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NCT05838716 · ClinicalTrials.gov registry record · Phase 3
Vitamin D for Prostate Endocrine Therapy
A Phase 3 study of Stage III Prostate Cancer AJCC v8 and Stage IVA Prostate Cancer AJCC v8, sponsored by University of Rochester.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 240
- Enrollment target
- 20
- Study locations
NCT05838716: Recruiting Phase 3 study of Stage III Prostate Cancer AJCC v8 and Stage IVA Prostate Cancer AJCC v8, sponsored by University of Rochester.
NCT05838716 is a Phase 3 study of Stage III Prostate Cancer AJCC v8 and Stage IVA Prostate Cancer AJCC v8 that is actively recruiting participants, run by University of Rochester. The registered enrollment target is 240 participants, roughly in line with the 241-participant average among 28 other Stage III Prostate Cancer AJCC v8 trials with a reported enrollment target. The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05838716, a Phase 3 study of Stage III Prostate Cancer AJCC v8 and Stage IVA Prostate Cancer AJCC v8, is actively recruiting participants, sponsored by University of Rochester.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 240 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps the body absorb calcium. Calcium is one of the main building blocks of bone. A lack of vitamin D can lead to bone diseases such as osteoporosis or rickets. This trial may help researchers determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.
Primary Outcome
Will determine the efficacy of high-dose vitamin D (HDVD) supplementation versus placebo in reducing BMD loss as measured at the total hip via dual-energy x-ray absorptiometry (DXA) at 52 weeks. Will use analysis of covariance (ANCOVA) with group (vitamin D or placebo) as the main factor, baseline timepoint (\[T\]1) BMD as covariate, and week 52 (T3) BMD as the outcome. Study site will be included as a random effect independent of residual error. An initial linear mixed model (LMM) will be fit u
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Quality-of-Life Assessment
- DRUG Placebo Administration
- PROCEDURE Dual X-ray Absorptiometry
- DIETARY_SUPPLEMENT D Vitamin
Study Locations (20)
Illinois
- Carle at The Riverfront - Danville
- Cancer Care Specialists of Illinois - Decatur - Decatur
- Carle Physician Group-Effingham - Effingham
- Carle Physician Group-Mattoon/Charleston - Mattoon
- Cancer Care Center of O'Fallon - O'Fallon
- Carle Cancer Center - Urbana
Minnesota
- Mercy Hospital - Coon Rapids
- Minnesota Oncology Hematology PA-Maplewood - Maplewood
- Saint John's Hospital - Healtheast - Maplewood
- Park Nicollet Clinic - Saint Louis Park - Saint Louis Park
- Regions Hospital - Saint Paul
Kansas
- University of Kansas Cancer Center - Kansas City
- University of Kansas Cancer Center-Overland Park - Overland Park
- University of Kansas Health System Saint Francis Campus - Topeka
- University of Kansas Hospital-Westwood Cancer Center - Westwood
Louisiana
- Louisiana State University Health Science Center - New Orleans
- University Medical Center New Orleans - New Orleans
- Ochsner Medical Center Jefferson - New Orleans
Delaware
- Helen F Graham Cancer Center - Newark
- Medical Oncology Hematology Consultants PA - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2023-12-14 |
| Est. Completion | 2029-04-29 |
| Phase | Phase 3 |
What NCT05838716 shows while recruiting
NCT05838716 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 241-participant average among 28 other Stage III Prostate Cancer AJCC v8 trials with a reported enrollment target.
The record links to 4 conditions, with Stage III Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05838716 names 20 study sites across 5 states, led by Illinois, Minnesota, Kansas.
Frequently Asked Questions
What is clinical trial NCT05838716 about?
NCT05838716 is a clinical study titled "Vitamin D for Prostate Endocrine Therapy". This phase III trial tests whether high-dose vitamin D works in treating androgen-deprivation therapy (ADT)-induced bone loss in patients with prostate cancer who are undergoing androgen-deprivation therapy. Vitamins are substances that the body needs to grow and develop normally. Vitamin D helps th...
What is the current status of trial NCT05838716?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 240 participants. The study started on 2023-12-14. Estimated completion is 2029-04-29.
What conditions does trial NCT05838716 study?
This clinical trial studies the following conditions: Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8.
What interventions are being tested in trial NCT05838716?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Quality-of-Life Assessment (OTHER), Placebo Administration (DRUG), Dual X-ray Absorptiometry (PROCEDURE), D Vitamin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05838716?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05838716 being conducted?
This trial has 20 study locations across Delaware, Illinois, Kansas, Louisiana, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Prostate Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05838716's enrollment target sits among peer trials
240 4th of 28 higher than 25 of 28 other Stage III Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Prostate Cancer AJCC v8 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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