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Randomized Placebo-Controlled, Double-Blind Study Of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer


N/A
18 Years
N/A
Open (Enrolling)
Male
Adenocarcinoma of the Prostate, Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer, Stage IV Prostate Cancer

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Trial Information

Randomized Placebo-Controlled, Double-Blind Study Of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer


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 CYP24, 27B1, 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 for 9 months in the absence
of disease progression or unacceptable toxicity. After a wash-out period of 3 months,
patients then receive placebo PO once daily for 9 months in the absence of disease
progression or unacceptable toxicity.

ARM II: Patients receive placebo PO once daily for 9 months in the absence of disease
progression or unacceptable toxicity. After a wash-out period of 3 months, patients then
receive cholecalciferol PO once daily for 9 months in the absence of disease progression or
unacceptable toxicity.


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

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

PSA response

Outcome Time Frame:

Up to 21 months

Safety Issue:

No

Principal Investigator

Donald Trump

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

I 128308

NCT ID:

NCT00887432

Start Date:

December 2009

Completion Date:

Related Keywords:

  • Adenocarcinoma of the Prostate
  • Stage I Prostate Cancer
  • Stage II Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263