Not Yet RecruitingPhase 3

Comparative Analysis of Immunological Responses to Vitamin D Replacement Therapy in Black and West African Men Diagnosed With Prostate Cancer: Elucidating Differential Effects on Immune Function Between Patients With Localized Disease and Those With Metastatic Progression

Nigeria200 participantsStarted 2026-06-01

Plain-language summary

This study is testing whether fixing vitamin D deficiency in Black/West African men with prostate cancer can strengthen their immune system, improve quality of life, and even slow cancer progression compared to those who remain deficient. Key ideas being tested: 1. More than half of Black/West African prostate cancer patients don't have enough vitamin D. 2. Low vitamin D weakens immune cell function and affects quality of life, but these problems improve after 8 weeks of vitamin D supplements. 3. Immune cell function differs between patients with advanced/recurrent prostate cancer and those with localized disease. 4. Patients with advanced disease who show stronger immune responses after vitamin D correction may live longer without their PSA levels rising (a marker of cancer progression). 5. Immune cell function in Black/West African patients is different from that in Black/African American patients, and this will be checked by comparing data with a parallel Mayo Clinic study. Overall goals: 1 . Measure how widespread vitamin D deficiency is in Black/West African prostate cancer patients. 2\. Understand how vitamin D levels affect immunity and quality of life. 3. Compare immune function between different groups (localized vs. advanced disease, West African vs. African American patients). 4 . See if vitamin D replacement improves both patient well-being and cancer outcomes. Study Flow 1\. Recruitment \& Consent: Patients with prostate cancer (localized or advanced) are invited and give written consent. 2 . Initial Blood Test (10 mL): Check vitamin D and calcium levels. 3. Eligibility: If vitamin D is low (\<30 ng/mL), patients join the treatment phase. 4\. Baseline Testing (50 mL blood + QOL survey): Immune function measured; quality of life survey completed; virtual doctor consult. 5\. Treatment (8 weeks): Daily vitamin D3 pills (2000 IU, free); patients keep a medication diary. 6\. Midpoint Check (Week 4): Phone call to check side effects and compliance. 7 .End of Treatment (Week 8): Repeat blood tests (60 mL), second QOL survey, virtual consult. 8\. Follow up (up to 3 years). Annual phone calls and medical record review to track progression-free survival. In short, the study is trying to show that vitamin D deficiency is common in Black/West African prostate cancer patients, that it harms immune function and quality of life, and that correcting it could improve both health and cancer survival.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Self-identified Black/West African Males, Age ≥18 years * Patients with a previous history of localized or metastatic or locally recurrent prostate cancer * Willing to travel to the University of Ilorin Surgery Outpatient Department (SOPD UITH)for baseline and 8 weeks visit for blood collection, if eligible. Exclusion Criteria: * Known hypersensitivity to vitamin D. * End-stage renal failure on dialysis * Liver cirrhosis * Currently taking a vitamin D or multivitamin supplement, which 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. * History of hypercalcemia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically looking at Black and West African men with prostate cancer — does my background and diagnosis fit the type of patient this study is designed for, and is it worth discussing with my care team?
2The trial is comparing immune responses to vitamin D replacement in men with localized prostate cancer versus those with metastatic disease — given my current stage, which group would I potentially fall into, and how might that affect what I could learn or gain from participating?
3Since this is a Phase 3 trial that hasn't started recruiting yet, how long might it be before it opens, and should I be pursuing standard treatment options in the meantime rather than waiting to see if I can enroll?
4The study is measuring vitamin D deficiency and serum vitamin D levels as primary outcomes — does my doctor already know my current vitamin D levels, and is there any reason to address a potential deficiency now regardless of whether this trial becomes an option?
5Because this trial is focused on understanding immune responses rather than directly testing a new cancer treatment, can my doctor help me understand whether joining this kind of observational or comparative study would interfere with, delay, or complement any standard prostate cancer treatments I might need?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Men with Advanced Prostate Cancer with Vitamin D Deficiency

Timeframe: 48 months

Serum levels of Vitamin D in African Men with Advanced Prostate Cancer .

Timeframe: The test will be done at the time of recruitment and at 8 weeks after the supplementation

Trial details

NCT IDNCT07598032

SponsorUniversity of Ilorin Teaching Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-01

Contact for this trial

Ademola A Popoola, MD

+2348032224299 ademolapopoola@unilorin.edu.ng

View on ClinicalTrials.gov More Prostate Cancer (Adenocarcinoma) trials