Actively Recruiting

Phase 3
Age: 50Years +
MALE
NCT05838716

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

Age: 50Years +
MALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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Vitamin D for Prostate Endocrine Therapy | DecenTrialz