Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
Status
RECRUITING
Phase
EARLY_PHASE1
Age
≥ 18 Years
Enrollments
400Conditions
Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8Summary
This early phase I is to find out how common vitamin D insufficiency is among African American patients with a history of prostate cancer that has not spread to other parts of the body (localized) or has spread to other places in the body (metastatic) and how vitamin D insufficiency affects the immune system. This study also aims to find out if replacing vitamin D results in normalization of the immune function. Information from this study may benefit prostate cancer patients by identifying vitamin D insufficiency which in several studies had been found to contribute to more aggressive prostate cancers.
Detailed Description
PRIMARY OBJECTIVES:
I. Determine the prevalence of vitamin D insufficiency among black / African American (AA) prostate cancer patients.
II. Determine the changes in circulating immunological cell function among patients with vitamin D insufficiency and the effects of vitamin D replacement on those changes.
III. Determine the acceptability of cholecalciferol (vitamin D) replacement therapy among black / AA prostate cancer patients and potential impact on health-related quality of life.
IV. Determine if there are differences in the peripheral blood immunological cell function in black / AA patients with metastatic or locally recurrent prostate cancer compared to those with localized prostate cancer.
V. Determine if vitamin D replacement is associated with improvement in progression free survival (PFS) of black/AA patients with prostate cancer with detectable changes in immune response compared to those with no detectable changes in immune response and compared to stage matched historical controls.
OUTLINE:
Patients with low vitamin D3 levels receive cholecalciferol orally (PO) daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.
Locations
2 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- Clinical Trials Referral Office
- 855-776-0015
- [email protected]
Principal Investigator
- Gerardo Colon-Otero, M.D.
Status
- RECRUITING
Contact Person
- Clinical Trials Referral Office
- 855-776-0015
- [email protected]
Principal Investigator
- Gerardo Colon-Otero, M.D.
Eligibility Criteria
Inclusion Criteria:
* African American males, age >= 18 years
* Patients with a previous history of localized or metastatic or locally recurrent prostate cancer
* Patients with Vitamin D levels below 30 ng/mL
Exclusion Criteria:
* Known hypersensitivity to vitamin D
* End stage renal failure on dialysis
* Liver cirrhosis
* Currently taking a vitamin D or multivitamin supplement, that has more than 400 IU/10mcg of vitamin D daily for the past month
* Legal inability or restricted legal ability. Medical or psychological conditions not allowing proper study completion or informed consent signature
* Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection
* History of hypercalcemia
Study Plan
Treatment (cholecalciferol)
EXPERIMENTAL
Patients with low vitamin D3 levels receive cholecalciferol PO daily for 8 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the study.
DIETARY_SUPPLEMENT:
CholecalciferolDescription:
Given POOTHER:
Quality-of-Life AssessmentDescription:
Ancillary studiesPROCEDURE:
Biospecimen CollectionDescription:
Undergo blood sample collection
Outcome Measures
Primary Outcome Measures
Effects of vitamin D replacement on the peripheral blood cells' immunological function
Differences in peripheral blood immunological function among Black / African American (AA) patients with localized prostate cancer versus metastatic or locally recurrent prostate cancer
Levels of antigen-specific T cells and antibodies
Prevalence of vitamin D insufficiency among Black/AA patients with prostate cancer
Acceptability of vitamin D replacement therapy among Black/AA patients with prostate cancer
Progression free survival (PFS)
Timeline
Last Updated
April 9, 2024Start Date
September 16, 2021Today
February 5, 2025Completion Date ( Estimated )
August 31, 2026
Sponsors of this trial
Lead Sponsor
Mayo Clinic
RECRUITING 
21 - 64 Years