Vitamin D for Prostate Endocrine Therapy

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8

In brief

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.

Key facts

Study ID

NCT05838716

Run by

University of Rochester

People needed

240

Starts

2023-12-14

Expected to finish

2029-04-29

Last updated by the study team

2026-01-15

Who can join

Age: 50 and older. Sex: male. Healthy volunteers: not accepted.

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
• Be able to swallow pills and capsules
• Be able to speak and read English

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

Where it is running

• Medical Oncology Hematology Consultants PA — Newark, Delaware, United States (enrolling)
• Carle at The Riverfront — Danville, Illinois, United States (enrolling)
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States (enrolling)
• Carle Physician Group-Effingham — Effingham, Illinois, United States (enrolling)
• Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States (enrolling)
• Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States (enrolling)
• Carle Cancer Center — Urbana, Illinois, United States (enrolling)
• University of Kansas Cancer Center — Kansas City, Kansas, United States (enrolling)
• University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States (enrolling)
• University of Kansas Health System Saint Francis Campus — Topeka, Kansas, United States (enrolling)
• University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States (enrolling)
• Louisiana State University Health Science Center — New Orleans, Louisiana, United States (enrolling)
• University Medical Center New Orleans — New Orleans, Louisiana, United States (enrolling)
• Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States (enrolling)
• Mercy Hospital — Coon Rapids, Minnesota, United States (enrolling)
• Minnesota Oncology Hematology PA-Maplewood — Maplewood, Minnesota, United States (enrolling)
• Saint John's Hospital - Healtheast — Maplewood, Minnesota, United States (enrolling)
• Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States (enrolling)
• Regions Hospital — Saint Paul, Minnesota, United States (enrolling)
• Ridgeview Medical Center — Waconia, Minnesota, United States (enrolling)
• University of Kansas Cancer Center - North — Kansas City, Missouri, United States (enrolling)
• University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States (enrolling)
• Mercy Hospital Saint Louis — St Louis, Missouri, United States (enrolling)
• OptumCare Cancer Care at Charleston — Las Vegas, Nevada, United States (enrolling)
• Helen F Graham Cancer Center — Newark, Delaware, United States (enrolling)

Full record on ClinicalTrials.gov

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