Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00499408|
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : February 17, 2014
Last Update Posted : November 21, 2018
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: Vitamin D Dietary Supplement: soy||Phase 2|
- 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|
Experimental: Soy and Vitamin D
Patients will receive oral supplementation with both 2,000 IU per day of vitamin D (cholecalciferol) and soy (160 mg per day soy isoflavones). Serum PSA and plasma levels of vitamin D will be assessed monthly. Soy isoflavones levels will be assessed every three months.
Dietary Supplement: Vitamin D
Patients will receive oral supplementation of 2,000 IU per day of vitamin D (cholecalciferol)
Other Name: cholecalciferol
Dietary Supplement: soy
Patients will receive oral supplementation of soy (160 mg per day soy isoflavones).
Other Name: isoflavones
- 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 ]
- Number of Adverse Events, Grades 1-5 [ Time Frame: up to one year ]Toxicity will be graded according to the revised NCI Common Terminology Criteria for Adverse Events v 3.0, (CTCAE). Number of events with grade 1-5 will be reported.
- Time to Progression [ Time Frame: up to three years ]Progression will be defined as a 50% rise in serum PSA compared to the baseline value confirmed on at least two measurements at least two weeks apart.
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|