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| Sponsor: | Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00018538 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: calcifidiol |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Calcifidol Therapy in Men With Cancer |
Eligibility| Genders 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.
Contacts and Locations| United States, Florida | |
| VAMC Miami, FL | |
| Miami, Florida, United States, 33125 | |
| Investigator: | Guy Howard, Ph.D | |
| Investigator: | Gary Schwartz, Ph.D, MPH | |
| Investigator: | James Schlesselman, Ph.D |
More Information
| Study ID Numbers: | ONCO-09-99S |
| Study First Received: | July 3, 2001 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00018538 History of Changes |
| Health Authority: | United States: Federal Government |
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vitamin D prostatic neoplasms neoplasm recurrence |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |