Calcifidol Therapy in Men With Cancer

Prostate Cancer Clinical Trial

Official title:

Calcifidol Therapy in Men With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00018538
• Other study ID #: ONCO-09-99S
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2001
• Last updated: January 20, 2009
• Start date: October 1999
• Est. completion date: September 2002

Study information

• Verified date: December 2004
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• calcifidiol

Locations

Country	Name	City	State
United States	VAMC Miami, FL	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States,