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Phase II Study of Cholecalciferol and Soy Supplementation in Patients With Biochemically Recurrent Prostate Cancer Following Failed Definitive Local Therapy
Alternate Title Basic Trial Information Objectives Entry Criteria Expected Enrollment Outcomes Outline Trial Contact Information Registry Information
Alternate Title
Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer
Basic Trial Information
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Phase
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Status
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Protocol IDs
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Phase II
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Biomarker/Laboratory analysis, Treatment
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Active
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Over 18
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NCI
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CCCWFU-85106 CCCWFU-IRB00000371, CCCWFU 85106, NCT00499408
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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.
Entry Criteria Disease Characteristics:
- Histologically confirmed adenocarcinoma of the prostate
- No evidence of metastatic disease by bone scan or CT scan
- Biochemical-only relapse after failed radical prostatectomy, brachytherapy, or external beam radiotherapy
- Meets American Society for Therapeutic Radiology and Oncology definition of biochemical relapse as 3 consecutive rising PSA levels obtained at least 1 month apart
- PSA doubling time of ≥ 6 months, as demonstrated by 3 PSA measurements obtained ≥ 2 months apart
- Minimum PSA ≥ 1.5 ng/mL
- Bone scan and CT scan required for PSA ≥ 10 ng/ mL
- Testosterone ≥ 150 ng/dL
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No clinically evident brain metastases
Prior/Concurrent Therapy:
- More than 6 months since prior hormonal therapy
- At least 2 years since prior definitive radiotherapy
- More than 1 year since prior phytotherapeutics, including PC-SPES and saw palmetto
- More than 3 months since prior soy, cholecalciferol (> 400 IU per day), calcium, fish oil, or multivitamin supplements
- No concurrent cholecalciferol, calcium, or soy supplements
- No concurrent chemotherapy with nonstudy drugs
Patient Characteristics:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Absolute granulocyte count ≥ 1,000/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9.0 g/dL
- Creatinine ≤ 2.0 mg/dL
- Total bilirubin ≤ 2.0
mg/dL
- Calcium > 8.5 mg/dL and < 10.5 mg/dL
- No serious medical illness that would limit survival to < 3 months, or psychiatric condition that would preclude giving informed consent
- 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
- No active, uncontrolled bacterial, viral, or fungal infection
- No hemorrhagic disorder
- No history of hypercalcemia
Expected Enrollment 36Outcomes Primary Outcome(s)Response of serum PSA
Secondary Outcome(s)Changes in PSA slope Changes in PSA doubling time Toxicity as assessed by NCI CTCAE v3.0 Time to progression 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
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.
Trial Contact Information
Trial Lead Organizations Wake Forest University Comprehensive Cancer Center | | | Frank Torti, MD, MPH, Protocol chair | | | | Trial Sites
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U.S.A. |
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North Carolina |
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Winston-Salem |
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| | | | | | | | Wake Forest University Comprehensive Cancer Center |
| | Clinical Trials Office - Wake Forest University Comprehensive Cancer Center | |
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South Carolina |
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Charleston |
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| | | Hollings Cancer Center at Medical University of South Carolina |
| | Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina | |
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Tennessee |
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Nashville |
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| | | Vanderbilt-Ingram Cancer Center |
| | Clinical Trials Office - Vanderbilt-Ingram Cancer Center | |
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Registry Information | | Official Title | | Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy | | Trial Start Date | | 2007-04-20 | | Trial Completion Date | | 2009-04-20 (estimated) | | Registered in ClinicalTrials.gov | | NCT00499408 | | Date Submitted to PDQ | | 2007-06-06 | | Information Last Verified | | 2008-09-08 | | NCI Grant/Contract Number | | CA12197 |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. Back to Top |
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