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Radiotherapy And Androgen Deprivation More Beneficial Than Radiotherapy Alone in Some Prostate Cancer Patients

In a recent study funded by grants from the National Cancer Institute and published in the New England Journal of Medicine, it was reported that short-term androgen-deprivation therapy improves survival in men with intermediate-risk, localized prostate cancer.  From 1994 to 2001, one thousand seventy nine men with localized prostate cancer and prostate-specific antigen levels of 20 ng/mL or less were randomized to receive radiotherapy alone (992 patients) or radiotherapy plus four months of androgen-deprivation therapy (987 patients).

The overall ten-year survival rate was significantly higher with combination therapy than with radiation alone, and combination therapy decreased disease-specific deaths.  The median follow-up period was 9.1 years, and the ten-year rate of overall survival was 62% among patients receiving radiotherapy plus short-term ADT (the combined-therapy group), as compared with 57% among patients receiving only radiotherapy.  The addition of short-term ADT was associated with a decrease in the 10-year disease-specific mortality from eight percent to four percent. Biochemical failure, distant metastases, and the rate of positive findings on repeat prostate biopsy at two years were significantly improved with radiotherapy plus short-term ADT.  In the two groups, acute and late radiation-induced toxic effects were similar.

The study was carried out because it had not been known whether short-term androgen-deprivation therapy (ADT) before and during radiotherapy improves cancer control and overall survival among patients with early, localized prostate adenocarcinoma.

It was found in a post-hoc analysis that the benefits of combination therapy were limited to men with intermediate-risk disease rather than men with low-risk cancer.

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HIFU Treatment looks Promising for Localized Prostate Cancer

Data from a large clinical registry showed that over 80 percent of men with localized prostate cancer had negative biopsies for as long as 10 years after treatment with high-intensity focused ultrasound (HIFU).

The negative biopsy rate ranged from 78.3% of patients with high-risk prostate cancer to 89.3% for men with low-risk disease. The 10-year biochemical failure-free survival was 56% by a U.S. definition of biochemical failure and 42% by a German definition.

As reported at the American Urological Association meeting, the most common adverse events were urinary incontinence (mostly grade I) and urethral stenosis (bladder outlet obstruction) occurring in 20.6% and 18.5% of patients, respectively.

HIFU is available throughout Europe but not in the U.S., and it has appealed to many men as a noninvasive therapeutic option for early prostate cancer.  Whole-gland application of high-intensity ultrasound produces thermal and mechanical effects.  HIFU energy rapidly heats tissue to a temperature of greater than 80° C.  The ultrasound also generates gas bubbles that cause cavitation when they collapse, leading to the rupture of cell walls.

Roman Ganzer, MD, of the University of Regensberg in Germany. presented data on 2,552 prostate cancer patients treated with the Ablatherm HIFU system.  The mean age of the study population was 70.1 years.  Eight hundred twenty (32.1%) of patients received short-term hormonal therapy prior to HIFU treatment.  On average, the patients were followed for 3.3 years and as long as 16 years.  Overall, 83% of the patients had negative biopsies at follow-up, including 89.3% of low-risk patients, 81.2% of intermediate-risk patients, and 78.3% of high-risk patients.

In addition to incontinence and urethral stricture, the most common adverse events were infection and urinary retention, both at 11%.

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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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Alpha Blocker Improves Symptoms of Chronic Prostatitis

Recent findings show that treatment with a specific alpha blocker helps reduce symptoms and improve quality of life for men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS).  This alpha-blocker, called silodosin, works by selectively relaxing the muscles in the neck of the urinary bladder and prostate.  It has been approved in Canada, the United States, the EU and Japan to treat symptoms of another prostate gland condition, benign prostatic hyperplasia, which is commonly referred to as an enlarged prostate.

Although CP/CPPS is the most common form of prostatitis, it is the most misunderstood and difficult to treat because the symptoms are very similar to other conditions and requires a significant amount of testing and screening to identify.

Curtis Nickel, a professor in the Department of Urology, practicing urologist at Kingston General Hospital and Canada Research Chair in Urologic Pain and Inflammation, emphasized that antibiotics are commonly used as a treatment, but they are not typically effective.  This could be because CP/CPPS does not seem to be caused by a bacterial infection.

CP/CPPS is a debilitating condition; patients with this condition suffer from discomfort in the lower pelvic area including the bladder area, testicles, and penis.  Symptoms may be severe and can include painful and frequent urination and difficult or painful ejaculation.  The cause of CP/CPPS is not known.

In Dr. Nickel’s study, about 60 percent of men reported feeling better after treatment with silodosin as opposed to 30 percent of participants who were given a placebo.  These results for patients feeling better is higher than a similar study he conducted several years ago that tested the effects of a different alpha blocker.

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No Relationship Between Small Prostate Size and High Grade Cancer

Previously, radical prostatectomy series have shown an inverse relationship between prostate size and high grade cancer.  It was suggested that smaller sized prostates arise in a low androgen environment, which enables development of more aggressive cancer.  A recent study by a team of authors from Stanford University School of Medicine in the Journal of Urology, however, shows that small prostate size is not associated with high grade cancer.  The authors argue that previous observations are the result of ascertainment bias driven by prostate specific antigen performance.

The study’s authors analyzed 1,404 patients from the Stanford Radical Prostatectomy Database with clinical stage T1c (723) and T2 (681) disease who had surgery between 1988 and 2002 and underwent detailed morphommetric mapping by a single pathologist.  They used multivariate linear regression to analyze the effects of age, prostate weight and prostate specific antigen on total and high grade cancer volume and percentage of high grade disease.

Patients who underwent biopsy due to abnormal prostate specific antigen (stage T1c had a prostate weight that was negatively associated with total cancer volume, which is the volume of high grade disease and percentage of high grade disease.  For patients who underwent biopsy based on abnormal rectal examination (stage T2), these relationships were not present.

The authors conclude that improved prostate specific antigen performance for high grade disease results in ascertainment bias in patients with T1c disease.  For this reason, the relationship between prostate size and high grade disease may be a result of grade dependent performance of prostate specific antigen rather than true tumor biology.

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New Technology May Encourage Doctors to Recommend Prostate Surgery

A new study finds that after hospitals in Wisconsin received robotic surgery technology, the number of prostate removals there doubled within three months.  In contrast, the number of prostate surgeries remained the same at hospitals that did not purchase this new two-million dollar technology.

This finding was published in the peer-reviewed journal Cancer. It comes just months after a Johns Hopkins report showing that hospital websites often hype robotic surgery without considering the risks and play up the benefits leading the study authors to worry that the new technology is encouraging doctors to recommend surgery to patients.

Each robot, in addition to the initial cost of nearly $2 million, requires more than $100,000 per year for maintenance.  Jim Hu, MD, director of urologic robotic surgery at Brigham and Women’s Hospital in Boston, who was not involved in the new study, suggested that hospitals that acquire this expensive technology might feel pressure to cover its costs by performing more surgeries.    The new technology is now used in almost three-quarters of all prostate removals nationwide.  Yair Lotan, MD, from the University of Texas Southwestern Medical Center at Dallas, who was not involved in the study, said that The bulk of evidence, however, does not show it to be more effective in saving lives than traditional surgery.

Joan Neuner, MD, MPh, of the Medical College of Wisconsin and colleagues found that between 2002 and 2008, Wisconsin hospitals performed more than 10,000 prostate removal surgeries. Almost one in four hospitals purchased surgical robots in that period.  Although fewer men had prostate cancer in 2007, there were 1,760 prostatectomies in 2007 compared to 1,400 in 2002.

Dr. Neuner and colleagues attribute these findings partly to patient demand, driven by aggressive marketing by manufacturers and hospitals.  Dr. Lotan reports that patients often request the robotic surgery without knowing the risks involved.  While shorter recovery times, less blood loss, and smaller scars are benefits of the robotic system, the technology extends the operation time. Dr. Hu emphasizes that the safety of surgeries depends more on the skills of the surgeon than on the technology involved.

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Hormone Therapy Used to Treat Prostate Cancer Increases Vertebral Fractures

A recent study found that androgen deprivation therapy (ADT), a hormone therapy that is used to treat prostate cancer, speeds up loss of bone mineral density and increases vertebral fractures, particularly in white men.  The study was published in the Journal of Urology.

The men in the study were enrolled in a fracture prevention trial for prostate cancer patients receiving ADT and were at least 70 years old or had low bone mineral density at the lumbar spine or total hip.

Lead author of the study, Philip J. Saylor, MD, of Boston’s Massachusetts General Hospital, and his colleagues studied 1244 men, including 162 (13%) who had a vertebral fracture at baseline.  Although white race, osteoporosis and low bone density were significantly associated with this finding, age, country of residence and body mass index were not.  According to Saylor, older age, low bone mineral density, and white race prompt patients and doctors to discuss preventative therapy.

The duration of ADT was also not linked to prevalent vertebral fractures, perhaps because the effect on bone mineral density is most apparent in the first year of therapy and the average duration at study entry was four years.

The authors concluded the article by stating that these observations should inform the assessment and management of fracture risk among such men.  Also, in a related editorial, Paul Maroni and E. David Crawford, MDs, of the University of Colorado Health Sciences Center in Denver emphasized the importance of assessing bone health before ADT given the frequency and urgency of the condition.

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Simple Postage Stamp Test Objectively Assesses ED

According to the results of a small clinical study at Fox-Chase Cancer Center in Philadelphia, a simple, inexpensive home test for erectile dysfunction showed a good correlation with prostate cancer patients’ and partners’ subjective assessments of their sex life.

Objective measures of nocturnal tumescence, erectile dysfunction (ED), and overall sexual function had significant associations for up to a year with the “stamp” test, a do-it-yourself nocturnal penile tumescence assessment.  This test supplements subjective information provided by patients and their sexual partners.  The findings were presented by Lanea Keller, MD, at the American Society for Radiation Oncology.  Dr. Keller found that after high-dose IMRT (intensity-modulated radiation therapy), both the patient’s and the partner’s perception of their overall sex life was reflected by a positive stamp test as well as their own perception of erectile dysfunction.

After radiation therapy for localized prostate cancer, men often have concerns about sexual function.  According to Keller, the information clinicians use to assess erectile and other aspects of sexual function comes mainly from standardized questionnaires, which elicit responses that may be subjective.

Adding the results of an objective test, which involves a strip of postage stamps, could help in the assessment and decision making related to sexual function.  The test involves a man wrapping a strip of postage stamps around the base of the penis.  If he has a normal nocturnal tumescence response, the stamps separate at one or more of the perforations, resulting in a positive test.  Ninety-four prostate cancer patients were evaluated using this test.  The men completed the Expanded Prostate Cancer Index Composite (EPIC) and International Index of Erectile Function (IIEF) questionnaires at baseline and at six, 12, and 24 months after treatment. During the weeks that they completed the questionnaires, the patients also performed stamp tests on various nights.  Their partners also completed an IIEF partner questionnaire at the same time intervals.  The correlation between patients’ and partners’ questionnaire responses and the stamp test was analyzed.

The median age of the patients was 62.5.  Ninety-seven percent of the patients had stage T1c or T2a cancer.  Keller reported that 68 patients had positive stamp tests at baseline. The number of positive tests declined to 33 at six months, 32 at 12 months, and 30 at 24 months.  A positive stamp test at baseline had no relationship with patients’ or partners’ overall satisfaction with their sex life. At all of the follow-up periods, the stamp test had one or more significant or borderline-significant associations with the subjective assessments of sexual function and satisfaction.

At all three time intervals after IMRT, a positive stamp test was associated with patients’ overall satisfaction with their sex life, the partner’s perception of the patient’s erectile dysfunction, and partners’ overall satisfaction with their sex life.  A positive stamp test’s correlation with subjective measures tended to be strongest at one year.

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Weight Loss Increases Libido in Obese Men with Type 2 Diabetes

A small Australian clinical study showed that sexual function improved significantly and quickly in obese men with type 2 diabetes after weight loss with reduced-calorie diets.  For 31 men who lost five percent to ten percent of their body weight in eight weeks, erectile function, sexual desire, and urinary symptoms all improved significantly.  According to an article published in the Journal of Sexual Medicine, metabolic parameters, including blood glucose, insulin sensitivity, and lipid profile, also responded favorably to either a low-calorie, meal-replacement diet or a high protein-low carbohydrate diet.

The improvements were maintained during a year of follow-up.  Joan Khoo, MRCP, of Changi General Hospital in Singapore, and Australian co-authors wrote, “Further improvements during weight maintenance, using a high-protein low-fat diet, suggest that both nutrient quality and caloric restriction contribute to these benefits.”  Although the favorable effect of weight loss on sexual function is not new, this study may be the first to demonstrate an impact on sexual desire.

Another important finding was weight loss’ apparently favorable effect on systemic inflammation.  Obesity and type 2 diabetes increase the risk of erectile dysfunction and lower urinary tract symptoms (LUTS), which are associated with each other and with systemic inflammation and endothelial dysfunction.

Rapid weight loss through dieting can improve erectile dysfunction and LUTS. Previous studies also have shown improved endothelial function and reduced inflammation after weight loss, especially for people who lose at least 10 percent of body weight.  Not much data had been collected regarding the influence of macronutrient composition on associations between weight loss, endothelial function, systemic inflammation, sexual function, and LUTS in obese men.

All 31 men involved in the study had type 2 diabetes, a body mass index greater than 30, and a waist circumference of at least 102cm.  They were randomized to two dietary plans.  The first plan was a liquid meal-replacement consumed twice daily and one small, nutritionally balanced meal, providing a total energy of about 900 kcal/day (low-calorie diet).  The second plan was a low-fat, low-carbohydrate diet designed to reduce energy intake by about 600 kcal/day.

The first assessment occurred after eight weeks, and follow-up continued for an additional 44 weeks.  The participants who opted to stay in the study for long-term follow-up consumed the high-protein diet during the follow-up.

Men in the low-calorie diet group had about ten percent reduction in mean body weight and waist circumference at eight weeks, as compared with about five percent among men assigned to the high-protein diet.  Weight loss at eight weeks averaged 9.5kg with the low-calorie diet and 5.4 kg with the high-protein diet, both of which were statistically significant.

In general, inflammatory markers decreased significantly in the high-protein group but not the low-calorie group, but the men assigned to the high-protein diet had higher baseline levels of the markers.  About half of the men remained in the study for the entire 52 weeks. Of those who did, improvements were either maintained or increased.

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