Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
Patients will receive oral supplementation of 2,000 IU per day of vitamin D (cholecalciferol)
DIETARY_SUPPLEMENTsoy
Patients will receive oral supplementation of soy (160 mg per day soy isoflavones).
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment | up to one year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in PSA Slope | up to one year | — |
| Changes in PSA Doubling Time | up to one year | — |
| Number of Adverse Events, Grades 1-5 | up to one year | 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 | up to three years | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D and Soy Supplementation oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones) | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Vitamin D and Soy Supplementation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 19 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Age, Continuous | 72.4 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment United States | 26 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 26 |
| other Total, other adverse events | 26 / 26 |
| serious Total, serious adverse events | 5 / 26 |
Outcome results
Primary
Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment
Time frame: up to one year
Population: Only 23 participants evaluable for a response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vitamin D and Soy Supplementation | Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment | 0 participants |
Secondary
Changes in PSA Doubling Time
Time frame: up to one year
Population: Data not collected
Secondary
Changes in PSA Slope
Time frame: up to one year
Population: Data not collected
Secondary
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 frame: up to one year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vitamin D and Soy Supplementation | Number of Adverse Events, Grades 1-5 | Grade 4 | 0 events |
| Vitamin D and Soy Supplementation | Number of Adverse Events, Grades 1-5 | Grade 5 | 1 events |
| Vitamin D and Soy Supplementation | Number of Adverse Events, Grades 1-5 | Grade 1 | 93 events |
| Vitamin D and Soy Supplementation | Number of Adverse Events, Grades 1-5 | Grade 2 | 30 events |
| Vitamin D and Soy Supplementation | Number of Adverse Events, Grades 1-5 | Grade 3 | 7 events |
Secondary
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.
Time frame: up to three years
Population: 16 subjects progress out of the 23 evaluable for response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vitamin D and Soy Supplementation | Time to Progression | 10.3 months |