High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients (URCC-22053)

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 researcher determine if high-dose vitamin D helps keep bones strong, lowers number of falls, and lessens fatigue in men getting androgen-deprivation therapy.

  • 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 at least 6 planned months of treatment remaining (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 an total serum calcium of less than or equal to 10.5 mg/dl
  • Have a normal GFR (glomerular filtration rate)
  • 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 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 10.5 mg/dl)
  • Have a history of hypercalcemia or vitamin D toxicity/sensitivity

Sponsor(s)

University of Rochester NCORP Research Base

Learn More

To learn more, visit ClinicalTrials.Gov

Locations

Gibbs Cancer Center
2759 Hwy 14 South
Greer, SC 29650


St. Francis Cancer Center
104 Innovation Dr.
Greenville, SC 29607