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Sept. 19, 2002 |
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Browse Archives n Lung n Breast n General n Prostate n Leukemia n Lymphoma n Colon n News/Issues |
Vitamin D for prostate cancer trial gets under way PORTLAND, Ore. -- Sept. 19, 2002 -- Researchers at Oregon Health & Science University today launched 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 study led by Dr. Tomasz Beer will enroll approximately 232 patients with advanced prostate cancer at 20 medical centers in the United States, including OHSU. It is a randomized, double-blind trial, meaning neither patients nor researchers will know who is receiving the study medications. Additional sites will be added during the next several months. "Late-stage prostate cancer patients have few treatment options," said Beer in a press release. "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." Results from the initial OHSU study were presented at the American Society of Clinical Oncology (ASCO) conference last May by Beer who is assistant professor of medicine (hematology and medical oncology) in the OHSU School of Medicine. 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 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 Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere, or ASCENT, trial is supported by Novacea Inc., in collaboration with Aventis Pharmaceuticals Inc. 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. The multi-center ASCENT will determine whether high doses of the 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. The study design calls for the combination treatment to achieve a 50 percent or more reduction in prostate specific antigen (PSA) levels in patients to be considered effective. 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. 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). Treatment options at late stage of illness are extremely limited and include palliative radiotherapy and, in some patients, palliative chemotherapy. Palliative refers to treatment aimed at easing symptoms rather than cure. Overall, roughly one in six American men will develop prostate cancer during his lifetime. If detected early, however, treatment can be highly effective. |
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