Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer

NCT ID: NCT00499408

Last Updated: 2018-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2012-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DIETARY_SUPPLEMENT

Patients will receive oral supplementation of 2,000 IU per day of vitamin D (cholecalciferol)

soy

Intervention Type: DIETARY_SUPPLEMENT

Patients will receive oral supplementation of soy (160 mg per day soy isoflavones).

Interventions

Vitamin D

Patients will receive oral supplementation of 2,000 IU per day of vitamin D (cholecalciferol)

Intervention Type: DIETARY_SUPPLEMENT

soy

Patients will receive oral supplementation of soy (160 mg per day soy isoflavones).

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

cholecalciferol; isoflavones

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

K.C. Balaji, MD

Role: STUDY_CHAIR

Wake Forest University Health Sciences

Locations

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCCWFU-85106

Identifier Type: -

Identifier Source: secondary_id

CCCWFU-IRB00000371

Identifier Type: -

Identifier Source: secondary_id

IRB00000371

Identifier Type: -

Identifier Source: org_study_id