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โ† Trials
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Vitamin D for Prostate Endocrine Therapy

RecruitingPhase 3Ages 50 Years - anyMaleUniversity of Rochester
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Biospecimen Collection
  • D Vitamin
  • Dual X-ray Absorptiometry
  • Placebo Administration
  • Quality-of-Life Assessment
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Where

51 sites
Helen F Graham Cancer Center
Newark, United States
Medical Oncology Hematology Consultants PA
Newark, United States
Carle at The Riverfront
Danville, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, United States
Carle Physician Group-Effingham
Effingham, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, United States
Cancer Care Center of O'Fallon
O'Fallon, United States
Carle Cancer Center
Urbana, United States

โ€ฆand 43 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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