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RECRUITING
NCT05838716
PHASE3

Vitamin D for Prostate Endocrine Therapy

Sponsor: University of Rochester

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2023-12-14

Completion Date

2029-04-29

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo collection of blood

DIETARY_SUPPLEMENT

D Vitamin

Given PO

PROCEDURE

Dual X-ray Absorptiometry

Undergo DXA scan

DRUG

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire 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