Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Comprehensive Cancer Center of Wake Forest University
Collaborator:
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00499408
First received: July 10, 2007
Last updated: February 1, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy |
Resource links provided by NLM:
Further study details as provided by Comprehensive Cancer Center of Wake Forest University:
Primary Outcome Measures:
- Response of serum PSA [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in PSA slope [ Designated as safety issue: No ]
- Changes in PSA doubling time [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Time to progression [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
| Estimated Enrollment: | 36 |
| Study Start Date: | April 2007 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion:
- Age > 18 years
- Histologically confirmed adenocarcinoma of the prostate
- Biochemical relapse following definitive therapy by ASTRO criteria (PSA with 3 consecutive rising measurements separated by at least one month) and minimum PSA ≥ 1.0 ng/mL
- PSA doubling time of ≥ 6 months, as demonstrated by 3 PSA measurements obtained ≥ 2 months apart
- No hormonal therapy in 6 months prior to enrollment
- ECOG performance status 0-2
- Life expectancy > 3 months
- At least 2 years since prior definitive radiotherapy
- No concurrent cholecalciferol, calcium, or soy supplements
- 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
- Testosterone ≥ 150 ng/dL
Exclusion:
- No clinically evident brain metastases
- Concurrent cholecalciferol, calcium, or soy supplements
- Concurrent chemotherapy with nonstudy drugs
- Serious medical illness that would limit survival to < 3 months, or psychiatric condition that would preclude giving informed consent
- 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
- Active, uncontrolled bacterial, viral, or fungal infection
- Hemorrhagic disorder
- Evidence of metastatic disease by bone scan or CT scan
- History of hypercalcemia
- More History of exposure to other phytotherapeutics, including PC-SPES and Saw Palmetto, within the last year.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00499408
Locations
| United States, North Carolina | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
Investigators
| Study Chair: | K.C. Balaji, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00499408 History of Changes |
| Other Study ID Numbers: | CDR0000554969, P30CA012197, CCCWFU-85106, CCCWFU-IRB00000371 |
| Study First Received: | July 10, 2007 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Comprehensive Cancer Center of Wake Forest University:
|
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Cholecalciferol Vitamin D Vitamins Genistein Micronutrients Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Bone Density Conservation Agents Phytoestrogens Estrogens, Non-Steroidal Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anticarcinogenic Agents Protective Agents Antineoplastic Agents Therapeutic Uses Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013