NCT00524680

Brief Summary

RATIONALE: Vitamin D may be effective in treating patients with prostate cancer. PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
Completed

Started Jun 2007

Typical duration for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 2, 2015

Completed
Last Updated

November 2, 2015

Status Verified

September 1, 2015

Enrollment Period

3.9 years

First QC Date

August 31, 2007

Results QC Date

March 17, 2015

Last Update Submit

September 30, 2015

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostaterecurrent prostate cancerstage I prostate cancerstage II prostate cancerstage III prostate cancerstage IV prostate cancer

Outcome Measures

Primary Outcomes (1)

  • Pattern of Response of Serum 25(OH) D3 Levels

    Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.

    Baseline, at 1, 3, 6 months

Secondary Outcomes (3)

  • Pattern of Response of Parathormone

    Baseline, at 1, 3, 6 months

  • Toxicity

    Baseline, at 1, 3 and 6 months

  • Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls

    Baseline, at 1, 3 ,6 months

Study Arms (4)

Arm I

EXPERIMENTAL

Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.

Dietary Supplement: cholecalciferol

Arm II

EXPERIMENTAL

Patients receive 6,000 IU of vitamin D3 once daily.

Dietary Supplement: cholecalciferol

Arm III

EXPERIMENTAL

Patients receive 8,000 IU of vitamin D3 once daily.

Dietary Supplement: cholecalciferol

Arm IV

EXPERIMENTAL

Patients receive 10,000 IU of vitamin D3 once daily.

Dietary Supplement: cholecalciferol

Interventions

cholecalciferolDIETARY_SUPPLEMENT

Given orally

Arm IArm IIArm IIIArm IV

Eligibility Criteria

Age18 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG performance status 0-2
  • Creatinine ≤ 2.0 mg/dL
  • Corrected serum calcium ≤ 10.5 mg/dL

You may not qualify if:

  • History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
  • Hypersensitivity to cholecalciferol or one of its components
  • PRIOR CONCURRENT THERAPY:
  • No other concurrent vitamin D supplementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Senior Administrator, Compliance - Clinical Research Services
Organization
Roswell Park Cancer Institute
716-845-2300

Study Officials

  • Donald L. Trump, MD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 3, 2007

Study Start

June 1, 2007

Primary Completion

May 1, 2011

Study Completion

March 1, 2013

Last Updated

November 2, 2015

Results First Posted

November 2, 2015

Record last verified: 2015-09

Locations

US(1)