Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
240 participants
INTERVENTIONAL
2023-12-14
2029-04-29
Brief Summary
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Detailed Description
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I. To evaluate the effect of high-dose vitamin D (HDVD) supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the total hip over 52 weeks as measured by dual-energy x-ray absorptiometry (DXA).
II. To evaluate the effect of HDVD supplementation in prostate cancer patients on ADT-induced bone mineral density loss in the femoral neck, distal radius, and lumbar spine (L1-L4) over 52 weeks as measured by DXA.
SECONDARY OBJECTIVES:
I. To evaluate the effect of HDVD supplementation on falls over 52 weeks as measured by the Falls History questionnaire.
II. To evaluate the effect of HDVD supplementation on fractures over 52 weeks as determined by the Clinical Record Information - Follow-up Form.
III. To evaluate the effect of HDVD supplementation on quality of life over 52 weeks as measured by the Functional Assessment of Cancer Therapy- Prostate (FACT-P).
EXPLORATORY OBJECTIVE:
I. To evaluate the effect of HDVD supplementation on pain, fatigue, sleep, and activities of daily living over 52 weeks as measured by patient-reported outcomes.
OUTLINE: After undergoing collection of blood and DXA scan, patients are randomized to 1 of 2 arms.
ARM I: Patients receive HDVD orally (PO) once a week (QW) for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
ARM II: Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Arm I (HDVD)
Patients receive HDVD PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
Biospecimen Collection
Undergo collection of blood
D Vitamin
Given PO
Dual X-ray Absorptiometry
Undergo DXA scan
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (placebo)
Patients receive placebo PO QW for 52 weeks. Patients also undergo collection of blood and DXA scan on study.
Biospecimen Collection
Undergo collection of blood
Dual X-ray Absorptiometry
Undergo DXA scan
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Rochester
OTHER
Responsible Party
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Luke Peppone
URCC Study Chair
Principal Investigators
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Luke J Peppone
Role: PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base
Locations
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Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Carle Physician Group-Effingham
Effingham, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
University of Kansas Cancer Center - North
Kansas City, Missouri, United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States
CarolinaEast Medical Center
New Bern, North Carolina, United States
Nash UNC HealthCare
Rocky Mount, North Carolina, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States
Community Medical Center
Scranton, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States
Saint Francis Hospital
Greenville, South Carolina, United States
Saint Francis Cancer Center
Greenville, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
SMC Center for Hematology Oncology Union
Union, South Carolina, United States
Regional Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, United States
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, United States
Ballad Health Cancer Care - Bristol
Bristol, Virginia, United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Countries
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Facility Contacts
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Site Public Contact
Role: primary
Site Public Contact
Role: primary
Site Public Contact
Role: primary
Other Identifiers
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NCI-2022-07664
Identifier Type: REGISTRY
Identifier Source: secondary_id
URCC-22053
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-22053
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-22053
Identifier Type: OTHER
Identifier Source: secondary_id
URCC-22053
Identifier Type: -
Identifier Source: org_study_id
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