Clinical trial · Interventional
Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer
Phase II Trial of Vitamin D and Soy Supplementation for Biochemically Recurrent Prostate Cancer Following Definitive Local Therapy
NCT00499408CI-TRIAL-00035914completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| soy | Dietary Supplement | — | UNRESOLVED |
| Vitamin D | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Soy and Vitamin D
- 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.
- interventionNames
- Dietary Supplement: Vitamin D
- Dietary Supplement: soy
Primary outcomes (1)
- measure
- Number of Participants Showing a 50% Reduction in Serum Prostate Specific Antigen(PSA) During Treatment
- timeFrame
- up to one year
Secondary outcomes (4)
- measure
- Changes in PSA Slope
- timeFrame
- up to one year
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.