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Vitamin D for Prostate Endocrine Therapy
High-dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients
Who can join
Ages 50 and older · Men
Full eligibility criteria
Inclusion 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 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 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
About the study
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.
What is being tested
- Biospecimen Collection (procedure)
- D Vitamin (dietary supplement)
- Dual X-ray Absorptiometry (procedure)
- Placebo Administration (drug)
- Quality-of-Life Assessment (other)
- Questionnaire Administration (other)
Sponsor: University of Rochester · Participants: 240 · Started: Dec 14, 2023
Contact the study team
Official record on ClinicalTrials.gov — NCT05838716
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.