Vitamin D for Prostate Endocrine Therapy
Recruiting · NCT05838716 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Rochester
View the official record on ClinicalTrials.gov →Interventions studied
Biospecimen CollectionD VitaminDual X-ray AbsorptiometryPlacebo AdministrationQuality-of-Life AssessmentQuestionnaire Administration
What this trial is about
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.
Who can take part
Age range
50 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed)
- Be age 50 years or older
- Be starting ADT or have received their first ADT treatment in the past 6 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \[LHRH\] antagonists and LHRH agonists are permitted)
- Have a total serum vitamin D between 10 and 32 ng/ml
- Have a total serum calcium of less than or equal to 10.5 mg/dl
- Have a normal GFR (glomerular filtration rate \> 30ml)
- Agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided by the study
- Be able to provide written informed consent
- Be able to swallow pills and capsules
- Be able to speak and read English
Exclusion criteria
- Have long term (greater than 3 months) use of any pharmacologic bone-modifying agent including but not limited to oral or intravenous (IV) bisphosphonates, denosumab, or teriparatide prior to enrollment
- Have a diagnosis of stage IV chronic kidney disease
- Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg/dl)
- Have a history of hypercalcemia or vitamin D toxicity/sensitivity
Where it is running
51 locations listed across 14 US states.
- 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