RecruitingStage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage III Prostate Cancer AJCC v8

Vitamin D for Prostate Endocrine Therapy

Eligible age

50+ yrs

Accepts

Men

Locations

14 states

Healthy volunteers

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About this 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.

Sponsor: University of Rochester

You may qualify if…

✓ 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

You may not qualify if…

✕ 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