Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients

MC210501 Differences in Immunological Effects of Vitamin D Replacement Among Black/ African American (AA) Prostate Cancer Patients With Localized Versus Metastatic Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Localized Prostate Carcinoma; Locally Recurrent Prostate Carcinoma
• Intervention / Treatment: Other: Quality-of-Life Assessment; Procedure: Biospecimen Collection; Dietary supplement: Cholecalciferol

Detailed Description

PRIMARY OBJECTIVE:

I. Determine the changes in circulating immunological cell function among patients with vitamin D insufficiency and the effects of vitamin D replacement on those changes.

SECONDARY OBJECTIVES:

I. Determine the prevalence of vitamin D insufficiency among black / African American (AA) prostate cancer patients.

II. 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.

III. Determine if vitamin D replacement is associated with improvement in prostate-specific antigen (PSA) progression free survival (PSA-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.

CORRELATIVE OBJECTIVE:

I. Determine if there are differences in the peripheral blood immunological cell function in Black/AA patients compared to West African/Black patients from Nigeria.

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.

After completion of study treatment, patients are followed up at 56 days and then annually for 3 years.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
• Study Contact Backup: Name: Cancer Center Clinical Trials; Phone Number: 866-273-4681 or 507-266-4000

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Principal Investigator: Cassandra N. Moore, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
  • Florida
    • Jacksonville, Florida, United States, 32224-9980
      • Recruiting
      • Mayo Clinic in Florida
      • Principal Investigator: Gerardo Colon-Otero, M.D.
      • Contact: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pre-Registration:

  • African American males, age >= 18 years
  • Patients with a previous history of localized or metastatic or locally recurrent prostate cancer

• Registration:

  • Patients with Vitamin D levels below 30 ng/ml

Exclusion Criteria:

• Pre-Registration:

  • 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

• Registration:

  • Chemotherapy or surgery or radiation within the last 3 weeks prior to blood collection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment (cholecalciferol); 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.	Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Dietary supplement: Cholecalciferol; Given PO; Other Names: Vitamin D3; 9,10-Secocholesta-5,7,10(19)-trien-3-ol; Calciol; Delsterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in circulating immunological cell function	Participants will have blood drawn to measure serum levels of 25-hydroxyvitamin D (25OHD) and to determine immune response. Laboratory endpoints for the levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared. A participant will be considered to have responded if they have developed a ≥3-fold increase in antigen-specific T cells or antibodies at 8 weeks. If T-cell immunity is undetectable, a positive response will be defined as ≥50 antigen-specific T cells/million PBMCs.	Baseline; 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of vitamin D insufficiency	Participants will have blood drawn to measure serum levels of 25OHD. The mean and median 25OHD level will be estimated, as well as the percentage of participants that have low vitamin D levels (<30 ng/mL).	Baseline; 8 weeks
Differences in the peripheral blood immunological cell function	Levels of antigen-specific T cells and antibodies before and after vitamin D supplementation will be compared between black/AA patients with metastatic or locally recurrent prostate cancer and those with localized prostate cancer	Baseline; 8 weeks
Vitamin D replacement association with PSA progression free survival (PSA-PFS)	Participants with detectable changes in immune response will be compared to those with no detectable changes in immune response and compared to stage-matched historical controls to determine whether vitamin D replacement is associated with improvement in PFA-PFS.	Up to 3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	Assessed by the Human Services' Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life (HRQOL) Healthy Days Questionnaire. The questionnaire consists of 144 questions about an individual's self-rated general health over the past 30 days. Questions ask about the number of days for which mental and physical health was not good (# of days, none, or don't know/not sure) and whether poor mental or physical health days affected usual activities (yes, no, or don't know/not sure). A higher score (more healthy days) reflects better physical and mental well-being, while a lower score (more unhealthy days) indicates a greater impact from poor physical or mental health and activity limitations.	Baseline; 8 weeks
Difference in peripheral blood immunological cell function by population	A similar parallel study is being conducted at the University of Ilorin in Ilorin, Nigeria. Immunological results from the study at Mayo Clinic will be compared retrospectively with the results from the study in Nigeria under a separate study protocol.	Up to 3 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: Congressionally Directed Medical Research Programs
• Investigators: Principal Investigator: Gerardo Colon-Otero, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 29, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: September 8, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Investigative Techniques; Lipids; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Cholestenes; Cholestanes; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Cholecalciferol; Specimen Handling
• Other Study ID Numbers: MC210501 (Mayo Clinic in Florida); 21-004555 (Other Identifier: Mayo Clinic Institutional Review Board); HT94252411104 (Other Grant/Funding Number: Department of Defense); PC230672P11 (Other Grant/Funding Number: Department of Defense)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No