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Calcifidol Therapy in Men With Cancer

NCT00018538 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2009-01-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

calcifidiol

Sponsors & Collaborators

Principal Investigators

  • Guy Howard, Ph.D

  • Gary Schwartz, Ph.D, MPH

  • James Schlesselman, Ph.D

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-10-31
Completion
2002-09-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00018538 on ClinicalTrials.gov