Public reporting burden for this collection of information is estimated to average I hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing this collection of information. Send comments regarding this burden estimate or any other aspect of this collection of Information, Including suggestions for reducing this burden to Washington Headquarters Services, Directorate for Information Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington, VA 22202-4302, and to the Office of Management and Budget,
A UTHOR(S)Srinivasan Vijayakumar, Ph.D.
PERFORMING ORGANIZA TION NAME(S) AND ADDRESS(ES) 8. PERFORMING ORGANIZA TIONThe University of California REPORT NUMBER Davis, California 95616-8670vijay@ucdavis .edu
SPONSORING / MONITORING 10. SPONSORING / MONITORING AGENCY NAME(S) AND ADDRESS(ES) AGENCY REPORT NUMBER
U.S. Army Medical Research and Materiel CommandFort Detrick, Maryland 21702-5012
SUPPLEMENTARY NOTES
12a. DISTRIBUTION/A VAILABILITY STATEMENT 12b. DISTRIBUTION CODEApproved for Public Release; Distribution Unlimited
ABSTRACT (Maximum 200 Words)Prostate cancer patients receive either surgery or radiation therapy as treatment for cancer. Among patients receiving radiation therapy, nearly 50% have an elevation of PSA within five years of treatment. These patients then receive hormone treatment. In this study, we wish to test the theory that chemopreventive agents, which show the ability to prevent or delay the growth of prostate cancer cells in the laboratory, may also prevent or delay the reappearance of prostate cancer in patients who have undergone radiation to treat their prostate cancer. We propose to have prostate cancer patients who have already undergone radiation treatment take a non-toxic chemopreventive agent [a synthetic form of vitamin D, I la-hydroxyvitamin D5] for two years and see if their reoccurrence rate can be decreased. Unlike regular vitamin D, D5 does not make calcium in the bloodstream reach levels that cause serious side effects. Forty patients will participate. They will be randomized to D5 or placebo arms. A biopsy will be done at the end of the study and the tissue will be analyzed for any benefit of D5 in decreasing the recurrence of prostate cancer and also for any differences between the groups in terms of expressed intermediate molecular biomarkers.
INTRODUCTIONWe plan to conduct a phase I/I safety/chemoprevention study to determine whether taking a non-toxic Vitamin D analog, 1 a(OH)D5 (D5), can safely delay prostate cancer recurrence when administered after radiation therapy (RT). The newly synthesized analog 1 a(OH)D5 (1 aHydroxy-24-ethyl-cholecalciferol) has shown anti-tumor activity at non-hypercalcemic concentrations in animals. Based on our preliminary research, we believe D5 can be given in effective doses without causing harmful side effects. Forty randomized patients will receive either D5 or placebo, 12-60 months after completion of RT (20 ...