Actively Recruiting
Vitamin D for Prostate Endocrine Therapy
Led by University of Rochester · Updated on 2026-01-15
240
Participants Needed
51
Research Sites
280 weeks
Total Duration
On this page
Sponsors
U
University of Rochester
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Vitamin D for Prostate Endocrine Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Stage I-IV prostate cancer without bone metastases (lymph node involvement and prior primary cancer allowed)
- Age 50 years or older
- Starting ADT or received first ADT treatment within past 6 months, with at least 6 months planned treatment
- Total serum vitamin D between 10 and 32 ng/ml
- Total serum calcium less than or equal to 10.5 mg/dl
- Normal kidney function with glomerular filtration rate over 30 ml
- Agree not to take calcium or vitamin D supplements other than study-provided during intervention
- Able to provide written informed consent
- Able to swallow pills or capsules
- Able to speak and read English
You will not qualify if you...
- Long-term use (over 3 months) of bone-modifying drugs such as bisphosphonates, denosumab, or teriparatide before enrollment
- Diagnosis of stage IV chronic kidney disease
- Diagnosis of grade II or greater hypercalcemia (serum calcium over 11.5 mg/dl)
- History of hypercalcemia or vitamin D toxicity or sensitivity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 51 locations
1
Helen F Graham Cancer Center
Newark, Delaware, United States, 19713
Actively Recruiting
2
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States, 19713
Actively Recruiting
3
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
4
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States, 62526
Actively Recruiting
5
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
6
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
7
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States, 62269
Actively Recruiting
8
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
9
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
10
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
11
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States, 66606
Actively Recruiting
12
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
13
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
14
University Medical Center New Orleans
New Orleans, Louisiana, United States, 70112
Actively Recruiting
15
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States, 70121
Actively Recruiting
16
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
17
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Actively Recruiting
18
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Actively Recruiting
19
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
20
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
21
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Actively Recruiting
22
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
23
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
24
Mercy Hospital Saint Louis
St Louis, Missouri, United States, 63141
Actively Recruiting
25
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States, 89102
Actively Recruiting
26
CarolinaEast Medical Center
New Bern, North Carolina, United States, 28561
Actively Recruiting
27
Nash UNC HealthCare
Rocky Mount, North Carolina, United States, 27804
Actively Recruiting
28
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Actively Recruiting
29
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States, 18519
Actively Recruiting
30
Community Medical Center
Scranton, Pennsylvania, United States, 18510
Actively Recruiting
31
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States, 18711
Actively Recruiting
32
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States, 29341
Actively Recruiting
33
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Actively Recruiting
34
Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Actively Recruiting
35
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Actively Recruiting
36
Spartanburg Medical Center
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
37
SMC Center for Hematology Oncology Union
Union, South Carolina, United States, 29379
Actively Recruiting
38
Regional Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, United States, 37604
Actively Recruiting
39
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, United States, 37660
Actively Recruiting
40
Ballad Health Cancer Care - Bristol
Bristol, Virginia, United States, 24201
Actively Recruiting
41
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, United States, 23116
Actively Recruiting
42
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, United States, 23114
Actively Recruiting
43
Bon Secours Saint Mary's Hospital
Richmond, Virginia, United States, 23226
Actively Recruiting
44
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, United States, 23230
Actively Recruiting
45
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States, 23235
Actively Recruiting
46
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
47
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24033
Actively Recruiting
48
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States, 54301
Actively Recruiting
49
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States, 54303
Actively Recruiting
50
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
51
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235-1495
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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