Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00499408|
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : February 17, 2014
Last Update Posted : December 6, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: cholecalciferol Dietary Supplement: genistein Dietary Supplement: soy isoflavones Genetic: polymerase chain reaction Genetic: protein expression analysis Other: immunologic technique Other: laboratory biomarker analysis||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy|
|Study Start Date :||April 2007|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
- Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment [ Time Frame: up to one year ]
- Changes in PSA Slope [ Time Frame: up to one year ]
- Changes in PSA Doubling Time [ Time Frame: up to one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499408
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||K.C. Balaji, MD||Wake Forest University Health Sciences|