Clinical trial NCT05045066: Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
Official title: Differences in Immunological Effects of Vitamin D Replacement Among Black/African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Localized Prostate Carcinoma
Stage IV Prostate Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 400
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Effects of vitamin D replacement on the peripheral blood cells' immunological function
timeFrame: Up to 2 years
measure: Differences in peripheral blood immunological function among Black / African American (AA) patients with localized prostate cancer versus metastatic or locally recurrent prostate cancer
timeFrame: Up to 2 years
measure: Levels of antigen-specific T cells and antibodies
timeFrame: Up to 2 years
measure: Prevalence of vitamin D insufficiency among Black/AA patients with prostate cancer
timeFrame: Up to 2 years
measure: Acceptability of vitamin D replacement therapy among Black/AA patients with prostate cancer
timeFrame: Up to 8 weeks
measure: Progression free survival (PFS)
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Gerardo Colon-Otero, M.D.
role: PRINCIPAL_INVESTIGATOR
References: