Clinical trial NCT00887432: Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation
Official title: Randomized Placebo-Controlled, Double-Blind Study of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Adenocarcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-04-24
Enrollment: 132
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: PSA Response
timeFrame: 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
Secondary outcomes:
measure: Slope of PSA Concentration Over Time
timeFrame: 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
measure: Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
timeFrame: Up to 30 days after completion of study treatment (up to 22 months from start of study).
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: James Mohler
role: PRINCIPAL_INVESTIGATOR
References: