Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response of serum PSA
K.C. Balaji, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|