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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
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

Full criteria on ClinicalTrials.gov

Sites (51)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ballad Health Cancer Care - Bristol
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BristolUnited StatesRecruiting
Adena Regional Medical Center
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ChillicotheUnited StatesRecruiting
Mercy Hospital
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Coon RapidsUnited StatesRecruiting
Carle at The Riverfront
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DanvilleUnited StatesRecruiting
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesRecruiting
Geisinger Cancer Center Dickson City
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Dickson CityUnited StatesRecruiting
Carle Physician Group-Effingham
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EffinghamUnited StatesRecruiting
Gibbs Cancer Center-Gaffney
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GaffneyUnited StatesRecruiting
Saint Vincent Hospital Cancer Center at Saint Mary's
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Green BayUnited StatesRecruiting
Saint Vincent Hospital Cancer Center Green Bay
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Green BayUnited StatesRecruiting
Saint Francis Cancer Center
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GreenvilleUnited StatesRecruiting
Saint Francis Hospital
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GreenvilleUnited StatesRecruiting
Gibbs Cancer Center-Pelham
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GreerUnited StatesRecruiting
Regional Cancer Center at Johnson City Medical Center
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Johnson CityUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - North
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Kansas CityUnited StatesRecruiting
Ballad Health Cancer Care - Kingsport
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KingsportUnited StatesRecruiting
Gundersen Lutheran Medical Center
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La CrosseUnited StatesRecruiting
OptumCare Cancer Care at Charleston
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Las VegasUnited StatesRecruiting
University of Kansas Cancer Center - Lee's Summit
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Lee's SummitUnited StatesRecruiting
Saint John's Hospital - Healtheast
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MaplewoodUnited StatesRecruiting
Minnesota Oncology Hematology PA-Maplewood
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MaplewoodUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesRecruiting
Bon Secours Memorial Regional Medical Center
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MechanicsvilleUnited StatesRecruiting
Bon Secours Saint Francis Medical Center
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MidlothianUnited StatesRecruiting
Helen F Graham Cancer Center
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NewarkUnited StatesRecruiting
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesRecruiting
CarolinaEast Medical Center
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New BernUnited StatesRecruiting
Ochsner Medical Center Jefferson
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New OrleansUnited StatesRecruiting
University Medical Center New Orleans
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New OrleansUnited StatesRecruiting
Louisiana State University Health Science Center
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New OrleansUnited StatesRecruiting
Cancer Care Center of O'Fallon
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O'FallonUnited StatesRecruiting
University of Kansas Cancer Center-Overland Park
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Overland ParkUnited StatesRecruiting
Bon Secours Saint Mary's Hospital
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RichmondUnited StatesRecruiting
Bon Secours Cancer Institute at Reynolds Crossing
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RichmondUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
VCU Massey Cancer Center at Stony Point
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RichmondUnited StatesRecruiting
Carilion Roanoke Memorial Hospital
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RoanokeUnited StatesRecruiting
Nash UNC HealthCare
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Rocky MountUnited StatesRecruiting
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesRecruiting
Regions Hospital
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Saint PaulUnited StatesRecruiting
Community Medical Center
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ScrantonUnited StatesRecruiting
Spartanburg Medical Center
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SpartanburgUnited StatesRecruiting
Mercy Hospital Saint Louis
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St LouisUnited StatesRecruiting
Saint Vincent Hospital Cancer Center at Sturgeon Bay
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Sturgeon BayUnited StatesRecruiting
University of Kansas Health System Saint Francis Campus
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TopekaUnited StatesRecruiting
SMC Center for Hematology Oncology Union
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UnionUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
Ridgeview Medical Center
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WaconiaUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
Geisinger Wyoming Valley/Henry Cancer Center
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Wilkes-BarreUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.