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

NCT05045066 | Recruiting Early Phase 1 DMC FDA Drug

• 4 other identifiers: MC210501HT94252411104PC230672P1121-004555
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

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.

Conditions

Localized Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Locally Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Prevalence of vitamin D insufficiency

  Baseline; 8 weeks

• Differences in the peripheral blood immunological cell function

  Baseline; 8 weeks

• Vitamin D replacement association with PSA progression free survival (PSA-PFS)

  Up to 3 years

Other Outcomes (2)

• Change in Quality of Life

  Baseline; 8 weeks

• Difference in peripheral blood immunological cell function by population

  Up to 3 years

Study Arms (1)

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: Cholecalciferol; Other: Quality-of-Life Assessment; Procedure: Biospecimen Collection

Interventions

Cholecalciferol DIETARY_SUPPLEMENT

Given PO

Also known as: 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3

Treatment (cholecalciferol)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (cholecalciferol)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (cholecalciferol)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cholecalciferol; Specimen Handling

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Gerardo Colon-Otero, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Cancer Center Clinical Trials

CONTACT

866-273-4681 or 507-266-4000

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2021
• First Posted: September 16, 2021
• Study Start: December 29, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2029
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (2)