the presence of tumor while leaving normal stroma relatively untouched.

Some of the authors of the gene expression study disclosed relationships with Proveri, a company involved in translational research related to the study.

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No Significant Association Found Between Androgen Deprivation Therapy and Cardiovascular Death

Treatment with androgen deprivation therapy (ADT) does not significantly increase the risk of cardiovascular mortality according to evaluation of mortality data in a large registry of men treated for prostate cancer.

ADT is commonly used to treat prostate cancer.  Some studies have shown that it may increase the risk of cardiovascular disease, but other studies have not confirmed the association and it remains controversial.  The authors of the recent study tried to explore the evidence further by analyzing the patients registry CAPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor), which includes men with confirmed prostate cancer recruited from 40 mostly community-based US urological practices.

Men who are diagnosed with localized prostate cancer between 1995 and 2007 were included in the analysis, and in order to try to control for factors that may confound the relationship between ADT and cardiovascular death, patients who used and did not use ADT were matched by their propensity to receive ADT.  These patients were categorized into three groups: primary ADT monotherapy, local treatment plus ADT, and watchful waiting/active surveillance (WW/AS).  Initial outcomes were associations between treatment and cardiovascular cause, prostate cancer, and other causes.  Study investigators assessed cause of death using death certificates.

At the point of data capture, there were 13,887 men in the registry, of whom 7,248 were eligible for the analysis.  The majority (71.3%) received local treatment only, 6.7% received local treatment plus ADT, 15% received primary ADT, and 7 percent WW/AS.  It was found that 21.7% received AFT at some point.  Nine hundred seventy six of these men died during the study period, 1.4% from prostate cancer, 2.7% from cardiovascular disease, and 9.4 percent due to other causes.  Patients treated with ADT or WW/AS had a higher likelihood of death due to prostate cancer than those treated just with local therapy.

The largest risk of cardiovascular death was in those treated with WW/AS compared to those only receiving local therapy.  The difference for those treated with local therapy plus ADT was not significant.

The authors’ conclusion is that the increased rate of cardiovascular death in the WW/AS group compared to the ADT group suggests that there are possibly unmeasured variables that affect treatment selection and that confound the association between ADT and cardiovascular death.  The research team notes that when patients were match on propensity to receive ADT, there was no significant association.  The limitation so the study included the relatively small number of deaths in some groups, and the assignment of cause of death from death certificates.

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Pre-op Counseling For Prostate Surgery Not Effective

Researchers have found that over half of men undergoing radical prostatectomy have unrealistic expectations about some of the outcomes.

Daniela Wittmann, MSW, and colleagues at the University of Michigan Comprehensive Cancer Center in Ann Arbor, Michigan found that despite a pre-operative education program, 61 percent of men expected the same or better sexual function a year after surgery as they had before.  Sixty percent of men expected difficulties with urinary incontinence to be the same or better.  These findings were published in the Journal of Urology.

Wittmann and colleagues found that a substantial proportion of patients, 17 percent and 12 percent, respectively for both effects, expected better performance a year after surgery than before even though they had been told that such an outcome was improbable.  The researchers argued that this finding suggests that pre-op education should be followed up with post-surgery support for prostate cancer survivors.

The research team asked men undergoing radical prostatectomy to fill out the short form of the Expanded Prostate Index Composite questionnaire, both before and a year after surgery to get an idea of their urinary, bowel, hormonal, and sexual function.

The men were also asked, after pre-op counseling but before surgery, to fill out the Expanded Prostate Index Composite-Expectations questionnaire, which detailed what level of function they expected a year later.  Both questionnaires assess five domains: incontinence, urinary irritative symptoms, bowel function, hormonal function, and sexual function.

Analysis of the 152 participants showed that 36 percent and 40 percent expected the same function at one year as at baseline in urinary incontinence and sexual function, respectively, while 12 percent and 17 percent expected better function.  Forty-seven percent and 44 percent of patients had lower than expected function for urinary incontinence and sexual function, respectively.  Expectations matched or were better than outcomes for 78 percent of patients for urinary irritative symptoms.  Expectations of bowel and hormonal function largely matched outcomes, with 92 percent and 86 percent, respectively, having outcomes that were the same as or better than expected.

Wittmann said that these differences may arise from the way that the pre-op counseling is given.  The research tem cautioned that the study had a low response rate.  Out of 526 patients who signed consent forms, only 152 completed all the questionnaires.  This makes it difficult to generalize the findings.  Also, while the counseling on sexual matters was standardized, the information provided by surgeons on other outcomes was not.

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Saturation Biopsy Detects More Cancers

According to a new report, analysis of 20 to 24 biopsy cores is superior to analysis of 12 to 14 cores for detecting prostate cancer in men who’ve had a normal prostate biopsy in the past.

J. Stephen Jones, M.D., from Cleveland Clinic, Ohio said, “We have shown that transrectal saturation biopsy is as easy and safe to perform as standard biopsy while detecting almost 1/3 more cancers. With these findings, we are confident that this approach offers benefit with negligible downside.”

Jones did however caution that it would be premature to suggest that this should be made universal for a number of reasons.  First, this has only been shown in one study.  Second, this must be balanced against the potential to detect clinically insignificant cancers that we might be better not knowing about even though saturation biopsy detected almost a third more cancers and had equivalence complication rates.

Jones and colleagues compared the results of extended and saturation prostate biopsy protocols in a first repeat prostate biopsy population of 1056 men (393 with a 12 to 14-core extended biopsy and 663 with a 20 to 24-core saturation biopsy.  The authors reported their findings in the Journal of Urology. The detection rate was significantly higher in the saturation biopsy group than in the extended biopsy group.  Over a third of the positive biopsies (37.8%), however, met predetermined criteria for clinical insignificance, and there was a trend toward increased detection of clinically insignificant cancer in saturation compared to extended biopsies (40.1 percent compared to 32.6 percent).

For higher-risk populations, detection rates were higher for saturation biopsy than for extended biopsy, but the differences did not reach statistical significance.  The increased detection with saturation biopsy was significant for men whose initial biopsy was completely normal.

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Prostate Cancer Vaccine Fights Tumors Without Damaging Healthy Tissue In Mice

Researchers have developed a vaccine that destroys even advanced prostate tumors without any side effects.  The vaccine has only been shown to work in mice, but the researchers from the Mayo Clinic in Rochester Minnesota and at the University of Leeds in England hope that the treatment can someday work in humans.

The researchers created a vaccine that tricks the immune system to think existing tumors are antigens by using DNA from healthy prostate cells, thus triggering its antibodies to destroy the tumors.  Eighty percent of prostate cancer cells were destroyed without harming healthy tissue in mice.

The findings were published in the peer-reviewed journal Nature Medicine.  The study’s author Richard Vile, Ph.D., professor of immunology at the Mayo Clinic said that it might take three to five years for their to be a human version of the vaccine.  More research is needed to clear some FDA hurdles.

Prostate cancer is one of the deadliest cancers.  It strikes about 220,000 men each year and kills about 32,000.  Existing conventional treatments include surgery, radiation therapy, and hormone therapy, which can damage surrounding prostate tissue.  For this reason, the researchers were pleased that the vaccine did not destroy healthy tissue in mice.

The researchers are, however, cautioning men to not get their hopes up.  Dr. Kate Holmes, research manager at England’s Prostate Cancer charity, said that even though they are hopeful that the results of this study could help to form the basis of a new cancer vaccine in the future, researchers have only studied this possibility in mice.

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