Clinical trial · Interventional
Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation
Randomized Placebo-Controlled, Double-Blind Study of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer
NCT00887432CI-TRIAL-00054668completedN/AResults 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)
This randomized clinical trial studies how well cholecalciferol supplement works in treating patients with localized prostate cancer undergoing observation. Cholecalciferol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly.
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 Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cholecalciferol | Dietary Supplement | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Patient Observation | Other | — | UNRESOLVED |
| Placebo Administration | Drug | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (cholecalciferol and placebo)
- description
- Patients receive cholecalciferol PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II.
- interventionNames
- Dietary Supplement: Cholecalciferol
- Other: Laboratory Biomarker Analysis
- Other: Patient Observation
- Drug: Placebo Administration
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- Arm II (placebo and cholecalciferol)
- description
- Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I.
- interventionNames
- Dietary Supplement: Cholecalciferol
- Other: Laboratory Biomarker Analysis
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient with clinically localized, histologically proven adenocarcinoma of prostate who has not received any treatment for prostate cancer ever and has chosen active surveillance; treatment for prostate cancer is defined as prostatectomy, androgen deprivation, brachytherapy or a full course of external beam irradiation * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Willingness to comply with study guidelines * Willingness and ability to consent * 25(OH) D3 level less than 40 ng/ml within 3 months of initiation of study; most recent 25 hydroxy D level within last 3 month would be used Exclusion Criteria: * History of malabsorption syndrome e.g., pancreatic insufficiency, celiac disease, tropical sprue * Creatinine \> 2.0 mg/dL * Corrected serum calcium level of \> 10.5 mg/dL (serum corrected calcium = serum calcium + 0.8\[4-serum albumin\]) * Most recent PSA value more than 18 months ago * Prior or current therapy for prostate cancer * Documented history of nephrolithiasis within the past 5 years * Patients receiving finasteride (Proscar) or dutasteride (Avodart) or men who have received either agent within 90 days of entry are ineligible * Patients cannot take any additional vitamin D supplementation during study treatment; patients taking \> 2000 IU per day prior to treatment will be ineligible
References
Publications (0)
Data not yet available
No reference posted for this study.