Saint-Prex, Switzerland, 8 February 2016 – Ferring Pharmaceuticals announced today the commencement of the Phase 3b PRONOUNCE Trial. The trial will compare the occurrence of major adverse cardiovascular events (MACEs) in patients with prostate cancer and cardiovascular disease (CVD), receiving the GnRH receptor antagonist, degarelix, to patients receiving a GnRH receptor agonist, leuprolide.
Prostate cancer is the second most common form of cancer in men worldwide with 1.1 million cases diagnosed and over 300,000 deaths in 2012.1 Androgen deprivation therapy (ADT) is considered the gold-standard treatment for patients with advanced prostate cancer.2 However, ADT has shown to be associated with increased risk for CVD. This increase in risk is particularly apparent within the first year of treatment initiation.3,4,5
A retrospective analysis of pooled data from six Phase 3 clinical trials suggests that there may be a difference in the risk of a major CV event when patients with prostate cancer and a history of CVD were treated with the GnRH antagonist, as compared to GnRH agonists.6 The PRONOUNCE Trial has been initiated to compare the cardiovascular safety profile of two types of ADT treatment, the GnRH antagonist (degarelix) and a GnRH agonist (leuprolide) over a one year treatment period. The primary endpoint of the PRONOUNCE Trial is time from patient randomization to the first confirmed occurrence of the composite MACE endpoint.
“Since increased risk of CVD is found among men at advanced age and with prostate cancer, it is critical that cardiovascular status is considered in the management of patients in which ADT is initiated” said Dr. Howard Scher, Chief of the Genitourinary Oncology Service at the Memorial Sloan-Kettering Cancer Center and co-principal investigator of the PRONOUNCE Trial. “The PRONOUNCE Trial could provide valuable insight into the cardiovascular safety profile of GnRH antagonists and GnRH agonists and contribute to informed clinical decision making.”
Ferring Pharmaceuticals is partnering with Duke Clinical Research Institute (DCRI), an institute of the Duke University School of Medicine, USA, to conduct the PRONOUNCE Trial. The DCRI will provide academic leadership with its world-renowned CVD clinical trial expertise.
“This eagerly anticipated trial represents the first cardiovascular outcomes trial conducted in patients with cancer and represents a unique collaboration among cardiologists, oncologists, and urologists who are involved in the care of patients with CVD and prostate cancer,” said Dr. Matthew Roe, Associate Professor of Medicine at Duke University Medical Center and the Duke Clinical Research Institute.
The PRONOUNCE Trial will enroll approximately 900 patients over 50 trial sites in the USA and Canada with the First Patient First Visit (FPFV) due to take place in February 2016.
Dr. Pascal Danglas, Chief Medical Officer, Ferring Pharmaceuticals, commented: “The start of the PRONOUNCE Trial marks another important milestone in Ferring’s long-standing commitment to improving the lives of men living with prostate cancer and addressing the unmet needs of patients with prostate cancer and pre-existing CVD.”
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About PRONOUNCE Trial
The PRONOUNCE Trial is a large, 1-year, randomised, controlled, prospective cardiovascular safety trial comparing the occurrence of independently adjudicated major adverse cardiovascular events (MACEs) in patients with prostate cancer and CVD receiving degarelix (GnRH antagonist) to patients receiving leuprolide (GnRH agonist). Further information on the PRONOUNCE trial is available at: https://clinicaltrials.gov/ct2/show/NCT02663908?term=pronounce&rank=1.
Degarelix is an antagonist form of androgen deprivation therapy that reversibly binds to the GnRH receptors, inhibiting the production of testosterone immediately. By suppressing the production of testosterone, tumour growth is inhibited.7 Degarelix was approved for the treatment of advanced hormone-dependent prostate cancer in the US in 2008, and in the EU in 2009. Today it is available in approximately 53 countries around the world, including Asia, Latin America and the Middle East.
About prostate cancer
Prostate cancer is the second most common form of cancer in men worldwide accounting for 15% of the cancers diagnosed in men. It is the fifth leading cause of death from cancer in men accounting for 6.6% of the total male deaths in 2012.1 Prostate cancer develops from cells in the prostate gland that begin to grow out of control. In most cases, prostate cancer grows slowly and can remain undetected throughout a man's life, although it can grow and spread quickly.8 The seven types of standard treatment are: watchful waiting or active surveillance, surgery, radiation therapy or radiopharmaceutical therapy, hormone therapy, chemotherapy, biologic therapy or bisphosphonate therapy.7
About Ferring Pharmaceuticals
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.
1WHO GLOBOCAN 2012: http://globocan.iarc.fr/old/FactSheets/cancers/prostate-new.asp#MORTALITY [Last Accessed: January 2016]
2Chowdhury S et al. Trends in Urology and Men’s Health. 2014:5: 26-27
3Keating NL et al. J Clin Oncol. 2006 Sep 20;24(27):4448-56.
4D'Amico AV et al. J Clin Oncol. 2007 Jun;25(17):2420-2425
5Kintzel PE. Pharmacotherapy. 2008;28(12):1511-22.
6Albertsen PC et al. Eur Urol. 2014 ;65:565-73
7National Cancer Institute. Prostate Cancer (PDQ(R)): Treatment: Treatment Option Overview. http://www.cancer.gov/types/prostate/patient/prostate-treatment-pdq [Last Accessed: January 2016]
8American Cancer Society. Cancer Reference Information, Overview: Prostate Cancer. http://www.cancer.org [Last Accessed: January 2016]