Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Cholecalciferol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly. PURPOSE: This randomized clinical trial is studying how well cholecalciferol supplement works in treating patients with localized prostate cancer undergoing observation.
| Condition | Intervention |
|---|---|
|
Adenocarcinoma of the Prostate Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer |
Dietary Supplement: cholecalciferol Drug: Placebo 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 |
- PSA response [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- Pattern of response of PSA dynamics [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- Absolute change in PSA [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE version 3.0 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | April 2009 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral cholecalciferol 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 oral placebo once daily for 9 months in the absence of disease progression or unacceptable toxicity.
|
Dietary Supplement: cholecalciferol
6,000 IU daily of vitamin D3 provided as 3 capsules of 2000 IU each given orally.
Other Names:
Drug: Placebo Administration
Daily placebo provided as 3 capsules of a rice based placebo given orally.
|
|
Experimental: Arm II
Patients receive oral placebo 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 oral cholecalciferol once daily for 9 months in the absence of disease progression or unacceptable toxicity.
|
Dietary Supplement: cholecalciferol
6,000 IU daily of vitamin D3 provided as 3 capsules of 2000 IU each given orally.
Other Names:
Drug: Placebo Administration
Daily placebo provided as 3 capsules of a rice based placebo given orally.
|
Detailed Description:
PRIMARY OBJECTIVES: I. To determine the change in PSAV, PSADT and slope with oral high dose vitamin D3 supplementation 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. (Correlative) II. To evaluate relationship between CYP24, 27B1, SNPs and serum 25(OH) vitamin D response to oral D3 supplementation. (Correlative) III. To assess the changes in functional assessment in response to 25(OH) vitamin D supplementation. (Optional Correlative) OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral cholecalciferol 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 oral placebo once daily for 9 months in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive oral placebo 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 oral cholecalciferol once daily for 9 months in the absence of disease progression or unacceptable toxicity.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion
- 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)
- Age > 18 years
- 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
Contacts and Locations| Contact: Roswell Park Cancer Institute | 1-877-275-7724 | AskRPCI@roswellpark.org |
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
| Contact: Donald L. Trump, MD 716-845-5772 donald.trump@roswellpark.org | |
| Principal Investigator: Donald L. Trump | |
| Principal Investigator: | Donald Trump | 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 |
| Study First Received: | April 23, 2009 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Genital Diseases, Male Prostatic Diseases Cholecalciferol Vitamin D Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on May 23, 2013