Author Interviews, JAMA, Mental Health Research, Urology / 21.03.2017

MedicalResearch.com Interview with: Blayne Welk, MD, FRCSC Assistant Professor of Surgery Western University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Concerns have been raised by regulatory agencies and patients about possible serious psychiatric side effects associated with the use of 5 alpha reductase inhibitors. These medications can be used for both enlarged prostates and alopecia. We used administrative data to assess for potential psychiatric side effects associated with finasteride and dutasteride usage in older men with benign prostatic enlargement. In our study we found that there was no increased risk of suicide associated with the use of these medications. However, there was a small increase in both self-harm and new onset depression associated with the use of 5 alpha reductase inhibitors. (more…)
Author Interviews, Prostate Cancer, Urology / 19.02.2017

MedicalResearch.com Interview with: Yoshifumi Kadono, MD. PhD. Department of Integrative Cancer Therapy and Urology, Kanazawa University Graduate School of Medical Science, Kanazawa, Ishikawa, Japan  MedicalResearch.com: What is the background for this study? What are the main findings? Response: I had experienced some patients who underwent radical prostatectomy (RP) complained penile shortening after RP. Once I checked that kind of reports, some reports mentioned the phenomenon of penile shortening (PS) after radical prostatectomy; however, the results were little bit different and the reasons of PS after RP were not well elucidated. Therefore, we started our study to obtain our data. In our study, the penile length (PL) was measured before, 10 days after, and at 1, 3, 6, 9, 12, 18, and 24 months after RP. And the PL at 10 days after RP was shortest, and it gradually recovered thereafter. Penile length at 12 months after radical prostatectomy was not significantly different from preoperative penile length. Based on MRI investigation, slight vertical repositioning of the membranous urethra after radical prostatectomy caused chronological changes in penile length. (more…)
Author Interviews, Kidney Stones, Urology / 25.01.2017

MedicalResearch.com Interview with: Li Hao Richie Xu MD Division of Mineral Metabolism University of Texas Southwestern Medical Center Dallas, Texas, United States MedicalResearch.com: What is the background for this study? What are the main findings? Response: Over the past three decades, the prevalence of the kidney stones has escalated in the United States. Changes in dietary patterns, increasing body weight and obesity likely contributed to this significantly higher prevalence of kidney stone. In this study, we explored temporal changes in stone composition, demographic characteristics, and in serum and urinary kidney stone risk profile in kidney stone forming population for the last 35 years. The proportion of uric acid stones has been almost doubled during this period. Although age and body mass index (BMI) increased over time in both uric acid and calcium stone formers, uric acid stone formers were consistently older, had higher BMI, and lower urinary pH than calcium stone formers. In addition, over time, the proportion of female vs. male increased in calcium stone formers, but not in uric acid stone formers. The most significant urinary parameter differentiating uric acid stone formers from calcium stone formers is 24-hour urinary pH. (more…)
Author Interviews, CMAJ, Pharmacology, Urology / 19.11.2016

MedicalResearch.com Interview with: Emma Maund, MSc PhD Nordic Cochrane Centre MedicalResearch.com: What is the background for this study? Response: Duloxetine has been approved in Europe for the treatment of stress urinary incontinence in women. It is not approved for this indication in the US and Canada. Currently, reasons why marketing authorization applications are withdrawn or denied are not published by either the Canadian or the US drug agency. However, the FDA has said that a higher-than-expected rate of suicide attempts - 2.6 timer higher - was observed in the open-label extensions of controlled trials of duloxetine for stress urinary incontinence. Given the FDA’s statement about the rate of suicide attempts, we wanted to determine whether duloxetine increased the risk of suicidality, violence or their possible precursors (drug induced akathisia, an extreme type of restlessness; activation, which consists of stimulating effects such as insomnia, anxiety and agitation; emotional disturbance, such as depersonalization and derealization; or psychotic events, such as delusions and hallucinations) in the randomized phases of the trials. We therefore assessed the benefits and harms of duloxetine in stress urinary incontinence using clinical study reports, including individual patient data, of the 4 main trials submitted by Eli Lilly to the European Medicines Agency. (more…)
Author Interviews, JAMA, Prostate, Prostate Cancer, Surgical Research, Urology / 15.11.2016

MedicalResearch.com Interview with: Jim C. Hu, M.D., M.P.H. Ronald P. Lynch Professor of Urologic Oncology Director of the LeFrak Center for Robotic Surgery Weill Cornell Medicine Urology New York Presbyterian/Weill Cornell New York, NY 10065 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The US Preventative Services Task Force (USPSTF) recommended against PSA testing in men older than 75 years in 2008 and more recently in all US men regardless of age in 2012. This was largely based on a faulty study, the prostate, lung, colo-rectal and ovarian screening study. We demonstrated in May 2016 that this randomized trial did not compare screening to no screening or apples to oranges, as it set out to do. It compared screening to screening. Although controversial, the guidelines were well-intentioned, as recognize that there is over-diagnosis and over-treatment of men with prostate cancer. Given this background, the goal of our study was to explore the downstream consequences of the recommendation against PSA screening. As such, we explored 3 separate databases to characterize national procedure volumes for prostate needle biopsy and radical prostatectomy, or surgery to cure prostate cancer. The main finding was that prostate biopsy numbers decreased by 29% and radical prostatectomy surgeries decreased by 16% when comparing before to after USPSTF recommendations against PSA screening. Therefore practice patterns followed policy. Prostate biopsies are usually performed due to an elevated, abnormal screening PSA. However, it is also performed to monitor low-risk, slow growing prostate cancers. We also found that while the overall number of prostate biopsies decreased, there was a 29% increase in the proportion or percentage of biopsies performed due to active surveillance, or monitoring of low risk prostate cancers which should be done periodically. Therefore we provide the first national study to demonstrate that there is less over-diagnosis and over-treatment of prostate cancer. However, the concern is that we also recently demonstrated that there is more aggressive prostate cancer on surgical pathology for men who go on to radical prostatectomy. They have high grade, higher stage cancers, which have a lower chance of cure. The link is: http://www.prostatecancerreports.org/fulltext/2016/_Hu_JC160708.pdf (more…)
Author Interviews, Journal Clinical Oncology, Prostate Cancer, Surgical Research, Urology / 30.09.2016

MedicalResearch.com Interview with: Eric Jacobs, PHD Strategic Director, Pharmacoepidemiology American Cancer Society, Inc. 250 Williams St. Atlanta, GA 30303 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Vasectomy is a common, inexpensive, and very effective method of long-term birth control. However, in 2014, an analysis from a large epidemiologic cohort study, the Health Professionals Follow-Up Study, found that vasectomy was associated with about 10% higher overall risk of prostate cancer and about 20% higher risk of fatal prostate cancer. Together with other researchers at the American Cancer Society, I analyzed the association between vasectomy and fatal prostate cancer among more than 363,000 men in the Cancer Prevention Study II (CPS-II) cohort, age 40 and older, who were followed for up to 30 years. This is the largest prospective analysis of vasectomy and fatal prostate cancer to date. We also examined vasectomy and prostate cancer in a subset of about 66,000 CPS-II study participants who were followed for new diagnoses of prostate cancer. We found no link between having had a vasectomy and risk of either developing or dying from prostate cancer. (more…)
Author Interviews, Endocrinology, Prostate, Prostate Cancer, Testosterone, Urology / 19.09.2016

MedicalResearch.com Interview with: Dr. Jesse Ory Department of Urology, Faculty of Medicine Dalhousie University, Halifax Nova Scotia, Canada  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The use of Testosterone Therapy (TT) in men diagnosed with and treated for prostate cancer (CaP) has been highly controversial for several decades. Unfortunately, this controversy is largely founded on the results of a single patient in a study by Huggins and Hodges in the 1940s [1]. This wasn't challenged until recently, when Morgentaler reviewed the literature on the topic and found no scientific basis for the assumption that TT will act like fuel on the fire of prostate cancer [2]. He also proposed a mechanism, the "saturation hypothesis" that helps account for why TT may in fact be safe for men with prostate cancer. [3]. Over the past decade, retrospective evidence has been accumulating that supports the safety of Testosterone Therapy in hypogonadal men with CaP on Active Surveillance, or in those who have been definitively treated for prostate cancer.. (more…)
Author Interviews, Prostate, Prostate Cancer, Urology / 01.09.2016

MedicalResearch.com Interview with: Jim C. Hu, MD Ronald Lynch Professor of Urologic Oncology Weill Cornell Medicine New York, NY 10065 MedicalResearch.com: What is the background for this study? Response: Initial results from the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO), a large-scale randomized controlled trial of prostate cancer screening in the United States, radically changed the landscape of prostate cancer screening insofar as it led the United States Preventative Services Task Force (USPSTF) to recommend against routine screening with prostate-specific antigen (PSA). Though many subsequent studies have continued to investigate the role of PSA in screening, there is a paucity of data examining the use of digital rectal examination (DRE) for screening in the PSA era. Indeed, the USPSTF recommendation did not explicitly address DRE, calling for further research to evaluate the role of periodic DRE in prostate cancer screening. Likewise, while recent guidelines from the National Comprehensive Cancer Network (NCCN) recommend use of PSA in all men who elect screening, the role of digital rectal examination is equivocal. We sought to evaluate the value of  digital rectal examination and PSA for detection of clinically significant prostate cancer and prostate cancer-specific (PCSM) and overall mortality in a secondary analysis of the PLCO. (more…)
Author Interviews, Prostate Cancer, Urology / 17.08.2016

MedicalResearch.com Interview with: Jennifer Cullen Meyer, PhD, MPH Director of Epidemiologic Research, Center for Prostate Disease Research Assistant Professor, Norman M. Rich Dept. of Surgery, Uniformed Services University Rockville, MD 20852 MedicalResearch.com: What is the background for this study? Response: Men diagnosed with prostate cancer who are at low risk for cancer progression may choose to defer immediate treatment with curative intent and, instead, monitor their cancer. This strategy is referred to as “active surveillance.” The primary benefit of active surveillance is that it allows men to temporarily defer definitive cancer treatments that are known to cause decrements in health-related quality of life (HRQoL). Studies have shown that HRQoL is better in men choosing active surveillance as compared to other treatment modalities. However, prior to our study, it was not known whether men on active surveillance experience worse HRQoL than men without prostate cancer. (more…)
Author Interviews, Erectile Dysfunction, Prostate Cancer, Urology / 05.08.2016

MedicalResearch.com Interview with: Juzar Jamnagerwalla, MD Division of Urology, Department of Surgery Cedars-Sinai Medical Center Los Angeles, California MedicalResearch.com: What is the background for this study? What are the main findings? Response: In mouse models phosphodiesterase type-5 inhibitors (PDE-5i) have been shown to have anti-neoplastic activity, and given the routine use of PDE-5i for treatment of erectile dysfunction after prostatectomy several studies have examined the association between PDE-5i use and biochemical recurrence after treatment for prostate cancer with mixed findings. Only one previous study has explored the association between risk of prostate cancer, finding that men on PDE-5i had a lower chance of being diagnosed with prostate cancer. Given this, we tested the relationship between PDE-5i use and risk of prostate cancer in 6,501 men in the REDUCE study finding that PDE-5i use was not associated with prostate cancer diagnosis. On secondary analysis, among North American men who had a much higher baseline use of PDE-5i use, there was an inverse association between PDE-5i use and prostate cancer diagnosis, which approached, but did not reach statistical significance. (more…)
Author Interviews, Prostate, Prostate Cancer, Urology / 04.06.2016

MedicalResearch.com Interview with: Kenneth A. Iczkowski, M.D. Department of Pathology Medical College of Wisconsin Milwaukee, WI 53226 MedicalResearch.com: What is the background for this study? Dr. Iczkowski: The International Society of Urological Pathology (ISUP) in 2014 proposed use of a new 5-tier grade grouping system to supplement traditional Gleason grading to facilitate prognosis stratification and treatment1. The 5 categories subsume: Gleason 3+3=6, Gleason 3+4=7, Gleason 4+3=7, Gleason 8, and Gleason 9-10. We desired to determine whether men with a highest Gleason score of 3+5=8 or 5+3=8 in their set of prostate biopsy specimens, would have differing outcomes from those with Gleason 4+4=8. Because Gleason 5 cancer has been demonstrated to have a higher biologic potential than Gleason 4, it was expected that Gleason score 8 pattern with any Gleason 5 pattern would have a worse outcome. (more…)
Author Interviews, Prostate, Urology / 01.06.2016

MedicalResearch.com Interview with: Kevin T. McVary, MD, FACS Chair, Division of Urology The Pavilion at St. John’s Hospital Springfield, IL Chair and Professor of Urology SIU School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Dr. McVary: Benign Prostatic Hyperplasia (BPH) is a localized enlargement of the prostate gland in aging adult men. It affects approximately 75% of men over the age of 65. This excess growth of tissue compresses and obstructs the urethra, reducing the flow of urine from the bladder and sometimes blocking it entirely. As the symptoms increase, they can greatly impact a man’s quality of life. Both BPH and the existing treatments for it can negatively affect an individual’s sex life. The Rezūm II IDE pivotal study was a prospective, multicenter, randomized (2:1) controlled trial that enrolled 197 patients across 15 clinical sites in the U.S. The main finding showed that radiofrequency generated convective water vapor thermal therapy provides rapid and sustainable improvement of lower urinary tract symptoms (LUTS) secondary to BPH and urinary flow over a 12-month period without negative effects on erectile and ejaculatory function. These results support the application of convective water vapor energy (WAVE) technology as safe and effective minimally invasive therapeutic alternative for symptomatic BPH. Additionally, no treatment or device related de novo erectile dysfunction occurred after thermal therapy, ejaculatory bother score improved 31% over baseline, and 27% of subjects achieved minimal clinically important differences (MCIDs) in erectile function scores at 1 year, including those with moderate to severe ED. (more…)
Author Interviews, Chemotherapy, Urology / 24.05.2016

MedicalResearch.com Interview with: Alejandro Sousa, MD, PhD Department of Urology, Comarcal Hospital Monforte, Spain MedicalResearch.com: What is the background for this study? Dr. Sousa: Bladder Cancer management has remained stable over the past 25 years, with very little in the way of new therapies or approaches being developed. Traditional treatment using intravesical Mitomycin C for Non Muscle Invasive Bladder Cancer (NMIBC) patients is limited due it's low absorption levels. Device assisted therapies that deliver Chemo-hyperthermia offer a new hope, with the potential for improved outcomes and better disease management due the the increased drug activity and better efficacy. We wanted to investigate the optimal treatment regime for this new therapy and whether it provides a safe and effective alternative to current standard treatment. (more…)
Author Interviews, Prostate, Prostate Cancer, Testosterone, Urology / 14.05.2016

MedicalResearch.com Interview with: Ryan Flannigan MD FRCSC PGY 5 Urology Resident Department of Urological Sciences University of British Columbia MedicalResearch.com: What is the background for this study? Dr. Flannigan: In the aging population the incidence of both prostate cancer and testosterone deficiency (TD) increase and even overlap in many patients. However, since Huggins’ original research in 1940, we have understood that prostate cancer is largely regulated by the androgen receptor (AR). Thus, the thought of treating someone with exogenous testosterone (T) was concerning for fear of further activation of the androgen receptor, and therefore promoting prostate cancer growth. However, further research has continued to add clarity to this complex interaction between androgens and the prostate. The saturation theory describes the observation that prostate specific antigen (PSA) responds to increasing serum testosterone levels only to a value of approximately 8.7nmol/L, with no inflation of PSA beyond these T levels. This is likely not the whole story when it comes to the interaction of T and the prostate, but it does suggest the prostate may not experience changes in cellular function with serum testosterone beyond low levels. It is also understood that prostate cancer requires AR activation to grow but is not caused by AR activation. Thus, we hypothesized that among those with un-treated prostate cancer, ie. patients on active surveillance, would not experience changes in biochemical recurrence (BCR) or changes in disease progression. In addition, we hypothesized that patients with previously treated prostate cancer would not have viable prostate cancer cells and thus, PSA would not increase. (more…)
Author Interviews, Biomarkers, Prostate Cancer, Urology / 12.05.2016

MedicalResearch.com Interview with: Jonathan Shoag MD Urology Resident at Cornell Department of Urology and Dr. Jim C. Hu MD Ronald Lynch Professor of Urologic Oncology Professor of Urology Director, Lefrak Center for Robotic Surgery Attending Urologist, New York-Presbyterian Hospital (Cornell campus) MedicalResearch.com: What is the background for this study? Response: Prostate Specific Antigen (PSA) is a blood test that is used to detect prostate cancers and to follow a cancer’s response to treatment. PSA was widely implemented as a screening tool for prostate cancer in the early 1990s, and became a routine test during an annual physical for men over 40. Doctors started using it because values above a “normal” threshold were associated with a greater risk of prostate cancer. Following the adoption of PSA screening in the early 1990s, there has been a large increase in the number of men diagnosed with cancer, and a decrease of approximately 50% in the rate of prostate cancer death. The PLCO trial was a large randomized trial designed and funded by the National Cancer Institute (NCI) to determine the effect of PSA screening on death from prostate cancer. The trial found that men randomized/assigned to prostate cancer screening had the same number of prostate cancer deaths as men in the control group of the trial, arguing that PSA screening does not decrease prostate cancer mortality. This was a major piece of evidence used by the United States Preventative Services Task Force (USPSTF) to form its 2012 recommendation against PSA screening. The argument was that in spite of the other evidence showing a benefit to PSA testing, including US epidemiologic trends, and another large randomized trial showing PSA screening was effective (the ERSPC), we now had good evidence showing no benefit to PSA testing in the US. Since 2012 we have seen dramatic declines in prostate cancer screening in the US as a result. (more…)
Author Interviews, MRI, Prostate Cancer, Urology / 11.05.2016

MedicalResearch.com Interview with: Dr. Vikas Gulani MD, PhD Director, MRI, University Hospitals Case Medical Center Associate Professor, Radiology CWRU School of Medicine Cleveland, OH  MedicalResearch.com: What is the background for this study? Dr. Gulani: For men that have a suspicion for prostate cancer either via the prostate specific antigen (PSA) test or a digital rectal exam, the current standard of care is to perform a transrectal ultrasound (TRUS) guided biopsy to detect cancer. The problem with TRUS biopsy is that most tumors are not visible on ultrasound and hence many significant cancers are missed. At the same time this strategy detects a high number of low risk, indolent cancers, and leads to overtreatment of disease that would be better left untreated. Diagnostic MRI and MRI-guided biopsy (cognitive, ultrasound-MR fusion, or in-gantry) have been shown to be effective in detecting clinically significant prostate cancer. However, despite these advantages there is reluctance to incorporate MRI into standard practice because it is perceived to be expensive. Our goal was to determine if this presumption is true, and evaluate the cost-effectiveness of the MRI-guided techniques most commonly used. MedicalResearch.com: What are the main findings? Dr. Gulani: We found that every MRI strategy we evaluated was cost-effective compared to standard biopsy. Cognitive MRI guided biopsy – where the operator performs an ultrasound biopsy based on knowledge of lesion location from the MRI – was the most cost-effective strategy compared to standard biopsy. In-gantry MRI yielded the highest net health benefits as measured in quality adjusted life years. (more…)
Abuse and Neglect, Author Interviews, NYU, Pharmacology, Urology / 11.05.2016

MedicalResearch.com Interview with: Dr. Jed Kaminetsky MD Clinical Assistant Professor Department of Urology NYU Langone Medical Center  MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Kaminetsky: Nocturia is a voiding disorder not well treated by available drugs for overactive bladder and benign prostatic hypertrophy. Desmopressin stimulates the kidneys to concentrate the urine which results in a greatly reduced volume of urine formation for a period of time. Serenity Pharmaceuticals has spent many years developing a low dose nasal spray version of desmopressin called Noctiva specifically for nocturia. The study reported now is a large, placebo controlled phase 3 trial to confirm the statistical efficacy and clinical benefit of this treatment for nocturia. (more…)
Author Interviews, Kidney Disease, Urology / 10.05.2016

MedicalResearch.com Interview with: Hiten D. Patel, MD, MPH Resident, Urological Surgery James Buchanan Brady Urological Institute The Johns Hopkins Medical Institutions Baltimore, Maryland 21287  MedicalResearch.com: What is the background for this study? Dr. Patel: The study reports results of a systematic review contracted by the Agency for Healthcare Research and Quality based on input from stakeholders. Part of the motivation was due to the American Urological Association's desire to use the results as a basis to update relevant clinical guidelines. There are four major management options for clinically localized small renal masses diagnosed on imaging including active surveillance, thermal ablation, partial nephrectomy, and radical nephrectomy. The body of research evaluating these management options is broad, but many of the studies performing comparative analyses have limitations. Therefore, the systematic review aimed to evaluate a number of outcomes (e.g. overall survival, cancer specific survival, local recurrence, metastasis, renal function, complications, and perioperative outcomes) based on available comparative studies in the literature. (more…)
Author Interviews, Urology / 03.05.2016

MedicalResearch.com Interview with: Errol Singh, M.D. Urologist and CEO of PercuVision MedicalResearch.com: What is the background for this study? Dr. Singh: We set out to better understand the American public’s fears around Foley catheters and hopefully bring attention to the fact that hospitalizations due to infections from urinary catheters are on the rise. Interestingly enough, 20 percent of hospital patients undergo a urinary catheterization, which is the second most common procedure following intravenous therapy. The procedure, however, often leads to complications including infections mostly caused by trauma. MedicalResearch.com: What are the main findings? Dr. Singh: The main findings of the 2016 Urinary Catheter Fear Survey revealed that three out of five men (58 percent) are fearful of urinary catheterizations, while one out of every four men is very fearful of the procedure. Younger men also seem to be more fearful than their older counterparts. More than two-thirds (68 percent) of men ages 18-34 surveyed are fearful of urinary catheterizations, compared to 43 percent of males 65 and over. Clearly, females are less fearful, with 46 percent of women saying they are not fearful of urinary catheterizations, compared to 37 percent of men. It’s also important to note that half of all women surveyed say they fear the procedure, and 25 percent reporting they are very fearful. You can find more of the 2016 Urinary Catheter Fear Survey results on our website atwww.percuvision.com. (more…)
Author Interviews, Urology / 11.04.2016

MedicalResearch.com Interview with: Dr. H. Bob Smouse MD Interventional Radiology, Radiology OSF Saint Francis Medical Center Peoria, IL MedicalResearch.com: What is the background for this study? Dr. Smouse: For more than twenty years I've seen my patients with severe blockages of the ureter undergo two separate invasive procedures to implant one ureteral stent. Even though these procedures are done with interventional techniques, they require sedation, radiation, time off work, and occasionally have some level of pain and discomfort. Being able to potentially eliminate an entire invasive procedure for these patients has been a goal of mine for years. MedicalResearch.com: What are the main findings? Dr. Smouse: All devices tested showed 100% success in implantation and 100% success in converting from an internal-external nephroureteral catheter into an internal nephroureteral stent without the need for a second invasive procedure. (more…)
Author Interviews, Erectile Dysfunction, Stem Cells, Urology / 03.04.2016

MedicalResearch.com Interview with: Dr. Michael Zahalsky MD Medical Director of Urological Oncology North Broward Medical Center, Florida MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Zahalsky: Erectile dysfunction or the inability to maintain an erection satisfactory for sexual intercourse is a disease that affects hundreds of millions of men worldwide. Currently, the most utilized methods to help treat these men include oral medications, injectable medications and penile prostheses. We sought out new alternatives to treat and potentially even cure erectile dysfunction by using stem cells and biologic-based therapies - treatments that are now being used in various fields of medicine from orthopedics to plastic surgery. We decided to see how their effect will influence Erectile Dysfunction by evaluating blood flow to the penis. In the past we studied Peyronie’s Disease using a similar treatment modality and showed that with a single injection blood flow improved, plaque size decreased, and penile curvature lessened.  There have been many animal studies, as well, showing the benefit of biologic-based therapies in the treatment of Erectile Dysfunction and Peyronie’s Disease. We chose to use placental matrix derived mesenchymal stem cells in this study on Erectile Dysfunction. We had a small sample of 8 patients who underwent treatment. We had statistically significant increase in blood flow into the penis.  This was demonstrated by an increase in peak systolic velocity using color doppler on ultrasound. (more…)
Author Interviews, BMJ, Prostate, Prostate Cancer, Urology / 08.03.2016

MedicalResearch.com Interview with: Robert Nam, MD, FRCSC Ajmera Family Chair in Urologic Oncology Professor of Surgery University of Toronto Head, Genitourinary Cancer Site Odette Cancer Centre Sunnybrook Health Sciences Centre Toronto, Ontario MedicalResearch.com: What is the background for this study? Response: Prostate cancer treatment is associated with a number of complications including erectile dysfunction and urinary incontinence. Two years ago, we published a paper examining other, previously undescribed complications. The most controversial finding was a significantly increased risk of secondary cancers among men treated with radiotherapy. We therefore wanted to assess this in a meta-analysis, examining all the research currently available on the topic. MedicalResearch.com: What are the main findings? Response: We found that, for patients with prostate cancer, radiotherapy treatment was associated with significantly increased rates of bladder cancer, colorectal cancer and rectal cancer. There wasn't an increased risk for other cancers such as lung and blood system cancer. However, the absolute rates of these cancers remained low (1-4% of patients). (more…)
Author Interviews, Biomarkers, Cleveland Clinic, Genetic Research, Personalized Medicine, Prostate, Prostate Cancer, Urology / 07.03.2016

MedicalResearch.com Interview with: Eric A. Klein, MD Chairman, Glickman Urological and Kidney Institute Cleveland Clinic MedicalResearch.com: What is the background for this study? What are the main findings? Dr. Klein: Prostate cancer is an enigma. While this tumor is the second leading cause of cancer death among American men, most newly diagnosed disease detected by PSA screening is biologically indolent and does not require immediate therapy. Currently, the main clinical challenge in these men is to distinguish between those who can be managed by active surveillance from those who require curative intervention. Current clinical and pathological tools used for risk stratification are limited in accuracy for distinguishing between these scenarios. An abundance of research in the last decade has provided evidence that genomics can offer meaningful and clinically actionable biological information to help inform decision making, and current National Comprehensive Cancer Network (NCCN) guidelines on prostate cancer endorse the use of commercially available genomic tools for men considering active surveillance.[1] It has been previously shown that the 22-gene genomic classifier, Decipher, accurately predicts the likelihood of metastasis and prostate cancer specific mortality when measured on tissue from radical prostatectomy specimens.[2] In multiple validation studies, it performed with higher accuracy and discrimination compared to clinical risk factors alone. The current study[3] is the first to examine whether the use of Decipher might aid decision making when measured on biopsy tissue at the time of diagnosis. Men with available needle biopsy samples were identified from a study cohort that previously had Decipher performed on their matched radical prostatectomy tissue. In this cohort of mixed low, intermediate and high risk men, Biopsy Decipher predicted the risk of metastasis 10 years post RP with high accuracy, outperforming NCCN clinical risk categorization, biopsy Gleason score and pre-operative PSA. Furthermore, this study showed that Decipher reclassified 46% of patients into lower or higher risk classification compared to NCCN classification alone. The study also showed that Biopsy Decipher can identify men that are at high risk for adverse pathology as defined by the presence of primary Gleason pattern 4 or greater. (more…)
Author Interviews, Erectile Dysfunction, Prostate, Prostate Cancer, Surgical Research, Urology / 29.02.2016

Medicalresearch.com Interview with: Dr. Pedro Recabal, MD and Memorial Sloan Kettering Cancer Center Department of Surgery, Urology Service New York, NY Urology service, Fundacion Arturo Lopez Perez, Santiago, Chile Dr. Vincent P. Laudone, Memorial Sloan Kettering Cancer Center Department of Surgery Urology Service New York, NY Medicalresearch.com What is the background for this study? Response:  One of the most concerning adverse events that may arise following surgery for prostate cancer (radical prostatectomy) is postoperative erectile dysfunction. The loss of erectile function after surgery is most frequently caused by intraoperative injury to the neurovascular bundles, tiny packages of blood vessels and nerves that conduct the impulses responsible for erection. It is known that if both bundles are removed, patients seldom recover erectile function. Accordingly, neurovascular bundle preservation during Radical prostatectomy has proven benefits in terms of erectile function recovery. However, as these bundles are intimately associated with the posterolateral aspects of the prostate, they must be carefully separated from the surface of the prostate without cutting them, applying excessive traction, or using cautery, all of which could produce irreversible damage and the consequent loss of function. During this dissection, the surgeon risks cutting into the prostatic capsule , which could result in leaving tumor behind. In some cases, the tumor extends beyond the prostate into the neurovascular bundles, and an attempt to preserve these structures could also result in incomplete tumor removal, defeating the purpose of radical prostatectomy. Therefore, many urologists treating patients with “aggressive” tumors (such as the patients in our cohort) would try to avoid leaving cancer behind by removing not only the prostate but also the tissue around it, including the neurovascular bundles. In other words, if you had to chose between removing all the cancer but loosing erectile function, or preserving erectile function but risking an incomplete cancer removal, most patients and surgeons naturally lean towards the first option. Also, in many centers, patients with aggressive prostate cancers are managed with combined treatments (multimodal therapy), by adding hormonal therapy and/or radiotherapy, which could also result in erectile dysfunction. As such, many surgeons believe that there is no rationale for attempting to preserve the neurovascular bundles in these “high-risk” patients because most will end up with erectile dysfunction . However, with the advent of MRI (and integrating other clinical information such as location of the positive biopsies, and intraoperative cues), surgeons can now have a better idea of where the cancer is located, which may aid in surgical planning. For instance, if a tumor is located in the anterior prostate, removing the neurovascular bundles (located on the posterolateral aspects) would provide no oncologic benefit, regardless of the aggressiveness of the tumor. Similarly, if the tumor compromises only the left side, removing the right neurovascular bundle is unlikely to help the patient, but can instead result in harm. Moreover, neurovascular bundle preservation is not an all-or-none procedure; on each side, these bundles can be completely preserved (meaning dissecting exactly along the border between the prostate and the bundle); partially preserved (meaning preserving some of the nerves that are further away from the prostate, and removing the ones that are closer to the prostate); or completely removed along with the prostate (This has been graded in a scale from 1 to 4, where 1 represents complete preservation, and 4 represents complete removal of the neurovascular bundle, with 2 and 3 being partial preservation. This grade is recorded by the surgeon for each side, at the end of the procedure.) As such, sometimes it’s possible to preserve part of the bundle, even if there is a tumor on the same side We designed a retrospective study to look at how high volume surgeons at MSKCC performed radical prostatectomy in high risk patients (how frequently and to what extent where the neurovascular bundles preserved), and what were the outcomes in terms of positive surgical margins (a surrogate for “leaving tumor behind”); use of additional oncologic treatments such as hormone therapy or radiotherapy, and finally, erectile function recovery in patients with functional erections before the operation. The patients in our cohort had at least one NCCN-defined high risk criteria (Gleason score ≥ 8; PSA ≥ 20 ng/ml; Clinical stage ≥ T3). (more…)
Author Interviews, OBGYNE, Urology / 25.02.2016

MedicalResearch.com Interview with: Kari Aarne Olavi Tikkinen, M.D PHD Adjunct Professor Department of Urology Helsinki University Central Hospital and University of Helsinki Helsinki, Finland Medical Research: What is the background for this study? Dr. Tikkinen: ?Stress and urgency incontinence are the two most frequent and the most bothersome urinary symptoms among women. It has been estimated that about twelve percent of women report significant bother from stress incontinence and eight percent from urgency incontinence. Both stress urinary incontinence and urgency urinary incontinence are associated with substantial physical and psychological morbidity, and large societal costs. An extensive body of evidence suggests that delivering vaginally versus caesarean section increases rates of post-partum stress urinary incontinence. The magnitude of long term effects of different delivery modes on stress and urgency urinary incontinence remain, however, uncertain. ? (more…)
Author Interviews, Biomarkers, Mayo Clinic, Prostate, Prostate Cancer, Urology / 12.01.2016

MedicalResearch.com Interview with: R. Jeffrey Karnes MD Department of Urology, Mayo Clinic, Rochester, MN 55905   MedicalResearch: What is the background for this study? What are the main findings? Dr. Karnes: Cancer recurrence following radical prostatectomy is a concern for men undergoing definitive surgical treatment for prostate cancer. Approximately 20-35% of patients develop a rising prostate specific antigen following radical prostatectomy for clinically localized prostate cancer. PSA monitoring is an important tool for cancer surveillance; however, a standard PSA cutpoint to indicate biochemical recurrence has yet to be established. Over 60 different definitions have been described in literature. This variation creates confusion for the patients and clinicians. By studying a large group of patients who underwent radical prostatectomy at Mayo Clinic, we found that a PSA cutpoint of 0.4 ng/mL is the optimal definition for biochemical recurrence. (more…)
Author Interviews, Prostate, Prostate Cancer, Urology / 26.11.2015

MedicalResearch.com Interview with: Isaac Yi Kim, MD, PhD Acting Chief and Associate Professor, Division of Urology Rutgers Robert Wood Johnson Medical School Chief, Section of Urologic Oncology and Young Suk "Joseph" Kwon, MD Post-doctoral fellow  Section of Urologic Oncology Rutgers Cancer Institute of New Jersey Rutgers, The State University of New Jersey New Brunswick, NJ 08903 Medical Research: What is the background for this study? Response: Although PSA < 10 ng/mL is a typically required condition under which many active surveillance (AS) protocols operate, this current guideline may predispose lower risk patients with incongruently elevated PSA to aggressive and potentially unnecessary therapies. Specifically, urologists infrequently encounter patients with PSA > 10 ng/ml but biopsy demonstrating a relatively lower risk prostate cancer (PCa). Therefore, we wanted to test whether active surveillance may be a viable option in some men with a histologically favorable risk prostate cancer and serum PSA between 10 and 20 ng/ml. Medical Research: What are the main findings? Response: We compared oncologic outcomes in men with favorable biopsy histology and varying PSA levels: low, intermediate, and high PSA levels. The rates of upstaging and upgrading were similar between the intermediate PSA (IP) (≥10 and 20) and low PSA (LP) (<10) group. In contrast, the high PSA  (HP) (≥20) group had higher incidences of both upstaging (p=0.02) and upgrading to ≥4+3 (p=0.046) compared to the IP group. BCR-free survival rates revealed no pair-wise inter-group differences, except between low PSA and high PSA . (more…)
Author Interviews, JAMA, Outcomes & Safety, Urinary Tract Infections, Urology / 19.11.2015

MedicalResearch.com Interview with: Jerome A. Leis, MD MSc FRCPC Staff physician, General Internal Medicine and Infectious Diseases Physician Lead, Antimicrobial Stewardship Team Staff member, Centre for Quality Improvement and Patient Safety Sunnybrook Health Sciences Centre Assistant Professor, Department of Medicine, University of Toronto Medical Research: What is the background for this study? What are the main findings? Dr. Leis: Overuse of urinary catheters leads to significant morbidity among hospitalized patients.  In most hospitals, discontinuation of urinary catheters relies on individual providers remembering to re-assess whether patients have an ongoing reason for a urinary catheter.  We engaged all of the attending physicians to agree on the appropriate reasons for leaving a urinary catheter in place and developed a medical directive for nurses to remove all urinary catheters lacking these indications.  This nurse-led intervention resulted in a significant reduction in urinary catheter use and catheter-associated urinary tract infections, compared with wards that continued to rely on usual practice. (more…)