ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Calcifidol Therapy in Men With Cancer

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   Cancer    Prostate Cancer   

Drug Information available for:   Vitamin D    Ergocalciferol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Calcifidol Therapy in Men With Cancer

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

Investigators
Investigator:     Guy Howard, Ph.D    
Investigator:     Gary Schwartz, Ph.D, MPH    
Investigator:     James Schlesselman, Ph.D    
  More Information


Study ID Numbers:   ONCO-09-99S
First Received:   July 3, 2001
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00018538
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Vitamin D
Prostatic Diseases
Genital Neoplasms, Male
Ergocalciferols
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers