RecruitingPhase 3NCT05838716

Vitamin D for Prostate Endocrine Therapy

High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients


Sponsor

University of Rochester

Enrollment

240 participants

Start Date

Dec 14, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether vitamin D supplements can help reduce the side effects of androgen deprivation therapy (ADT) — a hormone-blocking treatment for prostate cancer. ADT can cause bone thinning, muscle loss, and fatigue, and low vitamin D levels may make these worse. **You may be eligible if...** - You have been diagnosed with Stage I to IV prostate cancer that has not spread to bone - You are 50 years or older - You are starting ADT or began it within the past 6 months, with at least 6 months of treatment planned - Your vitamin D levels are currently low (between 10 and 32 ng/mL) **You may NOT be eligible if...** - Your cancer has already spread to the bones - Your vitamin D levels are already in the normal range - You have conditions that interfere with calcium or vitamin D metabolism (such as certain kidney or parathyroid disorders) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo collection of blood

DIETARY_SUPPLEMENTD Vitamin

Given PO

PROCEDUREDual X-ray Absorptiometry

Undergo DXA scan

DRUGPlacebo Administration

Given PO

OTHERQuality-of-Life Assessment

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies


Locations(51)

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

University of Kansas Cancer Center - North

Kansas City, Missouri, United States

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

CarolinaEast Medical Center

New Bern, North Carolina, United States

Nash UNC HealthCare

Rocky Mount, North Carolina, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

Geisinger Cancer Center Dickson City

Dickson City, Pennsylvania, United States

Community Medical Center

Scranton, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

Saint Francis Hospital

Greenville, South Carolina, United States

Saint Francis Cancer Center

Greenville, South Carolina, United States

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Spartanburg Medical Center

Spartanburg, South Carolina, United States

SMC Center for Hematology Oncology Union

Union, South Carolina, United States

Regional Cancer Center at Johnson City Medical Center

Johnson City, Tennessee, United States

Ballad Health Cancer Care - Kingsport

Kingsport, Tennessee, United States

Ballad Health Cancer Care - Bristol

Bristol, Virginia, United States

Bon Secours Memorial Regional Medical Center

Mechanicsville, Virginia, United States

Bon Secours Saint Francis Medical Center

Midlothian, Virginia, United States

Bon Secours Saint Mary's Hospital

Richmond, Virginia, United States

Bon Secours Cancer Institute at Reynolds Crossing

Richmond, Virginia, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, United States

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, United States

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NCT05838716


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