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Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy
RATIONALE: Vitamin D and soy extract may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment. PURPOSE: This phase II trial is studying how well giving vitamin D together with soy supplements works in treating patients with recurrent prostate cancer.
OBJECTIVES: * Test the response of biochemically recurrent prostate cancer to a combination of cholecalciferol (i.e., vitamin D) and soy isoflavones (i.e., soy extract) after failed definitive local therapy as determined by PSA response. OUTLINE: Patients receive oral cholecalciferol twice daily and a soy supplement (i.e., soy bar or shake) once daily. Treatment continues for 3-12 months in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to measure serum PSA, serum calcium, plasma cholecalciferol, and plasma soy isoflavone levels. Blood samples are also analyzed for expression of cholecalciferol receptor, p21, and p27 in peripheral blood lymphocytes as surrogate markers of the actions of cholecalciferol and genistein. Protein expression is assessed by immunoblot analysis of cell lysates as well as quantitative polymerase chain reaction. Patients complete a toxicity questionnaire once each month to assess for cholecalciferol and soy supplementation toxicities and symptoms of hypercalcemia. After completion of study therapy, patients are followed every 3 months for 1 year.
Age
18 - 120 years
Sex
MALE
Healthy Volunteers
No
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Start Date
April 1, 2007
Primary Completion Date
December 1, 2012
Completion Date
December 1, 2012
Last Updated
November 21, 2018
26
ACTUAL participants
Vitamin D
DIETARY_SUPPLEMENT
soy
DIETARY_SUPPLEMENT
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT04550494
NCT05691465
Data Source & Attribution
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