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NEW STUDY EXPANDS LOOK AT
EFFECTS OF HIGH-DOSE
VITAMIN D WITH
DOCETAXEL FOR ADVANCED PROSTATE CANCER PATIENTS
National,
multicenter study born out of smaller Oregon trial
PORTLAND, Ore.
- Researchers at Oregon Health & Science University today announced
the launch of a national study to investigate the effect of
high-dose vitamin D in combination with the chemotherapy agent
docetaxel (Taxotere), for patients with advanced prostate cancer.
The ASCENT (AIPC
Study of
Calcitriol
Enhancing
Taxotere)
study is a multicenter, randomized, double-blind trial based on the
promising results of a preliminary study in Oregon. ASCENT will
determine whether a high dose of an active form of vitamin D, called
calcitriol, taken once a week in combination with docetaxel, is any
more effective than docetaxel alone for patients with
androgen-independent prostate cancer (AIPC), an advanced form of
prostate cancer.
“Late-stage prostate cancer patients
have few treatment options, and we are cautiously hopeful that this
study will further confirm and extend the promising results we’ve
already seen with docetaxel in combination with high-dose pulse
administration (HDPA) calcitriol,” said OHSU Cancer Institute
oncologist Tomasz Beer, M.D., study chairman and assistant professor
of medicine (hematology and medical oncology) in the OHSU School of
Medicine.
The study will enroll approximately
232 patients at about 20 medical centers in the United States,
including OHSU. Additional sites will be added during the next
several months.
The study hopes to achieve a
reduction of 50 percent or more in prostate specific antigen (PSA)
levels in patients. PSA is a substance produced within the prostate
gland, and a high PSA level may indicate the presence of cancer. In
patients with advanced prostate cancer, many clinicians use elevated
PSA levels as an indicator of disease progression.
Results from the initial OHSU study
were presented by Beer at the American Society of Clinical Oncology
conference last May. In that trial, 81 percent (30 of 37) of
patients treated with HDPA calcitriol in combination with docetaxel
had a reduction in PSA levels of more than 50 percent. Four
--more--
other studies of docetaxel without
calcitriol have reported that 38 percent to 46 percent of the
patients had more than a 50 percent reduction in PSA levels, about
half the rate as those patients on the combination therapy.
The ASCENT trial is supported by
Novacea Inc. (www.novacea.com
<http://www.novacea.com>),
in collaboration with Aventis Pharmaceuticals Inc. (www.aventis.com
<http://www.aventis.com>).
Novacea has manufactured a new formulation of calcitriol, DN-101,
that was specifically designed for use in the HDPA calcitriol
treatment of patients with cancer. Aventis is the manufacturer of
Taxotere, the brand name of the chemotherapy agent docetaxel.
Prostate cancer is
the most common cancer in men, with approximately 189,000 new cases
diagnosed and roughly 30,200 deaths in the United States each year (2002
Cancer Facts and Figures,
American Cancer Society). The most effective treatment for
disseminated prostate cancer is androgen deprivation depletion from
surgical or pharmacological means. Treatment options at late stage
of illness are extremely limited and include palliative radiotherapy
and, in some patients, palliative chemotherapy. Overall, roughly one
in six American men will develop prostate cancer during his
lifetime. If detected early, however, treatment can be highly
effective.
Oregon Health & Science University
is a health and research university focused on improving the
well-being of people in Oregon and beyond. OHSU educates health
practitioners, bioscientists, high-technology professionals, and
environmental scientists and engineers, and it undertakes the
indispensable functions of patient care, community service and
biomedical research.
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