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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
soy
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Soy and Vitamin D

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment

Secondary Outcome Measures

Changes in PSA Slope
Changes in PSA Doubling Time
Number of Adverse Events, Grades 1-5
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
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.

Full Information

First Posted
July 10, 2007
Last Updated
October 25, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00499408
Brief Title
Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer
Official Title
Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Soy and Vitamin D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
cholecalciferol
Intervention Description
Patients will receive oral supplementation of 2,000 IU per day of vitamin D (cholecalciferol)
Intervention Type
Dietary Supplement
Intervention Name(s)
soy
Other Intervention Name(s)
isoflavones
Intervention Description
Patients will receive oral supplementation of soy (160 mg per day soy isoflavones).
Primary Outcome Measure Information:
Title
Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment
Time Frame
up to one year
Secondary Outcome Measure Information:
Title
Changes in PSA Slope
Time Frame
up to one year
Title
Changes in PSA Doubling Time
Time Frame
up to one year
Title
Number of Adverse Events, Grades 1-5
Description
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 Frame
up to one year
Title
Time to Progression
Description
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.
Time Frame
up to three years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K.C. Balaji, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

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