RECRUITING

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

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.

Conditions

Stage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8Stage IVA Prostate Cancer AJCC v8
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Related Conditions:

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

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Stage I Prostate Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Newark

Helen F Graham Cancer Center, Newark, Delaware, United States, 19713

Newark

Medical Oncology Hematology Consultants PA, Newark, Delaware, United States, 19713

Danville

Carle at The Riverfront, Danville, Illinois, United States, 61832

Decatur

Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States, 62526

Effingham

Carle Physician Group-Effingham, Effingham, Illinois, United States, 62401

Mattoon

Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States, 61938

O'Fallon

Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States, 62269

Urbana

Carle Cancer Center, Urbana, Illinois, United States, 61801

Kansas City

University of Kansas Cancer Center, Kansas City, Kansas, United States, 66160

Overland Park

University of Kansas Cancer Center-Overland Park, Overland Park, Kansas, United States, 66210

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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 60 years or older
  • * 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)
  • * Have a total serum vitamin D between 10 and 27 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
  • * 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

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester NCORP Research Base,

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

Study Record Dates

2032-07-29