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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05045066
The ClinicalTrials.gov registry entry for NCT05045066 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 127-participant average among 37 other Metastatic Prostate Carcinoma trials with a reported enrollment target (73% higher). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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