Ferring announces the start of the PRONOUNCE Trial for patients with advanced prostate cancer & cardiovascular disease receiv...
February 08 2016 - 5:06AM
Business Wire
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.”
- Ends -
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
.
About degarelix:
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 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.
References
1 WHO GLOBOCAN 2012:
http://globocan.iarc.fr/old/FactSheets/cancers/prostate-new.asp#MORTALITY
[Last Accessed: January 2016]
2 Chowdhury S et al. Trends in Urology and Men’s Health. 2014:5:
26-27
3 Keating NL et al. J Clin Oncol. 2006 Sep
20;24(27):4448-56.
4 D'Amico AV et al. J Clin Oncol. 2007 Jun;25(17):2420-2425
5 Kintzel PE. Pharmacotherapy. 2008;28(12):1511-22.
6 Albertsen PC et al. Eur Urol. 2014 ;65:565-73
7 National Cancer Institute. Prostate Cancer (PDQ(R)):
Treatment: Treatment Option Overview.
http://www.cancer.gov/types/prostate/patient/prostate-treatment-pdq
[Last Accessed: January 2016]
8 American Cancer Society. Cancer Reference Information,
Overview: Prostate Cancer. http://www.cancer.org [Last Accessed:
January 2016]
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Ferring PharmaceuticalsHelen GallagherTel. +41 58 301 00
51helen.gallagher@ferring.comorNicole Barraud-EstoppeyTel. +41 58
301 00 53nicole.barraud-estoppey@ferring.com