Calcifidol Therapy in Men With Cancer

NCT00018538 | Completed Phase 2

• 1 other identifier: ONCO-09-99S
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

vitamin D; prostatic neoplasms; neoplasm recurrence

Interventions

calcifidiol DRUG

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VAMC Miami, FL

Miami, Florida, 33125, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guy Howard, Ph.D

• Gary Schwartz, Ph.D, MPH

• James Schlesselman, Ph.D

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: July 3, 2001
• First Posted: July 5, 2001
• Study Start: October 1, 1999
• Study Completion: September 1, 2002
• Last Updated: January 21, 2009

Record last verified: 2004-12

Locations

US (1)