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RECRUITING Phase 3

Vitamin D for Prostate Endocrine Therapy

NCT05838716 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 240 participants
Start Date 2023-12-14
Est. Completion 2029-04-29
Phase Phase 3

Sponsor

University of Rochester

437 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05838716

The ClinicalTrials.gov registry entry for NCT05838716 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 437 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05838716 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Illinois, Minnesota, Kansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05838716?

This trial is sponsored by University of Rochester, which has 437 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial