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Degarelix

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https://www.readbyqxmd.com/read/29051056/recovery-of-serum-testosterone-levels-and-sexual-function-in-patients-treated-with-short-term-luteinizing-hormone-releasing-hormone-antagonist-as-a-neoadjuvant-therapy-before-external-radiotherapy-for-intermediate-risk-prostate-cancer-preliminary-prospective
#1
Takahiro Inoue, Takashi Mizowaki, Daijiro Kabata, Ayumi Shintani, Naoki Terada, Toshinari Yamasaki, Hiromitsu Negoro, Takashi Kobayashi, Kiyonao Nakamura, Haruo Inokuchi, Osamu Ogawa
INTRODUCTION: External beam radiation therapy (EBRT) with short-term androgen deprivation therapy is the standard of care for intermediate-risk prostate cancer patients. However, no study to date has evaluated the hormonal kinetics or sexual and hormonal function recovery after cessation of short-term luteinizing hormone (LH)-releasing hormone (LHRH) antagonist treatment. PATIENTS AND METHODS: Ten intermediate-risk prostate cancer patients (mean age, 69.9 years) were included...
September 23, 2017: Clinical Genitourinary Cancer
https://www.readbyqxmd.com/read/28960413/an-efficient-synthesis-of-deuterium-labeled-degarelix-acetate-a-third-generation-gonadotropin-releasing-hormone-receptor-antagonist
#2
Yu Huang, Jingshun Chen, Baomin Liu, Hua Wang, Lu Zhang, Zhengbang Chen, Yinsheng Zhang
Degarelix acetate, a third-generation gonadotropin-releasing hormone (GnRH) receptor antagonist, shows great potential in the treatment of many androgen-related diseases. To support clinical studies of degarelix acetate, deuterium-labeled degarelix is highly desired for use as an internal standard. Using D2 O/D3 PO4 as a deuterium source, 2-amino-3-(naphthalen-2-yl)propanoic acid was converted to deuterated degarelix acetate in 13 steps and in 14% overall yield.
September 29, 2017: Journal of Labelled Compounds & Radiopharmaceuticals
https://www.readbyqxmd.com/read/28870102/therapeutic-outcomes-of-the-lhrh-antagonists
#3
REVIEW
Athanasios Dellis, Athanasios Papatsoris
Recently, LHRH antagonists have been established in the management of advanced prostate cancer, although the vast majority of Medical Oncologists and Urologists still prefer the LHRH agonists. Areas Covered: In this article we assess the therapeutic outcomes and the safety of the LHRH antagonists (mainly degarelix) compared to the LHRH agonists. Expert Commentary: Relevant studies demonstrated that LHRH antagonists are at least non-inferior to the LHRH agonists regarding therapeutic efficacy and safety, while there is potential benefit over the LHRH agonists in terms of cardiovascular morbidity and disease control...
October 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28851333/a-gonadotropin-releasing-hormone-antagonist-reduces-serum-adrenal-androgen-levels-in-prostate-cancer-patients
#4
Yoshiyuki Miyazawa, Yoshitaka Sekine, Takahiro Syuto, Masashi Nomura, Hidekazu Koike, Hiroshi Matsui, Yasuhiro Shibata, Kazuto Ito, Kazuhiro Suzuki
BACKGROUND: Adrenal androgens play an important role in the development of castration-resistant prostate cancer therapeutics. The effect of gonadotropin-releasing hormone (GnRH) antagonists on adrenal androgens has not been studied sufficiently. We measured testicular and adrenal androgen levels in patients treated with a GnRH antagonist. METHODS: This study included 47 patients with histologically proven prostate cancer. All of the patients were treated with the GnRH antagonist degarelix...
August 29, 2017: BMC Urology
https://www.readbyqxmd.com/read/28680962/switching-from-an-lhrh-antagonist-to-an-lhrh-agonist-a-case-report-of-10-finnish-patients-with-advanced-prostate-cancer
#5
Harri Visapää
INTRODUCTION: Luteinizing hormone-releasing hormone (LHRH) analogues are widely used for the treatment of advanced hormone-dependent prostate cancer. However, there are currently no clinical guidelines for switching between LHRH analogues. It has been reported that there may be clinical benefits for patients switching between different formulations of LHRH agonists, as well as from an LHRH agonist to LHRH antagonist, but there are no published data on switching from an LHRH antagonist to an LHRH agonist...
2017: Oncology and Therapy
https://www.readbyqxmd.com/read/28660498/effect-of-degarelix-a-gonadotropin-releasing-hormone-receptor-antagonist-for-the-treatment-of-prostate-cancer-on-cardiac-repolarisation-in-a-randomised-placebo-and-active-comparator-controlled-thorough-qt-qtc-trial-in-healthy-men
#6
Håkan Olsson, Niclas Petri, Lars Erichsen, Anders Malmberg, Lars Grundemar
BACKGROUND AND OBJECTIVES: Degarelix is a gonadotropin-releasing hormone antagonist registered for the treatment of advanced hormone-dependent prostate cancer. Treatment causing androgen deprivation is associated with QT prolongation and this study investigated whether degarelix at supratherapeutic concentrations has an intrinsic effect per se on cardiac repolarisation and the QT interval. METHODS: This was a single-centre, randomised, crossover study comparing the effect of degarelix, placebo, and the positive control moxifloxacin on the QT interval...
June 28, 2017: Clinical Drug Investigation
https://www.readbyqxmd.com/read/28480768/degarelix-versus-luteinizing-hormone-releasing-hormone-agonists-for-the-treatment-of-prostate-cancer
#7
REVIEW
Timothy N Clinton, Solomon L Woldu, Ganesh V Raj
Androgen deprivation therapy (ADT) is the mainstay for advanced, hormone-sensitive prostate cancer, and options include surgical castration, luteinizing hormone-releasing hormone (LHRH) agonist, and more recently, gonadotropin releasing hormone (GnRH) antagonist therapy. Our understanding of the mechanisms and adverse effects of ADT has increased substantially, including the class-specific adverse effects of ADT. Areas covered: This review will summarize the pharmacodynamic and pharmacokinetic properties of the GnRH antagonist degarelix and its role in the management of advanced prostate cancer, the clinical evidence supporting its regulatory approval, as well as potential benefits and disadvantages over traditional LHRH agonist therapy...
June 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28405705/-cost-effectiveness-of-gnrh-antagonists-in-patients-with-prostate-cancer-and-cardiovascular-risk-comparative-analysis-against-leuprorelin-by-the-number-needed-to-treat
#8
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...
July 2017: Der Urologe. Ausg. A
https://www.readbyqxmd.com/read/28394542/-effectiveness-and-safety-of-degarelix-in-treating-hormone-sensitive-prostate-cancer-review-of-the-recent-literature
#9
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
https://www.readbyqxmd.com/read/28394498/degarelix-versus-goserelin-plus-bicalutamide-in-the-short-term-relief-of-lower-urinary-tract-symptoms-in-prostate-cancer-patients-results-of-a-pooled-analysis
#10
RANDOMIZED CONTROLLED TRIAL
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
https://www.readbyqxmd.com/read/28347774/polyanion-based-controlled-release-system-for-the-gnrh-receptor-antagonist-degarelix
#11
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...
June 15, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28334771/efficacy-and-safety-of-a-3-month-dosing-regimen-of-degarelix-in-japanese-patients-with-prostate-cancer-a-phase-ii-maintenance-dose-finding-study
#12
RANDOMIZED CONTROLLED TRIAL
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...
May 1, 2017: Japanese Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28149927/the-relationship-of-industry-payments-to-prescribing-behavior-a-study-of-degarelix-and-denosumab
#13
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
https://www.readbyqxmd.com/read/27943135/degarelix-for-treating-advanced-hormone-dependent-prostate-cancer-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#14
REVIEW
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...
July 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/27919966/multimodal-primary-treatment-of-metastatic-prostate-cancer-with-androgen-deprivation-and-radiation
#15
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
https://www.readbyqxmd.com/read/27793455/effects-of-long-acting-gnrh-antagonist-degarelix-acetate-on-plasma-insulin-like-peptide-3-testosterone-and-luteinizing-hormone-concentrations-and-scrotal-circumference-in-male-goats
#16
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
https://www.readbyqxmd.com/read/27768220/gnrh-agonist-or-antagonist-in-the-treatment-of-prostate-cancer-a-comparision-based-on-oncological-results
#17
REVIEW
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
https://www.readbyqxmd.com/read/27756786/a-phase-ii-randomized-open-label-study-of-neoadjuvant-degarelix-versus-lhrh-agonist-in-prostate-cancer-patients-prior-to-radical-prostatectomy
#18
RANDOMIZED CONTROLLED TRIAL
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.Experimental Design: Thirty-nine patients were randomly assigned to one of three different neoadjuvant arms: degarelix only, degarelix/bicalutamide, or LHRH agonist/bicalutamide...
April 15, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/27586506/a-comparative-study-on-the-efficacies-of-gonadotropin-releasing-hormone-gnrh-agonist-and-gnrh-antagonist-in-neoadjuvant-androgen-deprivation-therapy-combined-with-transperineal-prostate-brachytherapy-for-localized-prostate-cancer
#19
RANDOMIZED CONTROLLED TRIAL
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
https://www.readbyqxmd.com/read/27569357/-giant-prostate-carcinoma-a-case-report-and-long-term-outcomes-in-japanese-patients
#20
REVIEW
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
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