Vitamin D for Prostate Endocrine Therapy
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.
- Condition
- Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
- Tested
- Biospecimen Collection, D Vitamin, Dual X-ray Absorptiometry, Placebo Administration, Quality-of-Life Assessment, Questi...
- Sponsor
- University of Rochester
Who can join
- Age
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 13
- Minimum age: 50 years
- Eligible sex: Male
- Study condition: Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8, Stage IVA Prostate Cancer AJCC v8
- 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 4
- 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
51 sites, 51 recruiting
Ballad Health Cancer Care - Bristol
Bristol, Virginia, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Geisinger Cancer Center Dickson City
Dickson City, Pennsylvania, United States
and 45 more sites on ClinicalTrials.gov
Potential match only. Final eligibility is determined by the study team.