Tag Archive | "radical prostatectomy"

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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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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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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Surgery Improves Longevity and Quality of Life for cT3 Prostate Cancer Patients

Researchers at the Mayo Clinic, a leading nonprofit institution providing medical care, research and education for people from all walks of life based in Rochester, Minnesota, have found that long-term survival rates for patients with advanced prostate cancer suggest that they can be good candidates for surgery.  The research team found a twenty-year survival rate for 80 percent of patients diagnosed with cancer that has potentially spread locally from inside the prostate to immediately outside of it, known as cT3 prostate cancer, and who had been treated with radical prostatectomy, which is surgery to remove the prostate gland.  These findings were presented at the annual meeting of the American Urological Association in Washington.

Previously, patients who had cT3 prostate cancer were offered radiation or hormone treatment but not radical prostatectomy.

R. Jeffrey Karnes, MD, an Assistant Professor at the Mayo Clinic’s Department of Urology said that the identification and expansion of candidates for surgery that results in improved and longer outcomes for patients has improved. Other study investigators from the Mayo Clinic include Christopher Mitchell, M.D., Eric Umbreit, M.D., Rachel Carlson and Laureano Rangel.

The 80 percent survival rate for cT3 diagnoses at 20 years is compared to 90 percent for cT2, which is cancer confined to the prostate.  The study included patients with cT3 diagnoses and who were operated on between 1987 and 1997.  Ongoing research will continue to examine the current data.  This long-term follow-up is an important advance in understanding the quality outcomes for these cT3 patients.

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Post Prostate Surgery Pelvic Floor Exercises Ineffective in Improving Male Incontinence

According to a two randomized trials reported in The Lancet one-to-one pelvic floor exercise therapy for urinary incontinence after prostate surgery is no more effective than standard care.

Cathryn Glazener, PhD, from the University of Aberdeen, United Kingdom, and colleagues, reported that urinary incontinence is common immediately after prostate surgery.  As a result men are often advised to do pelvic floor exercises, but evidence to support this had been inconclusive.  The study sought to establish if formal one-to-one pelvic floor muscle training reduces incontinence.  It was supported by the National Institute of Health and Health Technology Assessment Programme.

The first trial enrolled men in the United Kingdom who had incontinence six weeks after radical prostatectomy, and the second trial enrolled men in the United Kingdom who had incontinence six weeks after transurethral resection of the prostate (TURP).  These trials compared the effect of four one-to-one therapy sessions during a three-month period to standard are and lifestyle advice only.

In trial 1, the rate of urinary incontinence at 12 months in the intervention group was not significantly different from that in the control group. Findings were similar in trial 2. These findings were unchanged by adjustment for minimization factors or by treatment-received analyses.  There were no adverse effects reported in either trial.

The authors conclude that one-to-one conservative physical therapy for men who are incontinent after prostate surgery is unlikely to be physically effective or cost effective.

Limitations of this study include incomplete blinding and lack of objective measures of incontinence.

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Men’s Expections for Urinary and Sexual Function After Prostate Surgery Are Not Met

A recent study in the Journal of Urology, led by Daniela Wittmann at the University of Michigan, found that man’s expectations to have better urinary and sexual function a year after the surgery than before it went unmet.

The study used a survey of 152 men, recruited between June 2007 and November 2008, undergoing radical prostatectomy before the surgery after they had received counseling on the risks of the procedure.

Of the patients 36% and 40% expected the same as baseline function at one year in urinary incontinence and sexual function, respectively, and 17%, 45%, 39%, 15% and 32% expected worse than baseline function at one year in urinary incontinence, urinary irritable symptoms, bowel function, hormonal function and sexual function, respectively. One year after prostatectomy fewer than 22% of patients attained lower than expected urinary irritable symptoms, and bowel and hormonal function, but 47% and 44% of patients attained lower than expected function for urinary incontinence and sexual function, respectively. Twelve percent and 17% of patients expected better than baseline urinary incontinence and sexual function at one year after surgery.

Other recent studies have shown that about one in four men recovered the ability to have intercourse one year after surgery and that some amount of incontinence was common even though men were generally not significantly bothered by it.

Tracey Krupski of the University of Virginia, who wrote an editorial that was published with the study, said that a support network may help new cancer patients understand the realities of life after surgery, while Wittmann said that involving patients’ partners is important to successfully regaining sexual function.

Although the study did not examine whether men would make a different treatment decision given what they know after the surgery, Wittmann said that she thinks that only a small proportion of these men would choose not to have surgery given the cancer-related risks.

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Diabetes Mellitus is Associated With Increased Prostate Tumor Risk

Even though previous studies have suggested that men with diabetes mellitus (DM) have a lower risk of prostate cancer, Duke University researchers now report that their findings suggest that there is a relationship between DM and increased risk of aggressive prostate tumors.

Leah Gerber, MSc, and colleagues at the Duke University Prostate Center retrospectively analyzed statistical data from 1,848 men from the center’s database who underwent radical prostatectomy for prostate cancer at Duke University Medical Center between 1999 and 2009 and who had complete clinical information.  The number of patients with DM at time of surgery was 197 or 10.7% of men in the study.

After the researchers adjusted for demographic and clinical covariates, they found that men with preexisting DM had almost 50% increased risk of aggressive prostate cancer compared to men without DM.  Race and obesity did not appear to have an effect on this association.  These findings could partly explain why meta-analyses show that pre-existing DM is a significant risk factor for prostate cancer and overall mortality.  Gerber reports that if the findings hold in other populations, then the finding can be used to stratify patients by risk and identify therapeutic agents acting within the molecular pathways by both disease processes.  Additionally, the team reported that investigating pharmacological agents used to treat DM should continue to determine a potential benefit against prostate cancer.

The study data was presented at the 2011 annual meeting of the American Urological Association and funded by the Duke Division of Urologic Surgery.

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Mortality Rate for Prostate Cancer Higher in UK than US

According to researchers in the United Kingdom, prostate cancer is the cause of half of the deaths of men diagnosed with the disease, challenging the notion that prostate caner patients die with rather than of the disease.  Their data show that the number of deaths specifically from prostate cancer was around 20 percent.  In contrast, about 15 percent of men diagnosed with prostate cancer die from this disease in the United States.

Experts attribute this difference to the high uptake of testing for prostate-specific antigen (PSA) in asymptomatic men in the United States and the low uptake in the United Kingdom.

While British researchers say that routine PSA testing in the United States is picking up disease that might be clinically insignificant, thus leading to over-diagnosis and over-treatment of prostate cancer, American researchers argue that PSA testing detects prostate cancer at an earlier stage when it is still treatable and curable, leading to lower mortality rates in the United States.

The new data from the United Kingdom are from an analysis of 50,066 men diagnosed with prostate cancer between 1997 and 2006 from the Thames Cancer Registry.  Patients were followed until the end of 2007.  This registry covers a population of 12 million in Southeast England.  During the study period, 20,181 of the men died.  Prostate cancer was the cause of death in 49.7% of the men who had died.  These results held after researchers controlled for age, cancer stage, and first treatment.  Other causes of death included cardiovascular disease, other cancers, and pneumonia.

Prostate cancer was the cause of death in 74.3% of men who had stage IV cancer at diagnosis, in 46.4% of all men 75 years and older, and in 31% of all men who underwent radical prostatectomy.

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Use Caution When Deciding on HIFU

Normally, high-intensity focused ultrasound (HIFU) is used as a salvage treatment for prostate cancer. Recently, a movement has taken place to push HIFU as a front-line use, but both the US Food and Drug Administration and the European Association of Urology classify the procedure as experimental.

The first case series to report outcomes in men after failed whole-gland HIFU and salvage radical prostatectomy suggests that there is reason for caution.

Researchers report they were alarmed at the pathology results. Morbidity appeared to be higher after salvage prostatectomy than after primary surgery.

Declan G. Murphy, MD, from the Department of Urological Oncology at the Peter MacCallum Cancer Centre in Melbourne, Australia, notes, “Whether it is that standard prostate biopsy cannot be relied on to predict final pathological outcome, or that HIFU ‘makes cancer angry,’ patients should be fully counseled about what we know and, importantly, what we do not know about HIFU treatment for localized prostate cancer today.”
“Our own initial experience with HIFU treatment for primary and recurrent prostate cancer unfortunately led us to conclude that the technology is not yet suitable for mainstream clinical practice, and led us to suspend our program,“ Dr. Murphy added.

Dr. Lawrentschuk believes that using radical prostatectomy as salvage treatment after the failure of primary HIFU is feasible; however, he is concerned about the rate of extraprostatic extension.

“HIFU is experimental and should only be done in studies where patients are told of the risks of failure and the poor results of salvage. They need very careful monitoring, follow-up biopsies, etc. I do not advise patients to have HIFU. There may be a problem with HIFU selecting out more aggressive cells, but this warrants further study,” explains Dr. Lawrentschuk.

“Experimental treatments are fraught with danger. I was surprised at the aggressive nature of the disease and the recurrences in this supposedly low-risk group,” he continues. “I think HIFU is inadequate in its current form, perhaps because of poor patient selection for HIFU and a lack of standardized ways of detecting post-HIFU recurrences in a timely fashion.”

Howard Sandler, MD, chair of radiation oncology at Cedars-Sinai Medical Center’s Samuel Oschin Comprehensive Cancer Institute in Los Angeles, California, also reviewed the study.

“I wouldn’t conclude that the high number with extracapsular extension is a result of HIFU. It is more likely that patients who fail HIFU had worse cancers in any case from the start. Additionally, there may have been a bit of a delay after some suspicion of recurrence before salvage surgery was done, given the presurgery PSA [prostate-specific antigen] of 3.8, with the nadir PSA of 1.0. Thus, patients waited on average for their PSA to rise from 1.0 to 3.8 before something was done. During this interval, extracapsular extension may have occurred,” Dr. Sandler explained.

Overall, Dr. Sandler believes that HIFU is a poor choice for whole-gland ablation and focal therapy.

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