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.

Key Inclusion Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.

• 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

Key Exclusion Criteria

A patient will not be eligible for this trial if any of the following criteria apply.

• 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