Recruiting
Phase 3

Vitamin D

Sponsor:

University of Rochester

Code:

NCT05838716

Conditions

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Stage IVA Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

D Vitamin

Dual X-ray Absorptiometry

Placebo Administration

Quality-of-Life Assessment

Study Details

Brief summary:

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

Stage I Prostate Cancer AJCC v8

Stage II Prostate Cancer AJCC v8

Stage III Prostate Cancer AJCC v8

Stage IVA Prostate Cancer AJCC v8

Study ID

NCT05838716

Start date

Dec 14, 2023

Status verified date

Jan, 2026

Completion date

Apr 29, 2029

Anticipated

Primary completion date

Apr 29, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (HDVD)

Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.

placebo comparator: Arm II (placebo)

Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.

Interventions

Biospecimen Collection

Undergo collection of blood

D Vitamin

Given PO

Dual X-ray Absorptiometry

Undergo DXA scan

Placebo Administration

Given PO

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Reduction of bone mineral density (BMD) loss as measured at the total hip [ Time Frame: At 52 weeks ]
  • Reduction of BMD loss as measured at the femoral neck [ Time Frame: At 52 weeks ]
  • Reduction of BMD loss as measured at the distal radius [ Time Frame: At 52 weeks ]
  • Reduction of BMD loss as measured at the lumbar spine [ Time Frame: At 52 weeks ]

Central Contacts and Locations

Locations

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Vamsi K. Vasireddy

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Vamsi K. Vasireddy

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Vamsi K. Vasireddy

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Vamsi K. Vasireddy

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Elizabeth M. Wulff

University of Kansas Cancer Center-Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Elizabeth M. Wulff

University of Kansas Health System Saint Francis Campus

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Site Public Contact

785-295-8000KUCC_Navigation@kumc.edu

Principal Investigator:

Elizabeth M. Wulff

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Elizabeth M. Wulff

Louisiana State University Health Science Center

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Rajasree P. Chowdry

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Site Public Contact

504-210-3539emede1@lsuhsc.edu

Principal Investigator:

Rajasree P. Chowdry

Ochsner Medical Center Jefferson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Site Public Contact

504-842-8084Elisemarie.curry@ochsner.org

Principal Investigator:

Brian T. Halbert

Mercy Hospital

Recruiting

Coon Rapids, Minnesota, United States, 55433

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Minnesota Oncology Hematology PA-Maplewood

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Saint John's Hospital - Healtheast

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Regions Hospital

Recruiting

Saint Paul, Minnesota, United States, 55101

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

Ridgeview Medical Center

Recruiting

Waconia, Minnesota, United States, 55387

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Sarah E. Jax

University of Kansas Cancer Center - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Elizabeth M. Wulff

University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Elizabeth M. Wulff

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

OptumCare Cancer Care at Charleston

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

Khawaja S. Jahangir

CarolinaEast Medical Center

Recruiting

New Bern, North Carolina, United States, 28561

Contacts

Site Public Contact

252-634-6589lharrison@carolinaeasthealth.com

Principal Investigator:

Seth M. Miller

Nash UNC HealthCare

Recruiting

Rocky Mount, North Carolina, United States, 27804

Contacts

Site Public Contact

252-952-8000

Principal Investigator:

Elie B. Choufani

Adena Regional Medical Center

Recruiting

Chillicothe, Ohio, United States, 45601

Contacts

Site Public Contact

877-779-7585Jeffh@columbusccop.org

Principal Investigator:

Aruna C. Gowda

Geisinger Cancer Center Dickson City

Recruiting

Dickson City, Pennsylvania, United States, 18519

Contacts

Site Public Contact

877-204-6081hemoncctrials@geisinger.edu

Principal Investigator:

Heath B. Mackley

Community Medical Center

Recruiting

Scranton, Pennsylvania, United States, 18510

Contacts

Site Public Contact

570-703-4768HemonCCTrials@geisinger.edu

Principal Investigator:

Heath B. Mackley

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Heath B. Mackley

Gibbs Cancer Center-Gaffney

Recruiting

Gaffney, South Carolina, United States, 29341

Contacts

Site Public Contact

864-560-6104kmertz-rivera@gibbscc.org

Principal Investigator:

Michael Humeniuk

Saint Francis Hospital

Recruiting

Greenville, South Carolina, United States, 29601

Contacts

Site Public Contact

864-603-6234Heather_Rich@bshsi.org

Principal Investigator:

Stephen H. Dyar

Saint Francis Cancer Center

Recruiting

Greenville, South Carolina, United States, 29607

Contacts

Site Public Contact

864-603-6234Heather_Rich@bshsi.org

Principal Investigator:

Stephen H. Dyar

Gibbs Cancer Center-Pelham

Recruiting

Greer, South Carolina, United States, 29651

Contacts

Site Public Contact

864-560-6104kmertz-rivera@gibbscc.org

Principal Investigator:

Michael Humeniuk

Spartanburg Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

Site Public Contact

864-560-6104kmertz-rivera@gibbscc.org

Principal Investigator:

Michael Humeniuk

SMC Center for Hematology Oncology Union

Recruiting

Union, South Carolina, United States, 29379

Contacts

Site Public Contact

864-560-6104kmertz-rivera@gibbscc.org

Principal Investigator:

Michael Humeniuk

Regional Cancer Center at Johnson City Medical Center

Recruiting

Johnson City, Tennessee, United States, 37604

Contacts

Site Public Contact

423-431-5654charles.mays@balladhealth.org

Principal Investigator:

Asheesh Shipstone

Ballad Health Cancer Care - Kingsport

Recruiting

Kingsport, Tennessee, United States, 37660

Contacts

Site Public Contact

423-431-5654charles.mays@balladhealth.org

Principal Investigator:

Asheesh Shipstone

Ballad Health Cancer Care - Bristol

Recruiting

Bristol, Virginia, United States, 24201

Contacts

Site Public Contact

423-431-5654charles.mays@balladhealth.org

Principal Investigator:

Asheesh Shipstone

Bon Secours Memorial Regional Medical Center

Recruiting

Mechanicsville, Virginia, United States, 23116

Contacts

Site Public Contact

804-893-8978anne_carmellat@bshsi.org

Principal Investigator:

William J. Irvin

Bon Secours Saint Francis Medical Center

Recruiting

Midlothian, Virginia, United States, 23114

Contacts

Site Public Contact

804-893-8978anne_carmellat@bshsi.org

Principal Investigator:

William J. Irvin

Bon Secours Saint Mary's Hospital

Recruiting

Richmond, Virginia, United States, 23226

Contacts

Site Public Contact

804-893-8978anne_carmellat@bshsi.org

Principal Investigator:

William J. Irvin

Bon Secours Cancer Institute at Reynolds Crossing

Recruiting

Richmond, Virginia, United States, 23230

Contacts

Site Public Contact

804-893-8978Anne_caramella@bshsi.org

Principal Investigator:

William J. Irvin

VCU Massey Cancer Center at Stony Point

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Site Public Contact

ctoclinops@vcu.edu

Principal Investigator:

Asit K. Paul

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430CTOclinops@vcu.edu

Principal Investigator:

Asit K. Paul

Carilion Roanoke Memorial Hospital

Recruiting

Roanoke, Virginia, United States, 24033

Contacts

Site Public Contact

540-981-7377

Principal Investigator:

Asit K. Paul

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Site Public Contact

920-433-8889WI_research_admin@hshs.org

Principal Investigator:

Brian L. Burnette

Saint Vincent Hospital Cancer Center at Saint Mary's

Recruiting

Green Bay, Wisconsin, United States, 54303

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Brian L. Burnette

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Site Public Contact

608-775-2385cancerctr@gundersenhealth.org

Principal Investigator:

Kurt Oettel

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Recruiting

Sturgeon Bay, Wisconsin, United States, 54235-1495

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Brian L. Burnette

More Information

Sponsor

University of Rochester

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Rochester on 2026-01-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.