Localized Prostate CarcinomaEarly Phase 1NCT05045066
Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
A Early Phase 1 study testing Cholecalciferol, Quality-of-Life Assessment and Biospecimen Collection in people with Localized Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8, run by Mayo Clinic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Locally Recurrent Prostate Carcinoma
- What is being tested?
- Cholecalciferol, Quality-of-Life Assessment and Biospecimen Collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Dec 2021to 31 Aug 2031
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Center Clinical Trials contact
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Gerardo Colon-Otero, M.D.
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Cassandra N. Moore, M.D.
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Localized Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Locally Recurrent Prostate Carcinoma, Metastatic Prostate Carcinoma
- Being tested
- Cholecalciferol, Quality-of-Life Assessment, Biospecimen Collection
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDietary supplement
Also called 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3
Given PO
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Cholecalciferol; Other: Quality-of-Life Assessment; Procedure: Biospecimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; 8 weeks
Secondary outcomes (3)
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).
Measured: 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
Measured: 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.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start29 Dec 2021
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Gerardo Colon-Otero, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05045066
- Sponsor's protocol ID
- MC210501
- Other IDs
- HT94252411104, PC230672P11, 21-004555
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No