Author Interviews, Brigham & Women's - Harvard, JAMA, Prostate Cancer, Radiation Therapy, Surgical Research / 16.11.2018

MedicalResearch.com Interview with: Anthony Victor D'Amico, MD, PhD Professor and Chief, Genitourinary Radiation Oncology Harvard Medical School MedicalResearch.com: What is the background for this study? Response: This study investigated whether surgery followed by the use of adjuvant low dose radiation and short course hormonal therapy as compared to high dose radiation and hormonal therapy could provide an equivalent low risk of death from prostate cancer amongst men presenting with aggressive and not infrequently fatal Gleason score 9 or 10 prostate cancer. It has been shown previously (https://jamanetwork.com/journals/jama/fullarticle/2673969) and validated in the current study that surgery alone in such cases leads to a more then 2.5-fold increase in the risk of death from prostate cancer as compared to high dose radiation and hormonal therapy.  (more…)
Author Interviews, Biomarkers, Endocrinology, Prostate Cancer / 14.11.2018

MedicalResearch.com Interview with: Vincenza Conteduca, MD, PhD Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Srl - IRCCS Meldola , Italy MedicalResearch.com: What is the background for this study? What are the main findings? Response: In our previous publications, we showed that the study of plasma cell-free DNA holds promise for improving treatment choice in metastatic castration-resistant prostate cancer (mCRPC). Specifically, we demonstrated that the detection in plasma of aberrations (copy number alterations and/or point somatic mutations) of androgen receptor (AR), using an easy and robust multiplex droplet digital PCR method, predicted an adverse outcome in mCRPC patients treated with second-generation AR-directed therapies (abiraterone or enzalutamide) in both settings: chemotherapy-naïve and post-docetaxel. This current multi-institution work builds on our previous discoveries. We investigated the association of androgen receptor status and survival in men treated with docetaxel. Moreover, we performed an exploratory analysis in patients treated with docetaxel or AR-directed therapies as first-line therapy. Interestingly, we observed that plasma AR-gained patients do not have a worse outcome compared to AR-normal patients when treated with docetaxel as first-line therapy. This introduces the opportunity to use plasma to select for docetaxel in preference to androgen receptor-directed therapies in AR gained mCRPC patients. (more…)
Author Interviews, Biomarkers, Cancer Research, Prostate Cancer / 28.10.2018

MedicalResearch.com Interview with: Davide Pellacani Ph.D. Postdoctoral Fellow, Eaves' Lab Terry Fox Laboratory, BC Cancer Research Centre Vancouver, BC MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prostate cancer is characterized by frequent DNA methylation changes compared to normal tissue. Nevertheless, understanding which of those changes lead to the acquisition of malignant proprieties is complicated by the predominance of cells with luminal features in prostate cancers. In this study we generated DNA methylation maps of two distinct cell populations found within prostate cancer samples (called basal and luminal) and their normal counterparts. These datasets clearly showed that many of the common DNA methylation changes found in prostate cancer are present in luminal cells from both cancer and normal tissues. These changes are not necessarily cancer-specific, and are likely due to the bias associated with analyzing tissues in bulk, where most cancer cells have luminal-like features. We used these datasets to derive two cancer-specific and phenotype-independent DNA methylation signatures: one specific to prostate cancer luminal cells, and one composed of changes measured in both luminal and basal cancer cells. We then validated the potential clinical utility of these signatures by testing their ability to distinguish prostate cancer from normal samples, and tumours that have already escaped the prostate from those that have not, using the publicly available dataset from The Cancer Genome Atlas. (more…)
Author Interviews, Endocrinology, JAMA, Prostate Cancer, UCLA / 22.09.2018

MedicalResearch.com Interview with: 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: Three large randomized trials demonstrated an overall survival (OS) benefit when androgen deprivation therapy (ADT) is combined with radiotherapy (RT) for high-risk prostate cancer (PCa). The duration of ADT in these seminal studies ranged from six months to lifelong. Because ADT has multiple attendant adverse effects--including bone loss, altered metabolism, diminished muscle mass, gynecomastia, hot flashes, and possibly increased cardiovascular events--shortening the duration of ADT without compromising oncologic effectiveness has been an area of active study. Five trials have compared various durations of ADT, reaching conflicting conclusions with respect to overall survival outcomes, with some suggesting an improvement with longer durations of ADT and others failing to show a uniform survival benefit. Most of these trials have amalgamated Gleason grade group 4 (Gleason score 8) PCa with Gleason grade group (GG) 5 (Gleason score 9-10) PCa. Emerging data indicate that GS 9-10 PCa constitutes a distinct subset of high-risk PCa with inferior outcomes and earlier progression than GS 8 disease. With the knowledge that GS 9-10 PCas constitute a distinct, more aggressive form of PCa, one might hypothesize that longer durations of ADT may be more advantageous in both augmenting local control and controlling potential micrometastatic disease. Alternatively, as GS 9-10 lesions by definition contain highly de-differentiated Gleason pattern 5 disease foci and may proceed to a castrate-resistant state more rapidly, one may also hypothesize that GS 9-10 lesions are less responsive to ADT, and longer durations may be counter-productive. In order to identify differences in the impact of ADT duration on clinical outcomes of patients with GG 4 and GG 5 PCa, we performed an individual patient-level meta-analysis of six randomized trials. Our working hypothesis was that longer durations of ADT would offer significant survival benefits in both groups. (more…)
Alcohol, Author Interviews, Prostate Cancer / 23.08.2018

MedicalResearch.com Interview with: Emma H. Allott, PhD Research Assistant Professor of Nutrition UNC GILLINGS SCHOOL OF GLOBAL PUBLIC HEALTH University of North Carolina, Chapel Hill  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prostate cancer development may span decades. In addition, the prostate grows rapidly during puberty and therefore may be particularly susceptible to dietary or lifestyle factors during this time. Our study found that heavier alcohol intake earlier in life, as well as higher cumulative alcohol intake across the lifespan, was associated with an increased odds of being diagnosed with an aggressive (clinically significant) prostate cancer in later life. However, current alcohol intake at the time of prostate cancer diagnosis was unrelated to tumor aggressiveness. (more…)
Author Interviews, Cost of Health Care, JAMA, Medicare, NYU, Prostate Cancer / 22.08.2018

MedicalResearch.com Interview with: Danil V. Makarov, MD, MHS Department of Urology and Department of Population Health New York University Langone School of Medicine VA New York Harbor Healthcare System, Robert F. Wagner Graduate School of Public Service Cancer Institute, New York University School of Medicine, New York MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Reducing prostate cancer staging imaging for men with low-risk disease is an important national priority to improve widespread guideline-concordant practice, as determined by the National Comprehensive Cancer Network guidelines. It appears that prostate cancer imaging rates vary by several factors, including health care setting. Within Veterans Health Administration (VHA), physicians receive no financial incentive to provide more services. Outside VHA, the fee-for-service model used in Medicare may encourage provision of more healthcare services due to direct physician reimbursement. In our study, we compared these health systems by investigating the association between prostate cancer imaging rates and a VA vs fee-for-service health care setting. We used novel methods to directly compare Veterans, Medicare Recipients, and Veterans that chose to receive care from both the VA at private facilities using Medicare insurance through the Choice Act with regard to rates of guideline-discordant imaging for prostate cancer. We found that Medicare beneficiaries were significantly more likely to receive guideline-discordant prostate cancer imaging than men treated only in VA. Moreover, we found that men with low-risk prostate cancer patients in the VA-only group had the lowest likelihood of guideline-discordant imaging, those in the VA and Medicare group had the next highest likelihood of guideline-discordant imaging (in the middle), and those in the Medicare-only group had the highest likelihood of guideline-discordant imaging.  (more…)
Author Interviews, Cancer Research, JAMA, Prostate Cancer / 26.07.2018

MedicalResearch.com Interview with: Alison L. Allan, PhD Department of Oncology, Western University London Regional Cancer Program, London Health Sciences Centre London, Ontario, Canada  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: This was an international collaborative study between Lawson Health Research Institute (London, ON), Memorial Sloan Kettering Cancer Center (New York), the Royal Marsden (London, UK) and molecular diagnostics company Epic Sciences (San Diego, CA). The study used a liquid biopsy test developed by Epic Sciences that examines circulating tumour cells (CTCs) in blood samples from patients with advanced prostate cancer who are deciding whether to switch from hormone-targeting therapy to chemotherapy. CTCs are cancer cells that leave a tumour, enter the blood stream and invade other parts of the body, causing the spread of cancer. The test identifies whether or not a patient’s CTCs contain a protein in the nucleus called AR-V7. The research team set out to determine whether the presence of this protein predicted which treatment would best prolong a patient’s life. They found that patients who tested positive for the protein responded best to taxane-based chemotherapy while those who tested negative for the protein responded best to hormone-targeting therapy with drugs called androgen-receptor signaling (ARS) inhibitors. These are the two most widely used drug classes to treat advanced prostate cancer. (more…)
Author Interviews, Biomarkers, Cancer Research, Genetic Research, Prostate Cancer / 23.07.2018

MedicalResearch.com Interview with: Gong-Hong Wei, PhD Professor, Academy Research Fellow Faculty of Biochemistry and Molecular Medicine, Biocenter Oulu University of Oulu, Finland MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prostate cancer is the second most common cancer and the fifth leading cause of cancer-related death in men, with more than 1,100,000 new cases diagnosed and 300,000 deaths yearly around the globe. Among the risk factors for prostate cancer development, the genetic heritability of prostate cancer has been reported near 60%. Over the past decade, genome-wide association studies have identified more than 150 independent single nucleotide polymorphisms (SNPs) associated with prostate cancer risk. However, we know very little mechanisms accounting for these associations. SNP rs11672691 at the chromosome 19q13 locus has been found not only associated with prostate cancer risk but also aggressiveness, a form of prostate cancer often with worse prognosis and eventually progression to incurable stage. However, how this genomic variant accounts for prostate cancer severity remains totally unknown. Here we found the association of rs11672691 with additional clinical features of aggressive prostate cancer in an independent cohort of patients with prostate cancer, and discovered a rs11672691-mediated gene regulatory network including several novel genes, HOXA2, CEACAM21 and PCAT19, likely causing prostate cancer progression to incurable stage. In particular, the risk G (guanine) allele of rs11672691 was associated with higher RNA levels of PCAT19 and CEACAM21, and poor prognosis in prostate cancer patients. Rs11672691 G allele enhances chromatin binding of HOXA2 to regulate the expression of CEACAM21 and PCAT19. Using the CRISPR-Cas9 genome editing method, we revealed that rs11672691 genotype directly influence HOXA2 in regulating PCAT19 and CEACAM21 expression, and prostate cancer cellular phenotype. (more…)
Author Interviews, Prostate, Prostate Cancer, Urology / 06.07.2018

MedicalResearch.com Interview with: 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.  (more…)
Author Interviews, Cancer Research, Genetic Research, Nature, Prostate Cancer / 13.06.2018

MedicalResearch.com Interview with: Fredrick R. Schumacher, PhD, MPH. Associate Professor, Department of Population & Quantitative Health Sciences Case Western Reserve University Cleveland MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Our study examines the genetic underpinnings of prostate cancer initiation using technology to test variants across the genome. Our study focused on men of European ancestry and included over 80,000 men with prostate cancer and 60,000 men without disease. We discovered 63 novel genetic variants associated with prostate cancer risk, which increases our knowledge of prostate cancer genetic risk factors by more than 60%. A genetic risk score created from the combination of 163 new and known prostate cancer risk variants revealed men with the highest genetic risk score are nearly seven times more likely to develop disease compared to the average man. Additionally, men with the lowest genetic risk score have a 85% risk reduction of developing prostate cancer compared to the average. Lastly, these new discoveries uncover several biological mechanisms involved in the initiation of prostate cancer. (more…)
Author Interviews, JAMA, MRI, Prostate Cancer / 11.06.2018

MedicalResearch.com Interview with: Dr. Lars Boesen MD PhD Department of Urology Herlev Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The current standard of care in prostate cancer diagnosis includes untargeted transrectal ultrasound-guided biopsies for all biopsy-naïve men with clinically suspicion of prostate cancer. However, this strategy that practically has remained unchanged for decades has limited diagnostic accuracy as significant cancers are missed or under-graded and insignificant cancers are unintendedly detected by the random sampling leading to possible overtreatment. Multiparametric MRI in the diagnosis of prostate cancer has been studied extensively in recent years and has improved detection, localization, staging and risk stratification. It has been suggested that if multiparametric MRIs were used as a triage test prior to biopsies, a significant proportion of men might safely avoid prostate biopsies and the diagnostic ratio of significant vs. insignificant cancer could be improved compared to performing standard biopsies in all men. However, multiparametric MRIs are generally time-consuming (~40 min scan time), expensive and include intravenous contrast media. This reduces its feasibility for widespread clinical implementation in larger patient populations in the western community with its high PCa prevalence. The development of a simpler and faster (~15 min) biparametric MRI protocol using less scan sequences and circumvents intravenous contrast-media seems to preserve adequate diagnostic accuracy in a detection setting and could facilitate dissemination of prostate MRI as a triage test before any biopsy. Here we present a large prospective study that assesses the diagnostic accuracy of a novel biparametric MRI to rule out significant prostate cancer in N=1020 biopsy-naive men with clinically suspicion of prostate cancer. We found that a low suspicion biparametric MRI had a very high negative predictive value (97%) for ruling out significant cancer on confirmatory biopsies. Furthermore, bpMRI suspicion scores were strongly associated with prostate cancer detection rates and restricting biopsies (targeted plus standard) to men with suspicious biparametric MRIs meant 30% could avoid prostate biopsies, improved significant prostate cancer diagnosis by 11%, and reduced insignificant prostate cancer diagnosis by 40% compared to our current diagnostic approach – standard biopsies for all men with clinically suspicion of prostate cancer.  (more…)
Author Interviews, Biomarkers, Prostate Cancer / 03.06.2018

MedicalResearch.com Interview with: James T. Kearns, MD Clinical Fellow, Department of Urology University of Washington School of Medicine Seattle, WA MedicalResearch.com: What is the background for this study? What are the main findings? Response: The effects of the USPSTF recommendation against prostate cancer screening had not been fully characterized among a younger population, particularly with respect to downstream effects such as prostate biopsy, prostate cancer diagnosis, and treatment for prostate cancer. We found that PSA testing decreased in the years surrounding the USPSTF recommendation, but we also found a larger proportionate decrease in prostate biopsy, prostate cancer diagnosis, and use of surgery or radiation for the treatment of prostate cancer. (more…)
Author Interviews, Prostate, Prostate Cancer, Urology / 31.05.2018

MedicalResearch.com Interview with: 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.. (more…)
Author Interviews, JAMA / 30.05.2018

MedicalResearch.com Interview with: “Stop smoking!” by Emil_95 is licensed under CC BY 2.0Shahrokh F. Shariat, M.D. Professor and Chairman Department of Urology, Comprehensive Cancer Center Medical University Vienna Adjunct Professor of Urology and Medical Oncology Weill Medical College of Cornell University, New York, NY, USA Adjunct Professor of Urology UT Southwestern, Dallas, TX MedicalResearch.com: What is the background for this study? What are the main findings? Response: We know that tobacco smoking produces more than 70 carcinogens and is associated with worse prognosis in many solid cancers. Although the association between cigarette smoking and prostate cancer death has been demonstrated, such association regarding other end points is still unclear. We evaluated different disease endpoints, such as recurrence, occurrence of metastasis and cancer-specific mortality at an earlier stage of disease. We found that smokers who underwent primary treatment for localized prostate cancer - such as radical prostatectomy and radiotherapy - are at increased risk of recurrence, metastasis and cancer-specific mortality.  (more…)
Author Interviews, J&J-Janssen, Prostate, Prostate Cancer, Urology / 30.05.2018

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, JAMA, Medical Imaging, Prostate Cancer, Technology / 17.05.2018

MedicalResearch.com Interview with: Andrew J. Armstrong, MD ScM FACP Associate Professor of Medicine, Surgery, Pharmacology and Cancer Biology Associate Director for Clinical Research in Genitourinary Oncology Duke Cancer Institute Divisions of Medical Oncology and Urology Duke University MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Men with prostate cancer commonly develop bone metastases and undergo nuclear medicine bone scans. However, these scans are non-quantitative, and disease burden has been challenging to assess over time and to relate to clinical outcomes. We developed a software program and measurement called the automated bone scan index that essentially reads a standard of care nuclear bone scan, provides a quantitative metric, and demonstrate in a phase 3 trial that this aBSI is highly associated with clinical outcomes including survival, time to symptomatic progression, and prostate cancer specific survival. We accomplished this within a prospective phase 3 international trial of men with metastatic hormone resistant prostate cancer who were followed over a long period of time.  All bone scans were read and measured using the aBSI at baseline, and we found that the aBSI was highly prognostic.  This work validates prior smaller phase 2 BSI studies, and demonstrates both the feasibility and clinical utility for incorporating the aBSI into clinical practice to provide this important prognostic information to patients and providers. (more…)
Author Interviews, JAMA, Prostate Cancer / 11.05.2018

MedicalResearch.com Interview with: Alex Krist, M.D., M.P.H Professor of family medicine and population health Virginia Commonwealth University and Active clinician and teacher at the Fairfax Family Practice residency MedicalResearch.com: What is the background for this study? What are the main findings? Response: Prostate cancer is one of the most common cancers to affect men. However, the decision about whether to be screened is complex and personal. The U.S. Preventive Services Task Force reviewed the latest research on the benefits and harms of screening for prostate cancer using PSA-based testing, as well as evidence on treatment. We found that men who are 55 to 69 years old should discuss the benefits and harms of screening with their doctor, so they can make the best choice for themselves based on their values and individual circumstances. Men age 70 and older should not be screened, as the benefits of screening diminish as men age and the harms are greater. (more…)
Author Interviews, Cancer Research, MRI, Prostate Cancer / 21.03.2018

MedicalResearch.com Interview with: Veeru Kasivisvanathan MBBS BSc MRCS MSc PGCert Lead for CPD, Division of Surgery and Interventional Science, UCL Academic Section Committee, British Association of Urological Surgeons Twitter: @veerukasi PRECISION Study Coordinator https://clinicaltrials.gov/ct2/show/NCT02380027   MedicalResearch.com: What is the background for this study? What are the main findings? 
  • We knew that there were limitations in the standard of care pathway for the diagnosis of prostate cancer, TRUS biopsy which missed harmful cancers and over diagnosed harmless cancers.
  • Emerging reports in the literature showed that using an alternative diagnostic pathway, MRI and MRI-targeted biopsy, showed promising prostate cancer detection rates
  • In 2012 we set out in an international working group to design a study that could change clinical practice and replace the standard of care with a pathway involving MRI 
(more…)
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.  (more…)
Author Interviews, Primary Care, Prostate Cancer / 14.03.2018

MedicalResearch.com Interview with: Dr. Jason Profetto, MD, CCFP Family and Academic Medicine Chair, Clinical Skills Undergraduate Medical Education McMaster University MedicalResearch.com: What is the background for this study?  Response: The main reason that prompted me to investigate the issue of digital rectal exams in primary care for prostate screening was that it appeared to be rather dogmatic practice (continually practiced by many despite updated data suggesting a lack of benefit).  I was very curious to see if there was any data that suggested the digital rectal exams was indeed a useful indicator in primary practice (ie. Family Medicine) in detecting prostate cancer in asymptomatic men.  Intuitively, I didn’t believe the DRE was accurate mainly because in medical school it’s generally under-represented in clinical skills teaching and poorly taught and assessed (not just in Ontario, but also Canada).  As a result, it seemed bizarre to me that this specific clinical skills was being used as a routine measure in family medicine to screen for prostate cancer.  Also, for me this was a big issue as many men in my practice were used to having yearly “rectal exams” done and I thought it was time to really take a closer look at the research to see whether or not we can support this practice. MedicalResearch.com: What are the main findings? Response: The main findings suggest that the digital rectal exam is not helpful/accurate in detecting prostate cancer in asymptomatic men in family practice or primary care. (more…)
Author Interviews, JAMA, Prostate Cancer / 10.03.2018

MedicalResearch.com Interview with: Amar U. Kishan, MD Assistant Professor Department of Radiation Oncology University of California, Los Angeles MedicalResearch.com: What is the background for this study? Response: Patients with high risk prostate cancer have several curative treatment options: radical prostatectomy, external beam radiotherapy with androgen deprivation therapy, and external beam radiotherapy with a brachytherapy boost, also with androgen deprivation therapy (so-called extremely dose-escalated radiotherapy). Prior attempts at comparing long-term clinical outcomes between these treatment options have been hampered by the fact that standards of care have changed significantly with respect to the appropriate dose of radiation and the usage of androgen deprivation therapy. Therefore, many comparative effectiveness reports are in essence comparing apples with rotten oranges. Further, not all high risk prostate cancers are the same. Gleason score 9-10 disease is a particularly aggressive form of prostate cancer that is much more likely to metastasize and potentially cause death. Thankfully, this is a rarer type of prostate cancer -- but this also means that not much data are available specifically for this type of disease. Therefore, we launched a multi-institutional study of men with Gleason score 9-10 disease, including 1809 men treated across 12 institutions. All men were treated between 2000 and 2013 and therefore were more likely to have treatments that would be commensurate with modern standards.  (more…)
Author Interviews, Biomarkers, Prostate Cancer / 07.03.2018

MedicalResearch.com Interview with: Richard Martin Professor of Clinical Epidemiology Head of Section, Clinical Epidemiology & Public Health Population Health Sciences Bristol Medical School  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Screening for prostate cancer using the PSA test aims to detect prostate cancer at an early stage, before symptoms develop, when treatment can be offered that may avoid the risks of advanced cancer or may extend life. Evidence from a large European trial suggests that PSA screening at 2 to 4 yearly intervals could reduce prostate-cancer deaths by 20%. after 13 years of follow-up. However, there are problems with the accuracy of the PSA test and potential harmful consequences. In particular, using the PSA test to screen for prostate cancer results in some tested men being diagnosed with low-risk, harmless cancers that are unlikely to progress or require treatment.  This problem may be particularly exacerbated when using repeated PSA testing as a screening strategy. The CAP trial offered a one-off PSA test to men aged 50-69 years in the UK. The goal of this low-intensity, one-off PSA testing was to avoid unnecessary screening while still identifying men with high risk, aggressive cancers for whom screening and early detection can reduce morbidity and mortality. However, we found that after an average 10-years of follow-up, the PSA test still detected too many low-risk prostate cancers, while also missing cancers that did need treatment. After an average 10-years of follow-up, the group who had been screened had the same percentage of men dying from prostate cancer as those who had not been screened (0.29%).  (more…)
ASCO, Author Interviews, Biomarkers, Prostate Cancer / 20.02.2018

MedicalResearch.com Interview with: https://cellmaxlife.com/Atul Sharan Co-Founder & CEO at CellMax  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Approximately 30 million men in the United States take the Prostate-Specific Antigen (PSA) screening test. Recent studies published in the Annals of Internal Medicine have established that PSA screenings have resulted in reduced mortality from prostate cancer. However, the problem with the PSA test is that many patients will receive indeterminate results. Only one in five of patients who have taken the test will have a positive biopsy for prostate cancer, but 33 percent of these patients could suffer from biopsy related side effects, and 1 percent will require hospitalization. This study showed that the CellMax CTC blood test can predict which patients in the gray zone will need/have a positive prostate biopsy with a much lower false positive rate than current standard of care tests, potentially reducing unnecessary biopsies in this group by up to 90 percent. At the same time, the sensitivity of this test at 80 percent was comparable to the current standard of care tests, meaning this test was also accurate in ruling out biopsy in patients.  (more…)
Author Interviews, Biomarkers, CT Scanning, MRI, Prostate Cancer / 07.02.2018

MedicalResearch.com Interview with: Jeremie Calais PhD Ahmanson Translational Imaging Division UCLA Nuclear Medicine Department Los Angeles, CA 90095Jeremie Calais MD Ahmanson Translational Imaging Division UCLA Nuclear Medicine Department Los Angeles, CA 90095  MedicalResearch.com: What is the background for this study? What are the main findings? Response: The only curative treatment for recurrent prostate cancer after radical prostatectomy is salvage radiotherapy. Unfortunately, current standard imaging modalities are too insensitive to visualize the location of the recurrence until it is too late. As a result, salvage radiotherapy is directed to areas only suspected to harbor the recurrence based upon a "best guess" approach according to standard guidelines that define radiotherapy treatment volumes. PSMA PET/CT is a new imaging technique with sensitivity sufficient to detect and localize the recurrent prostate cancer early enough to potentially guide salvage radiotherapy. The first sign of prostate cancer recurrence is a rising PSA. For salvage radiotherapy to be successful, it should be initiated before the PSA rises above 1 ng/mL, and ideally, closer to 0.2 ng/mL or lower. PSMA PET/CT localizes sites of prostate cancer recurrence in up to 70% of patients with low PSA, below < 1.0. In the US it is not yet FDA approved and currently only used for research purposes. In our current study we included 270 patients with early recurrence of prostate cancer after surgery from Germany and UCLA,  we found that 20 % of the patients had at least one lesion detected by  PSMA PET/CT which was NOT covered by the standard radiation fields. Obviously, salvage radiotherapy is only curative if recurrent disease is completely encompassed by the radiotherapy fields and would have failed in these patients. (more…)
Author Interviews, JAMA, Prostate Cancer, Radiation Therapy / 27.01.2018

MedicalResearch.com Interview with: Jason Alexander Efstathiou, D., PH.D Director, Genitourinary Division Department of Radiation Oncology Clinical Co-Director, The Claire and John Bertucci Center for Genitourinary Cancers Multidisciplinary Clinic Massachusetts General Hospital MedicalResearch.com: What is the background for this study? What are the main findings?  Response: When surgery has probably failed to cure a patient, the best prospective data supports the use of postoperative radiation therapy. The debate now centers on the optimal timing of such post-prostatectomy radiation therapy; is it adjuvant (ART) for all (with adverse pathologic features) or early salvage (ESRT) for some (who experience biochemical failure)? (more…)
Author Interviews, Biomarkers, Prostate Cancer / 24.10.2017

MedicalResearch.com Interview with: Zahava Berkowitz, MSPH, MSc Statistician Division of Cancer Prevention and Control Centers for Disease Control and Prevention MedicalResearch.com: What is the background for this study? Response: The US Preventive Services Task Force 2017 draft prostate cancer screening recommendations  suggest that clinicians inform men aged 55–69 years about the potential benefits and harms of PSA-based screening for prostate cancer. The CDC conducted an analysis using the National Health Interview Surveys in 2005, 2008, 2010, 2013, and 2015 to describe trends in the receipt of routine PSA testing in the past year by age group (40–54, 55–69, ≥70 years) and by risk group. We compared routine PSA screening among higher risk men (defined as African American men or men with a family history of prostate cancer) with other men. The analysis was conducted because CDC wanted to examine how the guidelines affect men at higher risk. The 2017 guideline did not include specific guidelines for African American men who have a higher incidence of prostate cancer than white men, more likely to develop prostate cancer at a young age, more likely to have a high-risk diagnosis and die from prostate cancer. (more…)
Author Interviews, Cancer Research / 18.10.2017

MedicalResearch.com Interview with: Craig Tendler, M.D. Vice President, Late-Stage Development and Global Medical Affairs for Oncology, Hematology and Supportive Care Janssen Research & Development, LLC.  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Janssen announced the submission of a supplemental New Drug Application (sNDA) to the FDA seeking to expand the indication of ZYTIGA in combination with prednisone and androgen deprivation therapy (ADT) to include treatment of patients with high-risk metastatic hormone naïve prostate cancer (HNPC) or newly diagnosed, high-risk metastatic hormone sensitive prostate cancer (HSPC). This submission is based on the pivotal Phase 3 LATITUDE trial results presented earlier this year at the plenary session of the American Society of Clinical Oncology (ASCO) Annual Meeting, which found that in patients with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHNPC), abiraterone acetate with prednisone in combination with androgen deprivation therapy (ADT) demonstrated a significant improvement in median overall survival (OS) and in radiographic progression-free survival (rPFS). Additional data, which were presented at the 2017 European Society for Medical Oncology (ESMO) Annual Conference, demonstrated clinically meaningful and statistically significant improvements in patient reported outcomes (PRO) in patients with high-risk mHNPC who received ZYTIGA in combination with prednisone and ADT compared to placebo plus ADT alone. (more…)