NCT05838716RecruitingPhase 3
Vitamin D for Prostate Endocrine Therapy
High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
Source: ClinicalTrials.gov · Last updated 15 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 20 Apr 2023
- Start date
- 14 Dec 2023
- Primary completion date
- 29 Apr 2029
- Lead sponsor
- University of Rochester
- Diseases
- Prostate cancer
- NCT number
- NCT05838716
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 240
- From 14 Dec 2023 to the primary completion date, 29 Apr 2029
- 51 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Have a diagnosis of stage IV chronic kidney disease
- Have a history of hypercalcemia or vitamin D toxicity/sensitivity
Lab values
- Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg/dl)
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: Male · Does not accept healthy volunteers
Sites (51)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ballad Health Cancer Care - Bristol Coordinator of this site? Confirm its status | Bristol | United States | Recruiting |
| Adena Regional Medical Center Coordinator of this site? Confirm its status | Chillicothe | United States | Recruiting |
| Mercy Hospital Coordinator of this site? Confirm its status | Coon Rapids | United States | Recruiting |
| Carle at The Riverfront Coordinator of this site? Confirm its status | Danville | United States | Recruiting |
| Cancer Care Specialists of Illinois - Decatur Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| Geisinger Cancer Center Dickson City Coordinator of this site? Confirm its status | Dickson City | United States | Recruiting |
| Carle Physician Group-Effingham Coordinator of this site? Confirm its status | Effingham | United States | Recruiting |
| Gibbs Cancer Center-Gaffney Coordinator of this site? Confirm its status | Gaffney | United States | Recruiting |
| Saint Vincent Hospital Cancer Center at Saint Mary's Coordinator of this site? Confirm its status | Green Bay | United States | Recruiting |
| Saint Vincent Hospital Cancer Center Green Bay Coordinator of this site? Confirm its status | Green Bay | United States | Recruiting |
| Saint Francis Cancer Center Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Saint Francis Hospital Coordinator of this site? Confirm its status | Greenville | United States | Recruiting |
| Gibbs Cancer Center-Pelham Coordinator of this site? Confirm its status | Greer | United States | Recruiting |
| Regional Cancer Center at Johnson City Medical Center Coordinator of this site? Confirm its status | Johnson City | United States | Recruiting |
| University of Kansas Cancer Center Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| University of Kansas Cancer Center - North Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
| Ballad Health Cancer Care - Kingsport Coordinator of this site? Confirm its status | Kingsport | United States | Recruiting |
| Gundersen Lutheran Medical Center Coordinator of this site? Confirm its status | La Crosse | United States | Recruiting |
| OptumCare Cancer Care at Charleston Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| University of Kansas Cancer Center - Lee's Summit Coordinator of this site? Confirm its status | Lee's Summit | United States | Recruiting |
| Saint John's Hospital - Healtheast Coordinator of this site? Confirm its status | Maplewood | United States | Recruiting |
| Minnesota Oncology Hematology PA-Maplewood Coordinator of this site? Confirm its status | Maplewood | United States | Recruiting |
| Carle Physician Group-Mattoon/Charleston Coordinator of this site? Confirm its status | Mattoon | United States | Recruiting |
| Bon Secours Memorial Regional Medical Center Coordinator of this site? Confirm its status | Mechanicsville | United States | Recruiting |
| Bon Secours Saint Francis Medical Center Coordinator of this site? Confirm its status | Midlothian | United States | Recruiting |
| Helen F Graham Cancer Center Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| Medical Oncology Hematology Consultants PA Coordinator of this site? Confirm its status | Newark | United States | Recruiting |
| CarolinaEast Medical Center Coordinator of this site? Confirm its status | New Bern | United States | Recruiting |
| Ochsner Medical Center Jefferson Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| University Medical Center New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Louisiana State University Health Science Center Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Cancer Care Center of O'Fallon Coordinator of this site? Confirm its status | O'Fallon | United States | Recruiting |
| University of Kansas Cancer Center-Overland Park Coordinator of this site? Confirm its status | Overland Park | United States | Recruiting |
| Bon Secours Saint Mary's Hospital Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Bon Secours Cancer Institute at Reynolds Crossing Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| VCU Massey Comprehensive Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| VCU Massey Cancer Center at Stony Point Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| Carilion Roanoke Memorial Hospital Coordinator of this site? Confirm its status | Roanoke | United States | Recruiting |
| Nash UNC HealthCare Coordinator of this site? Confirm its status | Rocky Mount | United States | Recruiting |
| Park Nicollet Clinic - Saint Louis Park Coordinator of this site? Confirm its status | Saint Louis Park | United States | Recruiting |
| Regions Hospital Coordinator of this site? Confirm its status | Saint Paul | United States | Recruiting |
| Community Medical Center Coordinator of this site? Confirm its status | Scranton | United States | Recruiting |
| Spartanburg Medical Center Coordinator of this site? Confirm its status | Spartanburg | United States | Recruiting |
| Mercy Hospital Saint Louis Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay Coordinator of this site? Confirm its status | Sturgeon Bay | United States | Recruiting |
| University of Kansas Health System Saint Francis Campus Coordinator of this site? Confirm its status | Topeka | United States | Recruiting |
| SMC Center for Hematology Oncology Union Coordinator of this site? Confirm its status | Union | United States | Recruiting |
| Carle Cancer Center Coordinator of this site? Confirm its status | Urbana | United States | Recruiting |
| Ridgeview Medical Center Coordinator of this site? Confirm its status | Waconia | United States | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center Coordinator of this site? Confirm its status | Westwood | United States | Recruiting |
| Geisinger Wyoming Valley/Henry Cancer Center Coordinator of this site? Confirm its status | Wilkes-Barre | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.