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Calcifidol Therapy in Men With Cancer

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00018538
First received: July 3, 2001
Last updated: January 20, 2009
Last verified: December 2004
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Calcifidol Therapy in Men With Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Study Start Date: October 1999
Estimated Study Completion Date: September 2002
  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00018538

Locations
United States, Florida
VAMC Miami, FL
Miami, Florida, United States, 33125
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Investigator: Guy Howard, Ph.D
Investigator: Gary Schwartz, Ph.D, MPH
Investigator: James Schlesselman, Ph.D
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00018538     History of Changes
Other Study ID Numbers: ONCO-09-99S
Study First Received: July 3, 2001
Last Updated: January 20, 2009
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
vitamin D
prostatic neoplasms
neoplasm recurrence

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013