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prostate cancer clinical trials

Mark T Corkum, Wei Liu, David A Palma, Glenn S Bauman, Robert E Dinniwell, Andrew Warner, Mark V Mishra, Alexander V Louie
BACKGROUND: Cancer patients frequently search the Internet for treatment options, and hospital websites are seen as reliable sources of knowledge. Guidelines support the use of proton radiotherapy in specific disease sites or on clinical trials. This study aims to evaluate direct-to-consumer advertising content and claims made by proton therapy centre (PTC) websites worldwide. METHODS: Operational PTC websites in English were identified through the Particle Therapy Co-Operative Group website...
March 15, 2018: Radiation Oncology
Jeff M Michalski, Jennifer Moughan, James Purdy, Walter Bosch, Deborah W Bruner, Jean-Paul Bahary, Harold Lau, Marie Duclos, Matthew Parliament, Gerard Morton, Daniel Hamstra, Michael Seider, Michael I Lock, Malti Patel, Hiram Gay, Eric Vigneault, Kathryn Winter, Howard Sandler
Importance: Optimizing radiation therapy techniques for localized prostate cancer can affect patient outcomes. Dose escalation improves biochemical control, but no prior trials were powered to detect overall survival (OS) differences. Objective: To determine whether radiation dose escalation to 79.2 Gy compared with 70.2 Gy would improve OS and other outcomes in prostate cancer. Design, Setting, and Participants: The NRG Oncology/RTOG 0126 randomized clinical trial randomized 1532 patients from 104 North American Radiation Therapy Oncology Group institutions March 2002 through August 2008...
March 15, 2018: JAMA Oncology
Folakemi T Odedina, R R Reams, E Kaninjing, J Nguyen, B Mochona, D E Lyon, N Askins, L S Behar-Horenstein
With the growing burden of cancer in minority populations and limited progress in eliminating cancer disparities, it has become important to develop a diverse oncology workforce in basic, clinical, and behavioral research who will address cancer disparities and increase the participation of minority populations in clinical trials. To address the lack of well-trained underrepresented minority cancer scientists in Florida, the University of Florida collaborated with Florida A&M University in 2012 to establish the Florida Prostate Cancer Research Training Opportunities for Outstanding Leaders (ReTOOL) Program...
March 15, 2018: Journal of Cancer Education: the Official Journal of the American Association for Cancer Education
Manish K Thakur, Lance Heilbrun, Kimberlee Dobson, Julie Boerner, Karri Stark, Jing Li, Daryn Smith, Elisabeth Heath, Joseph Fontana, Ulka Vaishampayan
BACKGROUND: Pasireotide (SOM230; Novartis Inc, Basel, Switzerland) is a multitargeted somatostatin receptor analogue likely to treat the neuroendocrine, and docetaxel resistant components within metastatic castrate-resistant prostate cancer (mCRPC). This phase I trial tested the combination of pasireotide, docetaxel, and prednisone in pretreated mCRPC. PATIENTS AND METHODS: Chemotherapy naive mCRPC patients received docetaxel 75 mg/m2 intravenously every 21 days and pasireotide intramuscularly every 28 days at escalating dose levels of 40, 60, and 80 mg...
February 13, 2018: Clinical Genitourinary Cancer
Paul J Keall, Emma Colvill, Ricky O'Brien, Vincent Caillet, Thomas Eade, Andrew Kneebone, George Hruby, Per R Poulsen, Benjamin Zwan, Peter B Greer, Jeremy Booth
PURPOSE: To report on the primary and secondary outcomes of a prospective clinical trial of electromagnetic-guided multileaf collimator (MLC) tracking radiation therapy for prostate cancer. METHODS AND MATERIALS: Twenty-eight men with prostate cancer were treated with electromagnetic-guided MLC tracking with volumetric modulated arc therapy. A total of 858 fractions were delivered, with the dose per fraction ranging from 2 to 13.75 Gy. The primary outcome was feasibility, with success determined if >95% of fractions were successfully delivered...
February 6, 2018: International Journal of Radiation Oncology, Biology, Physics
Ellen Wargowski, Laura E Johnson, Jens C Eickhoff, Lauren Delmastro, Mary Jane Staab, Glenn Liu, Douglas G McNeel
BACKGROUND: Prostatic acid phosphatase (PAP) is a prostate tumor antigen, and the target of the only FDA-approved anti-tumor vaccine, sipuleucel-T. We have previously reported in two clinical trials that a DNA vaccine encoding PAP (pTVG-HP) could elicit PAP-specific, Th1-biased T cells in patients with PSA-recurrent prostate cancer. In the current pilot trial we sought to evaluate whether this vaccine could augment PAP-specific immunity when used as a booster to immunization with sipuleucel-T in patients with metastatic, castration-resistant prostate cancer (mCRPC)...
March 13, 2018: Journal for Immunotherapy of Cancer
Derek S Tsang, Jennifer M Jones, Osai Samadi, Suhayb Shah, Nicholas Mitsakakis, Charles N Catton, William Jeon, Joshua To, Henriette Breunis, Shabbir M H Alibhai
PURPOSE: To evaluate the ability of a multimodal patient education initiative to improve adherence to healthy bone behaviors (HBBs) in men with prostate cancer receiving androgen deprivation therapy (ADT). METHODS: This was a pilot prospective, single-site, before-and-after clinical trial. The control arm (n = 51) received routine care. The intervention arm (n = 52) received multimodal HBB education which included a healthy bones prescription (BoneRx), focused face-to-face education with an oncology nurse or physician, and customized educational materials...
March 12, 2018: Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer
Bernadette Brown, Jane Young, David P Smith, Andrew B Kneebone, Andrew J Brooks, Sam Egger, Miranda Xhilaga, Amanda Dominello, Dianne L O'Connell, Mary Haines
BACKGROUND: This study assessed whether a theoretically conceptualised tailored intervention centred on multidisciplinary teams (MDTs) increased clinician referral behaviours in line with clinical practice guideline recommendations. METHODS: Nine hospital Sites in New South Wales (NSW), Australia with a urological MDT and involvement in a state-wide urological clinical network participated in this pragmatic stepped wedge, cluster randomised implementation trial...
March 12, 2018: Implementation Science: IS
Joo Yong Lee, Kang Su Cho
PURPOSE OF REVIEW: The use of 5-alpha reductase inhibitors (5ARIs) for the treatment of benign prostatic hyperplasia (BPH) and other diseases has been proposed and studied. However, the controversy about its benefits and harms for other diseases has persisted. In this review, we will discuss the newly identified effects of 5ARIs based on recently published studies. RECENT FINDINGS: These drugs are currently recommended in clinical guidelines for BPH. However, the reporting of adverse effects, including sexual dysfunction as well as neurologic, endocrine, and cardiovascular effects, have been controversial...
March 9, 2018: Current Opinion in Urology
Alicia K Morgans, Yu-Hui Chen, Christopher J Sweeney, David F Jarrard, Elizabeth R Plimack, Benjamin A Gartrell, Michael A Carducci, Maha Hussain, Jorge A Garcia, David Cella, Robert S DiPaola, Linda J Patrick-Miller
Purpose Chemohormonal therapy with docetaxel and androgen deprivation therapy (ADT+D) for metastatic hormone-sensitive prostate cancer improves overall survival as compared with androgen deprivation therapy (ADT) alone. We compared the quality of life (QOL) between patients with metastatic hormone-sensitive prostate cancer who were treated with ADT+D and those who were treated with ADT alone. Methods Men were randomly assigned to ADT+ D (six cycles) or to ADT alone. QOL was assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P), FACT-Taxane, Functional Assessment of Chronic Illness Therapy-Fatigue, and the Brief Pain Inventory at baseline and at 3, 6, 9, and 12 months...
March 9, 2018: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Dana E Rathkopf, Tomasz M Beer, Yohann Loriot, Celestia S Higano, Andrew J Armstrong, Cora N Sternberg, Johann S de Bono, Bertrand Tombal, Teresa Parli, Suman Bhattacharya, De Phung, Andrew Krivoshik, Howard I Scher, Michael J Morris
Importance: Drug development for metastatic castration-resistant prostate cancer has been limited by a lack of clinically relevant trial end points short of overall survival (OS). Radiographic progression-free survival (rPFS) as defined by the Prostate Cancer Clinical Trials Working Group 2 (PCWG2) is a candidate end point that represents a clinically meaningful benefit to patients. Objective: To demonstrate the robustness of the PCWG2 definition and to examine the relationship between rPFS and OS...
March 8, 2018: JAMA Oncology
Juan Guillermo Cataño, Carlos Gustavo Trujillo, Juan Ignacio Caicedo, Alejandra Bravo-Balado, Daniela Robledo, Angela Marcela Mariño-Alvarez, Adriana Pedraza, María Juliana Arcila, Mauricio Plata
OBJECTIVE: To evaluate the efficacy of lycopene intake in primary prevention of prostate cancer (PCa). METHODS: A systematic search of the literature was conducted in March 2015 and the articles published between the years 1990-2015 were reviewed. The following search terms were used: prostate cancer, prostatic neoplasm, lycopene, prevention, effectiveness and efficacy (MeSH). Publications including research in humans, written in English and whose texts were accessible were reviewed...
March 2018: Archivos Españoles de Urología
Jonathan Hayman, Ryan Phillips, Di Chen, Jamie Perin, Amol K Narang, Janson Trieu, Noura Radwan, Stephen Greco, Curtiland Deville, Todd McNutt, Daniel Y Song, Theodore L DeWeese, Phuoc T Tran
BACKGROUND: Undetectable End of Radiation PSA (EOR-PSA) has been shown to predict improved survival in prostate cancer (PCa). While validating the unfavorable intermediate-risk (UIR) and favorable intermediate-risk (FIR) stratifications among Johns Hopkins PCa patients treated with radiotherapy, we examined whether EOR-PSA could further risk stratify UIR men for survival. METHODS: A total of 302 IR patients were identified in the Johns Hopkins PCa database (178 UIR, 124 FIR)...
March 9, 2018: Prostate
Alessandro Magli, Eugenia Moretti, Annarita Tullio, Gianluca Giannarini, Fabrizio Tonetto, Mauro Urpis, Margherita Crespi, Claudio Foti, Agnese Prisco, Margherita Polsinelli, Gioacchino De Giorgi, Giulia Bravo, Paolo Scalchi, Marco Trovò
OBJECTIVE: The approach for treating high-risk prostate cancer still presents different unresolved issues. We report the safety and efficacy of a radiation therapy strategy based on the combination of moderate hypofractioned simultaneous integrated boost (SIB) and Image Guidance. MATERIALS AND METHODS: In this phase II trial of patients with high-risk prostate cancer, Image Guided SIB-IMRT plans (Simultaneous Intensity Modulated - Intensity Modulated Radiotherapy) were delivered between 2009 and 2012...
March 8, 2018: Prostate Cancer and Prostatic Diseases
Pierre Graff, Daniel Portalez, Amélie Lusque, Thomas Brun, Richard Aziza, Jonathan Khalifa, Mathieu Roumiguié, Marie-Laure Quintyn Ranty, Thomas Filleron, Jean-Marc Bachaud, Bernard Malavaud
PURPOSE: Focal therapy of prostate cancer requires precise positioning of therapeutic agents within well-characterized index tumors (ITs). We assessed the feasibility of low-dose-rate ultrafocal brachytherapy. METHODS AND MATERIALS: The present study was an institutional review board-approved European Clinical Trials Database-registered phase II protocol. Patients referred (October 2013 to August 2016) for active surveillance (prostate-specific antigen <10 ng/mL, cT1c-cT2a, Gleason score on referring biopsy specimens ≤6 (3+3), ≤3 positive biopsy cores, ≤50% of cancer) were preselected...
February 2, 2018: International Journal of Radiation Oncology, Biology, Physics
Keith E Steele, Tze Heng Tan, René Korn, Karma Dacosta, Charles Brown, Michael Kuziora, Johannes Zimmermann, Brian Laffin, Moritz Widmaier, Lorenz Rognoni, Ruben Cardenes, Katrin Schneider, Anmarie Boutrin, Philip Martin, Jiping Zha, Tobias Wiestler
BACKGROUND: Immuno-oncology and cancer immunotherapies are areas of intense research. The numbers and locations of CD8+ tumor-infiltrating lymphocytes (TILs) are important measures of the immune response to cancer with prognostic, pharmacodynamic, and predictive potential. We describe the development, validation, and application of advanced image analysis methods to characterize multiple immunohistochemistry-derived CD8 parameters in clinical and nonclinical tumor tissues. METHODS: Commercial resection tumors from nine cancer types, and paired screening/on-drug biopsies of non-small-cell lung carcinoma (NSCLC) patients enrolled in a phase 1/2 clinical trial investigating the PD-L1 antibody therapy durvalumab (NCT01693562), were immunostained for CD8...
March 6, 2018: Journal for Immunotherapy of Cancer
Richard M Martin, Jenny L Donovan, Emma L Turner, Chris Metcalfe, Grace J Young, Eleanor I Walsh, J Athene Lane, Sian Noble, Steven E Oliver, Simon Evans, Jonathan A C Sterne, Peter Holding, Yoav Ben-Shlomo, Peter Brindle, Naomi J Williams, Elizabeth M Hill, Siaw Yein Ng, Jessica Toole, Marta K Tazewell, Laura J Hughes, Charlotte F Davies, Joanna C Thorn, Elizabeth Down, George Davey Smith, David E Neal, Freddie C Hamdy
Importance: Prostate cancer screening remains controversial because potential mortality or quality-of-life benefits may be outweighed by harms from overdetection and overtreatment. Objective: To evaluate the effect of a single prostate-specific antigen (PSA) screening intervention and standardized diagnostic pathway on prostate cancer-specific mortality. Design, Setting, and Participants: The Cluster Randomized Trial of PSA Testing for Prostate Cancer (CAP) included 419 582 men aged 50 to 69 years and was conducted at 573 primary care practices across the United Kingdom...
March 6, 2018: JAMA: the Journal of the American Medical Association
Carsten Nieder, Ellinor Haukland, Adam Pawinski, Jan Norum
Recent research suggests that prostate-specific antigen (PSA) ≤ 0.2 ng/dl at 7 months is prognostic for better survival with androgen deprivation therapy for metastatic hormone-sensitive prostate cancer regardless of chemotherapy with docetaxel. These results were derived from a group of clinical trial participants. Therefore, we performed a confirmatory analysis in patients treated outside of trials. Furthermore, we limited inclusion to those who presented with metastases at the initial diagnosis of prostate cancer (synchronous metastases)...
March 5, 2018: Medical Oncology
August Kapogiannis, Sofia Tsoli, George Chrousos
BACKGROUND: Previous systematic reviews indicate that progressive muscle relaxation (PMR) and guided imagery (GI) are both effective interventions to decrease the psychological impact and to alleviate the adverse events in cancer patients undergoing chemotherapy treatment. To date, no review studies have investigated the effectiveness of a combination of PMR and GI. AIM: To systematically review the current state of knowledge regarding the effects of the PMR-GI combination on cancer patients receiving chemotherapy...
December 21, 2017: Explore: the Journal of Science and Healing
Yohann Foucher, Marine Lorent, Philippe Tessier, Stéphane Supiot, Véronique Sébille, Etienne Dantan
BACKGROUND: Patients with prostate cancer (PC) may be ready to make trade-offs between their quantity and their quality of life. For instance, elderly patients may prefer the absence of treatment if it is associated with a low-risk of disease progression, compared to treatments aiming at preventing disease progression but with a substantial deterioration of their Health-Related Quality of Life (HRQoL). Therefore, it seems relevant to compare the treatments by considering both survival and HRQoL...
March 5, 2018: Health and Quality of Life Outcomes
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