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NCT05045066 · ClinicalTrials.gov registry record · Early Phase 1
Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients
A Early Phase 1 study of Metastatic Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 220
- Enrollment target
- 2
- Study locations
NCT05045066: Recruiting Early Phase 1 study of Metastatic Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8, sponsored by Mayo Clinic.
NCT05045066 is a Early Phase 1 study of Metastatic Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8 that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 220 participants, above the 127-participant average among 37 other Metastatic Prostate Carcinoma trials with a reported enrollment target (73% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05045066, a Early Phase 1 study of Metastatic Prostate Carcinoma and Stage IV Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 220 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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-sp
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DIETARY_SUPPLEMENT Cholecalciferol
- OTHER Quality-of-Life Assessment
Study Locations (2)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2021-12-29 |
| Est. Completion | 2029-08-31 |
| Phase | Early Phase 1 |
What NCT05045066 shows while recruiting
NCT05045066 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, above the 127-participant average among 37 other Metastatic Prostate Carcinoma trials with a reported enrollment target (73% higher).
The record links to 4 conditions, with Metastatic Prostate Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT05045066 reports a single indexed study location in Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT05045066 about?
NCT05045066 is a clinical study titled "Immunological Effects of Vitamin D Replacement Among Black/African American Prostate Cancer Patients". 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 immu...
What is the current status of trial NCT05045066?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 220 participants. The study started on 2021-12-29. Estimated completion is 2029-08-31.
What conditions does trial NCT05045066 study?
This clinical trial studies the following conditions: Metastatic Prostate Carcinoma, Stage IV Prostate Cancer AJCC v8, Localized Prostate Carcinoma, Locally Recurrent Prostate Carcinoma.
What interventions are being tested in trial NCT05045066?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Cholecalciferol (DIETARY_SUPPLEMENT), Quality-of-Life Assessment (OTHER).
Who is sponsoring clinical trial NCT05045066?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05045066 being conducted?
This trial has 2 study locations across Arizona, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05045066's enrollment target sits among peer trials
220 4th of 37 higher than 34 of 37 other Metastatic Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Prostate Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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