Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer
This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) July 2007
| Sponsors and Collaborators: |
Wake Forest University
|
| Information provided by: |
National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: |
NCT00499408 |
|
Purpose
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 |
Intervention |
Phase |
Prostate Cancer
|
Drug: cholecalciferol
Drug: genistein
Drug: soy isoflavones
Procedure: biological markers
Procedure: biologically based therapies
Procedure: cancer prevention intervention
Procedure: complementary and alternative therapy
Procedure: diagnostic test
Procedure: immunological laboratory methods
Procedure: nutritional supplementation
Procedure: polymerase chain reaction
Procedure: protein expression
|
Phase II
|
MedlinePlus
related topics:
Prostate Cancer
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
Secondary Outcome Measures:
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Changes in PSA slope
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Changes in PSA doubling time
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Toxicity as assessed by NCI CTCAE v3.0
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Time to progression
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Correlation of cholecalciferol and soy isoflavones with vitamin D receptor signaling and p21 and p27 expression in peripheral blood lymphocytes as assessed by immunoblot analysis of cell lysates and quantitative PCR
Total Enrollment: 36
OBJECTIVES:
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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.
PROJECTED ACCRUAL:
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed adenocarcinoma of the prostate
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No evidence of metastatic disease by bone scan or CT scan
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Biochemical-only relapse after failed radical prostatectomy, brachytherapy, or external beam radiotherapy
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Meets American Society for Therapeutic Radiology and Oncology definition of biochemical relapse as 3 consecutive rising PSA levels obtained at least 1 month apart
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PSA doubling time of ≥ 6 months, as demonstrated by 3 PSA measurements obtained ≥ 2 months apart
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Minimum PSA ≥ 1.5 ng/mL
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Bone scan and CT scan required for PSA ≥ 10 ng/ mL
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Testosterone ≥ 150 ng/dL
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No clinically evident brain metastases
PATIENT CHARACTERISTICS:
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ECOG performance status 0-2
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Life expectancy > 3 months
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Absolute granulocyte count ≥ 1,000/mm³
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Platelet count ≥ 100,000/mm³
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Hemoglobin ≥ 9.0 g/dL
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Creatinine ≤ 2.0 mg/dL
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Total bilirubin ≤ 2.0 mg/dL
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Calcium > 8.5 mg/dL and < 10.5 mg/dL
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No serious medical illness that would limit survival to < 3 months, or psychiatric condition that would preclude giving informed consent
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No other malignancy except nonmelanoma skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for the past 5 years
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No active, uncontrolled bacterial, viral, or fungal infection
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No hemorrhagic disorder
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No history of hypercalcemia
PRIOR CONCURRENT THERAPY:
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More than 6 months since prior hormonal therapy
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At least 2 years since prior definitive radiotherapy
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More than 1 year since prior phytotherapeutics, including PC-SPES and saw palmetto
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More than 3 months since prior soy, cholecalciferol (> 400 IU per day), calcium, fish oil, or multivitamin supplements
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No concurrent cholecalciferol, calcium, or soy supplements
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No concurrent chemotherapy with nonstudy drugs
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00499408
Study chairs or principal investigators
Frank M. Torti, MD, MPH, Study Chair, Wake Forest University
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
