Phase 2 Completed N=26 Treatment

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

Source: ClinicalTrials.gov NCT00499408 ↗

Enrolled (actual)

Serious AEs

19.2%

Results posted

Feb 2014

Primary outcomePrimary: Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment — 0 participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment	—	—
SECONDARY Changes in PSA Slope	—	—
SECONDARY Changes in PSA Doubling Time	—	—
SECONDARY Number of Adverse Events, Grades 1-5	93; 30; 7; 0; 1	—
SECONDARY Time to Progression	10.3	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00499408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.