RECRUITING

High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

Talk to us

Conditions

Stage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients

Quick Facts

Study Start:2023-12-14
Study Completion:2032-07-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05838716

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be diagnosed with Stage I-IV prostate cancer without metastases to bone (lymph node involvement and prior diagnosis of a primary cancer is allowed)
  2. * Be age 60 years or older
  3. * Be starting ADT or have received their first ADT treatment in the past 3 months, with a total of at least 6 planned months of treatment (both luteinizing hormone-releasing hormone \[LHRH\] antagonists and LHRH agonists are permitted)
  4. * Have a total serum vitamin D between 10 and 27 ng/ml
  5. * Have a total serum calcium of less than or equal to 10.5 mg/dl
  6. * Have a normal GFR (glomerular filtration rate \> 30ml)
  7. * Agree not to take calcium and/or vitamin D supplements for the duration of the intervention other than those provided by the study
  8. * Be able to provide written informed consent
  9. * Be able to swallow pills and capsules
  10. * Be able to speak and read English
  1. * 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
  2. * Have a diagnosis of stage IV chronic kidney disease
  3. * Have a diagnosis of grade II or greater hypercalcemia (serum calcium greater than 11.5 mg/dl)
  4. * Have a history of hypercalcemia or vitamin D toxicity/sensitivity

Contacts and Locations

Study Contact

Brooke Burgess, MS
CONTACT
585-274-2346
URCC_22053@urmc.rochester.edu

Principal Investigator

Luke J Peppone, PhD
PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base

Study Locations (Sites)

Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
Carle Cancer Center
Urbana, Illinois, 61801
United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, 66210
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, 66205
United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
University of Kansas Cancer Center - North
Kansas City, Missouri, 64154
United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
United States
CarolinaEast Medical Center
New Bern, North Carolina, 28561
United States
Nash UNC HealthCare
Rocky Mount, North Carolina, 27804
United States
Community Medical Center
Scranton, Pennsylvania, 18510
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341
United States
Saint Francis Hospital
Greenville, South Carolina, 29601
United States
Saint Francis Cancer Center
Greenville, South Carolina, 29607
United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651
United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303
United States
SMC Center for Hematology Oncology Union
Union, South Carolina, 29379
United States
Regional Cancer Center at Johnson City Medical Center
Johnson City, Tennessee, 37604
United States
Ballad Health Cancer Care - Kingsport
Kingsport, Tennessee, 37660
United States
Ballad Health Cancer Care - Bristol
Bristol, Virginia, 24201
United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia, 23116
United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia, 23114
United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia, 23226
United States
Bon Secours Cancer Institute at Reynolds Crossing
Richmond, Virginia, 23230
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24033
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235-1495
United States

Collaborators and Investigators

Sponsor: University of Rochester NCORP Research Base

  • Luke J Peppone, PhD, PRINCIPAL_INVESTIGATOR, University of Rochester NCORP Research Base

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-14
Study Completion Date2032-07-29

Study Record Updates

Study Start Date2023-12-14
Study Completion Date2032-07-29

Terms related to this study

Additional Relevant MeSH Terms

  • Stage I Prostate Cancer AJCC v8
  • Stage II Prostate Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8
  • Stage IVA Prostate Cancer AJCC v8