Calcifidol Therapy in Men With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00018538
Recruitment Status : Completed
First Posted : July 5, 2001
Last Update Posted : January 21, 2009
Information provided by:
VA Office of Research and Development

Brief Summary:
Prostate cancer is a common occurrence in the aging population, with one in ten men destined to develop the disease. 40% of patients with prostate cancer experience a recurrence after definitive treatment. This study addresses the as-yet unresolved problem of the optimal management of early recurrence as manifested by increase in the accepted marker for this disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for developing an approach to this problem that will delay or prevent progression.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: calcifidiol Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Calcifidol Therapy in Men With Cancer
Study Start Date : October 1999
Study Completion Date : September 2002

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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Patients will be males with three successive rises in PSA after achieving a nadir post-definitive therapy. The following criteria must be met: pathologically confirmed prostate cancer, completion of definitive treatment in the form of local external beam radiation or definitive surgery and three successive rises in PSA with no clinical evidence of disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00018538

United States, Florida
VAMC Miami, FL
Miami, Florida, United States, 33125
Sponsors and Collaborators
US Department of Veterans Affairs
OverallOfficial: Guy Howard, Ph.D
OverallOfficial: Gary Schwartz, Ph.D, MPH
OverallOfficial: James Schlesselman, Ph.D Identifier: NCT00018538     History of Changes
Other Study ID Numbers: ONCO-09-99S
First Posted: July 5, 2001    Key Record Dates
Last Update Posted: January 21, 2009
Last Verified: December 2004

Keywords provided by VA Office of Research and Development:
vitamin D
prostatic neoplasms
neoplasm recurrence