NCT00887432

Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation

Completed NA Results posted Last updated 26 October 2021

What this trial tests

NA trial testing Cholecalciferol in Prostate Adenocarcinoma in 132 participants. Completed in 8 June 2020.

Timeline

8 April 2009

Primary endpoint
8 June 2020

8 June 2020

Quick facts

Lead sponsor	Roswell Park Cancer Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	132
Start date	8 April 2009
Primary completion	8 June 2020
Estimated completion	8 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Cholecalciferol (cholecalciferol) — full drug profile →
• Laboratory Biomarker Analysis — full drug profile →
• Patient Observation
• Placebo Administration — full drug profile →
• Quality-of-Life Assessment
• Questionnaire Administration

Conditions studied

• Prostate Adenocarcinoma — all drugs for Prostate Adenocarcinoma →

Sponsor

Roswell Park Cancer Institute

Who can join

18 and older, male only, with Prostate Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

PSA Response Primary · 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment

Difference in the mean change in PSA on vitamin D (9 month period: pre-Vitamin D to 9 months after start of vitamin D) versus on placebo (9 month period: pre-Placebo to 9 months after starting placebo). Compared using a paired t-test.

Group	Value	95% CI
Cholecalciferol	0.55	± 2.13
Placebo	0.31	± 1.86

Slope of PSA Concentration Over Time Secondary · 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment -Up to 30 days after completion of study treatment

The PSA levels were modeled as a function of treatment, time, their interaction, sequence, and a random subject effect using a linear mixed model. From this model, the subject specific PSA slope was obtained for each subject under each condition (vitamin D versus placebo). The PSA slopes were then compared between treatment conditions using linear mixed model to account for treatment arm and repeated measures.

Group	Value	95% CI
Cholecalciferol	0.000434	± 0.000089
Placebo	0.000245	± 0.000090

Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 Secondary · Up to 30 days after completion of study treatment (up to 22 months from start of study).

Summarizing the maximum observed treatment related adverse event. Summarize by arm and grade using frequencies and relative frequencies..

Group	Value	95% CI
Cholecalciferol	117
Placebo	118
Cholecalciferol	1
Placebo	2
Cholecalciferol	0
Placebo	0
Cholecalciferol	1
Placebo	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Within 30 days of treatment completion (up to 22 months from start of study).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cholecalciferol

Serious: 0/119 (0%)

Deaths: 0/119

Placebo

Serious: 0/120 (0%)

Deaths: 0/120

Other adverse events (3 terms — click to expand)

Reaction	System	Cholecalciferol	Placebo
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—
Nephrolithiasis	Renal and urinary disorders	—	—

Data from ClinicalTrials.gov NCT00887432 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Can Oncologists Predict the Efficacy of Treatments in Randomized Trials?
   Benjamin DM, Mandel DR, Barnes T, Krzyzanowska MK, et al · · 2021 · cited 6× · PMID 32936509 · DOI 10.1634/theoncologist.2020-0054