AACR, Author Interviews, Brigham & Women's - Harvard, Cancer Research, Nutrition, Prostate Cancer / 10.04.2021

MedicalResearch.com Interview with: [caption id="attachment_57108" align="alignleft" width="200"]Dr. Anna Plym PhD Postdoctoral Research Fellow Brigham and Women's Hospital Harvard T.H. Chan School of Public Health Dr. Plym[/caption] Dr. Anna Plym PhD Postdoctoral Research Fellow Brigham and Women's Hospital Harvard T.H. Chan School of Public Health  MedicalResearch.com: What is the background for this study? What are the main elements of the healthy lifestyle? Response: Prostate cancer is the most heritable of all cancers, with genetic factors accounting for a large proportion of cases. Although we do not currently know about all the genetic factors contributing, a recent study identified 269 genetic markers for prostate cancer, validated in multiple independent populations (Conti et al., Nature Genetics 2021, Plym et al, JNCI, 2021: https://academic.oup.com/jnci/advance-article-abstract/doi/10.1093/jnci/djab058/6207974). Based on a polygenic risk score derived from these 269 markers, we observed that men with a high polygenic risk score have over a 50% risk of developing prostate cancer within their lifetime. With this excess risk in mind, we were interested in possible ways in which the genetic risk of prostate could be attenuated. An increasing number of studies have suggested that lifestyle factors can affect the risk of lethal prostate cancer – however, these studies have seldom incorporated genetic factors. We know from other diseases that a healthy lifestyle is of benefit for individuals at high genetic risk, and we hypothesized that this would be the case for prostate cancer as well. In this study, we examined a healthy lifestyle score for lethal prostate cancer consisting of six components: healthy weight (BMI < 30), not smoking (never smoked or quit > 10 years ago), vigorous physical exercise (3 or more hours per week), high intake of tomatoes or tomato-based products (7 servings or more per week), high intake of fatty fish (1 or more serving per week) and low intake of processed meat (less than 3 servings/week of beef or pork hot dogs, bacon, salami, bologna, or other processed meat sandwiches) (Kenfield et al, JCO, 2016). 
Author Interviews, Brigham & Women's - Harvard, Cancer Research, COVID -19 Coronavirus, Prostate, Prostate Cancer, Surgical Research, Urology / 01.02.2021

MedicalResearch.com Interview with: [caption id="attachment_56523" align="alignleft" width="200"]David-Dan Nguyen Research Fellow | Center for Surgery and Public Health, Brigham and Women's Hospital MPH (Health Policy) Student | Harvard T.H. Chan School of Public Health Medical Student | McGill University Mr. Nguyen[/caption] David-Dan Nguyen Research Fellow | Center for Surgery and Public Health, Brigham and Women's Hospital MPH (Health Policy) Student | Harvard T.H. Chan School of Public Health Medical Student | McGill University MedicalResearch.com: What is the background for this study? Response: The COVID-19 pandemic has forced hospitals to delay the definitive treatment of cancers via surgery or radiation therapy. While previous evidence has shown that delaying the treatment of low-risk prostate cancer is not associated with worse outcomes, treatment delays for intermediate-risk and high-risk prostate cancer are more controversial. As such, we sought to determine if delays for these disease states negatively impacted oncological outcomes.
Author Interviews, Brigham & Women's - Harvard, JAMA, Prostate Cancer, Social Issues / 18.11.2020

MedicalResearch.com Interview with: David-Dan Nguyen, MPH Research Fellow | Center for Surgery and Public Health Brigham and Women's Hospital Medical Student | McGill University  MedicalResearch.com: What is the background for this study? Response: In 2017, the US Preventive Services Task Force updated its recommendation for PSA screening for prostate cancer from a grade D to a grade C for men aged 55 to 69 years. This updated recommendation endorsed shared decision making and harmonizes with the guidelines of the American Urological Association and the American Cancer Society which also recommend shared decision making for PSA screening. Shared decision making is a meaningful dialogue between the physician and the patient that namely includes a review of risks and expected outcomes of screening as well as the patient’s preferences and values. Understandably, the patient’s ability to critically assess the medical information provided (i.e. their health literacy) likely influences this process. We sought to characterize the effect of health literacy on shared decision making for PSA screening. We used data from 2016 when PSA screening for prostate cancer was not recommended by the US Preventive Services Task Force — in other words, we also sought to understand how health literacy impacted screening rates in the context of countervailing guidelines on PSA screening.
Author Interviews, Cancer Research, JAMA, Prostate Cancer, Technology / 13.11.2020

MedicalResearch.com Interview with: [caption id="attachment_55940" align="alignleft" width="200"]Dave Steiner MD PhD Clinical Research Scientist Google Health, Palo Alto, California Dr. Steiner[/caption] Dave Steiner MD PhD Clinical Research Scientist Google Health, Palo Alto, California MedicalResearch.com: What is the background for this study? Response: For prostate cancer patients, the grading of cancer in prostate biopsies by pathologists is central to risk stratification and treatment decisions. However, the grading process can be subjective, often resulting in variability among pathologists. This variability can complicate diagnostic and treatment decisions. As an initial step towards addressing this problem, we and others in the field have recently developed artificial intelligence (AI) algorithms that perform on-par with expert pathologists for prostate cancer grading. Such algorithms have the potential to improve the quality and efficiency of prostate biopsy grading, but the impact of these algorithms when used by pathologists has not been well studied. In the current study, we developed and evaluated an AI-based assistant tool for use by pathologists while reviewing prostate biopsies.
Author Interviews, Cancer Research, Prostate Cancer / 01.10.2020

[caption id="attachment_55541" align="alignleft" width="160"]Dr. Maha Hussain Dr. Hussain[/caption] MedicalResearch.com Interview with: Maha Hussain, MD, FACP, FASCO Genevieve Teuton Professor of MedicineDivision of Hem/Onc Deputy Director Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine MedicalResearch.com: What is the background for this study? Response: PROfound is an open-label international Phase III clinical trial which evaluated the efficacy and safety of Olaparib (Lynparza) versus enzalumatide or abiraterone and prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior treatment with NHA treatments (abiraterone and prednisone or enzalutamide) and have a qualifying tumor mutation in BRCA1/2, ATM or one of the other genes involved in the HRR pathway. The trial design included 2 cohorts; Cohort A included patients with BRCA1,2 or ATM and Cohort 2 included patients with 12 other HRR genes.
Author Interviews, Prostate Cancer / 22.06.2020

MedicalResearch.com Interview with: [caption id="attachment_54632" align="alignleft" width="200"]Dr Hayley Schultz | Research Associate BPharmSci(Hons), PhD UniSA Clinical and Health Sciences University of South Australia Adelaide SA  Dr. Schultz[/caption] Dr Hayley Schultz | Research Associate BPharmSci(Hons), PhD UniSA Clinical and Health Sciences University of South Australia Adelaide SA   MedicalResearch.com: What is the background for this study? Response: Zytiga is a blockbuster medication for treating prostate cancer containing the active ingredient abiraterone acetate, however the formulation is incredibly inefficient. Patients must take 1000 mg per day and fast for 2 hours prior to and 1 hour following its administration. This is because the drug is very water insoluble and has an oral bioavailability of less than 10%. This means only up to 10% of the dose is absorbed from the intestine and enters systemic circulation where it can have a therapeutic effect. The rest of the drug, at least 90% of the dose, moves through the gastrointestinal tract undissolved and is wasted down the toilet. Patients are required to fast when taking the medication as the drugs absorption is heavily and unpredictable increased in the presence of fatty and oily food. We developed a more efficient oral formulation for abiraterone acetate with a greater oral bioavailability, to reduce the dose of the drug and its side effects.
Author Interviews / 15.06.2020

MedicalResearch.com Interview with: [caption id="attachment_54579" align="alignleft" width="200"]Nicholas J. Vogelzang, MD, FASCO, FACP Dr. Vogelzang[/caption] Nicholas J. Vogelzang, MD, FASCO, FACP Medical Oncologist at Comprehensive Cancer Centers of Nevada Associate Chair, US Oncology Research Genitourinary Committee  MedicalResearch.com: What is the background for this study? Response: According to the American Cancer Society, prostate cancer is the second leading cause of cancer death in men in the U.S. New approaches are needed to target the androgen receptor (AR), a critical driver of metastatic castration resistant prostate cancer (mCRPC). Current agents work by decreasing androgen levels (abiraterone) or blocking androgen binding to AR (enzalutamide). Despite rapid and dramatic responses to standards of care, all patients with metastatic disease progress to the castration resistant state and their tumors continue to be dependent on the AR signaling axis.1 Study design:
  • “3 + 3” dose escalation; starting dose = 35 mg, orally, once daily with food
  • Dose increases dependent on toxicities
    • Range 25% to 100% based on severity of AEs
Inclusion criteria:
  • Men with mCRPC, regardless of AR status
  • At least two prior systemic therapies, at least one of which was abiraterone or enzalutamide
  • Disease progression on most recent therapy
    • Rising PSA or 2+ new lesions upon bone scan
Endpoints:
  • Primary:
    • Define the maximum tolerated dose and recommended phase 2 dose
  • Secondary:
    • Pharmacokinetics
    • Anti‐tumor activity (PSA50, RECIST criteria)
  • Exploratory:
    • Biomarkers
      • ctDNA mutational profiling
      • AR levels in optional paired biopsies
      • AR and AR‐ V7 levels in circulating tumor cells (CTCs) 
Author Interviews, Genetic Research, Nature, Prostate Cancer, Vanderbilt / 24.03.2020

MedicalResearch.com Interview with: [caption id="attachment_53622" align="alignleft" width="125"]Jeffrey R. Smith, MD PhD Department of Medicine, Division of Genetic Medicine Vanderbilt-Ingram Cancer Center, and Vanderbilt Genetics Institute Vanderbilt University Medical Center Medical Research Service Tennessee Valley Healthcare System, Veterans Administration Nashville, TN  Dr. Jeffrey Smith[/caption] Jeffrey R. Smith, MD PhD Department of Medicine, Division of Genetic Medicine Vanderbilt-Ingram Cancer Center, and Vanderbilt Genetics Institute Vanderbilt University Medical Center Medical Research Service Tennessee Valley Healthcare System, Veterans Administration Nashville, TN MedicalResearch.com: What is the background for this study?   Response: Roughly 20% of men with prostate cancer have a family history of the disease, and 5% meet criteria for hereditary prostate cancer. Although prostate cancer has the greatest heritability of all common cancers (twice that of breast cancer), extensive heterogeneity of its inherited causes has presented a considerable obstacle for traditional pedigree-based genetic investigative approaches. Inherited causes across, as well as within families are diverse. This study introduced a new familial case-control study design that uses extent of family history as a proxy for genetic burden. It compared a large number of men with prostate cancer, each from a separate family with a strong history of the disease, to screened men with no personal or family history. The study comprehensively deconstructs how the 8q24 chromosomal region impacts risk of hereditary prostate cancer, introducing several new analytical approaches. The locus had been known to alter risk of prostate, breast, colon, ovarian, and numerous additional cancers.
Author Interviews, Nutrition, Supplements, UCSD / 14.01.2020

MedicalResearch.com Interview with: [caption id="attachment_52764" align="alignleft" width="160"]Kellogg Parsons, MD, MHS Professor of Urology Moores UC San Diego Comprehensive Cancer Center Dr. Parsons[/caption] Kellogg Parsons, MD, MHS Professor of Urology Moores UC San Diego Comprehensive Cancer Center MedicalResearch.com: What is the background for this study? Response: Clinical guidelines for prostate cancer, circulated widely in the public domain, endorse the consumption of diets high in micronutrient-enriched vegetables. Drawing on expert opinion, epidemiological studies, and small preclinical experiments, these recommendations propose that vegetable-enriched diets may decrease cancer progression and death among prostate cancer survivors. However, data from randomized clinical trials focused on actionable clinical endpoints has been lacking. We utilized a specific behavioral intervention, grounded in the field of social psychology, to “nudge” patients with prostate cancer toward healthier food choices. The intervention is telephone-based, like a call center: patient-focused, convenient, and simple.
Author Interviews, Biomarkers, Prostate Cancer / 02.12.2019

MedicalResearch.com Interview with: Dr Jeremy Clark University of East Anglia Norwich Medical School MedicalResearch.com: What is the background for this study? Response: Earlier this year we published our pilot study which showed how useful we have found urine to be for diagnosing prostate cancer and predicting which cancers will get bigger and nastier up to 5 years later (Connell et al 2019). – Our PUR (Prostate Urine Risk) signatures separated men with low-risk cancer into two groups one of which had 8-times the rate of future development of aggressive cancer that the other. There is nothing in clinical use at present that can do this. The new development is our At-Home Urine collection system which means that we can now send out a urine collection kit to a man at home, he fills up a small pot with his first wee of the day and posts it back to us for PUR analysis. This makes the whole system so much less stressful for the patient. The idea behind it is as follows: the prostate lays just below the bladder, it is a secretory organ and these secretions carry cells and molecules from all over the prostate to the urethra which then get flushed out of the body on urination. If a cancer is present then tiny bits of the tumour are also carried with the secretions and we can detect these in the urine. As the prostate is constantly secreting the levels of biomarkers in the urethra will build up with time. Collecting from the first wee of the day means that overnight secretions can be collected which makes the analysis more sensitive and more robust.
Author Interviews, Heart Disease, Omega-3 Fatty Acids, Prostate Cancer / 20.11.2019

MedicalResearch.com Interview with: [caption id="attachment_52211" align="alignleft" width="200"]Jeffrey L. Anderson, MD FAHA FACC MACP Distinguished Research Physician Professor of Medicine with Tenure University of Utah School of Medicine Prof. Anderson[/caption] Jeffrey L. Anderson, MD FAHA FACC MACP Distinguished Research Physician Professor of Medicine with Tenure University of Utah School of Medicine MedicalResearch.com: What is the background for this study? Response: Omega-3 supplements are widely used for cardiovascular prevention. However, a study published in the Journal of the National Cancer Institute (105:1132, 2013) reported as an incidental finding in a plasma bank study that the risk of prostate cancer increased with increasing levels of docosahexaenoic acid (DHA) and trended to increase with eicosapentaenoic acid (EPA).
Author Interviews, Cancer Research, JAMA, MRI, Prostate Cancer, UCLA / 12.09.2019

MedicalResearch.com Interview with: [caption id="attachment_51263" align="alignleft" width="150"]Rajiv Jayadevan, MD Department of Urology UCLA Dr. Jayadevan[/caption] Rajiv Jayadevan, MD and  Leonard S. Marks, MD Department of Urology UCLA MedicalResearch.com: What is the background for this study? Response: Men with low risk prostate cancer often enter “active surveillance” programs. These programs allow patients to defer definitive treatment (and avoid their associated side effects) until more aggressive disease is detected, if at all. Patients typically undergo a “confirmatory biopsy” 6 to 12 months after diagnosis to verify that their disease is low risk, and then undergo repeat biopsies every 1 to 2 years. These biopsies have traditionally been performed under the guidance of transrectal ultrasonography. Transrectal ultrasonography is unable to accurately visualize tumors within the prostate, necessitating that biopsy cores be obtained systematically from all parts of the prostate. MRI-ultrasonography fusion biopsy is a newer technology that has been shown to characterize biopsy findings more accurately than transrectal ultrasonography, leading to improved disease detection. This technology also allows us to visualize tumors within the prostate, and directly target these tumors during a biopsy session.
Author Interviews, Bayer, FDA, Prostate Cancer / 16.08.2019

MedicalResearch.com Interview with: [caption id="attachment_50898" align="alignleft" width="133"]Neal D. Shore, MD, FACS Director, CPI, Carolina Urologic Research Center Atlantic Urology Clinics Myrtle Beach, South Carolina Dr. Shore[/caption] Neal D. Shore, MD, FACS Director, CPI, Carolina Urologic Research Center Atlantic Urology Clinics Myrtle Beach, South Carolina Neal D. Shore, MD, FACS is the Medical Director for the Carolina Urologic Research Center. He practices with Atlantic Urology Clinics in Myrtle Beach, South Carolina. Dr. Shore discusses the recent announcement that the FDA has approved Nubeqa®(darolutamide),  for the treatment of patients with non-metastatic castration-resistant prostate cancer..  MedicalResearch.com: What is the background for this study? How does NUBEQA®(darolutamide) differ from other treatments for nmCRPC?  Response: In 2017, patients did not have an approved therapy for non-metastatic castration-resistant prostate cancer, or nmCRPC. If untreated, patients with this diagnosis will go on to develop metastases, or progression of the cancer throughout the body. NUBEQA® (darolutamide) became the third and most recently approved treatment for nmCRPC, demonstrating a benefit of metastasis-free survival, or MFS. NUBEQA is different due to its adverse event and safety profile reported in the Phase III ARAMIS trial. In that study, there were no significant findings of falls and fractures as well as other adverse events reported from the earlier Phase III trials. 
Author Interviews, Cancer Research, FDA, Vaccine Studies / 14.08.2019

MedicalResearch.com Interview with: [caption id="attachment_50871" align="alignleft" width="150"]Dr. Graca Dores (left) and Dr. Perez-Vilar (senior author) Dr. Graca Dores (left) and Dr. Perez-Vilar (senior author)[/caption] Dr. Graca Dores MD MPH US Food and Drug Administration Center for Biologics Evaluation and Research Office of Biostatistics and Epidemiology Division of Epidemiology Silver Spring, Maryland Oklahoma City, OK MedicalResearch.com: What is the background for this study? Would you briefly explain what Sipuleucel-T is used for?  Response: Sipuleucel-T was the first therapeutic vaccine approved by the U.S. Food and Drug Administration (FDA) in 2010.  It is indicated for the treatment of asymptomatic or minimally symptomatic, metastatic, castration-resistant prostate cancer (CRPC; prostate cancer that spreads while an individual is on hormone-blocking therapy).  During the preparation of this product, the patient’s cells are collected (leukapheresis), sent for processing to generate a dose of patient-specific vaccine, and then administered intravenously back to the patient.  This process is repeated approximately every two weeks for a total of three doses. Except for the pre-marketing clinical trials that were reviewed during the sipuleucel-T approval process, post-marketing studies that have evaluated the safety profile of sipuleucel-T are scarce. Therefore, we used the FDA’s Adverse Event Reporting System (FAERS) database to summarize the adverse events reported to FDA by industry, medical professionals, and consumers.  We also assessed whether sipuleucel-T and specific adverse events (product-event pairs) were reported more than expected compared to all other drug/biologic-adverse event pairs in the FAERS database.
Author Interviews, Cancer Research, JAMA, MRI, Prostate Cancer / 07.08.2019

MedicalResearch.com Interview with: Dr Martha Elwenspoek PhD Research Associate in Epidemiology and Health Services Research NIHR CLAHRC West, Bristol MedicalResearch.com: What is the background for this study? Response: Prostate cancer is one of the most common cancers in men. Prostate cancer is usually diagnosed by taking 10 to 14 systematic samples from the prostate guided by ultrasound. However, these biopsies are unpleasant for patients, can miss cancer even when it’s present, can misclassify the severity of the cancer, and can cause side effects, such as bleeding and infection. If biopsies could be targeted better, men wouldn’t have to undergo so many and there would be less risk of getting a misleading result. Multiparametric MRI (mpMRI) scans are sometimes used before doing a biopsy to help diagnose prostate cancer, and while this approach is now being recommended by the UK National Institute for Clinical Excellence (NICE) their use isn’t widespread.
Author Interviews, Cancer Research, Hormone Therapy, JAMA, Prostate Cancer, University of Pennsylvania / 15.07.2019

MedicalResearch.com Interview with: [caption id="attachment_50254" align="alignleft" width="180"]Ravi Jayadevappa, PhD, MS Department of Medicine Perelman School of Medicine University of Pennsylvania Philadelphia, PA 19104-2676  Dr. Jayadevappa[/caption] Ravi Jayadevappa, PhD, MS Department of Medicine Perelman School of Medicine University of Pennsylvania Philadelphia, PA 19104-2676  MedicalResearch.com: What is the background for this study? Response: In the US, prostate cancer is the most commonly diagnosed non-skin cancer and the second leading cause of cancer death among men. Research shows that hormone therapy or ADT reduces the levels of male hormones in the body, called androgens, to stop them from stimulating cancer cells to grow., and thus is effective in reducing the spread and progression of prostate cancer. At the same time, some research has suggested that decreasing androgen levels may increase the risk factors for Alzheimer’s and dementia, including loss of lean body mass, diabetes, cardiovascular disease, and depression. The ADT therapy may lead to impaired neuron growth and the regeneration of axons, thus affecting the cognitive function. Thus there is growing interest in the possible association between exposure to ADT and cognitive dysfunction. Our study investigates the association between exposure to ADT and subsequent diagnosis of Alzheimer’s or dementia in elderly, fee-for-service Medicare enrollees using SEER-Medicare linked databases.
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, Environmental Risks, Genetic Research, Prostate Cancer / 20.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49841" align="alignleft" width="130"]Emanuela Taioli, MD, PhD, Director of the Institute for Translational Epidemiology Icahn School of Medicine at Mount Sinai Asociate director for Population Science Tisch Cancer Institute Dr. Taioli[/caption] Emanuela Taioli, MD, PhD, Director of the Institute for Translational Epidemiology Icahn School of Medicine at Mount Sinai Asociate director for Population Science Tisch Cancer Institute  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: An excess incidence of prostate cancer has been identified among World Trade Center responders. We wanted to study if this excess was associated with exposure to WTC dust The results suggest that respiratory exposure to WTC dust can induce inflammatory and immune responses in prostate tissue. Chronic inflammation could facilitate prostate cancer development Taken together, our results suggest that World Trade Center prostate cancer cases have a distinct gene expression pattern that may be the result of exposure to specific carcinogens during the WTC attacks. WTC dust-exposed rat prostate displayed unique changes in gene expression and immune cell infiltrates after acute dust exposure, suggesting that the effect of exposure may be measured locally in target organs such as prostate. In addition, some of the genes overexpressed in rat normal prostates as a consequence of exposure are also overexpressed in human prostate cancer tissues, suggesting a link between exposure, local immune dysregulation, and prostate cancer development
Author Interviews, Brigham & Women's - Harvard, Prostate Cancer, Weight Research / 10.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49690" align="alignleft" width="200"]Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA Dr. Dickerman[/caption] Barbra Dickerman, PhD Research Fellow Department of Epidemiology Harvard T.H. Chan School of Public Health Boston, MA MedicalResearch.com: What is the background for this study? Response: Obesity is associated with a higher risk of advanced prostate cancer and poorer prognosis after diagnosis. However, emerging evidence suggests that the specific distribution of body fat may be an important prognostic factor for prostate cancer outcomes. In this original investigation, we analyzed body fat distribution on computed tomography imaging and the risk of being diagnosed with, and dying from, prostate cancer. This study was conducted among 1,832 Icelandic men with over a decade of follow-up in the Age, Gene/Environment Susceptibility-Reykjavik Study.
Author Interviews, Cancer Research, Prostate Cancer / 03.06.2019

[caption id="attachment_49560" align="alignleft" width="181"] Dr. Julie Graff[/caption] MedicalResearch.com Interview with: Julie N. Graff, MD Associate Professor of Medicine Knight Cancer Institute Chief of Hematology/Oncology VA Portland Health Care System MedicalResearch.com: What is the background for this study? Response: Androgen deprivation therapy is often deployed in patients with a rising PSA after local therapy (such as radical prostatectomy or radiation therapy). With time, the prostate cancer can develop resistance to ADT, at which point it is called castration resistant prostate cancer (CRPC). There were 6 treatments for metastatic CRPC that have shown improved survival. However, in non-metastatic disease, there was nothing that showed improved survival. The SPARTAN study was designed to determine if a next generation androgen receptor antagonist could delay the time to metastatic disease. Overall survival was a secondary endpoint. 
ASCO, Author Interviews, Cancer Research, J&J-Janssen, NEJM, Prostate Cancer / 01.06.2019

MedicalResearch.com Interview with: [caption id="attachment_49474" align="alignleft" width="142"]Dr. Kim Chi. MDProfessor of MedicineMedical Oncologist and Medical Director at BC Cancer – VancouverUniversity of British Columbia,Principal Investigator of the TITAN Study. Dr. Kim Chi[/caption] Dr. Kim Chi. MD Professor of Medicine Medical Oncologist and Medical Director at BC Cancer – Vancouver University of British Columbia, Principal Investigator of the TITAN Study. MedicalResearch.com: What is the background for this study? Response: For more than 70 years, androgen deprivation therapy (ADT) has been the standard of care therapy for patients with metastatic prostate cancer. The Phase 3 TITAN study looked at adding apalutamide (®®®®) to ADT compared with placebo plus ADT in a broad group of patients with metastatic castration-sensitive prostate cancer (mCSPC), regardless of disease volume or prior docetaxel treatment history. Metastatic castration-sensitive prostate cancer is prostate cancer that still responds to androgen deprivation therapy and has spread to other parts of the body. Patients with mCSPC tend to have a poor prognosis, with a median overall survival (OS) of less than five years, underscoring the need for new treatment options. The dual primary endpoints of this study were overall survival and radiographic progression-free survival (rPFS). 
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.
Annals Internal Medicine, Author Interviews, Cancer Research, Prostate Cancer / 05.03.2019

MedicalResearch.com Interview with: Charlotte Skriver, PhD student, MSc Danish Cancer Society Research Center Statistics & Pharmacoepidemiology Danish Cancer Society Copenhagen  MedicalResearch.com: What is the background for this study?   Response: The drug aspirin is widely used due to its established protection against cardiovascular diseases. Increasing evidence also supports an effect of aspirin use on reducing the risk of and mortality from colorectal cancer and possibly other cancer types. Recent studies have suggested that aspirin use after a diagnosis of prostate cancer may improve the prognosis. We examined whether use of low-dose aspirin was associated with survival after prostate cancer in a nationwide study of prostate cancer patients in Denmark.
ASCO, Author Interviews, Cancer Research, NEJM, Prostate Cancer / 25.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47619" align="alignleft" width="180"]Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy Prof. Fizazi[/caption] Prof. Karim Fizazi, MD, PhD Head of the Department of Cancer Medicine Institute Gustave Roussy MedicalResearch.com: What is the background for this study? How does darolutamide differ from other medications for prostate cancer? Response: Despite recent treatment advances, there is still significant unmet need for new therapeutic options for men with non-metastatic castration-resistant prostate cancer (nmCRPC). In laymen’s terms, nmCRPC is cancer that has not spread beyond the prostate region; PSA levels are elevated, despite treatment with hormone therapy, and men with nmCRPC generally feel well and do not have symptoms. The unmet medical need is for treatments that achieve disease control and delay the spread of the cancer without impacting their daily lives or increasing the burden of disease with treatment side effects. While the current treatments in this space are effective in delaying onset of metastases, the side effects can be unpleasant and disruptive to men’s lives; particularly cognitive issues, seizures, impact on balance which may lead to falls and bone fractures, rash and hypertension. Furthermore, new treatment options that have limited interactions with medications typically used in this patient population are also important. 
Author Interviews, Genetic Research, JAMA, Prostate Cancer / 24.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47572" align="alignleft" width="160"]Masaki Shiota MD, PhD Department of Urology, Graduate School of Medical Sciences Kyushu University Fukuoka , Japan Dr. Shiota[/caption] Masaki Shiota MD, PhD Department of Urology Graduate School of Medical Sciences Kyushu University Fukuoka , Japan MedicalResearch.com: What is the background for this study? What are the main findings? Response:  3β-hydroxysteroid dehydrogenase-1 encoded by HSD3B1 is a rate-limiting enzyme required for all pathways of dihydrotestosterone synthesis, as well as converts abiraterone into Δ4-abiraterone (D4A), which blocks multiple steroidogenic enzymes and antagonizes the androgen receptor. A mutation (1245A>C) in HSD3B1 is shown to be resistant to proteasomal degradation, causing substantial accumulation of this enzyme and gain-of-function. Although the HSD3B1 (1245C) allele can be acquired by mutation, germ-line single nucleotide polymorphism (SNP; rs1047303) is also known to exist. Then, in this study, we investigated the significance of missense polymorphism in HSD3B1 gene among men treated with primary ADT or abiraterone. The results showed men carrying variant allele showed higher risk of progression in primary androgen-deprivation therapy, but vulnerable to abiraterone treatment.
ASCO, Author Interviews, Prostate Cancer / 22.02.2019

MedicalResearch.com Interview with: Kim Nguyen Chi, MD FRCPC Professor of Medicine, University of British Columbia Regional Medical Director, BC Cancer - Vancouver MedicalResearch.com: What is the background for this study? What are the main findings? Response: For over 70 years, androgen deprivation therapy (ADT) has been the main treatment therapy for metastatic prostate cancer patients. This Phase 3 final analysis study looked at adding abiraterone acetate and prednisone to ADT for patients with metastatic prostate cancer, with the primary objectives being to assess improvements in overall survival and radiographic progression-free survival. At the first interim analysis reported in 2017, both primary endpoints were met, and the study was unblinded and patients on the ADT and placebos arm crossed over to receive ADT with abiraterone and prednisone. This study is the final analysis reporting on overall survival. The study findings found abiraterone acetate and prednisone plus ADT continued to demonstrate an improvement in overall survival, hazard ratio (HR) = 0.66, meaning a 34% decrease in the risk of death associated with the use of ADT with abiraterone and prednisone. The median overall survival, which had not been reached before in the ADT with abiraterone and prednisone arm, was 53.3 months compared to 36.5 months for ADT plus placebo, prolonging median overall survival by 16.8 months.
Author Interviews, Emory, JAMA, Prostate Cancer, Radiation Therapy / 15.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47492" align="alignleft" width="200"]Deborah Watkins Bruner RN, PhD, FAAN Senior Vice President of Research Emory University Professor and Robert W. Woodruff Chair in Nursing Nell Hodgson Woodruff School of Nursing Professor, Department of Radiation Oncology Emory University School of Medicine Dr. Bruner[/caption] Deborah Watkins Bruner RN, PhD, FAAN Senior Vice President of Research Emory University Professor and Robert W. Woodruff Chair in Nursing Nell Hodgson Woodruff School of Nursing Professor, Department of Radiation Oncology Emory University School of Medicine MedicalResearch.com: What is the background for this study? Response: In a randomized clinical trial entitled, “Quality of Life in Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy” the NRG Oncology Group previously demonstrated that men with low risk prostate cancer had  similar 5-year disease- free survival of about 85%  when treated with either conventional radiotherapy  (C-RT) of 73.8 Gy in 41 fractions over 8.2 weeks, or with  hypofractionated radiotherapy (H-RT) of 70 Gy in 28 fractions over 5.6  weeks. However, late physician reported side effects of mild bowel and bladder symptoms were increased in patients treated  with H-RT and raised questions if the H-RT arm is acceptable to patients. The current study asked the patient’s directly about their bowel, bladder, sexual function, anxiety, depression and general quality of life using valid patient reported questionnaires. These questionnaires have been found to be more accurate for reporting patient symptoms than physician report alone.
Author Interviews, JAMA, Prostate Cancer, Radiation Therapy / 12.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47468" align="alignleft" width="200"]Amar U. Kishan, MD Assistant Professor Department of Radiation Oncology University of California, Los Angeles Dr. Kishan[/caption] Amar U. Kishan, MD Assistant Professor Department of Radiation Oncology University of California, Los Angeles MedicalResearch.com: What is the background for this study? What are the main findings? Response: Typical external beam radiation courses range up to 8-9 weeks in length (39-45 treatments). There are data that shorter courses, delivering a higher dose per day, may be just as effective. Stereotactic body radiotherapy (SBRT) really pushes this concept by condensing the treatment to just four to five treatments, with a high dose per day. Here, we present the pooled results of the outcomes of 2142 men with low and intermediate risk prostate cancer and a median of 6.9 years of followup. We demonstrate a very favorable efficacy and safety profile. Specifically, the rates of recurrences were 4.5% and 10.2% for low and intermediate risk disease at 7 years, and rates of late severe toxicity were 2.4% for urinary toxicity and 0.4% for gastrointestinal toxicity.
Author Interviews, MRI, Prostate Cancer, Technology / 12.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47464" align="alignleft" width="130"]Gaurav Pandey, Ph.D. Assistant Professor Department of Genetics and Genomic Sciences Icahn Institute of Data Science and Genomic Technology Icahn School of Medicine at Mount Sinai, New York  Dr. Pandey[/caption] Gaurav Pandey, Ph.D. Assistant Professor Department of Genetics and Genomic Sciences Icahn Institute of Data Science and Genomic Technology Icahn School of Medicine at Mount Sinai, New York  MedicalResearch.com: What is the background for this study?  Response: Multiparametric magnetic resonance imaging (mpMRI) has become increasingly important for the clinical assessment of prostate cancer (PCa), most routinely through PI-RADS v2, but its interpretation is generally variable due to its relatively subjective nature. Radiomics, a methodology that can analyze a large number of features of images that are difficult to study solely by visual assessment, combined with machine learning methods have shown potential for improving the accuracy and objectivity of mpMRI-based prostate cancer assessment. However, previous studies in this direction are generally limited to a small number of classification methods, evaluation using the AUC score only, and a non-rigorous assessment of all possible combinations of radiomics and machine learning methods.
Author Interviews, Cancer Research, Prostate Cancer, Radiation Therapy / 12.02.2019

MedicalResearch.com Interview with: [caption id="attachment_47453" align="alignleft" width="132"]Graham Kelly, BSc (Vet) (Hons, BVSc (Hons), PhD Managing Director and Chief Executive Officer Noxopharm  Dr. Kelly[/caption] Graham Kelly, BSc (Vet) (Hons, BVSc (Hons), PhD Managing Director and Chief Executive Officer Noxopharm  MedicalResearch.com: What is the background for this announcement? What are the main findings? Response: Veyonda is an experimental drug being developed as a means of enhancing the anti-cancer effect of radiotherapy. The Phase 1b DARRT-1 study is assessing the ability of Veyonda to boost a palliative dose of external beam radiotherapy (EBRT) applied to a single lesion, to result in a systemic response in non-irradiated lesions (known as an abscopal response) in men with metastatic, end-stage prostate cancer. The aim is to provide at the least better palliation, and at best a survival advantage. The reported data concerns the study’s initial dose-finding arm involving three different dosages of Veyonda. This arm involves 12 subjects and the report concerns their clinical status at 12-weeks post-irradiation. The data provide clinical evidence of an abscopal effect in at least half of the eight subjects receiving the two highest Veyonda dosages and demonstrate that the combination of Veyonda and palliative radiotherapy was well-tolerated. The 1200 mg dosage was confirmed as the therapeutic dose.