Trial record 1 of 1 for:    00887432
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Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00887432
First received: April 23, 2009
Last updated: July 14, 2014
Last verified: July 2014

April 23, 2009
July 14, 2014
December 2009
August 2014   (final data collection date for primary outcome measure)
PSA response [ Time Frame: Up to 21 months ] [ Designated as safety issue: No ]
Assessed by approximate t tests.
Change in PSA velocity, doubling time, and slope [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00887432 on ClinicalTrials.gov Archive Site
  • Pattern of response of PSA dynamics [ Time Frame: Up to 21 months ] [ Designated as safety issue: No ]
    Analyzed using the mixed model approach.
  • Absolute change in PSA [ Time Frame: Up to 21 months ] [ Designated as safety issue: No ]
    Analyzed using the mixed model approach.
  • Toxicity as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 [ Time Frame: Up to 21 months ] [ Designated as safety issue: Yes ]
    Will be compared as difference in proportion with 95% confidence intervals.
  • Pattern of response of PSA dynamics and absolute change in PSA [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.

PRIMARY OBJECTIVES:

I. To determine the prostate-specific antigen (PSA) response with oral high dose vitamin D3 supplementation (cholecalciferol) in patients with localized, histologically proven adenocarcinoma of the prostate who have not received any treatment for prostate cancer ever and have chosen expectant management.

SECONDARY OBJECTIVES:

I. To examine the pattern of response of PSA dynamics as well as the absolute change in PSA following vitamin D3 supplementation.

II. Assess the toxicity of vitamin D3 supplementation in men with prostate cancer.

TERTIARY OBJECTIVES:

I. Track occurrence of infections, deep venous thrombosis, vascular events and falls in the study population.

II. To evaluate relationship between cytochrome P450 family 24 (CYP24), 27B1, single-nucleotide polymorphism (SNPs) and serum 25(OH) vitamin D response to oral D3 supplementation.

III. To assess the changes in functional assessment in response to 25(OH) vitamin D supplementation.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive cholecalciferol orally (PO) once daily (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.

ARM II: 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Adenocarcinoma of the Prostate
  • Stage I Prostate Cancer
  • Stage II Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer
  • Dietary Supplement: cholecalciferol
    Given PO
    Other Names:
    • Calciol
    • Vitamin D3
  • Drug: placebo administration
    Given PO
  • Other: active surveillance
  • Other: laboratory biomarker analysis
    Correlative studies
  • Experimental: Arm I (cholecalciferol and placebo)
    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.
    Interventions:
    • Dietary Supplement: cholecalciferol
    • Drug: placebo administration
    • Other: active surveillance
    • Other: laboratory biomarker analysis
  • Experimental: Arm II (placebo and cholecalciferol)
    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.
    Interventions:
    • Dietary Supplement: cholecalciferol
    • Drug: placebo administration
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
Not Provided
August 2014   (final data collection date for primary outcome measure)

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
  • Vitamin D supplementation should not be done in any form other than that prescribed
  • 25(OH) D3 level less than 40ng/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 > 2.0mg/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
  • Ineligible if taking > 2000IU of vitamin D per day
Male
18 Years and older
No
United States
 
NCT00887432
I 128308, NCI-2009-01530, P30CA016056, I 128308, P30CA016056
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Donald Trump Roswell Park Cancer Institute
Roswell Park Cancer Institute
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP