Researchers Put Advanced Prostate Cancer On Trial

Can high-dose vitamin D, a naturally occurring• Prostate cancer is the third-leading cause of
hormone, improve an advanced prostate cancercancer death in men, after lung cancer and colorectal
patient's treatment with chemotherapy? That is whatcancer, and
researchers in the United States, Canada and Europe• This year, more than 234,460 men will be
are trying to determine.diagnosed with, and an estimated 27,350 men will die
For 20 years, scientists have explored the role offrom, prostate cancer in the United States.
vitamin D in the prevention, treatment and reductionProstate cancer occurs when cells within the prostate
of cancer and other autoimmune diseases. However,grow uncontrollably, producing multiple small tumors.
they all encountered the same problem-they couldAt this stage, the disease is often curable with
not administer enough vitamin D to fight the diseasestandard treatments such as surgery or radiation that
without causing severe toxicity.aim to remove or kill all cancerous cells in the
The promise of vitamin D to treat cancer was almostprostate. Unfortunately, at this stage, the cancer
shelved until researchers at Oregon Health & Scienceproduces few or no symptoms and can be difficult
University and Novacea, a biopharmaceuticalto detect.
company, were able to develop a highly concentratedIf untreated and allowed to grow, the cancerous cells
form of calcitriol, a derivative of vitamin D, that hadfrom the tumors can spread in a process called
the potential to be administered safely to patients.metastasis. In this process, prostate cancer cells are
Now, a clinical study is under way investigatingtransported through the lymphatic system and the
Asentar in the treatment of advanced prostatebloodstream to other parts of the body, where they
cancer. Patients take Asentar, which comes in a smallcan reside and grow as secondary tumors. Once
capsule, the day before their next Taxotere(R)cancerous cells begin to spread beyond the prostate,
(docetaxel) chemotherapy treatment. Researchersthe prostate cancer is considered to be recurrent.
will monitor patients to see if Asentar may helpRecurrent prostate cancer that progresses while a
patients to live longer while reducing some of thepatient is taking hormonal therapy is called
side effects caused by chemotherapy, such as bloodandrogen-independent prostate cancer (AIPC). At this
clots and fractures.stage in the disease, the cancer has generally
"This is a new and interesting approach to treatmetastasized (spread) to a patient's bones and/or
prostate cancer patients whose disease haslymph nodes. For AIPC patients, a combination of
progressed and who currently have limited treatmentdocetaxel and prednisone, approved by the FDA for
options," said Luke T. Nordquist, M.D. of Nebraskatreatment of AIPC with a two-month survival
Methodist Hospital, Omaha, Neb. "The previous Phasebenefit, has shown to prolong the lives of these
2 results showed that Asentar appeared to improvepatients. Some of the other chemotherapy drugs
survival while reducing some of the serious sideused to treat prostate cancer include doxorubicin,
effects of chemotherapy, an important finding thatetoposide, vinblastine, paclitaxel and carboplatin.
surprised many researchers and called for furtherResearchers at approximately 200 medical centers in
clinical evaluations."the United States, Canada and Europe are seeking to
All patients in the study will receive chemotherapyevaluate the potential survival and safety benefits of
treatment with docetaxel. In addition to docetaxel,Asentar in combination with docetaxel in a
half of the patients will receive prednisone (part of900-patient Phase 3 clinical trial, known as ASCENT-2.
the FDA-approved docetaxel regimen) and the otherAsentar is an investigational new drug currently in
half will receive the investigational agent, Asentar.clinical trials and has not been approved by the U.S.
According to the American Cancer Society:Food and Drug Administration.