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D Anderson, J Lehmann, T Ecker, S Vosgerau, V Donatz
BACKGROUND: Recent studies suggest that androgen deprivation therapy (ADT) is associated with increased cardiovascular (CV) risk for patients with hormone-sensitive prostate cancer (PCa) and pre-existing CV disease. This risk seems to be different for the gonadotropin-releasing hormone (GnRH) agonists leuprolide and goserelin and GnRH antagonists, whereas the slightly more expensive GnRH antagonist shows a beneficial risk profile. The present study assesses the cost effectiveness of degarelix compared to leuprolide for PCa patients with increased CV risk...
April 12, 2017: Der Urologe. Ausg. A
A V Govorov, A O Vasil'ev, D Yu Pushkar
Since their first clinical use in 1990 and up to the present time, the luteinizing hormone-releasing hormone (LHRH) analogues have formed the mainstay of androgen deprivation therapy of patients with hormone-sensitive prostate cancer. The transient testosterone surge inherent in this group of hormonal therapy medications might contribute to cardiovascular complications, limiting to some extent their use. Conversely, LHRH antagonists have a minimal adverse effect profile and their use in clinical practice is seen as more promising...
December 2016: Urologii︠a︡
Malcolm Mason, Pierre Richaud, Zsolt Bosnyak, Anders Malmberg, Anders Neijber
OBJECTIVE: In patients with prostate cancer (PCa), prostate enlargement may give rise to lower urinary tract symptoms (LUTS); many patients suffer from moderate-to-severe symptoms. We compare the efficacy of degarelix and goserelin plus bicalutamide in improving LUTS in PCa patients. METHODS: Data were pooled from three Phase 3, randomized clinical trials of once-monthly treatment for 12 weeks with degarelix (240/80 mg; n = 289) or goserelin (3.6 mg) plus bicalutamide (50 mg; n = 174) for initial flare protection...
May 2017: Lower Urinary Tract Symptoms
Michael Backofen, Gregoire Schwach, Wolfgang Koechling, Torsten Weiss, Achim Goepferich
The aim of this study was to investigate the interaction between the positively charged gonadotropin releasing hormone receptor antagonist degarelix and the two polyanions alginate and carboxymethyl cellulose (CMC). Light as well as transmission electron microscopy revealed that complexes formed by simple mixing of the peptide with one of the polymers had a nano-structure consisting of twisted fibers. The remarkable unique process of complex formation could be followed by isothermal titration calorimetry: We found that peptide self-aggregates dissolved upon the addition of polyanion and peptide-polymer-complexes formed thereafter with the anionic polymer as a template...
March 25, 2017: European Journal of Pharmaceutical Sciences
Seiichiro Ozono, Taiji Tsukamoto, Seiji Naito, Yasuo Ohashi, Takeshi Ueda, Tsutomu Nishiyama, Hideki Maeda, Hidehito Kusuoka, Rio Akazawa, Mototsugu Ito, Hideyuki Akaza
Objective: To evaluate the efficacy and safety of degarelix 3-month depot in Japanese patients with prostate cancer. Methods: In this Phase II, open-label, parallel-group study, 155 Japanese prostate cancer patients were randomized to treatment with degarelix administered subcutaneously at a maintenance dose of 360 or 480 mg every 84 days for 12 months, after receiving an initial dose of 240 mg. The primary endpoint was the cumulative probability of serum testosterone ≤0...
February 18, 2017: Japanese Journal of Clinical Oncology
Jathin Bandari, Robert M Turner, Bruce L Jacobs, David Canes, Ali Moinzadeh, Benjamin J Davies
INTRODUCTION: The influence of financial ties to pharmaceutical companies remains controversial. We aimed to assess a potential relationship between pharmaceutical payments and prescription patterns for degarelix and denosumab. MATERIALS AND METHODS: Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File (Medicare B) data containing 2012 claims compared to OpenPayments (Sunshine Act) data for the second half of 2013. Urologists and medical oncologists who billed Medicare for degarelix or denosumab were cross referenced in both databases and payments were aggregated into a consolidated dataset...
January 2017: Urology Practice
Lesley Uttley, Sophie Whyte, Timothy Gomersall, Shijie Ren, Ruth Wong, Duncan Chambers, Paul Tappenden
As part of its Single Technology Appraisal Process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of degarelix (Ferring Pharmaceuticals) to submit evidence for the clinical and cost effectiveness of degarelix for the treatment of advanced hormone-dependent prostate cancer. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG). The ERG produced a critical review of the evidence contained within the company's submission to NICE...
December 10, 2016: PharmacoEconomics
Timo Joensuu, Greetta Joensuu, Kalevi Kairemo, Timo Kiljunen, Maigo Riener, Aili Aaltonen, Martti Ala-Opas, Aki Kangasmäki, Tuomo Alanko, Lauri Taipale, Petteri Hervonen, Anna Bützow, Irene Virgolini, Akseli Hemminki
AIM: We combined anti-androgen therapy with radiotherapy in a first-line setting for metastatic prostate cancer aiming to cause maximal cancer-cell death to delay the emergence of castration-resistant disease. MATERIALS AND METHODS: In this non-randomized retrospective series of 46 patients, the initial median prostate-specific antigen (PSA) was 98.5 μg/l (range=6.7-15,500), median Gleason score 9 and most men had at least T3N1M1 disease. All patients received luteinizing hormone releasing hormone analog or degarelix with bicalutamide...
2016: Anticancer Research
M A Hannan, N Kawate, Y Fukami, W W P N Weerakoon, E E Büllesbach, T Inaba, H Tamada
We recently reported that plasma insulin-like peptide 3 (INSL3) concentrations increased soon after endogenous and exogenous stimulations of LH in male goats and bulls. However, the effects of LH suppression on INSL3 secretion are unknown in domestic animals. Here, we examined the effects of a long-acting GnRH antagonist (degarelix acetate; 4 mg/kg) on the secretions of plasma INSL3 and testosterone in two phases, an immediate and a long-term phase in male goats (n = 6; aged, 13-16 months). During the immediate phase, blood was taken at 15-minute intervals for 8 hours on Days -5, 0, and 3...
January 15, 2017: Theriogenology
Stefano Salciccia, Alessandro Gentilucci, Susanna Cattarino, Alessandro Sciarra
On the basis of the trials available, are we ready to consider GnRH antagonists better than agonists? Is there a population of patients who may benefit from antagonists more than agonists?We specifically focused our analysis on the significance of oncological results obtained in phase III trials directly comparing Degarelix with GnRH agonists. Oncological results were evaluated only in 1 trial (CS21) with some subanalysis and they were not the primary endpoints of the study. The follow-up duration was 364 days, and therefore, the number of events (all causes deaths and prostate cancer (PC), Prostate Specific Antigen (PSA), Hazard ratio (HR)-related deaths) was very low in both groups and this aspect strongly reduces the significance of overall survival evaluation...
November 18, 2016: Urologia
Rashid K Sayyid, Andrew Evans, Karen Hersey, Ranjena Maloni, Antonio Hurtado-Coll, Girish Kulkarni, Antonio Finelli, Alexandre R Zlotta, Robert Hamilton, Martin Gleave, Neil E Fleshner
PURPOSE: Degarelix, a new gonadotropin-releasing hormone (GnRH) receptor antagonist with demonstrated efficacy as first-line treatment in the management of high-risk prostate cancer, possesses some theoretical advantages over luteinizing hormone-releasing hormone (LHRH) analogues in terms of avoiding "testosterone flare" and lower follicle-stimulating hormone (FSH) levels. We set out to determine whether preoperative degarelix influenced surrogates of disease control in a randomized phase II study...
October 18, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Kenta Miki, Hiroshi Sasaki, Masahito Kido, Hiroyuki Takahashi, Manabu Aoki, Shin Egawa
BACKGROUND: Neoadjuvant androgen deprivation therapy (ADT) has been suggested to confer several clinical benefits in patients with prostate cancer (PCa) undergoing transperineal prostate brachytherapy (TPPB). Unlike gonadotropin-releasing hormone (GnRH) receptor agonists, a GnRH antagonist such as degarelix can achieve castrate levels of testosterone without testosterone flare. However, normalization of serum testosterone levels following completion of neoadjuvant ADT in either form of treatment has never been compared in clinical trials...
September 1, 2016: BMC Cancer
Jun Furumido, Takashige Abe, Hiroshi Kikuchi, Naoto Miyajima, Kunihiko Tsuchiya, Satoru Maruyama, Nobuo Shinohara
A 79-year-old male was referred to the Department of Gastroenterology in our hospital due to a large palpable abdominal mass, with the suspicion of a gastrointestinal stromal tumor. An abdominal computed tomographic (CT) scan revealed a huge mass of 270×208×144 mm which occupied the entire pelvic cavity. Since the specimens obtained by an endoscopic ultrasound-guided fine-needle aspiration via lower intestinal tract revealed a Gleason score 4+4 prostate adenocarcinoma, he was then referred to our department...
July 2016: Hinyokika Kiyo. Acta Urologica Japonica
Basetti Madhu, Greg L Shaw, Anne Y Warren, David E Neal, John R Griffiths
INTRODUCTION: The androgen receptor (AR) is the master regulator of prostate cancer cell metabolism. Degarelix is a novel gonadotrophin-releasing hormone blocker, used to decrease serum androgen levels in order to treat advanced human prostate cancer. Little is known of the rapid metabolic response of the human prostate cancer tissue samples to the decreased androgen levels. OBJECTIVES: To investigate the metabolic responses in benign and cancerous tissue samples from patients after treatment with Degarelix by using HRMAS (1)H NMR spectroscopy...
2016: Metabolomics: Official Journal of the Metabolomic Society
Alessandro Sciarra, Andrea Fasulo, Antonio Ciardi, Elisa Petrangeli, Alessandro Gentilucci, Martina Maggi, Michele Innocenzi, Federico Pierella, Vincenzo Gentile, Stefano Salciccia, Susanna Cattarino
Our aim was to systematically evaluate the benefits of degarelix as antagonist versus agonists of gonadotropin-releasing hormones (GnRH) for the treatment of advanced prostate cancer (PC). This comparison was performed either in terms of biochemical or oncological or safety profiles. To this end we, carried out a systematic review and meta-analysis of the literature.We selected only studies directly and prospectively analyzing the two treatments in the same population (randomized phase III studies). We followed the Preferred Reporting Items for Systematic Reviews and meta-analyses process for reporting studies...
July 2016: Medicine (Baltimore)
Seyed Alireza Hosseini, Fatemeh Rajabi, Ali Akbari Sari, Mohsen Ayati, Saeed Heidari, Fawzieh Ghamary
BACKGROUND: Hormone therapy is currently the mainstay in the management of locally advanced and metastatic prostate cancer. We performed a systematic review to compare safety, efficacy and effectiveness of degarelix, a new gonadotropin-releasing hormone (GnRH) antagonist (blocker), versus gonadotropin-releasing hormone (GnRH) agonists. METHODS: MEDLINE, Web of Science and the Cochrane library were searched to identify all of the published Randomized Controlled Trials (RCTs) that used degarelix versus gonadotropin-releasing hormone agonists with or without anti-androgen therapy for the treatment of prostate cancer...
2016: Medical Journal of the Islamic Republic of Iran
Fernando P Secin
INTRODUCTION: Luteinizing hormone releasing hormone (LhRh) antagonist degarelix has been approved by the Food and Drug Administration (FDA) for the treatment of advanced prostate cancer in 2008. However, the studies that followed such initial approval have several limitations. OBJECTIVE: To make a critical review of those publications. METHODS: Literature search on degarelix. RESULTS: The studies supporting the use of degarelix are criticized on the basis of selection bias in regards to the heterogeneous populations described, ad hoc analyses with low statistical merit, and the presentation of selected data that would appear to be favorable to the evaluated medication...
October 2016: Urologic Oncology
Junichi Hori, Naoki Wada, Gaku Tamaki, Makoto Azumi, Masafumi Kita, Tatsuya Iwata, Seiji Matsumoto, Hidehiro Kakizaki
OBJECTIVES: To investigate the efficacy of combination treatment of degarelix and antiandrogen in patients with prostate cancer. METHODS: We prospectively investigated the efficacy of combination treatment of degarelix and antiandrogen in 12 patients with treatment-naive prostate cancer. We surveyed PSA, LH, FSH and testosterone at day 3, 7, 14 and 28 during the initial month and thereafter once a month for 1 year. In cases with bone metastasis, we analyzed serum bone markers such as alkaline phosphatase(ALP), bone-type ALP and carboxyterminal telopeptide of type- I collagen once a month...
June 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
H Taniguchi, T Katano, K Nishida, H Kinoshita, T Matsuda, S Ito
Androgen deprivation therapy (ADT) is the standard medical approach to the management of prostate cancer. Patients switched from a GnRH antagonist to a GnRH agonist, did not experience a testosterone surge in spite of the occurrence of luteinizing hormone (LH) surge in our protocol of clinical study. To clarify this observation, male mice pre-treated with two different doses of the GnRH antagonist degarelix for 28 days were further administered the GnRH agonist leuprolide or chorionic gonadotropin, and testosterone production of the mice was studied...
September 2016: Andrology
Anki Knutsson, Sabrina Hsiung, Selvi Celik, Sara Rattik, Ingrid Yao Mattisson, Maria Wigren, Howard I Scher, Jan Nilsson, Anna Hultgårdh-Nilsson
Androgen-deprivation therapy (ADT) for prostate cancer has been associated with increased risk for development of cardiovascular events and recent pooled analyses of randomized intervention trials suggest that this primarily is the case for patients with pre-existing cardiovascular disease treated with gonadotropin-releasing hormone receptor (GnRH-R) agonists. In the present study we investigated the effects of the GnRH-R agonist leuprolide and the GnRH-R antagonist degarelix on established atherosclerotic plaques in ApoE(-/-) mice...
May 18, 2016: Scientific Reports
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