N/A
Completed N=132
Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation
Source: ClinicalTrials.gov NCT00887432 ↗Enrolled (actual)
132
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: PSA Response — 0.55; 0.31 ng/mL — p=0.431
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PSA Response |
0.55; 0.31 | 0.431 |
| SECONDARY Slope of PSA Concentration Over Time |
0.000434; 0.000245 | 0.112 |
| SECONDARY Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 |
117; 118; 1; 2; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00887432). 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.