Author Interviews, JAMA, Prostate, Prostate Cancer, Urology / 25.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49921" align="alignleft" width="160"]Kari Tikkinen, MD, PhD, Adjunct Professor Departments of Urology and Public Health University of Helsinki and Helsinki University Hospital Helsinki, Finland Dr. Tikkinen[/caption] Kari Tikkinen, MD, PhD, Adjunct Professor Departments of Urology and Public Health University of Helsinki and Helsinki University Hospital Helsinki, Finland MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Men’s choice of whether to undergo screening is value and preference sensitive: fully informed men will make different choices depending on their experience and perspective. For such decisions, shared decision-making represents an ideal approach to decision making. In shared decision-making both the patient and health care provider contribute to the medical decision-making process. The health care provider explains alternatives to patients, informs them of the best evidence regarding the anticipated consequences of a decision for or against the intervention, and helps them choose the option that best aligns with their preferences. All major guidelines of prostate cancer screening acknowledge the importance of informing men about risks and benefits of PSA screening. Shared decision-making is challenging because it requires time, knowledge, and specific skills. Prostate cancer screening decisions aids may, by summarizing the current best evidence and by supporting conversations that address what matters most to men, address these challenges. The impact of decision aids on the decision-making process is, however, uncertain. We therefore undertook a systematic review and meta-analysis of the randomized trials that have addressed the impact of decision aids in the context of prostate cancer screening. 
Author Interviews, Pharmaceutical Companies, Prostate, Urology / 31.05.2019

MedicalResearch.com Interview with: [caption id="attachment_49467" align="alignleft" width="160"]Steven A. Kaplan, M.D., FACS Professor of Urology Director, The Men's Health Program Icahn School of Medicine at Mount Sinai Dr. Kaplan[/caption] Steven A. Kaplan, M.D., FACS Professor of Urology Director, The Men's Health Program Icahn School of Medicine at Mount Sinai MedicalResearch.com: What is the background for this study? Response: PLUS is the first large-scale trial conducted in North America and Europe specifically designed to study the effects of mirabegron in controlling residual symptoms of urinary urgency and frequency in men with benign prostatic hyperplasia (BPH) using common agents such as tamsulosin (Flomax). We explored whether mirabegron (Myrbetriq), an agent approved for the treatment of overactive bladder (OAB), improved patient outcomes when added to tamsulosin. This was a randomized, double-blind, placebo-controlled, multi-center study enrolling 715 male patients 40 years of age and older.
Author Interviews, BMJ, Diabetes, Prostate, Urology / 24.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48763" align="alignleft" width="128"]Professor Ruth Andrew PhDChair of Pharmaceutical EndocrinologyUniversity/BHF Centre for Cardiovascular ScienceQueen's Medical Research InstituteUniversity of Edinburgh Dr. Andrew[/caption] Professor Ruth Andrew PhD Chair of Pharmaceutical Endocrinology University/BHF Centre for Cardiovascular Science Queen's Medical Research Institute University of Edinburgh  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our research group has been interested for a number of years in how stress hormones (called glucocorticoids) influence the risk of heart disease and diabetes. Glucocorticoids help us control stress and regulate how the body handles its fuel, for example the carbohydrate and fat we eat. However exposure to high levels of glucocorticoids, can increase the risk of diabetes, obesity and high blood pressure. We studied men with prostate disease who took 5α-reductase inhibitors, because over and above the beneficial actions of these drugs in the prostate, they also slow down inactivation of glucocorticoids. We had carried out some short term studies with the drugs in humans and found that they reduced the ability of insulin to regulate blood glucose. Therefore in the study we have just published in the BMJ, we examined how patients receiving these drugs long-term responded and particularly we were able to show that over an 11 year period that there was a small additional risk of developing type 2 diabetes, the type of disease common in older people, compared with other types of treatments.
Author Interviews, Prostate, Prostate Cancer, Urology / 06.07.2018

MedicalResearch.com Interview with: [caption id="attachment_42965" align="alignleft" width="149"]Prof. Hashim Ahmed Professor and Chair of Urology Imperial College London Prof. Ahmed[/caption] Prof. Hashim Ahmed Professor and Chair of Urology Imperial College London MedicalResearch.com: What is the background for this study? What are the main findings? Response: Men with localised clinically significant prostate cancer currently undergo radical (whole gland) surgery or radiotherapy. These treatments are effective but can cause urine leakage in 5-30% and erectile dysfunction in 30-60%. Radiotherapy can cause rectal problems in 5%. So, although there is benefit in treating the cancer in these men, the side effects significantly affect the quality of life. 
Author Interviews, Prostate, Prostate Cancer, Urology / 31.05.2018

MedicalResearch.com Interview with: [caption id="attachment_42036" align="alignleft" width="132"]Dr. Fred Saad, MD FRCS Full Professor and Chief of Urologic Oncology, CHUM; Medical Director of Interdisciplinary Urologic Oncology Group, CHUM; Department of Surgery/Faculty of Medicine; Institut du cancer de Montréal/CRCHUM Dr. Saad[/caption] Dr. Fred Saad, MD FRCS Professor and Chief of Urology Director of GU Oncology Raymond Garneau Chair in Prostate Cancer University of Montreal Hospital Center (CHUM) Director, Prostate Cancer Research , Montreal Cancer Institute MedicalResearch.com: What is the background for this study? What are the main findings? Response: Patient Reported Outcomes (PRO) data from the Phase 3 SPARTAN study showed adding ERLEADA (apalutamide) to androgen deprivation therapy (ADT) for patients with nmCRPC who were asymptomatic and well, did not worsen or cause detriment to HRQoL when compared to the placebo.The percent of patients who felt “quite a bit” or “very much” bothered was low (<2–6 percent of patients in the apalutamide group and 0–6 percent of those in the placebo group), suggesting that ERLEADA treatment was generally well-tolerated. This outcome, coupled with the efficacy results seen in SPARTAN, suggest that apalutamide can be given to patients at risk of metastasis without worry about compounded side effects or negative HRQoL..
Author Interviews, J&J-Janssen, Prostate, Prostate Cancer, Urology / 30.05.2018

MedicalResearch.com Interview with: [caption id="attachment_42036" align="alignleft" width="132"]Dr. Fred Saad, MD FRCS Full Professor and Chief of Urologic Oncology, CHUM; Medical Director of Interdisciplinary Urologic Oncology Group, CHUM; Department of Surgery/Faculty of Medicine; Institut du cancer de Montréal/CRCHUM Dr. Saad[/caption] Dr. Fred Saad, MD FRCS Full Professor and Chief of Urologic Oncology, CHUM; Medical Director of Interdisciplinary Urologic Oncology Group, CHUM; Department of Surgery/Faculty of Medicine; Institut du cancer de Montréal/CRCHUM MedicalResearch.com: What is the background for this study? What are the main findings? Response: The SPARTAN study was a Phase 3, randomized, double-blind, placebo-controlled, multicenter study that evaluated ERLEADA (apalutamide), a next-generation androgen signaling inhibitor, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who had a rapidly rising PSA (PSA doubling time ≤10 months). The post-hoc analysis presented at the American Urological Association (AUA) 2018 annual meeting showed in patients who received the treatment apalutamide while receiving continuous androgen deprivation therapy (ADT) significantly decreased the risk of PSA progression by 94 percent compared with the placebo group.
ASCO, Author Interviews, Prostate, Prostate Cancer, Urology / 15.03.2018

MedicalResearch.com Interview with: https://www.churchillpharma.com/ Paul Nemeth, Ph.D. Sr. Vice President, Regulatory Affairs, Clinical Development & Quality Assurance Churchill Pharmaceuticals LLC King of Prussia, PA 19406 MedicalResearch.com: What is the background for this study? Response: In the STAAR study, 53 patients with metastatic castration-resistant prostate cancer (mCRPC) were randomized to receive YONSA, an abiraterone acetate fine particle formulation 500 mg once daily in combination with 4 mg of methylpresnisolone twice daily or 1,000 mg daily of the originator abiraterone acetate (OAA) in combination with 5 mg of prednisone twice daily for a period of 84 days.  Previous studies in healthy volunteers under fasted conditions had shown that single oral doses of 500 mg of YONSA are bioequivalent to single oral doses of 1,000 mg OAA and that a background of 4 mg of methylprednisolone twice daily on a single oral dose of 500 mg of YONSA results in the same extent of absorption as a background of 5 mg of prednisone twice daily on a single oral dose of 1,000 mg of OAA. 
Author Interviews, Cost of Health Care, MRI, Prostate, Prostate Cancer / 21.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34738" align="alignleft" width="133"]Vikas Gulani, MD, PhD Director, MRI, UH Cleveland Medical Center Associate Professor, Radiology, CWRU School of Medicine Dr. Gulani[/caption] Vikas Gulani, MD, PhD Director, MRI, UH Cleveland Medical Center Associate Professor, Radiology, CWRU School of Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to learn if performing MR before prostate biopsy, followed by MR guided strategies for biopsy, are cost effective for the diagnosis of prostate cancer in men who have not previously undergone a biopsy and who have a suspicion of prostate cancer. The most significant findings are as follows: We found that all three MR guided strategies for lesion targeting (cognitive targeting, MR-ultrasound fusion targeting, and in-gantry targeting) are cost effective, as the increase in net health benefits as measured by addition of quality adjusted life years (QALY), outweigh the additional costs according to commonly accepted willingness to pay thresholds in the United States. Cognitive targeting was the most cost effective. In-gantry biopsy added the most health benefit, and this additional benefit was cost-effective as well.
Author Interviews, Prostate, Urology / 18.05.2017

MedicalResearch.com Interview with: Dr. Nikhil K. Gupta and Kevin McVary, MD, FACS Professor, Department of Surgery Chair, Division of Urology Southern Illinois University School of Medicine MedicalResearch.com: What is the background for this study? [caption id="attachment_34679" align="alignleft" width="300"]Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms. Pre Treatment.jpg: Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland, affecting 12 million men in the U.S., with nearly 800,000 newly diagnosed each year. An enlarged prostate squeezes down on the urethra causing lower urinary tract symptoms.[/caption] Response: Male lower urinary tract symptoms due to benign prostatic hyperplasia, or LUTS due to BPH, have most commonly been treated with a combination of medication, such as alpha-blockers and 5-alpha reductase inhibitors, and surgery, such as transurethral resection of prostate (TURP) and Greenlight photovaporization of prostate (PVP). These treatments, however, have potentially serious adverse and sexual side effects. Minimally invasive surgical therapies (MIST) for LUTS due to BPH have tried to thread the needle between medications and invasive surgery, giving effective relief of symptoms with minimal anesthetic need while preserving sexual function. Previously developed MISTs have been unable to provide durable relief of symptoms, causing patients to undergo multiple treatments in a short period of time, and have been limited by prostate size and conformation, e.g. the inability to treat a middle lobe or median bar. LUTS due to BPH is also very strongly and likely causally linked with obesity, and obesity seems to have an effect on the efficacy of treatment as well, as obesity affects response to medication and tends to dampen the treatment effect of TURP. Convective Radiofrequency Water Vapor Energy ablation of the prostate, named Rezūm®, is a new MIST that uses radiofrequency to generate energy in the form of water vapor. The water vapor acts as a convective energy source and, once injected into the treatment area, distributes itself evenly within the treated tissue, causing uniform necrosis througout the treated area. This mechanism using convection is in contrast to previous technologies using conductive heat energy, which created a heat gradient with tissue closest to the heat source receiving the largest amount of energy and tissue farthest from the heat source receiving almost no energy. Thus conductive energy has a different effect on different parts of the treated area. With Rezūm, MRI studies have shown that the water vapor creates a uniform treatment effect while staying within collagen barriers, obeying natural tissue planes and affecting only the intended treatment areas. The purpose of this study was to determine the efficacy of Rezūm in treatment of LUTS due to BPH, examine the treatment's effect on sexual function, and to determine whether obesity affected treatment efficacy.
Author Interviews, JAMA, Prostate, Prostate Cancer, Surgical Research, Urology / 15.11.2016

MedicalResearch.com Interview with: [caption id="attachment_29302" align="alignleft" width="134"]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 Dr. Jim Hu[/caption] 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
Author Interviews, Endocrinology, Prostate, Prostate Cancer, Testosterone, Urology / 19.09.2016

MedicalResearch.com Interview with: [caption id="attachment_28090" align="alignleft" width="133"]Dr. Jesse Ory Department of Urology, Faculty of Medicine Dalhousie University, Halifax Nova Scotia, Canada Dr. Jesse Ory[/caption] 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..
Author Interviews, Prostate, Prostate Cancer, Urology / 01.09.2016

MedicalResearch.com Interview with: [caption id="attachment_27566" align="alignleft" width="160"]Jim C. Hu, MD Ronald Lynch Professor of Urologic Oncology Weill Cornell Medicine New York, NY 10065 Dr. Jim Hu[/caption] 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.
Author Interviews, Prostate, Prostate Cancer, Urology / 04.06.2016

MedicalResearch.com Interview with: [caption id="attachment_24918" align="alignleft" width="147"]Kenneth A. Iczkowski, M.D. Department of Pathology Medical College of Wisconsin Milwaukee, WI 53226 Dr. Kenneth Iczkowski,[/caption] 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.
Author Interviews, Prostate, Urology / 01.06.2016

MedicalResearch.com Interview with: [caption id="attachment_24797" align="alignleft" width="164"]Kevin T. McVary, MD, FACS Chair, Division of Urology The Pavilion at St. John’s Hospital Springfield, IL Dr. Kevin T. McVary[/caption] 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.
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.
Author Interviews, BMJ, Prostate, Prostate Cancer, Urology / 08.03.2016

MedicalResearch.com Interview with: [caption id="attachment_22465" align="alignleft" width="120"]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 Dr. Robert Nam[/caption] 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).
Author Interviews, Biomarkers, Cleveland Clinic, Genetic Research, Personalized Medicine, Prostate, Prostate Cancer, Urology / 07.03.2016

MedicalResearch.com Interview with: [caption id="attachment_22405" align="alignleft" width="132"]Eric A. Klein, MD Chairman, Glickman Urological and Kidney Institute Cleveland Clinic Dr. Eric Klein[/caption] 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.
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).
Author Interviews, Biomarkers, Mayo Clinic, Prostate, Prostate Cancer, Urology / 12.01.2016

[caption id="attachment_20570" align="alignleft" width="125"]R. Jeffrey Karnes MD Department of Urology, Mayo Clinic, Rochester, MN 55905 Dr. R. Jeffrey Karnes[/caption] 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.
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 .
Author Interviews, Prostate, Urology / 21.05.2015

David F. Penson, MD, MPHHamilton and Howd Chair in Urologic Oncology Professor and Chair, Department of Urologic Surgery Director, Center for Surgical Quality and Outcomes Research Vanderbilt University Medical Center Nashville, TN 37232-2765MedicalResearch.com Interview with: David F. Penson, MD, MPH Hamilton and Howd Chair in Urologic Oncology Professor and Chair, Department of Urologic Surgery Director, Center for Surgical Quality and Outcomes Research Vanderbilt University Medical Center Nashville, TN 37232-2765 Medical Research: What is the background for this editorial? What are the main findings? Response: This editorial discusses the implication of the recent removal of the PSA data from the seer-medicare dataset. It reviews the significance of the action: specifically what it means for prior publications that used this information to address clinical research questions in prostate cancer. It makes the point that, while these datasets are powerful, researchers have stretched the limits of what they can do too far. Simply put, we cant always guarantee that the clinical data collected in administrative datasets will necessarily be accurate so we need to be more selective in how we use these data and not simply run analyses on the data just because it is easy.
Author Interviews, Prostate, Prostate Cancer, Urology / 16.01.2015

MedicalResearch.com Interview with: Mufaddal Mamawala, MBBS, MPH, CPH Biostatistician Johns Hopkins School of Medicine Brady Urological Institute Medical Research: What is the background for this study? What are the main findings? Dr. Mamawala: Twenty years after prostate-specific antigen (PSA) was FDA approved for the diagnosis of prostate cancer, its use remains highly controversial. There has been an ‘over- diagnosis’ and ‘over-treatment’ of low-risk prostate cancers that would have never progressed to a more lethal form of the disease during one’s life. Active surveillance (AS) is an alternative to immediate treatment, which allows for monitoring of favorable risk patients with selective delayed intervention among those with disease progression. However  ‘misclassification’ is a cause of concern for patients in the initial years of been in AS. The initial biopsy may have missed an area of prostate with an aggressive cancer, due to under-sampling of cores or due to randomness, such that this patient could get misclassified as having a low-risk disease and by the time the follow-up biopsy shows an aggressive cancer the window of curability is lost. However with more sampling of the prostate there is more likelihood to find an aggressive cancer. As such if the patient is compliant with their biopsies, and more prostate is sampled under the microscope, better are the chances of finding a higher risk cancer. Conversely if the patient has more biopsies that show no high-risk cancer then they are less likely to have a high-risk cancer on future biopsies. Thus we wanted to evaluate the risk of reclassification, from a low-risk disease to a high-risk disease (higher Gleason score, or increase in extent of the disease), over a period of time in compliant active surveillance patients.  The length of time under Active surveillance without reclassification has not been evaluated as a predictor of future reclassification. Biopsies are invasive procedures, and the fact that patient has to undergo this invasive procedure regularly is a deterrent from been in Active surveillance. This study would help to make informed decisions about the need for doing frequent biopsies in light with other clinical factors especially in older patients who had many non-reclassifying biopsies before. We found that the risk of reclassification was not equally distributed across time. As a result of ‘under sampling’ of prostate at diagnostic biopsy we had highest rates of reclassification in the first two years of been in Active surveillance with more than 50% of total reclassifications happening during those two years. The ‘low-risk’ and the ‘very-low-risk’ groups, determined by the Epstein criteria, had similar rates of reclassification in the first two years. After first two years the ‘low-risk’ group were 2.4 times as likely to have a higher risk of reclassification than the ‘very-low-risk’ group. In both the groups the risk of reclassification declined over time significantly by at least 30% with each biopsy that did not show reclassification.
Author Interviews, Prostate, Prostate Cancer, Testosterone / 29.11.2014

MedicalResearch.com Interview with: Prof. h.c.* Dr. Farid Saad on behalf of Dr. Haider and co-authors Global Medical Affairs, Andrology c/o Bayer Pharma AG, D-13342 Berlin *Gulf Medical University, Ajman, UAE Medical Research: What is the background for this study? Response: In early 1940s Dr. Charles Huggins demonstrated that in few men with metastatic prostate cancer, castration reduced tumor growth and androgen administration promoted tumor growth. This observation became the corner stone of androgen deprivation therapy (ADT) in men with prostate cancer for the past 7 decades without any clinical evidence to the contrary. Indeed, normal prostate growth depends on androgens and therefore testosterone and its metabolite DHT are responsible for the biochemical signaling in the prostate cells through interaction with the androgen receptor. Since tumor cells have been transformed from normal epithelial cells, it is no surprise that they retained the expression of the androgen receptor and continue to depend on their growth on the androgen signal. For the past 7 decades, physicians thought that testosterone is a carcinogen for the prostate, despite lack of any biochemical or clinical data. This long period of training physicians on this unproven concept, has precipitated in the minds of many clinicians that testosterone (T) causes prostate cancer. Based on a plethora of clinical data, there is no evidence to support such myth. In fact, many recent studies have debunked this hypothesis based on longitudinal and prospective studies. A newly advanced hypothesis was formulated suggesting that “T therapy does not pose a greater risk for development of PCa.” However this hypothesis is met with considerable skepticism. Interestingly, however, no new compelling evidence is available to discredit or dismiss this newly advanced hypothesis.
Author Interviews, Erectile Dysfunction, JAMA, Prostate, Prostate Cancer, Radiation Therapy / 01.04.2014

Dr. Thomas M. Pisansky MD Mayo Clinic, Rochester, MinnesotaMedicalResearch.com Interview with: Dr. Thomas M. Pisansky MD Mayo Clinic, Rochester, Minnesota MedicalResearch.com: What are the main findings of the study? Dr. Pisansky: This patient-reported outcomes research did not identify a beneficial effect of once-daily tadalafil to prevent radiotherapy-related erectile dysfunction in men with prostate cancer.
Author Interviews, Prostate / 25.11.2013

Dr Julia Wade PhD Research Associate University of Bristol, Clifton, BristolMedicalResearch.com Interview with: Dr Julia Wade PhD Research Associate University of Bristol, Clifton, Bristol MedicalResearch.com: What are the main findings of the study? Dr. Wade: We hope that our study provides men with more information about diagnosing prostate cancer.  A diagnosis of prostate cancer can only be confirmed through prostate biopsies after the finding of a raised PSA.  This biopsy process requires 10 or so samples to be taken rectally, with a local anaesthetic, and this has some side effects.  Most men describe prostate biopsies as uncomfortable, but around 40% report pain and many experience bleeding; a small number, 1%, are admitted to hospital and 10% need to see a doctor because of post-biopsy symptoms.   We found that the men who experienced post-biopsy symptoms as ‘problematic’ at 7 days post biopsy also experienced raised anxiety compared to men who experienced symptoms as non-problematic