Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2015 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00887432
First received: April 23, 2009
Last updated: October 9, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention
Prostate Adenocarcinoma
Dietary Supplement: Cholecalciferol
Other: Laboratory Biomarker Analysis
Other: Patient Observation
Drug: Placebo Administration
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Placebo-Controlled, Double-Blind Study of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • PSA response [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: No ]
    Assessed by approximate t tests.


Secondary Outcome Measures:
  • Absolute change in PSA [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: No ]
    Analyzed using the mixed model approach.

  • Pattern of response of PSA dynamics [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: No ]
    Analyzed using the mixed model approach.

  • Toxicity as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 30 days after completion of study treatment ] [ Designated as safety issue: Yes ]
    Will be compared as difference in proportion with 95% confidence intervals.


Estimated Enrollment: 100
Study Start Date: April 2009
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Dietary Supplement: Cholecalciferol
Given PO
Other Names:
  • 9,10-Secocholesta-5,7,10(19)-trien-3-ol
  • Calciol
  • Delsterol
  • Vitamin D3
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Patient Observation
Other Names:
  • Active Surveillance
  • deferred therapy
  • expectant management
  • Observation
  • Watchful Waiting
Drug: Placebo Administration
Given PO
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
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.
Dietary Supplement: Cholecalciferol
Given PO
Other Names:
  • 9,10-Secocholesta-5,7,10(19)-trien-3-ol
  • Calciol
  • Delsterol
  • Vitamin D3
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Patient Observation
Other Names:
  • Active Surveillance
  • deferred therapy
  • expectant management
  • Observation
  • Watchful Waiting
Drug: Placebo Administration
Given PO
Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies

Detailed Description:

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(hydroxy [OH]) vitamin D response to oral D3 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.

After completion of study treatment, patients are followed up for 30 days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887432

Locations
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park    877-275-7724    ASKRPCI@roswellpark.org   
Principal Investigator: James L. Mohler         
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
Principal Investigator: James Mohler Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00887432     History of Changes
Other Study ID Numbers: I 128308  NCI-2009-01530  I 128308  P30CA016056 
Study First Received: April 23, 2009
Last Updated: October 9, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Carcinoma
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Prostatic Diseases
Urogenital Neoplasms
Cholecalciferol
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on February 10, 2016